With the emergence of basket trials in the early-phase oncology setting, clinical research teams are…
Like patient consent forms, site Clinical Trial Agreements (CTA) have become increasingly complex, making their review a major roadblock to efficient site start-up. The CTA is undoubtedly an important piece in the clinical trial process. The challenge, however, is how to satisfy legal requirements while simultaneously adhering to aggressive study timelines? The answer is through harmonization.
The Canadian model Clinical Trial Template Agreement (mCTA) was inspired by a two-year collaborative project between The Association of Canadian Academic Healthcare Organizations (ACAHO) and Rx&D, a group representing Canada’s research-based bio-pharmaceutical companies. Their goal was to create a standard model contract for use by sponsors and sites to simplify and expedite the start-up times for clinical trials in Canada.
Scimega then took the key elements of this template, modified certain components to better meet the needs of the Reverse Feasibility network, and further customized it for use by our U.S. clients. The result is a rapid yet thorough review and approval process that meets the legal requirements of both sponsors and sites.
- Reduces back and forth between legal teams, saving you time and legal fees
- Allows you to leverage Scimega’s relationships and negotiation skills
- Eliminates delays in IRB approval
Check out this informative Quick Reference Guide for tips and strategies on how you can reduce the number of sites you need, accelerate your site start-up times by up to 50%, and at the same time enhance your patient recruitment. On top of that, you may also find out that you qualify to save up to 30% on your professional service fees.
If you like what you read about what’s being done to disrupt the status quo and improve the process then please share it with colleagues who you feel would also benefit.
Please let us know what you and your company are doing to stay ahead of the curve and beat competitors to market that may be bigger and better funded than you. It’s time for us all to collaborate and think differently.