BEFORE
Tekton Before RealTime
- Paper-based eRegulatory system
- Slow study start-up
- No remote monitoring
AFTER
Tekton After RealTime
- Digital eRegulatory system
- Faster study start-up
- Full remote monitoring
Overview
Tekton Research, Inc. is a privately held clinical research site based in Austin, Texas. They specialize in rheumatology, pediatrics, general medicine, women’s health, neurology, and dermatology studies for pharmaceutical and medical device companies.
The Challenge
Tekton Research wanted to enable full remote monitoring and needed to be able to upload, manage, and share source documents with monitors and sponsors without redacting sensitive patient health information.
The Solution
Tekton implemented RealTime-Complion, a flexible eRegulatory solution using unsurpassed metadata technology to ensure that documents are filed with the right information to enable easy and reliable search. The easy to use platform provides remote access to documents on any internet connected device. Thanks to the system’s ability to control access and permission by role and by document, Tekton is now able to share documents with sponsors and monitors while maintaining HIPAA compliance.
“During an FDA surveillance inspection of our site, the inspector was able to collect the required regulatory documents in less than an hour with Complion. And the inspector had no findings.”
Susan Bonner, BS, RPh, Regulatory Manager
Tekton Research, Inc.
The Results
Using the Complion platform, Tekton increased speed to inspection readiness fourfold over their previous paper-based system, as the platform automatically identifies missing training and signoff requirements. When the FDA conducted an unannounced surveillance inspection, the inspector needed only an hour to collect the 300+ documents needed. With Complion, Tektok can easily able to obtain signatures from the right people for the right versions of start-up documents such as the 1572, FDFs, Data Privacy forms, sponsor-specific CVs, etc. Plus, multiple users can file start-up documents simultaneously, even when working remotely.
- Key Takeaways
With RealTime-Complion, Tekton Research increased speed to inspection readiness fourfold over their previous paper-based system. Other benefits include:
- Accurate signoff
- Faster audit readiness
- Direct document access
- Faster study start-up
Ready to explore the leader in clinical site technology? We’d love to connect. Complete the form to learn how RealTime’s eRegulatory/eISF solutions can work for you.
