THOUGHT LEADERSHIP

Leveraging the advantages of electronically captured patient-reported data in early phase trials

As clinical trial planning begins, PROMETRIKA Clinical Trial Managers (CTMs) and Project Managers (PMs) are often asked by Sponsors to assess the pros and cons of using paper documentation (e.g., diaries) vs. electronic data entry for patient-reported data. Our broad experience with different phases of clinical trials helps us advise Sponsors on this decision.

The importance of keeping an inspection-ready electronic trial master file (eTMF) at all times cannot be understated; the TMF tells the story of the clinical trial and should serve as the ultimate source of truth for the study. An inspection-ready TMF is complete without being redundant and efficient while still upholding high standards of quality. This might sound like a lot of work, but don’t let it intimidate you; an inspection-ready TMF can be achieved by following the steps outlined below.

We had the opportunity to present our paper, “Optimizing SAS Programming Pipelines Using the %Unpack and %SearchReplace Macros for Version Control and Customization”, written by Ning Ning, Statistical Programmer I, and Assir Abushouk, Manager, Statistical Programming, at PharmaSUG 2025 in San Diago. The presentation focused on a practical SAS macro program we developed to address common challenges in clinical programming, particularly around version control, customization, and study startup efficiency in CROs.

PROMETRIKA’s Biostatics and Statistical Programming teams continually seek new and innovative ways to address the many functions of data analysis in clinical research. Our statistical programmers have had numerous successes in researching and developing new programs and methods that reduce time and steps in analyses.

At the recent CDISC Europe Interchange in Geneva, I had the honor of presenting the details of a project mapping clinical data into CDISC SDTM, with a twist. It was a small healthy volunteer study run at a single clinic where the site investigator built the data capture system in REDCap.