Pharma IT Insights

Notice to Sponsors: Validation and Qualification of Computerised Systems Used in Clinical Trials

By Jakob Juul Rasmussen

June 1, 2021

Pharma IT Insights

Notice to Sponsors: Validation and Qualification of Computerised Systems Used in Clinical Trials

By Jakob Juul Rasmussen

June 1, 2021


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Regarding the outsourcing of clinical trials, the relationship between sponsors and their Contract/Clinical Research Organisations (CROs) is a complex one.
This insight, provides a useful tool that can be used as a guide for sponsors looking to ensure a CRO's IT Systems are compliant.

CROs provide an invaluable outsourcing opportunity in pharma and medtech industries. However, sponsors are ultimately responsible for the provisioning of adequate validation for the computerized systems used within the partnership. That’s why your organization should be thinking about Computer System Validation (CSV) as early as possible! This best practice ensures compliance and will allow you to handle risks in due time.

Assessing CRO IT Systems

To aid in this process, Pharma IT proposes that you assess your CRO’s IT systems according to the following matrix and plan your CSV activities accordingly.  The matrix divides recommendations across four system uses, or category inputs (A-D), and from there, distinguishes between critical and non-critical computerised business systems.

This matrix should be used in conjunction with the advice shared in an insight published by Pharma IT earlier this year concerning the initial steps when conducting audits and approvals of CROs:

Tip 1: Make sure to include IT system validation as part of the vendor audit/approval process

Tip 2: If a system validation can’t be conducted as part of the vendor audit/approval process, establish a risk assessment

Tip 3: If you want to use your vendor’s own qualification documentation, make sure to read up on EMA GCP guidelines

To read a more detailed description of these tips, you can check out our full insight on the matter here.

Need further assistance? Pharma IT can help!

At Pharma IT, we are aware that conducting clinical trials is a complex process that involves expertise from a wide range of fields. For this reason, we have assembled a diverse, talented, and highly experienced team of Clinical Trials & Science Operations, Drug Development, CMC, and IT consultants.

Feel free to contact us if you’re in need of assistance — we’d be happy to help!


About the author(s)

Jakob Juul Rasmussen is Managing Director of Pharma IT and has over 14 years of experience managing IT projects within Pharma, Finance, and the Public Sector.