Tag: clinical trail management

  • What role does a clinical investigator pharmacist play?

    What role does a clinical investigator pharmacist play?

    Pharmacists can operate independently in a variety of capacities and hold a wide range of positions in clinical research. In the fields of clinical trial administration, medical writing, pharmacovigilance, research and development, and medico-marketing, pharmacists employ a variety of talents and are crucial contributors.

    • Clinical Investigator Pharmacist
      To address health difficulties and guarantee appropriate medication or treatments, pharmacists are on the front lines of care. When working in tandem or collaborating with physicians and the public, pharmacists are tasked with ensuring safe pharmaceutical practices for pharmaceutical corporations. 
    • For a new chemical entity to be prepared and given to patients after its safety and efficacy are determined by safety laws, it must first be established that the new chemical entity is safe and effective.
    • A close eye must be kept on the labeled and packed study medication to ensure that no unanticipated consequences arise. 
    • When evaluating the research drug’s formulation and form, study methodology and design, study drug selection, and other pharmaceutical elements, these pharmacists offer their professional judgment.
    • It is important to note that in addition to evaluating the study design and methods, as well as the choice of the study drug, its formulation, and the mode of administration, these pharmacists also provide expert advice about the study drug’s pharmacological properties while taking into consideration potential side effects, unexpected results, and interactions. 
    • To guarantee the quality and safety of medications, pharmacists are involved in different phases of the clinical trial procedure.

    A clinical research pharmacist’s duty
    When doing clinical research, pharmacists cooperate with a diverse range of professionals, such as project managers, research associates, research nurses, and others engaged in research and development.

    •  Pharmacists work primarily in the fields of clinical supply, research and development, ethical committees, and clinical research coordination through the application of laws and regulations required for clinical trials. 
    • In addition to working with researchers to define and plan study design, a pharmacist oversees all aspects of investigational study drugs. 
    • They also identify a wide range of subject-specific doses and dosage forms and provide training to team members such as clinical investigators and nurses in funding agencies and pharmaceutical companies.
    • Pharmacists are required by clinical trial coordinators at hospitals and clinical research organizations to evaluate the studies, provide information on the substance being studied, give protocol-specific instructions, mentor team members, and address code breaks. 
    • They have to check the labels on the container, make sure the medications are stored properly, and advise patients on how to take them. Clinical supply pharmacists oversee the production, labeling, and delivery of the research medication.

    Pharmacy Clinical Research Courses and Apprenticeships

    •  Experienced pharmacy workers have multiple chances due to the recent surge in clinical research and trials.
    • Clinicians can work at hospitals, government offices, private clinics, and other healthcare facilities thanks to these changes. 
    • Graduates of rigorous training and education programs acquire the skills necessary to work as research pharmacists. 
    • An approved pharmacy degree is a prerequisite for employment as a research pharmacist, as is ongoing education that keeps them abreast of developments in the field of pharmacological science. 
    • To acquire a higher degree of expertise in a particular field of interest, pharmacists might enroll in certificate programs. 
    • To ensure the safe distribution of their in-depth knowledge of the adverse effects of certain medications, these pharmacists need to be proficient communicators.
    • To maintain the safety of medications by effectively assessing prescriptions to fit patients’ needs, pharmacists must possess strong communication skills in addition to a wealth of knowledge on the side effects of particular pharmaceuticals.
    •  To ensure prescription delivery accuracy, pharmacists must be computer literate to use electronic health record (EHR) systems. To control inventories and supervise team members’ work, pharmacists require strong managerial abilities.

    Clinical trial management is in high demand in the pharmaceutical sector.

     Become a part of Sollers College’s Clinical Trial Management program and expand your skills. It covers FDA oversight, monitoring, adverse event reporting, IRB/IEC oversight, clinical trial phases, and much more. The pharmaceutical industry highly values this skill set.

  • 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.

  • 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. 

  • 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.

×