ACDM Latest News

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

Instem help over 700 international clients efficiently access, capture, analyze, report and submit high quality regulatory data, while maintaining compliance for their products around the world. This is combined with their unique ability to generate new knowledge through the extraction and harmonization of public and proprietary sources of actionable scientific information.

Instem joined the ACDM for its networking and educational benefits within the industry.

Members gain many benefits from membership, including:

• Access to training courses at a discounted rate
• Assign full ACDM membership to all individuals within your organisation
• Place an organisation profile, description and logo on the ACDM website
• Advertise jobs for your positions within your organisation
• Reduced price attendance at conferences and symposia
• Free attendance at Hot Topics

Find out more about becoming a corporate member here.

The R&D industry, especially those that are working on clinical trials, have been waiting for the new release of ICH GCP E6. The 3rd revision of the Good Clinical Practice (GCP) E6 guidance has been recently published as a draft, for public review and consultation.

What is changing in E6 revision 3? E6 is undergoing a complete restructure with the aim to address the complexity, diversity and new technology deployed in modern clinical trials and will consist mainly in two different main sections. One mainly focused on ‘traditional’ interventional clinical trials (Annex 1) and the other on ‘non-traditional’ clinical trials, to include designs such as pragmatic and decentralized clinical trials (Annex 2).

The ACDM Regulatory Considerations Expert Group is going to initiate a thorough review of this new draft guidance, to assess how new recommendations will impact on clinical trials and on any activities where data management is directly or indirectly involved. 

If you are interested in knowing more about this new ICH GCP guidance, and would like to be involved in this new challenge across the clinical trials environment, please reach out to the ACDM group or DMEG chair, Silvia Perez-Torres: https://lnkd.in/dCRGK5T%20 

The ACDM Regulatory Considerations Expert Group have reviewed and submitted comments on the recent draft FDA Guidance: Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers.

The guidance provides an overall overview about the most relevant key points to consider on the use of electronic systems, electronic records and electronic signatures in clinical investigations. It also provides recommendations regarding the requirements, under 21 CFR part 11, under which FDA considers electronic systems, electronic records, and electronic signatures to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.

This guidance has been open for public consultation and the Regulatory Considerations Expert Group have provided feedback to the FDA on some points that may need further clarity, on behalf of the ACDM. The final guidance is expected to be released once the FDA have reviewed and agreed on implementation feedback received for the whole international clinical trials community.

The ACDM Regulatory Considerations Expert Group looks at providing guidance information on a number of areas surrounding regulations. If you are interested in joining, find out more here: https://acdmglobal.org/regulatory-considerations-dmeg/

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

Founded in 2013, Algorics is a specialized data solutions partner to the clinical research and life sciences industry focusing on data management, biostatistics, programming, and data standardization. Driven by their next-generation technology suite – MetaVate and Clarity, an innovative solutions platform and a highly experienced team, they provide end-to-end, cost-effective, and high-quality analytical services. Underpinned by technology know-how and access to high-quality talent across the US, Europe, and Asia, they help their global portfolio of biopharmaceutical and CRO clients increase productivity and accelerate development, with robust data standardization and faster statistical reporting.

Algorics joined the ACDM to contribute to the impact the ACDM are creating for the clinical data community, participate in sharing their innovations, learn from peers and ultimately work towards a harmonious data ecosystem.

Members gain many benefits from membership, including:

• Access to training courses at a discounted rate
• Assign full ACDM membership to all individuals within your organisation
• Place an organisation profile, description and logo on the ACDM website
• Advertise jobs for your positions within your organisation
• Reduced price attendance at conferences and symposia
• Free attendance at Hot Topics

Find out more about becoming a corporate member here.

The European Medicines Agency (EMA) have published the new guidelines on computerised systems and electronic data in clinical trials.

This guideline will provide an understanding of regulatory expectations to validation, operation and safe use of IT systems in clinical trials.

Click here for more information.

The FDA has issued a final guidance to provide information on risk-based approaches to monitoring the conduct of clinical investigations of human drug and biological products, medical devices, and combination products.

Find out more.