Conducting clinical trials is a document intensive process, with all departments involved in the creation and review of documents related to submissions. These include protocols, reports, memos, certifications, contracts, quality agreements and clinical investigator agreements.
In 2009, Amarin needed a solution that could simplify and speed up this process, especially as the Phase 3 trials had received FDA approval to proceed.
- Assures document confidentiality
- Improves collaboration with reviewers working on the same document at the same time
- Cuts down on duplicate comments by letting reviewers see and respond to each other
When implementing PleaseReview, there was virtually no set up except knowing who was going to be set up on the system and the training was easy because PleaseReview is really intuitive for people to usePeggy Berry, Vice President and Head of Quality & Regulatory Affairs, Amarin