Clinical Data Management News & Insights

HMA/EMA joint Big Data Steering Group: Big Data Workplan 2023-2025

The joint HMA-EMA Big Data Steering Group (BDSG) have released their latest workplan, . . .

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ACT EU PA04 – Multi-stakeholder Workshop on ICH E6 R3

As part of the Accelerating Clinical Trials in the EU (ACT EU) multi-annual workplan . . .

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European Medicine’s Agency – Reflection paper on the use of artificial intelligence in the lifecycle of medicines

The EMA has opened a public consultation on a reflection paper presenting views . . .

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Welcome Instem as a new corporate member

The ACDM: Association for Clinical Data Management is delighted to welcome Instem as a new . . .

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Regulatory Considerations Expert Group reviews draft FDA Guidance

The ACDM Regulatory Considerations Expert Group have reviewed and submitted comments on . . .

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ICH GCP E6 Revision 3 is here. Regulatory Considerations Expert Group to review

The R&D industry, especially those that are working on clinical trials, have been . . .

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Welcome Algorics as a new corporate member

The ACDM: Association for Clinical Data Management is delighted to welcome Algorics as a . . .

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Consultation response on legislative proposals for clinical trials

The MHRA have published the public consultation response to the proposals to reform the . . .

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New MHRA Guidance

The MHRA have published new guidance on ‘Software and Artificial Intelligence (AI) as a . . .

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FDA Guidance for Industry 

The FDA has issued a final guidance to provide information on risk-based approaches to . . .

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Guideline on computerised systems and electronic data in clinical trials

The European Medicines Agency (EMA) have published the new guidelines on computerised . . .

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Welcome IROS – Insights Research Organization & Solutions as a new corporate member

The ACDM: Association for Clinical Data Management is delighted to welcome IROS – Insights . . .

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