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Tag: Careers in Healthcare

  • Clinical trial trends and market changes in 2021

    Clinical trial trends and market changes in 2021

    The Covid-19 epidemic created significant logistical issues that trial sponsors had to deal with and address quickly in the previous year, causing a sea change in the clinical trials business. Now that the dust has settled, pharmaceutical firms are confronted with a market that looks quite different from the one they were used to, yet trends they were previously aware of continue to increase in size and prominence.

    Increase in Vaccine Trials

    One of the most pressing global health issues of the last year sparked a race among many pharmaceutical and biotech companies to create a vaccine that may protect against SARS-CoV-2. Over 180 coronavirus vaccines are under preclinical testing, according to the WHO’s Covid-19 Candidate Vaccine Landscape and Tracker. Demand for vaccine trials will continue to be significant. As a result of many vaccination studies, enrollment and start-up times are affected.

    Disruptions to Clinical Trials

    There have been problems with clinical trials in the past. When there was a substantial risk of spreading the disease, clinical studies were forced to suspend enrollment. GlobalData’s Pharma Intelligence Center stated in March 2021 that the Covid-19 epidemic had disrupted more than 1,200 clinical studies worldwide. There were also supply chain issues, including logistical issues related to the provision and transportation of biological samples and supplementary materials for clinical studies, in addition to the point of delayed timeframes.

    Increase in Remote Trials in a Flash

    The conventional clinical trial supply chain saw a dramatic shift as it rapidly adopted the remote trial paradigm. With the help of service providers like Oximio, direct-to-patient techniques solved the logistical issues of distant trials.Clinical trial sponsors can more readily reach a worldwide audience with decentralized studies. Even the most remote locations where patients are situated are included in this. Despite the potential benefits of a more diverse patient population, sponsors must contend with issues related to dynamic customs rules and the shifting tax and regulatory requirements for each region.

    Patients should take personalized medicine.

    Medical genetic profiling is at the heart of personalized medicine, which aims at identifying a treatment that is best suited for each patient by looking at their genetic data. Health care might be transformed by this new trend, which would lead to more tailored studies with higher success rates. For participants, this means that they are more likely to receive effective therapy and do not cause any adverse side effects. On the other hand, sponsors benefit from reduced abandonment rates and more cost-effective studies. Trials focus on a small population of patients and have a considerably smaller number of participants.

    Expansion of Access to and Monitoring after the Trial

    Patients afflicted with severe, life-threatening diseases who are not participating in clinical trials but have no other treatment options can receive experimental therapies through extended access programs. Increasing post-trial duties for sponsors has led to increased demand for post-trial monitoring services.

    What are you waiting for? Sign up for our Clinical Trial Management certificate program today. It is designed to meet the demands of the industrial market.

  • Data science revolutionizes healthcare, but how exactly?

    Data science revolutionizes healthcare, but how exactly?

    Data science in healthcare is no longer a distant prospect. Advances in internet-based medical devices and artificial intelligence are poised to revolutionize clinical research and services. By integrating connected medical devices, patients will aggregate, store, and utilize their data more effectively. Furthermore, AI has been proven to be a key to hospital workflow optimization, cost control, and disease prevention.

    The trend toward big data in medicine and the growing demand for data scientists in the healthcare industry make now a great time to get into data science.

    The following are use cases that have a significant impact on the industry.

    Medicine with precision

    Today, data science can completely transform the way diseases are diagnosed and treated. Here’s how. Information on genetics, healing treatments, and outcomes are included in this section.

    Thus, there will be less risk of harm to the patient or of using inappropriate treatment.

    Also, data regarding a patient’s lifestyle and environmental exposure can determine what triggers certain diseases and conditions. High-performance genome analytics platforms and tools have also revolutionized data science in healthcare.

    Genomics Application Platform will allow hospitals to perform genome sequencing to diagnose and treat genetic diseases and improve the diagnosis and treatment of newborns with complex disorders. That is undoubtedly a crucial step for improving the prevention of illness. Data science’s growing importance in healthcare is also evident from this.

    Optimizing clinic workflow and performance

    Remember the TV show ER from the 90s? As a result of a lack of workflow orchestration, tensions between physicians and staff were frequently high.

    Healthcare facilities often face dynamic and unpredictable conditions.

    Moreover, productivity is challenged by numerous factors. A hospital’s patients’ needs, staff coordination, and resource allocation are a few examples.

    Preventing and controlling healthcare-associated infections

    In addition to handling one of the world’s most serious public health problems, data science plays a critical role. The problem is healthcare-associated infection (HAI). Each year, 100,000 patients in the European Union contract healthcare-associated infections. It leads to thousands of deaths.

    This certification program will prepare you for the workforce with workforce-ready skills. Get the skills employers want. This course for clinical supervisors will examine the effective learning methods in R, SAS, SQL, Machine Learning, and Tableau and how to apply them appropriately in practice.

  • 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?

    Get knowledge on Clinical Trial Management Software with Sollers Clinical Research certification program. Enroll now.

  • 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.

    Upskill yourself with Sollers Clinical Trial Management certification program to meet industrial needs.

  • Are You Looking to Start a Career in Life Sciences?

    Are You Looking to Start a Career in Life Sciences?

    Are you trying to shift towards a major career change path or simply looking for something new and distinct?  a career in life sciences would provide you with all of these opportunities to make a difference in the world by developing a life-saving vaccine or medication, maintaining the quality of foods to prevent widespread illnesses, or pushing society forward with technological breakthroughs. 

    Life sciences are often at the forefront of medical advancements, but they have played critical roles in other disciplines for hundreds of years, such as agriculture and food safety. Because there has always been a general need for the study of life sciences as they push and develop our society forward every day, it produces fresh demands for innovative individuals to keep the momentum going, resulting in an abundance of job security for those in the field. 

    What Are Job Opportunities Available?

    There is something for everyone with so many options across dozens of fields. Biochemists, clinical research associates, research assistants, and microbiologists are some of the most popular occupations in life sciences. Biomedical scientists, computational biologists, industrial pharmacists, and bioinformaticians are lesser-known but equally significant professional alternatives. 

    If you want to work in the medical industry, being a biomedical scientist is the most acceptable option. Examining tissue samples and assisting and advising medical physicians in diagnosing and treating their patients are among their responsibilities. A biomedical scientist must have a thorough understanding of pathology, anatomy, and physiology. Industrial pharmacist and clinical research associate are two more life science jobs significantly involved in the medical field.

    What’s the Best Way to Get Started?

    You must first earn a degree that is relevant to your career choice in order to realise your dream of working in one of the various life science professions.

    Are you prepared to take the first step? Talking to a university counsellor is a good place to start. Career advisors can assist you in determining the best path of study for your interests and needs. Sollers can assist you to find the best career growth. Most people who pursue a career in life science begin with a bachelor’s degree in biology, chemistry, life science, pharmacy, or computer science, and then pursue a master’s degree in a more specialised field, such as industrial pharmacy or biochemistry. Begin small and aspire to a career in life sciences!

    So what are you waiting for? We’ve got the Top booming Life Sciences Fields of 2030. So go ahead and have a look. Do your study, connect it to your persona, career goals, and hobbies, and, most importantly, decide on the type of career you want to create for yourself. Then go ahead and get in. Remember that a small pebble thrown into the ocean of Life Science today will return to you tomorrow in the form of a tsunami of employment prospects.

  • Future prospects of Pharmacovigilance

    Future prospects of Pharmacovigilance

    Why is Pharmacovigilance required in pharmaceutical markets for all countries? Majorly it is due to adverse drug reactions (ADR) that leads to severe illness, permanent side effects, and even death.

    With rising burden of chronic and non chronic diseases and increase in geriatic population growing pharmaceutical market, no surprise that there is a rapid growth for pharmacovigilance services  in worldwide market. Pharmacovigilance performs a much more pivotal role with the more stringent regulations and the increasing quality of patient centricity than 10 or 20 years ago.

    Current industry trends in pharmacovigilance:

    These days, the evolution of mobile applications, digital health devices, social media set a new standard for patient involvement. Recent statistics illustrate that there is a huge value for social media monitoring and provide valuable information related to drugs. Along with that proactive monitoring helps to give early warnings of new adverse events that helps in drug development and avoid preventable litigation.

    Will the exponential growth of digital health tools become primary for producing high-quality concerns? It stands to reason that proactively observing patient health through digital health materials could provide insight into decreasing the figure and severity of adverse events.

    Social media; Clinical data and electronic health records; Claims files;

    Regulatory reports and filings from different areas;

    ​Secondary data references present unprecedented difficulties in terms of procurement and combination with “classic” data sets. Usage of secondary data by pharmaceuticals is, as of today, just at the initial stage, also considering that it is not required from the regulatory point of view. 

    Recently, technology providers have started giving robust and flexible platforms that support Life Sciences organizations handling and combining multiple file types and including social media streams in their pharmacovigilance methods. Advanced algorithms and disproportionality review are now being developed to accommodate classical automatic reporting and social media streams.

    The secondary data references and advanced signal detection technologies help detect safety risks and take more rapid risk minimization.

    Cloud-based Reporting produces a robust global database of adverse events.

    Many businesses are now profiting from collecting and analyzing vast amounts of data in the cloud. As the amount of data sources grows, Life Sciences companies confront the critical need to optimize the intake, storage, and study of substantial volumes of data.

    The primary reason for transforming to the Cloud is

    Cost and efficiency: Cloud enables organizations to operate with massive data from incidents without yielding security, quality, and data privacy.

    Scalability: The adverse event case workload for Life Science companies has been growing regularly, with some businesses seeing a 50% rise yearly. 

    Simplicity: Cloud usage can simplify the life of companies by empowering them to evade concerns about module adaptability and mounting up servers. Cloud pharmacovigilance is a growing reality. 

    Sollers college provides a Drug Safety & Pharmacovigilance certificate/master’s program for the students/drug safety professionals who want to settle in the healthcare sector.

  • 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.

    Proficient professionals are taking a chance to showcase their expertise in research to assist in a better way. Sollers Clinical Trial certificate and Master’s program helps healthcare professionals for their career growth.

  • Role of Big Data in Clinical Trials and Drug Safety?

    Role of Big Data in Clinical Trials and Drug Safety?

    Clinical data and its analysis are essential to clinical research. Securing the overall quality of clinical data is eminent to give quality care and relevant decision-making in the pharmaceutical and healthcare fields.

    What establishes clinical data, what should you look for in it, and what sources are there to maintain data and data analysis and ensure their quality?

    Let’s take a look.

    Key to this development transformation is the burgeoning use of big data, which, in simple terms, transfers to the enormous quantity of data gathered over the clinical trial method.

    These vast data come from several sources, together with biomarkers, claims data, pharmaceutical research, electronic health records, patient registries, payer records, genomic sequencing, wearables, medical devices, and clinical trial data. Pharmaceutical and biotech companies can provide this data to increase patient recruitment, clinical trial design, site selection, and overall decision-making.

    Let’s understand how big data can be leveraged to resolve significant difficulties in recruitment and drug development. 

    • Problems on Quantity of data
    • Managing big data to recruit patients
    • Operating data technologies to involve patients and better health outcomes
    • Lessening clinical trial dropout rates with the use of big data
    • Gaining big data available for analysis sooner to minimize costs
    • Knowing big data’s role in the expectation of healthcare

    The need for data in the health care sector is beyond conception. Be it genomics, medical records, imaging data, the list is infinite. The collection of more data leads to an exponential increase in cost. 

    Internet of Things (IoT) consists of a system of interrelated, internet-connected things that can receive and transfer data across a wireless network without human intervention 

    The days of cardiovascular therapies, beta-blockers, antibiotic drugs, and broad-spectrum are long gone. These Days, many pharma companies are looking for a niche market that benefits from very particular therapies. 

    These therapies remain to expand, big data is expected to rise in value with regards to recruitment. 

    Operating data collection technology for specific patient groups

    With the advancement in data collection technology, there is a chance to interact with patients who have particular conditions & diseases on a direct basis. We can describe drugs and therapies which cure a patient’s disease and improves the quality of life. 

    Reducing clinical trial dropout rates

    Reduction in dropout rates in clinical trials has been a big issue. The thing is, the practice itself may not be effective for the patient. Finding the right patient for a fair trial is half the battle. The power of big data can ensure patients are matched with the appropriate test to fit their requirements.

    Obtaining big data ready for analysis sooner to decrease costs

    Do you know most pharma companies are wasting their money by not identifying proper patients at the start of a trial? Moreover, the time it takes to recruit a patient is a long, complicated method. 

    Knowing big data’s role in the future of healthcare

    The ability to leverage and interpret big data will be developed in a workforce of hungry and technologically competent individuals. This method will take time to create the proper foundation to increase big data to its full potential. 

    Sollers designs certificate programs for aspiring students and the people who want to switch their career in the health care sectors.

  • What is the Aim of Drug Safety & Pharmacovigilance?

    What is the Aim of Drug Safety & Pharmacovigilance?

    Pharmacovigilance is the heartbeat of pharmaceutical production. Do you think there’s something more significant than the safety of a patient? As a healthcare provider, your patient safety is your preference. Drug Safety & Pharmacovigilance, is intended to protect patients and disseminate information amongst professionals to reduce the risk of adverse events. You perform a risk-benefit estimate for every patient before any interruption or treatment decision is focal to keep your patient safe. Therefore, any science or activity that reinforces this concept is of great importance. And here, we can discuss the significance of pharmacovigilance.  

    What is Pharmacovigilance?

    The pharmacovigilance field is broad-ranging. It comprises drug interactions, prescription errors, lack of drug efficacy, unapproved medications, fallacious use of medicines, severe and persistent poisoning, case reports, drug-related mortality, and anything related to adverse drug reactions. 

    To succeed in this event, pharmacovigilance aims to regulate the adverse drug effects through its central international database, which accumulates the adverse effects of drug reports from all the countries worldwide. And now, let us have a broad discussion on the significance and consequence of pharmacovigilance.

    The importance of Pharmacovigilance:

    We have shown a notable rise in the number of clinical trials through the past few years, and this happening is a double-edged weapon!

    Although new medicine development is essential for a large portion of patients, the number of clinical trials may affect the function of ethics committees and regulators, which may lead to unethical patient practices, poor reporting of adverse effects, and inadequate patient monitoring during the phases of clinical trials. 

    What does pharmacovigilance do?

    The role of pharmacovigilance is to assess whether the benefits of a drug outweigh the risks, and it doesn’t stop after the medicines are certified. PV involves ongoing monitoring of medications to ensure they remain safe for use, primarily since previously undetected adverse events can occur at any time.

    This position has a significant impact on improving the medicines’ safety profile, intensifying patient care and safety, and also supporting the work of national drug regulatory authorities.

    The Quality of Pharmacovigilance in Clinical Trial Regulation:

    With the transformation on trends in clinical trials and altering demographics of the patients taking the medicines, outsourcing pharmacovigilance has been indulged as they have the proficiency to centralize data and hence, early identification of risks; guaranteeing the final aim, that is, the safety of human health is completed.

    The significance and roles of pharmacovigilance are vital; they are growing and extending throughout the years to incorporate various methods related to patient safety. Upskill your career with Drug Safety & Pharmacovigilance certification from Sollers.

  • Transform your Life with Life Science Career

    Transform your Life with Life Science Career

    Whether you’re striving to determine what is significant to pick along your college entry path or simply looking for something innovative and diverse to change your gear with a career transformation, there is a life science field waiting for you. 

    Technology quickly continues to advance, obtaining the right career that gives a steady future is essential. No matter what level you’re entering in your professional career, life sciences offer job satisfaction, endless opportunities, security, and competitive pay, preparing you to switch to an excellent career move you don’t want to miss out against.

    What Potential Does a Life Science Career Hold for You?

    What is your passion? If you think of making a difference in the world by producing a life-saving vaccine or medication, managing the quality of medicines to prevent adverse reactions, or pushing society into the future with breakthroughs in technology, a career in life sciences provides you all these opportunities.

    Life sciences are generally at the forefront of scientific discoveries in medicine. Still, they have also held pivotal roles in other fields, such as Clinical Data Science and medical writing, for decades. There’s always been an everyday need to study life sciences. They promote and improve our society further every day; it generates new requirements for innovative individuals to keep the energy, giving a hand to assured job security for those with a career in life science.

    High Industry growth

    Lack of skilled professionals in Life Science, producing challenges for employers. Qualified candidates in industries like Healthcare, Biotech, and Pharmaceutical have been highly sought out after. More firms are facing difficulty in the longer recruitment process to fill life sciences jobs, particularly in niche areas.

    What Are Job Opportunities Available?

    With so many openings across many fields, there is something for everyone. A couple of the numerous common careers in life sciences include biochemists, clinical research associates, research assistants, and microbiologists. Other unfamiliar yet still significant career opportunities include computational biologist, biomedical scientist, bioinformatician, biotechnologist, industrial pharmacist.

    Other life science careers massively included in the medical field industrial pharmacists and clinical research associates. An industrial pharmacist is accountable for developing safe, effective medications and taking them on the market. They may be required at any step of the process, whether striking, running clinical trials, or finally marketing the drug. Clinical research associates are slightly similar, as they oversee clinical trials of medicines, vaccines, and treatments to guarantee they work safely and effectively.

    How Do I Get Started?

    To accomplish your dream of settling a job in one of the many life science fields, you must first get a degree related to your career choice.

    Ready to take the first step? Speaking to a counselor at Sollers is an excellent way to get begun. Our career counselors can guide you and decide the course of study that best accommodates your interests and requirements. Start your industrial training through certificate and master’s courses with Sollers. Many of the students benefit from this course. Why late? Join now!

  • 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.

  • Data Science in Healthcare Sector

    Data Science in Healthcare Sector

    Data Science is swiftly arising to maintain all the industries of the world today. The Healthcare industry is producing a vast amount of data every day. Clinical trial systems, billing, Electronic medical records, billing, clinical procedures, various pieces of research, and data from wearables, continue to become vast volumes of information. It offers a worthwhile chance for healthcare providers to assure more reliable patient care powered by actionable perspicacity from previous patient data.  Data science is making it happen. 

    With advanced machine learning and analytics guidance, data scientists worldwide are constantly changing the healthcare industry. From changing care delivery to obtaining operational experience, they’re working to optimize every phase of healthcare operation by opening the potential of data.There are multiple domains in healthcare such as genetics, medical imaging, predictive diagnosis ,drug discovery and many others that make use of data science. 

    In this blog, Let’s discuss how data science is changing the healthcare sector.

    Benefits of Data Science in Healthcare

    Data Science advocates advancing healthcare tools and methods. It helps increase productivity in analysis and treatment and enhances the workflow of healthcare systems. The ultimate aims of the healthcare system are as follows:

    • To facilitate the workflow of the healthcare system
    • To decrease the risk of treatment failure
    • To implement proper treatment on time
    • To evade unnecessary emergency due to the non-availability of doctors
    • To reduce the waiting time of patients

    Data Science in Medical Imaging: 

    Data Science is helping to study medical images through recognition technology. 

    It aids in recognizing scanned images to find out the flaws in a human body for treating doctors to make an active treatment strategy. These medical image analyses include MRI (Magnetic Resonance Imaging), CT scan, sonography, X-ray, and many more. Proper analysis of the images of these tests improves valuable insights for the doctors to provide the patients with better treatment.

    Traditionally, doctors would manually examine these images and find variations within them. However, it was often challenging to see microscopic deformities, and as a consequence, doctors could not advise a proper diagnosis.

    With the arrival of deep learning technologies in data science, it is now feasible to detect microscopic deformations in the scanned images. Through image segmentation, it is attainable to search for defects present in the scanned images.

    Drug Discovery with Data Science

    Drug Discovery is a highly complex discipline.  It has now become a challenge for medical research institutes to find medicines or vaccines for diseases quickly. Since, to find a formula for treatment, the researchers have to understand the characteristics of the causative agent, it may require millions of test cases to do this. Pharmaceutical industries massively rely on data science to resolve their intricacies and produce better drugs for the people. Drug Discovery is a time-consuming process that also includes heavy financial investment and heavy testing. This data helps the researchers to develop models and find statistical relationships between the attributes.

    Our Clinical Data Science certificate program is designed in such a way that it will meet the industrial requirements.

  • Role of Pharmacist in Pharmacovigilance Field

    Role of Pharmacist in Pharmacovigilance Field

    The Pharmacy profession has experienced significant change over the last two to three decades. Pharmacists can use Pharmacovigilance systems interfaced with electronic health records to observe the drugs they fill and recognize adverse drug reactions quicker than non-pharmacists, thereby decreasing expensive healthcare costs.

    Pharmacovigilance information systems managed by pharmacists can recognize adverse drug reactions in emerging countries where quality control of medicines is questionable. Reports suggested that patients had insufficient knowledge about their prescribed drugs, although they had been using them for a while. 

    73% of pharmacists work in hospital or pharmacy settings, where they can face events based on adverse drug reactions or other drug-related problems. Their involvement in pharmacovigilance systems is crucial.

    The development of electronic information systems has been a milestone in identifying and intervening drug-related problems such as dosage, adverse reactions, interactions, compliance, or ineffectiveness. Such decision support systems in electronic medical records can capture drug-drug interactions or identify other issues (e.g., contraindications) with prescriptions before they are filled

    Pharmacists have a crucial role in the US and health systems to maintain the rational and safe use of medication, for they are drug experts who are specifically trained in this field. They ensure that the drugs in the marketplace we consume are generally safe, and all those identified as hazardous are taken off the market. 

    Pharmacovigilance is an excellent employment option for medical, pharmacy, and life science graduates. It has resulted in pharmacists taking on greater responsibility in managing minor illnesses and delivering public health interventions. There is no limit to the patients dealt with by pharmacists. 

    In the pharmaceutical sector, the number of career opportunities is nearly limitless. Pharmacists can play a role helping patients with chronic diseases have better medication at the correct time and get good clinical outcomes. Pharmacists serve as patient advocates, contributing information that permits patients to evaluate risk and improve their autonomy

    The pharmaceutical industry in the US is one of the most advanced industries of the country and the third-largest in the world. It is technologically strong and self-reliant. Effective use of pharmacists’ workforce will improve the outcome of pharmacotherapy and decrease global health costs. 

    Pharmacists can fully use their clinical abilities and usually involve diagnosis and therapeutic management. More than ever before, community pharmacists are now in a position to identify, record, and report medication safety incidents. 

    Sollers’ Drug Safety and Pharmacovigilance certification help Pharmacists to enrich their career growth in the Pharmaceutical sector. It might seem like a lateral move at first, but it will open more fantastic opportunities in the long term. 

  • Clinical Trials Changing Face in the Changing World

    Clinical Trials Changing Face in the Changing World

    Technological developments are bringing benefits across the Clinical Development soll life cycles for years. Now, the aspect of Clinical Trial development is even more improved.  In the light of pandemic COVID 19, the field uses new virtual trial technologies to maintain their studies and keep all the patients safe. 

    Innovation and Technology are familiar buzzwords that are common for all industries. But, we are required to remind ourselves that innovative technologies like Clinical Conductor and eTMF are intended to increase the productivity, efficiency, and convenience of a process or activity. It helps to retrieve the trail documents in a timely manner and maintenance of documents for post marketing studies. 

    Challenges in the Pharmaceutical industry:

    • High Clinical trial patient dropout rates
    • Lengthy patient recruitment time
    • Longer study closeouts due to questionable data quality
    • Investigative sites for essential data collection

    Post pandemic has given healthcare professionals new approaches. We have seen the evolution of Artificial Intelligence, the Internet of Medical Things, High precision medical sensors, etc., in the past decade. Now,  it’s easy to see how to include other purpose built-in technologies into clinical development, which can help trial sponsors to boost their clinical development processes. 

    One of the few positives of the pandemic is the limited opportunity to operate differently. All clinical trial stakeholders have been compelled to accommodate and have been surprised by the enduring benefits of virtual trial technologies in many instances. We observe a post-pandemic scenario with more virtual visits, minimizing the need for patients to travel to investigative sites. Increased device integrations with consumer and medical data capture tools, simplifying patients’ participation in clinical trials and improving their overall engagement.  By doing so, the business will profit from more modernized clinical trials, increased patient engagement, and expedited clinical development times.

    Taking all points into consideration, there is no dull day for the aspirants who are in the clinical field. A certification might help to accelerate your career growth in the Healthcare industry. Don’t worry about your educational and professional background. Attend our regular info sessions to get more details.

  • Evaluation of Adverse Drug Reactions

    Evaluation of Adverse Drug Reactions

    Pharmacovigilance is an arm for patient safety and care that aims to get the best results with medicines’ treatment. Unfortunately, because of many different factors, any medicine can  sometimes cause adverse reactions. 

    As we can see, the world of 2021 is different compared to previous years. We are now cautiously reopening and trying to get into the new normal state. Pharmacovigilance will recognize the risks in the least possible time when the medicine has been marketed and will aid to build and/or classify risk factors. When communicated adequately, this data enables intelligent, evidence-based guiding with potential for stopping many adverse reactions and will finally benefit each patient to obtain optimum therapy at a more economical cost to the health system.

    Adverse outcomes, preventable or otherwise affects the treatment. Mainly adverse events affect patients, but they also affect health care practitioners. Revealing information about adverse events has benefits for the patient and the physician and, ideally, strengthens the patient–physician relationship and promotes trust. 

    When to report

    A patient should communicate if they had a notable outcome.They can go to hospital and inform the medical advisers that they stopped using medication as they have this type of adverse reaction 

    FDA encourages the consumers to report whenever they find any adverse reactions. If the team gets bundles of reports about the same medicine they will respond and take possible actions. 

    What happens after a report is made?

    FDA examines all submitted reports and identifies the similar adverse events occurring with a specific medicine. 

    Depending on the severity of the adverse reactions, FDA may take any of the following decisions. 

    • Withdraw the medicine from the market 
    • Declare a drug safety communication to notify public 
    • Set some restrictions on the drug distribution
    • Renovate the drug’s labelling, insert or package.

    But almost everything starts with consumer feedback. Adverse event reporting allows us to do our job and report needed information back to consumers.

    Types of Adverse Drug Reactions:

    Mainly it is classified under

    • Dose-related
    • Allergic
    • Idiosyncratic

    In detailed it is segregated as 

    Type A – Augmented 

    Reactions which can be predicted from the known pharmacology of the drug. These are dose dependent.

    Ex: Bleeding, Headache etc., 

    Type B – Bizarre

    These are adverse reactions that depend upon promoting the growth of certain microorganisms and cannot be predicted from pharmacology.  

    Ex: Anaphylaxis, Hypersensitivity

    Type C – Chemical 

    Several adverse reactions rely upon the chemical nature of a drug rather than pharmacological properties and cause chemical irritation.

    Ex: Hepatotoxicity

    Type D – Delayed

    These reactions occur because of the physical nature of the formulation or the method of administration.

    E.g. Chemotherapy,   Secondary tumours,  Teratogenic effects

    Type E – Exit/End of treatment

    These are known as withdrawal reactions, these occur on withdrawal especially when drugs are stopped abruptly. 

    E.g. Phenytoin withdrawal  Seizures, Steroid withdrawal

     Type F – Familial

    Familial dysautonomia is a hereditary sensory disorder. It is a genetic disorder that affects the development and survival of certain nerve cells.

    Ex: poor muscle tone (hypotonia), frequent lung infections, and difficulty maintaining body temperature. 

    Type G – Genotoxicity 

    Several drugs can create genetic damage in humans. Distinctly, some are possibly genotoxic or carcinogenic. Few, but not all, teratogenic agents harm genetic material within the fetus.

    Type H -Hypersensitivity

    These are side-effects induced by hypersensitivity or allergy. They are apparently the most frequent adverse reactions after Type A reactions.

    Type U – Unclassified

    Some adverse reactions have a mechanism that is not known. This may constrain the introduction of new adverse reaction divisions in the future. Examples include muscular adverse effects,drug-induced taste disturbance.

    Drug Safety and Pharmacovigilance Training Program accomplish the demands of this ever-growing and profoundly regulated industry by offering a curriculum aligned with the real-time industry requirements, highly competent, and equips career readiness for professionals in the pharmaceutical industry.

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