Sollers College

Category: Clinical Research

  • From MBBS to Clinical Research: A Step-by-Step Guide for International Medical Graduates (IMGs)

    From MBBS to Clinical Research: A Step-by-Step Guide for International Medical Graduates (IMGs)

    Introduction The U.S. healthcare and pharmaceutical industries are rapidly expanding, particularly in clinical research. This surge presents an incredible opportunity for International Medical Graduates (IMGs) with MBBS degrees to transition into roles like Clinical Research Associate (CRA), Clinical Trial Coordinator, or Drug Safety Associate.

    If you’re preparing for USMLE, have ECFMG certification, or are exploring parallel career paths in healthcare, clinical research provides a meaningful and well-compensated option.

    Why Consider Clinical Research After MBBS?

    • Exploding Market: The global clinical trials market is projected to surpass $84.43 billion by 2030, reflecting a steady increase in demand for trained professionals. (Source: Grand View Research)
    • Attractive Compensation: Entry-level clinical research roles start at competitive salaries and offer quick upward mobility.
    • Relevance of Clinical Background: Your experience in patient care, understanding of medical terminology, and familiarity with pharmacology make you a prime candidate for research roles.

    Step-by-Step Pathway for IMGs to Enter Clinical Research

    Step 1: Define Your Career Objectives Decide whether your focus is clinical practice in the U.S. through USMLE or an alternative healthcare pathway like clinical research. If you’re leaning toward research, proceed with a focused approach.

    Step 2: Choose a Clinical Research Certification Program Enroll in a specialized clinical research course for healthcare professionals. Look for these core topics:

    • Good Clinical Practice (ICH-GCP)
    • Clinical Trial Protocols & Phases
    • FDA & EMA Guidelines
    • Ethics & Informed Consent Process
    • CRA/CRC Duties and Responsibilities

    Recommended Certifications:

    • ACRP Certified Clinical Research Associate (CCRA)
    • SOCRA Certified Clinical Research Professional (CCRP)
    • Postgraduate Certificate in Clinical Research (available via institutions or online platforms)

    Step 3: Acquire Practical Exposure Many hiring managers look for hands-on experience. Aim for:

    • Internships in Contract Research Organizations (CROs)
    • Volunteer roles in clinical trial sites or hospitals
    • Remote internships offered by certification programs

    Step 4: Customize Your U.S.-Ready Resume Emphasize:

    • Your MBBS degree and ECFMG status (if applicable)
    • Clinical rotations or hospital experience
    • Clinical research training or certifications
    • Key soft skills: detail orientation, ethics, analytical mindset

    Step 5: Start with Entry-Level Jobs Ideal positions to kick-start your journey:

    • Clinical Research Coordinator (CRC)
    • Clinical Trial Assistant (CTA)
    • Pharmacovigilance Associate / Drug Safety Specialist

    These roles often evolve into CRA or Clinical Project Manager positions within a few years.

    Expected Salary Range in the U.S.

    • Clinical Research Coordinator (CRC): $50,000–$70,000
    • Clinical Research Associate (CRA): $75,000–$120,000
    • Senior CRA / Project Manager: $100,000–$140,000+

    (Source: Payscale, Glassdoor, ClinicalTrials.gov job listings)

    Pro Tips for Success

    • Network: Connect with professionals via LinkedIn, alumni groups, and conferences like DIA Global.
    • Stay Updated: Follow regulatory changes from the FDA, EMA, and ICH.
    • Interview Preparation: Practice scenario-based questions and familiarize yourself with real clinical trial documents.

    Conclusion A career in clinical research offers IMGs a strategic and rewarding alternative to traditional clinical practice in the U.S. With the right training, certifications, and experience, your medical background becomes a powerful asset in this growing field.

    Whether you aim to become a CRA, a safety specialist, or a research coordinator, now is the right time to take the first step.

  • Why Clinical Trial Management Is One of the Fastest Growing Careers in the U.S. Healthcare Industry

    Why Clinical Trial Management Is One of the Fastest Growing Careers in the U.S. Healthcare Industry

    Introduction

    The U.S. healthcare system is undergoing a data and innovation-driven transformation—and at the heart of this revolution is Clinical Trial Management (CTM). With over 430,000 clinical trials registered globally (as per ClinicalTrials.gov), the demand for professionals who can manage these trials is at an all-time high.

    If you’re from a life sciences or medical background—whether you’re a B.Sc., M.Sc., MBBS, or a foreign medical graduate—this field offers not just lucrative salaries, but also a high-impact career improving human health on a global scale.

    Why Clinical Trial Management is Booming in the U.S.

    1. Explosive Growth in Clinical Research

    According to Grand View Research, the U.S. Clinical Trials Market was valued at over $23 billion in 2022 and is expected to grow significantly through 2030. This growth is driven by:

    • Rise in chronic and rare diseases
    • Need for personalized medicine
    • Acceleration of biotech and pharmaceutical R&D post-COVID-19

    2. Talent Shortage = More Opportunities

    There’s a significant shortage of skilled clinical research professionals, especially in roles like:

    • Clinical Trial Manager
    • Clinical Research Associate (CRA)
    • Clinical Data Coordinator
    • Site Manager

    More than 70% of organizations report delays in trial timelines due to staffing gaps
     Source: ACRP Workforce Survey, 2023

    What Does a Clinical Trial Manager Do?

    A Clinical Trial Manager (CTM) oversees the planning, execution, and monitoring of clinical trials. Their responsibilities include:

    • Coordinating with CROs and sponsors
    • Ensuring regulatory and ethical compliance
    • Managing budgets and timelines
    • Overseeing site selection, monitoring, and data collection

    CTM Salary in the USA

    Average salary for a Clinical Trial Manager in the U.S.:
    $110,000 to $145,000/year (can go higher with experience and certifications)

    Source: Glassdoor – CTM Salaries

    Who Can Transition into CTM Roles?

    Ideal Backgrounds:

    • B.Sc. or M.Sc. in Life Sciences (Biotech, Microbiology, Pharmacology, etc.)
    • MBBS and foreign-trained medical professionals
    • Pharm.D / B.Pharm / M.Pharm graduates

    Your clinical exposure, understanding of human anatomy, and scientific mindset provide a perfect foundation for clinical research roles.

    How to Enter Clinical Research or CTM Roles

    1. Enroll in a CTM-focused Program

    Look for industry-aligned programs that cover:

    • GCP (Good Clinical Practice)
    • ICH Guidelines
    • Trial Protocol Design
    • Regulatory Affairs
    • Site Management

    2. Gain Practical Exposure

    Hands-on experience with trial simulations, EDC tools like Medidata or Oracle Clinical, and remote/internship experience can help build a strong profile.

    3. Get Certified

    Popular certifications:

    • CCRA (Certified Clinical Research Associate)
    • CCRP (Certified Clinical Research Professional)
    • GCP Certification (Free on NIH or TransCelerate sites)

    Career Path in CTM

    Here’s a typical progression: Clinical Research Coordinator (CRC) → Clinical Research Associate (CRA) → Senior CRA → Clinical Trial Manager (CTM) → Director of Clinical Operations

    Final Thoughts

    Clinical Trial Management offers a rewarding, high-paying, and globally respected career path—especially for those with a strong background in science or medicine. With the increasing need for safe, efficient drug development, the clinical research sector is recession-proof, scalable, and future-ready.

    Sollers College offers comprehensive, hands-on Clinical Trial Management programs that are industry-certified, flexible, and career-oriented. Whether you’re transitioning from medicine or biology, we’ll help you get job-ready.

  • In what ways have health professionals played a vital role in drug testing?

    In what ways have health professionals played a vital role in drug testing?

    Medical professionals are essential to drug testing, helping from the very beginning to the point of approval. Their participation guarantees clinical trials‘ efficacy, safety, and moral conduct.

    The following are some significant ways that medical professionals are essential to drug testing:

    Designing clinical trials and developing protocols:

    • The clinical trial structure is designed with input from medical researchers and physicians, who also set important factors like dose, treatment plans, and participant inclusion and exclusion standards.
    • They guarantee participant welfare and data integrity by ensuring the study methods comply with legal and ethical requirements.

    Participant sourcing and screening:

    • Based on the trial’s inclusion criteria, doctors and nurses find qualified volunteers.
    • They gather comprehensive medical histories and perform preliminary health screens to make sure participants are qualified and to set baseline health indicators.

    Process for Verified Acceptance:

    • Medical staff must inform new participants about the trial’s goals, protocols, dangers, and rewards.
    • They secure informed permission, guaranteeing that subjects are aware of the experiment and willingly choose to take part.

    Delivering experimental medical care:

    • Clinicians follow the trial procedure when administering investigational medications.
    • They keep a careful eye on participants’ side effects and therapeutic results, guaranteeing precise and reliable treatment delivery.

    Surveillance and information gathering:

    • Medical staff monitors and documents participant health, treatment responses, and adverse effects during the experiment.
    • They collect extensive data by doing routine lab testing, physical examinations, and other evaluations.

    Controlling contrary occurrences:

    • When negative occurrences or side effects arise throughout the trial, medical staff is prepared to recognize them, record them, and handle them.
    • They decide if a participant should continue in the trial and administer any necessary medical treatment.

    Guaranteeing adherence and transparency:

    • Medical professionals ensure that the protocol is authorized and that regulations are followed when conducting the trial.
    • For regulatory assessment and clearance, they uphold complete and correct documentation.

    Interpretation and Analysis of Data:

    • To ascertain the medication’s safety and effectiveness, researchers and clinicians examine the data gathered.
    • Their knowledge is essential for deciphering the data and appreciating the findings’ therapeutic importance.

    Participant involvement and responsible surveillance:

    • Clinical trial oversight is carried out by ethics committees composed of medical professionals.
    • They support the rights and welfare of participants, making sure that clinical trials are carried out morally and that subjects receive considerate treatment.

    Regulatory Filings and Follow-Up After Trial:

    • Medical researchers gather data from the trial and provide comprehensive reports to regulatory agencies.
    • Additionally, they might conduct post-trial follow-ups to keep an eye on the medication’s long-term effects and provide participants with ongoing care if needed.

    In conclusion, medical professionals play a critical role in the effective conduct of pharmacological studies. Their knowledge and moral dedication guarantee that novel medications are thoroughly examined, with participant safety and scientific integrity given priority.

  • Why Autonomous Clinical Trials are the Best Chance of Success?

    Why Autonomous Clinical Trials are the Best Chance of Success?

    An autonomous clinical trial: what is it?

    • The terms virtual, home, remote, and siteless are some of the terms used to characterize the idea of autonomous trials. Whatever name the organization decides to use, the objective remains the same: easing patient participation in clinical trials by minimizing or doing away with the need for travel to designated locations.
    • Autonomous does not entail carrying out clinical trials without the presence of medical experts. The need for direct patient interaction is eliminated, and the process is also made more efficient. Instead, it focuses on areas where sponsors and CROs can adopt a hybrid approach to clinical research by utilizing technology and other cutting-edge solutions.
    • Individuals are aware that cutting down on the time and expense needed to enroll in clinical trials helps reduce participant burden while increasing efficiency and retention rates. The decentralized system could be viewed as the pinnacle of a patient-centered clinical trial design strategy.
    • It is noteworthy that there is a spectrum of autonomous trials. Even if implementing a completely autonomous model in which patients never have to visit a clinical site isn’t feasible, adding some virtual or at-home components.
    • There will be more home-based trials as technology develops and more clinical trials successfully incorporate autonomous components; participant expectations will rise in parallel.

    The principal advantages of autonomous clinical studies

    The main objective of autonomous clinical trials is to facilitate clinical trial participation as much as possible so that participants can carry on with their daily lives with as few gaps as possible.

    STUDIES AND PROSPECTS OF AUTONOMOUS CLINICAL TRIALS

    Many prospective trial participants will be maintaining full-time positions, managing health conditions, and raising families. In such a situation, it may not only be difficult but also impossible to require patients to attend site visits, which entail hours of travel and accumulated costs.

    Clinical trial development could significantly improve through fully autonomous trials in various ways, such as:

    • Simplifying the process of finding potential volunteers will expedite the patient recruitment process. If participation was simpler, more patients would be able and willing to participate, which would ease the pressure on sponsors and CROs to find participants.
    • Improving participant diversity by allowing patients to be recruited from a larger pool as opposed to just those who live close to a participating site. This is particularly advantageous for research on rare diseases, as clinical trials frequently involve the same small number of participants.
    • Because technology allows for greater autonomy, patients become more informed, knowledgeable, and involved. Numerous studies indicate that patients who are actively involved in their care perform tasks like keeping electronic diaries more accurately and truthfully. Additionally, electronic records can be automated and validated when needed.
    • Collecting more varied and useful data sets through real-time remote patient monitoring.
    • Additionally, gathering data in an authentic environment is likely to yield insights devoid of the prejudice that arises from completing evaluations in a medical setting.
    • Better data reliability and accuracy: Gathering data with wearables, apps, and smartphones keeps data organized and secure.
    • Standardized data collection and sharing are made possible by technological advancements, making results analysis, and reporting easier.

    As far as the autonomous trial is concerned, three fundamental principles must be followed:

    Technology that is simple to use and intuitive to learn should be used for accessibility. When patients can access technology on devices, they already own and are familiar with, and when it fits seamlessly into their daily routines, clinical trials benefit greatly from its use.

    Keep things as easy as possible for patients. Should the tasks assigned to them be excessively intricate, this can lead to tension and compromise the accuracy of outcomes due to increased opportunities for mistakes.

    Ensure that your processes and tools have undergone extensive testing and that you are aware of any potential hazards that need to be mitigated. This is all part of maintaining reliability. Use patient input to make continuous improvements as the trial goes on.

    Imagine a setting where groundbreaking medical research has the potential to transform healthcare delivery and improve people’s health. Soller’s clinical research management certificate and clinical trial management courses, along with clinical trial management training, serve the dual purpose of clinical research to learn and to heal.

    The need for qualified clinical researchers is growing in the US. As medicine advances, there will be a greater need for qualified professionals who can comprehend complex clinical data.

  • How Adaptive AI Boosts Clinical Trials Today?

    How Adaptive AI Boosts Clinical Trials Today?

    By 2024, adaptive AI is expected to continue gaining popularity worldwide and be swiftly embraced by additional sectors of the economy. However, despite its immense promise, adoption has been hampered for many by a lack of knowledge about the intricacies and capabilities of AI.

    Adaptive AI is expected to have the most influence in the healthcare and life sciences sectors.

    Synthetic data—high-fidelity data produced by algorithms that preserve patient privacy—is one of the most significant applications that life sciences can use today. There are innumerable uses for synthetic data.

    Enhancing the Design of Protocols

    • Organizations may make better decisions more quickly by enhancing protocol design with synthetic data and generative predictive modeling.
    • The trial can be shorter and more likely to succeed. Simulating outcomes for different patient subpopulations based on previous trials in similar medication classes can allow organizations to modify the parameters of a particular study and anticipate patient outcomes.
    • Using adaptive AI to design more flexible and resilient clinical trial protocols can result in safer and more effective trials, which in turn increases the chances of a trial’s
    • Data integrity can be improved by computational modeling and simulated data.
    • The utilization of synthetic datasets can expedite the decision-making process and enhance the overall efficacy of clinical trials.

    Adding to the data

    • Adding extra data to already existing clinical trial datasets can improve their balance and boost the generalization and resilience of the model.
    • Organizations can un-sample underrepresented groups in their trials and provide a more complete and varied representation of the actual circumstances by adding digital datasets to their current data.
    • Using this method enables researchers to create evidence that more accurately represents the whole demographic environment and to construct enhanced treatments.
    • By addressing the limits of skewed participant demographics, companies can achieve more general applicability, stronger conclusions, and improved validity.
    • Pharma companies can gain crucial insights from their current trial data by using synthetic data instead of expending money to locate the ideal settings and patients. 

    Navigating Previous Security Data Challenges

    • Cross-sponsor historical clinical trial data sharing has historically been hampered due to privacy issues.
    • In each clinical study, trial data is one of the most useful sources of information, but sharing this data can be extremely difficult due to the need to protect patient privacy. Patients are typically reluctant—and understandably so—to divulge personal health information.
    • Artificial intelligence in healthcare settings has already been generating attention from early adopters and executives, who emphasize strong privacy measures and procedures.
    • Numerous issues about patient privacy and data integrity can potentially be resolved with the use of synthetic datasets. These files maintain the integrity of the clinical trial dataset while guaranteeing patient privacy and protecting their data.
    • The application of adaptive AI in the pharmaceutical and healthcare sectors is still in its infancy, but despite many doubts and concerns, it is already showing promise as a tool that can help patients and businesses alike by addressing their main problems.

    Even though adaptive AI hasn’t been fully adopted yet, its prospective economic benefits seem promising. However, this can only happen after more AI tools designed specifically for the healthcare industry are developed.

  • A Pharmaceutical Industry’s Role in Clinical Trial Improvement?

    A Pharmaceutical Industry’s Role in Clinical Trial Improvement?

    The rush to create a vaccine has brought attention to the process of bringing a medication to market like never before, making it a good opportunity to look at several typical clinical trial bottlenecks.

    The drive to quickly develop a vaccine in record time should concentrate attention on common bottlenecks in the clinical trial process, as well as steps that the life sciences industry could take to reduce those bottlenecks and speed up the process for other drug candidates.

    One of the primary challenges faced by companies engaged in clinical trials is finding thousands of eligible participants to enroll to gather sufficient data necessary for FDA regulatory approval.

    Clinical trial sites, such as doctor’s offices, long-term care homes, and rehabilitation centers, can be integrated into the community to alleviate part of this bottleneck. It would be much easier for trial sponsors to access the patients needed for a particular trial and much more convenient for patients, to participate if there was an exam room, doctors, nurses, and researchers on-site.

    This is related to patient access in that trial sponsors must screen participants and determine whether patients meet the trial’s inclusion and exclusion criteria. The process of screening patients is often labor-intensive, manual, and slow. It involves making phone calls, leaving messages, setting up in-person meetings, and conducting screening interviews, all of which add time and cost to the process of developing new drugs.

    More clinical research organizations and pharmaceutical companies are using artificial intelligence for patient screening to address the problems. AI tools are used to guide patients through sessions based on the trial’s inclusion and exclusion criteria after they respond to trial advertisements. The AI program arranges for the patient to visit the study’s location to have additional discussions with clinicians if the patient is pre-qualified.

    There is a concerning lack of knowledge about clinical trials among the public, not to mention when and how patients can benefit from trials.  Sponsors and CROs should think about organizing public education events in the areas where clinical trials are being conducted to increase public knowledge of these studies.

    Many smaller medical practices lack the necessary infrastructure, such as staff members who are trained on informed consent and working with research ethics. To overcome these barriers, sponsors, and CROs can bring the tools and expertise needed to support community physician engagement.

    One must incorporate sizable sample sizes from a wide range of racial backgrounds because racial and ethnic differences greatly influence how individuals respond to medications. Hopefully, by raising awareness among patient populations and physician organizations, the diversity of patients’ racial and ethnic backgrounds will eventually show up. There are many ways that the clinical trial process could be improved, it’s important to keep in mind that trials frequently give patients access to treatments that could change their lives but which they would not otherwise have. The pandemic has brought to light the importance of streamlining the clinical trial procedure for the sake of human health in the future.

  • Health Computing innovations in pharmacovigilance?

    Health Computing innovations in pharmacovigilance?

    Pharmacovigilance is the research and practices associated with the identification, evaluation, comprehension, and avoidance of side effects and other medication-related issues. As it assists in tracking adverse effects (AE), adverse drug reactions (ADR), and any other safety problems missed during clinical trials, it is a crucial part of the post-marketing monitoring program for pharmaceuticals and medical devices.

    Pharmacovigilance efforts provide vital safety data that helps identify any new and previously unknown dangers as well as information regarding the advantages and disadvantages of the drug in a variety of patient populations.

    Underreporting is prevalent, and it is easy to overlook crucial safety information even though most businesses use pharmacovigilance activities and have multiple systems in place.

    Data is gathered for the FDA Adverse Event Reporting Systems (FAERS) database, which is then used by the FDA to make decisions about new warning labels, withdrawal/limited use of the product in the market, and reporting by sponsors and manufacturers. These systems are part of the FDA’s voluntary reporting systems for pharmacovigilance, used by the World Health Organization (WHO).

    Pharmacovigilance is a vital aspect of the therapeutic process yet it is often overlooked by sponsors, patient advocacy organizations, and pharmaceutical companies.

    Underreporting, misreporting, missing information, and inconsistencies in safety data are widespread due to voluntary and non-standard entry into systems. If sophisticated analytical approaches aren’t used, it might be challenging to analyze trends and patterns from a vast amount of data and come to relevant conclusions. Health computing innovations facilitate the gathering and analysis of safety data and adverse events, making them valuable tools for enhancing pharmacovigilance.

    Innovations in health computing make use of software, sensors, networking, and computer platforms for medical purposes. These consist of wearable technology, telehealth and telemedicine, mobile medical apps (mHealth), artificial intelligence (AI), and machine learning (ML).

    Pharmacovigilance can benefit from health computing in two key manners

    Wearable gadgets for data collection

    Health computing wearables such as smartphones, smartwatches, fitness trackers, and mobile apps are characterized by innovations in real-time data gathering and monitoring that enable the early detection, identification, and classification of adverse occurrences. This makes it possible for producers and regulatory bodies to act quickly to reduce any possible concerns.

    Social media and internet platforms

    Patients and caregivers provide information and safety concerns to online communities and social media platforms, which act as a valuable archive. The fact that patient-provided data is directly inputted and can be used to spot patterns in safety information about specific medication classes and medical equipment makes it significant.

    Electronic health records are a valuable source of information for identifying adverse drug reactions and for facilitating cross-functional information exchange with a network of healthcare providers, facilitating the tracking and correction of safety information. EHRs have more complete data that can be useful in comprehensively analyzing adverse events. Examples of this data include the time of medication administration, the development of symptoms, and a detailed clinical history.

    Telehealth identifies and promptly communicates safety issues of patients, telehealth platforms that allow for remote visits and patient monitoring instead of in-person consultations are essential. This approach, which can be connected with EHRs, enables doctors to recognize adverse occurrences and make the necessary adjustments, such as stopping a prescription or changing the dosage.

    Machine learning (ML) and artificial intelligence (AI) for analyzing data are used to sift through vast amounts of data produced by wearables and analyze them to find patterns and trends in safety data. AI enables signal detection to extract information about possible adverse drug occurrences and processing of pharmacovigilance data.

    On data gathered from social media sites, data mining and prediction employing AI and ML are also conducted. They also aid in the creation of predictive models.

    Data integration enables the combination and analysis of data from many sources, such as AI and cloud computing, which are extremely beneficial to the field of pharmacovigilance. These technologies are also essential for maintaining data security and privacy.

    NLP allows the extraction of structured safety and adverse event data from text-based documents, including social media platforms, electronic health records, and narrative reviews.

    Big data analytics is crucial for deriving algorithms on safety issues. This data is helpful for real-world evidence studies.

    The use of health informatics is crucial for efficient pharmacovigilance. It enables the accurate management of large amounts of data, making it easier for regulatory bodies to identify safety information and safeguard patient health.

  • What strategies can pharma companies use to accelerate drug development?

    What strategies can pharma companies use to accelerate drug development?

    Clinical trial efficiency may be enhanced by artificial intelligence (AI) enabled systems that enhance patient and location acquisition. Three Strategies Artificial Intelligence Can Enhance Clinical Research Advancements.

    AI can increase clinical trial diversity. 

    The population’s lack of access to basic medical treatment is alarming. The patient population encounters noteworthy obstacles when it comes to engaging in clinical trials, primarily transportation, time, and financial constraints to trial locations.

    Clinical trials can also result in a partial or skewed understanding of the safety and effectiveness of drugs in certain populations, which could have detrimental effects on the general public’s health.

    To solve these problems, significant efforts must be made to guarantee that clinical trials are inclusive and representative of the diverse patient population, as well as to expand access to healthcare for marginalized communities.

    Researchers and physicians must consider the influence of genetic variation on medication metabolism and treatment results. This is because varying patient populations may require customized doses and treatment regimens. A high-quality healthcare system for all patients is reflected in clinical research.

    Numerous clinical trials study initiations were postponed, and remote monitoring became more prevalent. Many industry stakeholders are pushing for the continued use of digital technology to reach a wider range of patients.

    Clinical trials are becoming more diverse and decentralized with the help of AI-enabled technology.

    Listed below are some instances. 

    • AI-powered patient IDs based on clinical characteristics quickly find possible subjects for clinical and observational research.
    • Remote patient monitoring using AI capabilities decreases the frequency of visits to the trial site, which increases participant retention while gathering objective, real-world health data.
    • Collaboration powered by AI improves clinical data exchange and reduces the time to diagnosis by gathering and analyzing vast amounts of data from hospital hubs and spoke networks.

    AI can boost monitoring accuracy and speed.

    • Most research teams employ manual techniques in the screening process for clinical trial volunteers, which increases the likelihood of human error and delays the process.
    • The challenge of reaching this goal is exacerbated by the tremendous problems sponsors have been having persuading their usual research sites to take part in clinical trials. This is partially explained by the growing need for clinical trials.
    • Efficiency in recruiting participants for clinical trials can be increased by using AI to perform real-time automated eligibility checks.

    AI has the potential to bridge the gaps between clinical care and trial research.

    • Artificial Intelligence is expediting the per-screening of clinical trial candidates by automating the analysis of hospital imaging at sites and referral facilities.

    Once a candidate has been found, AI software can use a communication system to spread their information. Subsequently, the enrollment procedure can be optimized and made more efficient.

  • How to Launch Your Career in Clinical Research?

    How to Launch Your Career in Clinical Research?

    CRAs who wish to advance their careers might wonder where to begin if they have some experience in clinical research. There may be a possibility of speeding your job up for ambitious and dedicated CRAs.

    You can advance your career in clinical research in three ways.

    Get benefits from CRO training programs

    When seeking a new position at a large clinical research organization (CRO) or seeking on-the-job training, don’t overlook these opportunities for career advancement. While many CROs provide mandatory training to their CRAs, additional, optional courses can help promote activity.

    Sollers is one of the prominent colleges in the US. It is committed to CRA career development and provides education and training through its learning platform. 

    This form of self-directed professional development can help you advance clinical research to more senior positions.

    Talking to someone who has already risen to a more senior position as a CRA is one of the most excellent methods to determine how to take the next step in your career as a CRA. It will be a project manager or line manager who has worked as a CRA before in most circumstances.

    Look for a Mentor

    A mentor may be a great resource in assisting you in realizing your professional development objectives and laying out the measures required to attain them. They may frequently propose particular areas where you should focus your efforts to develop new information and abilities and alert you to upcoming advancement chances.

    Mentors may also help you manage your short- and long-term career goals for planned career paths as clinical research specialists.

    Clinical researchers come from a variety of professions, including nursing and pharmacology. By understanding what your prior responsibilities assist you to contribute to your career as a CRA, you may celebrate and use your unique experience.

    It may have been your previous experience volunteering in hospitals that sparked your interest in clinical research. If you served as a clinical research coordinator (CRC) at a site, you may have seen how crucial organisation is to managing patients and supporting the trial.

    Utilize Your Unique Experience

    Regardless of what you performed before becoming a CRA, your previous experiences will undoubtedly influence how you approach clinical research. 

    As CRAs develop in their careers, those who can appreciate the significance of their particular history will have a more significant opportunity of applying those lessons to their present and future jobs.

    Contact us to understand how managers at a top CRO recognize high-potential professionals if you’re eager to advance your career as a CRA.

  • Benefits of Predictive Analysis in Healthcare Industry

    Benefits of Predictive Analysis in Healthcare Industry

    Almost all of the time, the healthcare business is under pressure to achieve greater results than previously. Doctors, nurses, workers, and others must be precise at all times. They are intended to be error-free, but we all know that is impossible.

    Both knowledge and experience have limits. However, artificial intelligence and machine learning in the clinical field (Clinical Data Science) may support and assist the healthcare business in being one step ahead of the competition at all times.

    Hospitals can improve their business operations and employee management. In the healthcare industry, predictive analytics assists clinicians in being proactive rather than reactive when a problem happens. The goal is to avoid or avert the catastrophe rather than to mitigate the harm after it occurs.

    Predictive Analytics:

    Artificial intelligence, machine learning, and the Internet of Things (IoT) can improve medical treatment and empower medical teams to provide extraordinary performance, which sounds exciting. But what is predictive analytics, exactly?

    As the name implies, predictive analytics is a field of advanced analytics that analyses previous data to anticipate future occurrences. To evaluate this past data and develop future insights, AI services, deep learning, machine learning algorithms, data mining, and statistical modeling are employed. For data processing and extraction, unstructured data is organized in an easy-to-understand manner.

    Choosing an Appropriate Location for New Clinics and Hospitals

    It takes a lot of effort to open a new clinic or medical institution. The first step is to choose the ideal location for the business. If management makes a mistake here, it might have ramifications throughout the company, resulting in losses. Predictive analytics may assist management in assessing potential sites based on a variety of characteristics. 

    Predictive analytics in healthcare can show you the benefits and drawbacks of opening a clinic in a specific area by looking at how rivals are performing and examining the site’s accessibility (among other factors).

    Improving Business Operations for Efficient Hospital Administration

    Hospital administration is possibly the most difficult of all. Even minor blunders and misunderstandings might result in life-threatening scenarios. Using sophisticated technology, however, is conceivable. Patients, hospitals, and insurance companies are working together to process claims and minimize issues thanks to predictive analytics in healthcare insurance.

    Identifying the Correct Target Audiences for Clinic Promotion

    As previously said, marketing the clinic is equally as crucial as providing high-quality treatments. The first step is to figure out who your target audiences are. 

    Healthcare firms use predictive analytics to rethink their marketing tactics to target families and audiences that are more likely to respond to commercials.

    Understanding Opportunities For The market growth

    In healthcare, real-time predictive analytics should not be confined to assisting doctors and experts. For a hospital or clinic to be successful, it must do far more than hire professionals. 

    It’s equally as crucial to promoting the healthcare center. How will people know they may go to your physicians for better treatment for their ailments?

    To provide the finest possible services, you must understand market trends, know which areas to invest in, how much to spend in, and how to maximize resource utilization. A certificate course in Clinical Data Science will help to achieve your career goals. 

  • A Complete Overview of CTMS Software

    A Complete Overview of CTMS Software

    A Complete Overview of CTMS Software

    The Clinical Trial Management System is a suite of tools for planning, managing, and tracking clinical studies. It is a complete project management tool that takes the Clinical research team from start to finish.

    Feature of Clinical Trial Management Software:

    The CTMS is a set of eClinical technologies that function best when they all work together:

    Access to current study information

    Access to accurate and up-to-date trial information was difficult for our team when working directly for sponsors and CROs. For example, an updated site roster was challenging to get, as were startup monitoring and site visit schedules. This wasted ample time. To accomplish their work and make sound judgments, the research team needs a CTMS solution.

    Collaboration

    The CTMS is a fantastic location for research team members to collaborate (e.g., sponsor, CROs, sites). Team members can work together on single research activity as a study launch, knowing they’re all using the newest data. Sponsors, CROs, sites, and other suppliers can also work together to keep research monitoring data current.

    Efficiency

    The CTMS helps your busy research team organize, track, and monitor the study efficiently. It can automatically check that you have finished the relevant parts (Word can’t do that). It may produce site payment tracking records based on your contracts when topic visits are finished.

    Oversight 

    The CTMS gives transparency to research launch, screening & enrollment, document collecting, site visits, monitoring reports, subject visit completion, action items, and issue management, among other components. Dashboards and data reports visualize and score one study or several research.

    CTMS and CC

    Considerations for CTMS Compliance, including support for 21 CFR Part 11:

    Traceable

    To track any data changes made in the system, the CTMS should have a comprehensive audit trail of who made what modifications.

    Archive Policy

    When records are removed from the CTMS, the data should be archived rather than deleted. Data that has been preserved may usually be retrieved quickly, but data that has been erased cannot. Data erasure attempts, whether negligent or malicious, are protected by archiving.

    E-Signature

    The CTMS should support electronic signatures for records needed by your study’s requirements. The CTMS planning and tracking are primarily for the study’s efficiency and efficacy rather than for regulatory purposes (e.g., the study project plan with target vs. actual milestone dates). eTMF, document management, and electronic visit reports, on the other hand, are all critical and should allow for e-signing.

    Account Admin

    The CTMS should need user authorization and authentication, including password expiration, idle session expiration, and account lockout control.

    Choosing the CTMS

    To help you choose the best clinical trial management software for your needs, here are some typical factors to consider:

    Feature Group

    Is there a must-have feature or study management pain point?

    Customization

    Custom field picklists, custom tracking fields, and even custom planning and tracking views are all possible with the CTMS (an alternative to building out another spreadsheet tracker).

    Utilities

    Do you need a system that works right away?

    Validation & Assurance

    Including regulated data such as site necessary papers and electronic visit reports in the CTMS?.

    Support

    The study management system must provide a clinical study help desk. Do you want your CTMS supplier to deliver professional services and client management?

    Cost

    If so, you want a solution that can scale up and down with you. Is there a setup fee? Is a multi-year contract required? Is there anything you can do now to prepare for future services?

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  • A New Collaboration to Advance Data Sharing in Clinical Research

    A New Collaboration to Advance Data Sharing in Clinical Research

    As clinical research experts, the importance of patient-donated data. Clinical trials may be time-consuming and even burdensome for patients, many organizations are trying to make the best use of their data.

    Although there is a lot of emphasis on integrating real-world data in medication research, clinical trial data is clean, vetted, and of high quality. Historical trial data, in my opinion, are the most valuable untapped resource in our sector.

    Biopharmaceutical firms are beginning to respond to requests from organizations such as the World Health Organization, the National Institutes of Health, the G7, and patient advocacy groups to extensively share patient-donated data. Clinical researchers are eager to make the required adjustments, but we aren’t used to such sharing in non-competitive settings. Furthermore, we may not have the internal resources or mechanisms in place to facilitate data exchange.

    To address these issues, a group of like-minded colleagues from biopharma, contract research companies, technology partners, data sharing platforms, and academic institutions formed the Clinical Research Data Sharing Alliance early this year (CRDSA). CRDSA was established as a collaborative platform for all parties to solve the logistical challenges of exchanging clinical trial data.

    CRDSA will focus on data privacy, data standards, and researcher education to increase both the quantity and value of data provided for secondary research.

    Consider a future in which we can enrol significantly fewer patients in control groups because we have enough secondary data to build a “synthetic” arm. Alternatively, we know ahead of time how many patients from various racial/ethnic groups we need to recruit since we used pooled trial data to predetermine the sub-groups. These future possibilities will necessitate regulatory policy improvements; we must invite regulators along for the ride to decide how synthetic or enhanced control arms can be acceptable for a registrational research. The CRDSA will establish the united, multi stakeholder voice required to effectively advocate for real policy change.

    The public interest is widely regarded as being served by the responsible dissemination of clinical trial data. Data sharing maximises clinical trial participants’ contributions to scientific knowledge, helping patients now and in the future. Sharing clinical trial data can allow for the replication of research findings, analysis for different fields of study, and exploratory work to create new research concepts. While there has been progress in the effort to improve clinical trial data exchange, obstacles persist.

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  • Risks and Benefits of Clinical Trials

    Risks and Benefits of Clinical Trials

    Clinical research has grown to be one of the primary components these days. It is a notable field of study which assists in providing advanced medical treatments and cures.Clinical trials are a necessary study tool for developing medical expertise and patient care.

    This transformation can make it difficult for a patient to want to join in a clinical trial.Researchers don’t know what the consequences of clinical trials will be. Clinical trials are essential for discovering diseases and the latest ways to detect, diagnose, and reduce the disease’s possibility of improving. 

    Clinical trials are conducted to consolidate relevant data to find new drugs for curing or restricting diseases. This data also supports industry and regulators in making meaningful choices about the safety and effectiveness of the disease or preventative medicines being studied. Clinical research project sponsors typically provide critical project constraints such as quality assurance to Contract Research Organizations or CROs.

    What is the Requirement for Quality Assurance (QA) in clinical trials?

    • Quality assurance in clinical trials ensures that globally received Good Clinical Practice (GCP) standards are followed to achieve the tests reasonably and collect high-quality data.
    • CROs help project sponsors with the protocol’s design, project monitoring, report evaluation, and project documentation to be sent to the regulatory authorities for approval.
    •  The clinical research data has to be good enough for verification during audits and inspections by regulatory organizations.
    • The regulations are stringent for clinical research. India has some of the most trusted clinical research duties offering superior quality assurance in clinical trials. 

    What are the Benefits of a Clinical Trial?

    • You may get a new strategy for a disease before it is ready for everyone.
    • You may have the opportunity to support others to get better treatment for their health problems in the future.

    Potential Risks of a Clinical Trial

    • The new medicine may produce severe side consequences or be difficult.
    • The new treatment may not work, or it may not be greater than the standard treatment.
    • You may NOT be part of the practice group that makes the new treatment. 
    • The clinical trial could inconvenience you.

    Along with the numerous advantages, clinical trials also comprise various risks. Let’s have a look at those:

    • It requires more regular visits to the lab than non-clinical trials.
    • Doctors can ask to linger at the hospital for close monitoring.
    • There might be some acute side effects of the trial process that can be life-threatening.
    • The exercise might work for any, but there are indications that it won’t work for a few people.

    Conclusion

    Clinical research in the US is improving with the help of the latest technologies, government facilities, and improved regulations/frameworks. Clinical research has cleared up many productive jobs and business possibilities in Clinical Operations, CDM, Medical writingsPharmacovigilance.

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  • How to Improve Clinical Trial Recruitment?

    How to Improve Clinical Trial Recruitment?

    Clinical trials are necessary for medical research. Producing new medicines to the market depends on the strength of research organizations and drug companies to test and verify their work vigorously through their Clinical Trials, but finding people willing to participate is notoriously tricky.

    Researchers rely on a constant stream of volunteers to test and validate their outcomes. Recruiting patients for clinical trials is difficult. The latest survey from Clinical Trials Transformation Initiative (CTTI) recorded that protocol-related and clinician-related effects are essential obstacles to recruitment; yet, patient-related blocks also majorly affect the success or failure of clinical enrolment. Limitations include patient perceptions and information about clinical trials, lack of awareness about possibilities to participate in studies, concerns about placebos, travel time, and trial-related expenses.

    Streamline patient testing with the point of care testing devices

    The accumulation of too much data or additional trial methods can lead to more persistent study visits and anticipate streamlining of study design. When addressing the study protocol, firms should recognize the potential influence of selecting medical equipment on patient enrolment and retention.

    Use social media and mobile platforms.

    How patients discover clinical trials has transformed over the years. Before, patients received about practices via media, mail, and their HCPs. Thanks to social media and smartphones, communication is much more direct today. Social media platforms like Twitter and Facebook have made it comparatively easy to recruit patients for clinical trials. Clinical trial sponsors and CROs have nudged up to the power of social media in reaching ‘e-patients.’

    Address patient concerns

    Misunderstandings about clinical trials are amongst the fundamental reasons patients miss chances to be handled within research settings. By building an effort to reach out to patients with available information, companies can dismiss these fears. 

    In producing and managing the trial, study managers should also ensure patients that they will be treated with respect and maintenance at each stage of the study.

    Make the process patient-centric

    The patient recruitment method should depend on individual patients and not diseases. The study design should include the patients’ decisions to ensure the clinical trial has meaningful endpoints. If a clinical trial doesn’t meet real patient requirements, it makes recruitment even more challenging. To make the procurement process patient-centered:

    • Getting feedback from patients about the study design
    • Engaging patients, their peers, and the community as volunteers in the trials
    • Giving input about clinical results
    • Producing research programs
    Improve patient screening methods

    Once patients have been recognized, an efficient screening process needs little travel and is minimally invasive. Thanks to technologies like random sampling, these methods are now possible. They enable applicants to submit their samples from wherever they are without visiting the research facility. 

    Remote reporting

    In recent years, the number and frequency of data points being collected during studies have increased massively. It implies members now coping with complex health requirements are being asked to travel further and attend more.

    But in an environment of instant messaging, wearables, and video calls, there is little demand. Regulatory bodies have accepted this and no longer need 100% on-site monitoring, which can significantly affect a sponsor’s ability to recruit and retain sufficient people to test their product adequately.

    One size doesn’t fit all.

    While companies can use several practical steps to successful patient recruitment limitations, one size does not fit all. Study managers should design an action plan at the start of each trial and ensure they partner with vendors excellently placed to help them achieve their specific goals for the study. The right combination of strategies will provide study managers to tailor their approach, so it works for different patient groups and physicians to enhance patient enrolment and long-term retention.

    Start your path to a career in Clinical Trial Management.The curriculum is focused on enhancing your ability at every stage of the clinical research process.

  • Rising Significance of Risk Based Monitoring in Coming years

    Rising Significance of Risk Based Monitoring in Coming years

    The complexity and cost of clinical trials have increased dramatically in recent years.With rapid advancements in Clinical trials, the methodologies used to support vital clinical trials are necessary to protect patient safety. Efficient monitoring is becoming critical to protect the well-being of trial participants and to maintain the integrity of final results; Risk-Based Monitoring is now generally accepted that the process for clinical trial monitoring needs to change. As the inclination towards using Risk-Based Monitoring increases there still remains an inertia to opt for this method. 

    The importance of Risk-Based Monitoring: 

    Taking a risk-based approach to study quality and the monitoring of any clinical investigation has a simplistic focus:

    • Recognize potential threats
    • Create a plan to monitor those activities
    • Improve monitoring methodology as needed

    Centralized Monitoring:

    A combined approach based on the recognized risk at each study site.

    Remote Monitoring:

    Utilization of low-cost clinical resources to perform monitoring activities that do not need onsite visits.

    Reduced Monitoring:

     SDV approach concentrates on patient visits, critical data, and selected patients, depending on the trial’s risk-benefit profile. 

    Triggered Monitoring:

    Depends on predefined trigger points such as patient enrollment rate and reported Serious Adverse Events (SAE).

    Let’s discuss the few essential needs for this: 

    Data Agnostic Integration:

    In the ever-changing Clinical trial landscape, patient trends, and data requirements, RBM needs a technology platform to future proof against the challenges. Acquiring an agnostic integration platform can help a services business remain agile.

    Risk-based monitoring(RBM)marks a paradigm shift from analyzing each piece of data from a trial to a more engrossed analysis that happens in real-time. Agnostic integration is a  platform that can interface with any operating system and database, preventing incompatibility, data corruption, and vendor lock-in. An agnostic approach is to simplify integration between critical systems of record and other apps that help the service’s business lifecycle.

    User Friendly Interface:

    A clear dashboard provides an edible format for the users to spot difficulties early and is significant. Clear and easy-to-use data visualization requires to be combined with quick access to the data below to let study teams examine data in detail down to the levels of performance by site or country and create bespoke reports. Make convinced the platform you choose uses clear and steady navigation routes that are recognizable to users.

    INTELLIGENT MONITORING

    Part of the power of RBM is enabling sponsors and CROs to move to more intelligent monitoring methods that can direct resources to monitor the sites or subjects who are at the most significant risk. Ensure the technology platform you select supports intelligent monitoring with real-time visualization and flags of trial-level issues like recruitment delays or protocol deviations. Early oversight of risk empowers you to quickly identify problems and roll out prompt interventions, like protocol amendments.

     When sponsors and CROs leverage available technologies and develop a risk-based monitoring plan upfront, it leads to less data collection for site personnel and less on-site data monitoring by CRAs. Clinical trials without efficient data collection technologies will continue to rely on the sites to scan pages and pages of documents so that CRAs can monitor remotely. This is not the intent of risk-based monitoring. For risk-based monitoring to work for sites, the trial must be designed to collect and analyze the data more reflectively and efficiently.

     Risk-based monitoring is taking over as it promises greater accuracy, lower prices, in-depth analysis, and timely results. The Short-term Program from Sollers in Risk-based Monitoring is an added advantage.

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