August 2019 – The CenterWatch Monthly : PDF
Fighting Back Against Scope Creep: Options for Clinical Trial Sites
Research sites often struggle to keep
studies on-time and within budget in
the face of resource-gobbling protocol amendments from sponsors. But sites
have more leverage than they realize, with
several options available for controlling —
or at least mitigating — ”scope creep”...
Risk-Based Monitoring May Be Efficient, But Also Costly, Industry Says
Drug sponsors using risk-based monitoring (RBM) of trials have run into roadblocks in implementing a concept the FDA says can help run studies more effectively and efficiently. Increased cost, personnel resources, adapting to new technology and uncertainty about regulatory priorities all are slowing momentum, industry experts say...
Also in this issue:
- Regulatory Update
- FDA Actions
- Study Lead Opportunities