FDA Posts PDUFA VII Meeting Minutes Centered on Sentinel, REMS Assessments
The FDA has released minutes from its meetings in early 2021 with industry on PDUFA reauthorization, discussions that focused on the agency’s Sentinel drug surveillance system and proposed Risk Evaluation and Mitigation Strategies (REMS) assessments. … [Read more...]
Five Ways Study Sites Benefit from Remote Monitoring
Authored and contributed to PharmaLeaders by Jeff Pool, VP of Revenue at Florence Healthcare Failed remote site access and monitoring attempts have left study sites with a computer full of access portals, FTP logins, document vaults, and emails. Why do sponsor remote site access and monitoring rollouts fail? Because the sponsor focuses on solving their access problems – … [Read more...]
5-Step Checklist for Compliant Marketing Campaigns
Author: Jim Walker, Contributing Editor, PharmaLeaders Issues surrounding customer privacy regulations continue to increase. It’s essential that marketers give greater attention to how they source leads, manage customer data, execute communications, and drive follow-up engagement. Working in a complaint communications environment requires a coordinated effort between … [Read more...]
Veeva and Cvent Announce Integration of Best-in-Class Events Management Capabilities
PLEASANTON, CA and TYSONS, VA — May 1, 2019 — Veeva Systems (NYSE:VEEV) and Cvent today announced the companies will integrate Veeva CRM Events Management with Cvent’s meetings management software. These complementary offerings will give joint customers an integrated solution for compliant end-to-end management of meetings and events, including congresses, conferences, and … [Read more...]