THOUGHT LEADERSHIP

Drug development and clinical research methods evolve continuously through establishment of new regulations and through adaptations to changes in treatment accessibility, technology, evolving knowledge in biology, and appearance of new diseases. 

Patient-centric trials, in which the perspective of the patient is considered in study design and performance, is one such new approach in clinical research that primarily focuses on reducing patient burden. 

An important aspect of PROMETRIKA’s work as a full-service CRO for sponsors is the monitoring and reporting of safety-related events during clinical trials. Our sponsor colleagues focus on drugs and biologics addressing rare diseases and other conditions that so far have proven difficult to treat. PROMETRIKA’s Safety and Pharmacovigilance activities are focused on accurate and timely drug safety reporting.

An important aspect of PROMETRIKA’s work as a full-service CRO for sponsors is the monitoring and reporting of safety-related events during clinical trials. Our sponsor colleagues focus on drugs and biologics addressing rare diseases and other conditions that so far have proven difficult to treat. PROMETRIKA’s Safety and Pharmacovigilance activities are focused on accurate and timely drug safety reporting.

Checklists. Some people hate them; some people love them. There have been whole books written about them. Some checklist fans say they live by their checklists. Cynics may see checklists as long, tedious, ineffective, bothersome, or just plain wrong. And, well, that’s sometimes true.

So what makes a good and effective checklist?

I can actually say that I have been working in the Clinical Trials industry since the last century.  I started as a database programmer, part of data management in a large (now huge) CRO.  In those days we used paper CRFs, entered by hand into a database platform that was built and maintained inhouse.  We had our own naming conventions for variables and could pretty much build whatever we wanted and group the data however it made sense to us.  Prior to deliverables, we printed out the entire database so data managers could review it. All the files were burned to floppy discs and we’d pop them in the mail to the sponsor.  With the amount of data we collect, and the requirement to do more, faster, can you even imagine doing that now?