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Bringing the Benefits of eCOA BYOD Strategies to Clinical Studies

pharmaphorum

Both the EMA and FDA have released draft guidance on the issue and are currently soliciting feedback. Increased study adherence: Patients are most familiar with their own devices, and the ability to download an application and complete entries on a device they understand increases their adherence to the study requirements.

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Methodology to Define a Pharma 4.0™ Roadmap

ISPE

™ Roadmap Emmie Heeren AREND JAN WASSINK Venkateshwar Rao Nalluri, PhD Sebastian NIEDERHAUSER 1 May 2023 In the context of data integrity, data flows are essential. The FDA, PIC/S, and WHO have all emphasized the importance and benefits of data flows in their guidance on data integrity. Published 30 November 2018.