grit42 selected by major European pharma company to expand use of historical toxicology data

A major European pharma company is implementing gritSEND by grit42 to support exploratory analysis of nonclinical study data and the use of historical control data. Computer system validation will prepare the platform for generation of virtual control groups (VCGs).

The gritSEND platform from grit42 has been selected for implementation at a big European pharma company as part of a new project between its pharmaceuticals and crop science divisions. The project will bring gritSEND into the company’s infrastructure to expand the use of existing toxicology data, supporting exploratory analysis, historical control data assessment, and preparations for future generation of virtual control groups for GLP toxicology studies.

The pharmaceuticals division will initially use gritSEND for exploratory analysis of animal and toxicology study data in the Standard for Exchange of Nonclinical Data (SEND) format. The implementation also includes computer system validation within the company’s infrastructure and deployment to their crop science division to address historical control data needs, including compilation, analysis, and reporting of historical control data (HCD) for regulatory safety assessment.

The platform will support the company’s response to evolving regulatory expectations for the use and reporting of HCD, including the scientific recommendations published by the European Food Safety Authority (EFSA).

“Historical toxicology data can provide valuable insights beyond the individual studies for which they were originally generated. Through this collaboration, we are creating a shared foundation for making these data more accessible and usable,” says a VP at the company, which, like grit 42, is also a key player in VICT3R (read more below).

“The new project will support exploratory analysis today while preparing us for future use of virtual control groups in GLP studies, allowing us to decrease the use of animals in safety studies.”

Preparing for virtual control groups in GLP studies

The company intends to use gritSEND to generate VCGs for GLP toxicology studies once the relevant use of the concept has been accepted by regulatory authorities, including the European Medicines Agency (EMA).

Virtual control groups (VCGs) draw on historical data from control animals in previous studies to replace or reduce concurrent animal control groups in new studies. The approach aims to reduce animal use in toxicology research while maintaining the scientific reliability of safety assessments.

Computer system validation is an integral part of the implementation project. The platform will be validated for its intended use within the company’s infrastructure to support its planned application in GLP studies. Validation of the deployed system and regulatory acceptance of the relevant VCG application are separate prerequisites for future use.

Building on grit42’s platform development in VICT3R

The platform builds on development work led by grit42 in collaboration with partners in the VICT3R project, a public-private partnership funded by the Innovative Health Initiative (IHI). VICT3R aims to develop and implement virtual control groups to reduce animal use in toxicology research, supporting the principles of Replacement, Reduction and Refinement.

Within the collaboration, grit42 leads the development of the data platform for managing historical control data and identifying suitable data for virtual control groups.

“Building on the learnings from VICT3R and the work we have done in the project, we can offer an easy-to-use platform that makes historical control data more accessible across the organisation and easier to analyse. It basically enables the organisation to get more value out of the data they already invested in generating,” says Claus Stie Kallesøe, CEO of grit42.

“The implementation across pharmaceuticals and crop science shows how a shared data platform can support several uses of toxicology data, from exploratory analysis to historical control data assessment and preparation for virtual control groups,” says Claus Stie Kallesøe, CEO of grit42.

“We look forward to working with teams across both divisions to put these capabilities into practice.”

The project has been initiated and will run through the end of 2027.