Read more about the article FDA Guidance for Industry:  Providing Regulatory Submissions in Alternate Electronic Format
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FDA Guidance for Industry: Providing Regulatory Submissions in Alternate Electronic Format

Issue Date: 24Jun2022   The US Food and Drug Administration has recently issued a final guidance for sponsors and applicants who receive an exemption or a waiver from providing regulatory…

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Read more about the article White Paper: Understanding Patient Recruitment and Retention 
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White Paper: Understanding Patient Recruitment and Retention 

Author:  Reeshav Mittal, Associate Director, Clinical Operations, Cloudbyz Inc.   Table of Contents Introduction What is RECRUITMENT? – SOME DEFINITIONS Major Critical Barriers to Patient Recruitment Retention in Clinical Trials…

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Regulatory Compliance Coverage & Reference between FDA 21 CFR Part 11 and EU Annex 11

Until recently, clinical trials have been performed in a mostly paper-based processes. Advancements in technology, surge in remote work and digitization of the processes is driving the clinical research industry…

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Solving Regulatory Challenges: CSV for Cloud-based Clinical Applications

A comprehensive session exploring the regulatory challenges for clinical application. Rajendra Sadare, Head - Quality & Compliance from Cloudbyz goes deeper to explain the challenges, the expectation and the possible solutions.Watch…

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Wearables in Clinical Trials: An Overview of Challenges

Wearable Tech-What’s It All About? Let’s start from the very beginning. What are people talking about when they say “wearables”, “wearable biosensors”, “wearable devices”, or “wearable technology” in clinical trials?…

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