Are your vendors meeting requirements?

? Attention clinical researchers and trial sponsors! ?

With the increased use of computerised systems in clinical trials, it is crucial that data integrity and patient safety are a top priority, and that the requirements for compliant data management are understood.

In March 2023, the EMA published guidance to address this, providing a comprehensive framework for the appropriate management of electronic data and systems throughout the clinical trial lifecycle. Key points covered include:

✅ Principles by which computerised systems should be designed, implemented, and maintained.
✅ The importance of validation to ensure reliability, accuracy, and compliance with regulatory requirements.
✅ Data management practices, including data entry, collection, storage, and backup, and the need for appropriate security measures to protect participant data.
✅ Recommendations for electronic data capture (EDC) systems
✅ Data handling and archiving practices, and the importance of maintaining data integrity, audit trails, and documentation during the archiving process.
✅ The implementation of a quality management system for computerised systems used in clinical trials. It highlights the need for proper documentation, standard operating procedures (SOPs), and training programs to ensure consistent and compliant use of these systems.

Do you need assistance in assuring the integrity of data and compliance with regulatory guidelines? Are you confident that your vendors are meeting requirements?

Don’t leave it to chance – our experienced team are on hand to provide you with comprehensive support and expert advice, and we currently have availability in Q3 and Q4 for computerised system vendor audits.

For further information on how we can assist you, or if you have any questions, don’t hesitate to contact us at info@towermains.com.