For years, technology’s detractors have bemoaned the loss of in-person interaction. While we admit this has been an issue on occasion, it’s now an asset to moving important clinical research forward.
Many human and animal health studies are either still done on paper or require labor-intensive source document verification (SDV). If sites are not using technology for direct data entry, in-person site visits are required to track the data throughout the life of the study.
Another prevalent challenge under current “social distancing” norms is to obtain signatures remotely that are CFR 21 Part 11 compliant. Many data managers are considering eliminating DocuSign as insecure. Adobe Sign has likewise been found by some to be untrustworthy as PDFs can be changed after the original signing. The print/sign/scan method is outdated and cost prohibitive. Many team members do not have printer/scanner combinations in their home office.
Finally, many GCP studies are struggling right now due to a lack of study participants coming into their clinics or bringing their pets back for follow-ups. Enrollment and compliance with a visit schedule are not feasible in these uncertain times where many patients aren’t even allowed in the door.
Given the challenges above, a robust electronic data capture system (EDC) can be more valuable to clinical trials than ever before. Prelude’s EDC, VISION, has been officially CFR 21 Part 11 compliant for close to two decades. The system has been purposefully designed to make direct data entry as seamless as using paper, with eCRFs capable of mirroring the same look and feel as a paper form.
Prelude’s new ePro application gives patients and pet owners unprecedented access to their own forms so that they can follow up on their enrollment schedule from their own home, in many cases eliminating the need to visit clinical sites.