THOUGHT LEADERSHIP

Medidata NEXT is hosted each year by PROMETRIKA’s technology partner Medidata to help sponsors stay informed on products and solutions for managing clinical trial data. I had the privilege of attending this year’s event in New York City as a PROMETRIKA representative. This was my first-ever industry conference, and Medidata NEXT set the bar high. The venue was in Times Square, and, upon entering the hotel, we were greeted with warm hospitality and a HUGE Medidata NEXT banner. The first event was the introductory keynote, which started with an impactful story of a diabetic mom and her daughter. This introduction served to remind attendees why we do what we do - help people living with medical challenges. The session continued for 2 hours and described the future direction of the Medidata platform.

On the surface, a medical writer has a simple calling: communicate medical information and research results clearly to the intended audience. How one achieves this goal is what sets apart a great medical writer. Arriving at a high-quality final document requires planning, clear communication, coordination between team members, and building consensus among stakeholders. These are not directly related to writing per se but are central to the success of our projects, so how does a medical writer learn and hone such skills?

Maybe you’ve heard of it before. Another string of letters in the alphabet soup of clinical trials - an IDMC - sometimes also called just a DMC and other times a DSMB. But what does it stand for, what is it, and more importantly, do you need one?

Clinical trials are rapidly evolving and becoming more complex as they continue to adopt novel technologies and approaches. Factors such as the number of sites and countries involved, study phase, indication, design, procedures, and the number of data sources and data points collected contribute to this complexity, imposing a strain on study execution. Furthermore, in recent years, the biopharmaceutical industry has witnessed changes in business practices and an increase in merger and acquisition activity.

CDISC standards in clinical trials are the cornerstone of any successful submission to regulatory agencies. While they are “standards,” the structure and the nuances of applying them are continually evolving and changing, making it important to keep up to date in order to provide quality submissions. Here at PROMETRIKA, a full-service CRO, our statistical programmers and biostatisticians engage in continuing education activities by attending webinars, conferences, and training sessions specifically related to CDISC standards in clinical trials.