Remote Study Start-up Whitepaper
Worried about your research program stalling due to Covid-19? Tranquil Clinical Research has the solution for safely and successfully starting up your trial during a pandemic.
The FDA’s Guidance on Conduct of Clinical Trials during the COVID-19 was recently updated on May 15th, 20201.
Even with this FDA guidance there is a lack of information on starting up clinical trials during this time. Sponsors may be conflicted on whether to hold study start or delay indefinitely.
Tranquil Clinical Research has the way to start up a clinical trial successfully and safely during a pandemic. Study start up times can take on average 5-6 months2; therefore, getting a head start on this process makes sense. You can use this “downtime” to your advantage and ensure that your trial is ready to enroll when the time is right.
Tranquil Clinical Research has e-solutions for regulatory document completion and submission, which are fully 21 CFR compliant. In addition, our systems allow for remote negotiation and full execution of budgets and contracts. Our team can complete the entire process, from feasibility, to site evaluation and through to site initiation, remotely. This effort will allow your trial to continue straight into recruitment once sites are able to engage with patients once more.
Your clinical trial will be safe with Tranquil.
Get in touch with our CEO, Karim Mohammed, today!
1 (March 2020 – Updated on May 14, 2020). FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency/Guidance for Industry, Investigators, and Institutional Review Boards
2 Morgan, C. (April 2018). Inconsistencies Prevalent in Study Start-Up. Drug Development and Delivery, 18(3)[wpdm_package id=’327′]