TBG’s collective drug and product regulatory experience helps companies avoid costly delays and unnecessary investor and partner risk. Our team can help development teams and investors from initial filing through regulatory approval.
TBG shared its views on the FDA’s proposed guidance for the implementation of penalties for non-compliance with existing clinical study results reporting obligations. TBG proposed a solution that allows clinical trial sponsors to verify that reporting requirements have been met.
In September 2018, the FDA released a draft guidance which proposed civil money penalties for non-compliance with the submission of clinical trial results for the inclusion in ClinicalTrials.gov.
TBG responded to the draft guidance giving their perspective on the proposed penalties and how clinical trial sponsors can ensure compliance with these requirements.
Bracken Data’s TrialCompliance Lite provides a fast and easy way to ensure your data in ClinicalTrials.gov is compliant with all current requirements. In three easy steps you can determine if your company's trial is compliant or not.
We have extensive experience in guiding development teams and investors from initial filing through regulatory approval.
We would be delighted to hear from you and discuss our consulting services. Please call +1 215 648 1208 to chat with us directly. Or write to us using the form provided here. We look forward to collaborating with you.