Latest News from ACDM
Established in 1987, The Association for Clinical Data Management (ACDM) is a Membership Organisation for individuals and organisations involved in the management of clinical data. Please find below the latest news from the ACDM.
August 16, 2023 | New Member
Welcome Instem as a new corporate member
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.
June 19, 2023 | News
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 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The ACDM Regulatory Considerations Expert Group is going to initiate a thorough review of this new draft guidance, to assess how new recommendations will impact on clinical trials and on any activities where data management is directly or indirectly involved.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
June 19, 2023 | News
Regulatory Considerations Expert Group reviews draft FDA Guidance
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/
May 18, 2023 | News
Welcome Algorics as a new corporate member
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.
April 25, 2023 | News
Guideline on computerised systems and electronic data in clinical trials
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.
April 25, 2023 | News
FDA Guidance for Industry
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.
More News
New MHRA Guidance April 25, 2023
Consultation response on legislative proposals for clinical trials April 25, 2023
Welcome IROS – Insights Research Organization & Solutions as a new corporate member February 9, 2023
Recommendation paper on decentralised elements in clinical trials December 19, 2022
Welcome George Clinical as a new corporate member December 16, 2022
Welcome Clinion as a new corporate member December 7, 2022
Welcome ClinoSol Research as a new corporate member October 18, 2022
CTU DMEG Update September 29, 2022
ICH E8 (R1) General Considerations for Clinical Studies Impact on Data Management April 5, 2022
Have your say – MHRA’s public consultation on proposals for legislative changes for clinical trials January 26, 2022
Signant Health are ACDM22 Photography sponsors November 19, 2021
Anju Software is exhibiting at ACDM22 October 29, 2021
SGS Health Science to sponsor ACDM Awards for the second year running October 1, 2021
ACDM Interactive September 7, 2021
nuvoteQ to be a Premier Sponsor of ACDM22 August 23, 2021
IQVIA to be a Premier Sponsor of ACDM22 August 19, 2021
Anju Software to be a Premier Sponsor of ACDM22 August 15, 2021
CORE to be Premier and Interactive Sponsor for ACDM22 August 12, 2021
eClinical Solutions to be Premier and Communications & Social Media Sponsor for ACDM22 August 5, 2021
ACDM Annual General Meeting July 29, 2021
Phastar announced as Premier & Conference Dinner Sponsor of ACDM22 July 1, 2021
New online training course – Risk Based Monitoring May 4, 2020
Building data management success in Sponsor/CRO relationships online webinar 30th April April 22, 2020
ACDM21 – Location announced April 8, 2020
ACDM Hot Topic Discussion – Implications of COVID-19 on clinical data management activities globally March 31, 2020
ACDM eDigital DMEG publishes its GDPR Q&A report March 30, 2020
ICON to be Premier & Award Sponsors for ACDM20 December 2, 2019
New Online Learning Course – Understanding Laboratory Data November 19, 2019
Nominations now open for ACDM Awards 2020 October 14, 2019
Phastar announced as Networking Sponsor for ACDM20 July 9, 2019
ACDM20 Dates & Venue July 1, 2019
Launch of Online Training from ACDM March 24, 2019
ACDM 2019 Awards Finalists February 22, 2019
Castor EDC to Sponsor ACDM19 January 15, 2019
Danone Nutricia Research to Sponsor ACDM19 November 26, 2018
ACDM19 Conference Programme November 21, 2018
Record Number of Abstracts Submitted for ACDM19 October 1, 2018
Phastar Sponsor ACDM19 September 3, 2018
Launch of Annual ACDM Awards September 1, 2018