Timing is Everything with Clinical Trial Disclosure 

March 31, 2015 Monique Garrett

Timing adn ComplianceClinical Trial Disclosure is a complex process. It is difficult to manage because of the dynamic nature of the data being disclosed as well as the registration requirements that are emerging. You cant just throw technology at it. But you can use technology, experience and documented processes to improve your approach. 

INTRODUCTION:

Clinical Trial Disclosure is a complex process. It is difficult to manage because of the dynamic nature of the data being disclosed as well as the registration requirements that are emerging. You cant just throw technology at it. But you can use technology, experience and documented processes to improve your approach. You can decrease actual resource time which can be a significant cost savings. but you can also decrease calendar time - which usually translates to increased compliance, decreased risk and a host of other good things. 

One clinical trial sponsor implemented PharmaCM as the foundation for their clinical trial transparency efforts. They measured actual and calendar times pre- and post-implementation. Check out their results!

Actual Time

  • Actual time for registration tasks (including initial registration and updates) were reduced by 75% (80 hours reduced to 20 hours).*

Calendar Time

  • Calendar time required for an initial registration decreased by 66% (180 days reduced to 60 days).
  • Calendar time for initial results decreased by 50% (360 days reduced to 180 days) while task time was reduced by 25% (120 hours reduced to 90).
  • Automated workflows enforced deadlines and helped to institutionalize compliance deliverables and deadlines

Assumes one initial study registration, 2 updates for protocol amendments and 1 requested update, one initial study results submission and one requested update to results. 

CONCLUSION:

There are lots of ways to measure the benefits of your clinical trial transparency efforts. Time savings yield much more value than simple resource costs. Make sure you are giving your team credit for their time savings!

If you'd like to see more case studies, check out the Resources page on the TrialScope website. 

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