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Important factors to consider when working with CRFs

pharmaphorum

Well-designed forms must: Gather data that’s complete, accurate, and of high quality. Be unambiguous and allow for accurate data entry. Avoid gathering more data than what is needed. Provide form completion guidelines to reduce data capture and data entry issues. Avoid duplication. Get user feedback.

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How using AI in clinical trials accelerates drug development

Pharmaceutical Technology

5 examples of AI for clinical trials By using AI-driven algorithms for a wide range of tasks, from data entry and analysis to improved medical diagnoses, companies can reduce the time and cost associated with drug development. Adverse event detection Adverse events, or unexpected side effects, are a crucial aspect of clinical trials.

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Considerations for safety data migration methods

European Pharmaceutical Review

For E2B and E2B hybrid migrations, it is important to consider the non-transferable data requirements for the database” If additional non-transferable data is required, a technical migration can be performed, which involves uploading ICSRs into the safety database as electronic E2B files with manual data entry for the additional data.

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The Best 24 Easy-to-Use AI Tools

FADIC

BRIA AI’s state-of-the-art technology allows real-time patient health monitoring, enabling clinicians to make informed decisions and take proactive measures to prevent adverse events. can analyse and optimise data, ensuring that it is accurate, up-to-date, and easy to interpret.

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What are the elements of quality control process in pharmaceuticals

GMPSOP

The analyst should ensure that the supervisor is notified as soon as an OOS event occurs, the sample is retained, and a documented investigation is commenced. Dealing with out-of-specification results Laboratory result out-of-specification events are a common occurrence in the quality control process. Checkout sample preview s.

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Overview of GLP requirements on everyday laboratory operations

GMPSOP

. – Record or capture all generated raw data directly, promptly and legibly. – Use traceable data sheets or sequentially numbered notebooks. – Date and sign or initial data entries on the day of entry. – Archive records so that they are protected, secure, and easily retrievable.

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Typical GMP documentation in a quality control laboratory

GMPSOP

Data management policy : This policy governs activities for data entry, storage, and retrieval to ensure the integrity of laboratory results. Record keeping policy : this policy outlines procedures for documenting laboratory activities, including data, results, and observations.