Flexibility and scalability are cornerstones of real world data capture

Nadia Mahmood, PhD, is Real World Studies Director at Cisiv. Nadia has designed and delivered systems for a wide variety of studies, including global post-approval safety, health outcome, registries, and post- marketing. As a subject matter expert on eCRF and study design for observational research, Nadia helps sponsor and CRO clients succeed in data collection and analysis for real world studies.

Renowned basketball coach John Wooden once said that “flexibility is the key to stability”.

While the basketball courts and the pharmaceutical industry are worlds apart, the statement holds for many aspects of modern-day medicines development where flexibility is increasingly critical to success. This is apparent not least in the growing area of real world data and evidence capture, where rising interest has brought a wide variety of study types and methods for teams to handle. In this article, I’ll tackle how flexibility and modular technology are instrumental to delivering successful real world evidence studies and how we at Cisiv help.

First of all, while real world evidence is a ‘hot’area, with the potential to transform how we deliver
medicines to patients, the business of capturing real world data comes with a host of known challenges. Typically, in a real world evidence study: Visit schedules are unstructured and follow routine clinical care; Missing data is common; With the lower frequency of data entry and monitoring, obtaining good quality and complete data can be challenging.