Bracken’s collective regulatory experience helps companies avoid costly delays and unnecessary risks. Our experts help development teams from initial regulatory authority contact including pre-IND communications, IND submission to NDA submissions and filing through regulatory approval.
In September 2018, the FDA released a draft guidance which proposed civil money penalties for non-compliance with the submission of clinical trial results for the inclusion in ClinicalTrials.gov.
Bracken responded to the draft guidance, giving their perspective on the proposed penalties and how clinical trial sponsors can ensure compliance with these requirements.
Bracken's Clinical Trials for HubSpot and Salesforce integrates public clinical trial data into your CRM, adding unique search functions, reporting capabilities, and automation.
No separate software, no downtime for a learning curve – just clean data that drives business.
Schedule a demonstration to learn how Clinical Trials for HubSpot & Salesforce can work for you.
We have extensive experience in guiding development teams from initial regulatory authority contact including pre-IND communications, IND submission to NDA submissions and 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.