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...

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