With the emergence of new and improved technology within clinical trials, Biometrics has catapulted from being “back-end” services to at the forefront of every study start-up. The additions of electronic patient reported outcomes (ePRO/Diary), eConsent, and IRT/RTSM either within the Electronic Data Capture (EDC) system or via Application Programming Interface (API), connections with external vendors have led data managers, programmers, and statisticians to be an integral part of study start-up and database build. This early involvement in critical, as these applications typically need to be set-up before the first subject is enrolled. This may include everything from eConsent being available at the very beginning of subject screening, and ePRO being available for subject entry, to the randomization list provided by the statistician being uploaded into IRT/RTSM for the subject to receive the correct treatment. These are all components that have become mainstream at the beginning of clinical trials. Linical is also seeing a vast increase in requests for software and systems to support de-centralized trials and telehealth - all of which are heavily supported through Biometrics.
The industry is starting to lean towards systems that offer more than just standard EDC. Sponsors are requesting a single sign-on clinical data management system that includes most, if not all, of the technology components along with analysis, reporting, and metrics. And…..they want it with the best quality and at an economical cost that will not over-burden their company or study budget. A clinical trial can have the best sites, study coordinators, CRAs, operations, and protocol design. However, if have you have not collected your data in the appropriate format, chosen the wrong EDC system, or cannot retrieve or analyze your data, then your efforts will have been futile.
So, what is the path forward? First, selecting a CRO/Vendor that can seamlessly bring all of the technology together to support your clinical trials in a timely, cost-efficient, quantitative and qualitative way is crucial. You want to make sure the technology is compliant and certified following ICH-GCP guidelines, CDISC/CDASH, 21 CFR Part 11, and GDPR just to name a few. Your selected partner and their highly skilled team of experts will ensure that the technology and data are properly managed from study start-up to the filing of your regulatory submission and everything in between.
Who? Linical
What? Your partner in Clinical Trials, Biometrics and Technology
When? Now
Why? Because we are the Right Size, Right Reach, and the Right Team
How? Contact Us!
Author:
Linical Biometrics Department