Ideagen
139 Case Studies
A Ideagen Case Study
Amarin Corporation, a biopharmaceutical company focused on cardiovascular therapeutics (headquartered in Dublin with a US office in New Jersey), faced a document‑intensive challenge as Phase 3 clinical trials began. Protocols, reports, contracts and other submission materials were circulated by email or hard copy, creating confidentiality risks and a slow, frustrating process for collating and reconciling many duplicated reviewer comments.
Amarin implemented PleaseTech’s PleaseReview private‑cloud solution, which required minimal setup and training and provides secure remote access company‑wide. By letting reviewers work on a single draft simultaneously and view each other’s comments, the tool eliminated duplicate feedback, improved collaboration across regulatory, quality, clinical, CMC and business teams, and significantly reduced the time needed to manage reviews.
Peggy Berry
, Vice President and Head of Quality & Regulatory Affairs