The global COVID-19 pandemic has brought our attention to the most crucial drug development and regulatory elements. The regulators and drug manufacturers are racing to find a cure for this deadly virus. With such pressures and shortened accelerated approval process, any proven antivirals and vaccines will be in the breaking news column for the next half of 2022. Requiring new methodologies and techniques for clinical trials due to the emergence of social distancing practices is rapidly changing the norms of the pharmaceutical industry. With the rise of 500+ global clinical trials on COVID-19 ..read more

In this Blog, we’ll educate ourselves about what randomization is in clinical trials, how to achieve it and why we need to randomize subjects in the first place. It is the process of assigning clinical trial participants to treatment groups. Randomization removes any bias (especially by treating the Investigator) and gives a fair chance of being assigned to any group. It is generally done by computer or IWRS systems. Why Randomize? To answer this, let’s first understand the outcome or result of a clinical trial. The real effect incurred by the investigative product is what justifies the whole ..read more

Medical coding is performed to categorize the medical terms reported appropriately so they can be analyzed or reviewed easily. This blog describes the process used for medical coding in clinical data management. In multicentric clinical trials, CRF information is collected by Investigators located at various sites in different countries; therefore, recording the medical terms uniformly becomes a challenge. As all data generated in these trials are ultimately subjected to further analysis. To simplify and unify these terminologies, medical coding is implemented to standardize Adverse Event ..read more

The foreign dental graduates are well versed in the daunting processes and years of struggles with the NBDE exams and DDS license for the U.S., the ORE exams and registration with GDC in the U.K. and so on. In this scenario, Drug Safety and Pharmacovigilance come as a great breeze of fresh air with its list of opportunities. Writing this makes me reflect on what I learned about the career options in Drug Safety and Pharmacovigilance as a foreign dental graduate. After interacting with various other safety personnel who started as dentists in this field, here are some career options for those ..read more

Case Assessments in Drug Safety and Pharmacovigilance: How does the information from a consumer having an adverse drug reaction reach a Drug Safety Associate or a Pharmacovigilance scientist in the Drug Safety Department? How is a case prioritized and classified as serious or nonserious? How important is case assessment? If one understands the importance of time and timeline in Pharmacovigilance – one would understand the necessity for a case assessment. The immediate steps after triage are to assess if the reported Adverse Drug Reaction is “Serious or Nonserious” or “Expected or Unexpected ..read more

What is Clinical Data Management and its Significance in the Research Industry? We’ll answer this question in this segment. Clinical Data Management is involved in all aspects of processing the clinical data, working with various computer applications and database systems to support collecting, cleaning, and validating subject or trial data. It is crucial to understand the need for CDM to picture its role and place on this big canvas. To obtain the trust of Regulatory authorities and adhere to quality industry standards, the pharma companies have to ensure that clinical data presented for subm ..read more

What is a Clinical Trial Protocol, and why do we need this document? Clinical trials are done to back up any research to answer the clinical problem and gain additional knowledge about new or established treatments. And Study Protocol is the first document you want your hands to know about the study design. For doing this research work, we need a methodology on which this whole process can be laid out. And protocol gives us that structured plot to carry out this research work step-wise. Moreover, the Protocol helps the researchers explain the study to the outside world. We also need a reviewab ..read more

Student Testimonial, Certificate Program in Drug Safety and Pharmacovigilance: I am a dentist (Bachelor of Dental Surgery) from Karnataka, India. As my internship was nearing an end, I was in two minds to pursue a clinical master’s or venture into a new field related to Clinical Research (a change of heart courtesy of the pandemic of 2020). Half-mindedly scrolling LinkedIn worked in my favor as I came across the Drug Safety and Pharmacovigilance course by Medipharm Solutions. Two months into the certificate program, I am glad to share it has been a great decision. I want to explain how this c ..read more

Artificial Intelligence in Drug Safety and Pharmacovigilance: Artificial intelligence (AI) is the broad-ranging branch of computer science that has infiltrated almost all areas concerned with healthcare and science. The obvious goal is creating smart machines capable of performing tasks that typically require human intelligence and expertise. With AI features like machine learning and deep learning, data scientists and analysts will soon prove to be an indispensable part of Pharmacovigilance in the coming years. Let’s have a look at how AI and Drug Safety interacts with each other. Facil ..read more

Healthcare is evolving, and so is Pharmacovigilance. The focus is shifting from primarily safety operations to proactive risk management, personalized medicine, and completely transparent data between pharma, patients, healthcare providers, and regulatory agencies. The expected trends are interesting, and for those interested in making a career in Safety and Pharmacovigilance, the pointers below would be helpful when mapping out your long-term plans. Let’s dive in. Drug Safety and Pharmacovigilance Career. Increased Capability of Safety Databases With the overwhelming influx of safety data ..read more