November 2018 – The CenterWatch Monthly : pdf
Clinical Trials and Big Data: TMI?
Clinical trials are plagued by data management problems, leading to unnecessary delays and FDA audits and potentially putting patients at risk, a new report says.
Build Quality Milestones into Sites, CRO Contracts
SAN DIEGO — Sponsors should build quality milestones into site contracts as insurance against FDA inspections, a veteran auditor told the recent MAGI conference here.
Also in this issue:
- Regulatory Update
- FDA Actions