This is because clinical trial protocols are often not detailed enough to require the specific actions that would ensure GCP compliance. For example, the Draft Guidance notes that a missing ...

A protocol designed to progressively increase physical therapy intensity for stroke survivors improved walking distance, ...

There is no need to reinvent the wheel. Look at the protocol with fresh eyes Most patients know little about clinical trial protocols and processes. Even if they understand the clinical trial ...

Patient enrollment is expected to begin in the first half of 2025, subject to final protocol review by regulatory authorities. Recruitment will commence at leading U.S. trial sites, with the potential ...

Examples of important protocol deviations provided in the guidance include the following: In general, the guidance emphasizes thoughtful clinical trial protocol design as a means to minimize ...

The US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.

Now such calls to make clinical trial data transparent – along with openly accessible protocols, papers, and summary results – are really burgeoning, and it’s easy to lose the plot.

The evolution of protocol management within eQMS represents another significant advance in clinical trials. Version control ...

A far shorter, simpler, and less toxic treatment protocol for patients with triple-negative breast cancer produced outcomes ...

Egnyte, a leader in secure content collaboration and governance, and Espero, a pioneer in clinical trial eProtocol innovation ...

Yunu, a leading provider of clinical trial imaging workflow and data management solutions, is pleased to announce its partnership with WCG, a global leader in clinical trial solutions, in support of ...