PVExpert™

This highly specialized service involves ‘on the firing line’ ammunition – as and when you need – to guarantee effectual negotiation with regulators and HTAs or other external stakeholders. Such ammunition is provided through access to panel of PV KOLs and SMEs to assess patient safety profiles, review safety data listing and perform signaling analysis.

PrimeVigilance’s experts can address ad-hoc questions during development of safety management plans of clinical campaigns, queries upon creating the pregnancy/safety guidelines and forms to ensure proper reporting of pregnancy and SAEs or during the preparation of charters for DSMB, Endpoint Assessment/Adjudication or Clinical Trial Steering Committees.

From committee charter creation – ideally starting upon finalizing the clinical trial/study protocol synopsis – to running and management (e.g., organizing ‘open’ sessions between DMC and Clinical Trial Steering Committee), our SMEs and regulatory experts can advise you on:

• Specific reporting requirements of DMC analysis and recommendations of serious and unexpected events related to the safety of the investigational product/IND or medical device/IDE, and
• Those events that do not strictly meet the definition of ‘serious’
• The appropriateness of collecting selective safety data in specific pre-approval or post-approval late-stage clinical trials, harnessing ICH E19, and contribute in your negotiations with regulators.