Evaluating and Selecting the Best Clinical Trial Data Management Partner

Sponsors at the forefront of clinical research are looking for much more than just another clinical trial data management partner. Today, the selection criteria is evolving almost as rapidly as technology itself. Sponsors are seeking a partner who has adopted a technology-forward roadmap, that includes automated data collection, superior analytic tools, and preparation for AI.

Two critical questions to consider:

1. What criteria are we using to evaluate partner(s) and select the best one?

An experienced and successful clinical data management partner will differ from other vendors in their platform’s robustness, functionality, integration, and user experience. Some key criteria to consider in your evaluation process:

• Capabilities: Is the platform feature rich, intuitive, and customizable?
• Seamless Integrations: Can we collect the data we need from EHRs and medical devices?
• Cost effectiveness: Does this partner fit our budget for upfront and ongoing costs?
• Scalability: Can this partner scale with our studies (and our success)?
• AI: How are they leveraging AI?
• Compliance: Do they adhere to 21 CFR Part II, GCP, GDPR, HIPAA?
• Reputation: Do they have ample experience with a track record of success?
• Support: How quickly can this partner respond to issues and mid-study changes?

2. Can this partner accelerate our FDA approvals?

While technology alone cannot guarantee FDA approval, it can significantly contribute to quicker regulatory submissions that ultimately lead to faster approvals, which is a priority for every Sponsor. The best clinical trial technology partner will:

• Streamline processes
• Improve data management & accessibility
• Provide real time data analytics & reporting
• Ensure data integrity via compliance & audit trails
• Improve the quality of your data
• Prepare your data for AI

If you’re seeking a clinical trial data management partner, contact Simplified Clinical to find out more about our service offerings and expertise.