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EQIPD · Project

Quality Management System That Makes Preclinical Drug Research Data Trustworthy

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Imagine spending millions developing a new drug, only to discover that the lab results you based your decisions on were unreliable. That's a real problem in pharma — preclinical studies (the ones before human trials) often can't be reproduced. EQIPD brought together 31 organizations from pharma and academia to build a practical quality system — think ISO certification but specifically for lab research — so companies can trust their data before committing to expensive clinical trials.

By the numbers
31
consortium partners from pharma and academia
9
countries represented in the consortium
19
industry partners involved in development
EUR 4,495,523
EU contribution to develop the system
7
SMEs in the consortium
21
project deliverables produced
The business problem

What needed solving

Pharmaceutical and biotech companies regularly make multi-million-euro decisions based on preclinical study data that may not be reproducible. When data quality fails, drug candidates advance to expensive clinical trials based on flawed evidence — or promising candidates get killed based on unreliable negative results. There is currently no widely adopted quality standard for non-regulated preclinical research, leaving a dangerous gap between lab work and regulatory studies.

The solution

What was built

EQIPD delivered a complete quality management system for preclinical research, including: consensus quality recommendations for non-regulated R&D, a working prototype of a quality reporting software module with an information exchange protocol for lab systems, a certified online educational platform for training researchers, and a governance system to ensure long-term sustainability. In total, 21 deliverables were produced.

Audience

Who needs this

Pharmaceutical companies with internal preclinical R&D labsContract Research Organizations running preclinical studiesBiotech startups preparing data packages for investors or regulatory submissionsResearch software companies building electronic lab notebooks or LIMSAcademic medical centers conducting translational research
Business applications

Who can put this to work

Pharmaceutical
enterprise
Target: Mid-to-large pharma companies with preclinical R&D pipelines

If you are a pharmaceutical company dealing with failed drug candidates that looked promising in preclinical studies — EQIPD developed a quality management system validated across multiple sites that helps you catch data quality problems before they derail your pipeline. The system was built by a consortium of 31 partners including 19 industry members, ensuring it works in real pharma environments.

Contract Research Organizations
mid-size
Target: CROs running preclinical studies for pharma clients

If you are a CRO competing for pharma contracts and need to demonstrate research rigor — EQIPD created consensus quality recommendations for non-regulated R&D and an online certified education platform. Adopting this system differentiates you from competitors by proving your data meets standards validated by 31 organizations across 9 countries.

Biotech / Life Sciences Software
SME
Target: Companies developing electronic lab notebooks or research data management tools

If you are a software company building tools for lab researchers — EQIPD developed a quality reporting module prototype with an information exchange protocol that enables transparent communication between study design assistants, electronic lab journals, and lab-based research software. Integrating this protocol into your product adds a proven quality layer your pharma customers demand.

Frequently asked

Quick answers

What would it cost to implement the EQIPD quality system?

Based on available project data, EQIPD was designed to provide simple, sustainable solutions that do not impair innovation or freedom of research. The project was backed by EUR 4,495,523 in EU funding and developed freely accessible consensus recommendations and an online educational platform, suggesting low adoption barriers. Specific licensing or implementation costs are not detailed in the project data.

Can this scale across a global pharma organization with multiple R&D sites?

Yes — the system was specifically validated through cross-site experiments and ring testing across a consortium of 31 partners in 9 countries including the US, UK, Germany, France, and others. The quality management system was designed for applicability beyond the initial neuroscience and safety focus areas.

What is the IP situation — can we use this freely?

EQIPD was funded under IMI2 (Innovative Medicines Initiative), a public-private partnership. The consensus quality recommendations and educational platform were designed for community-wide adoption. The quality reporting software module exists as a prototype with specifications for an information exchange protocol. Specific licensing terms should be confirmed with the consortium.

Does this meet regulatory requirements?

EQIPD specifically targets non-regulated R&D — the preclinical research that happens before formal regulatory studies. It fills the gap where GLP (Good Laboratory Practice) does not apply but data quality still matters critically for go/no-go decisions. The system complements rather than replaces existing regulatory compliance.

How quickly can we implement this?

The project delivered a complete quality management system with defined components, consensus recommendations, and a certified online educational platform for training staff. Based on the project's design for simplicity and sustainability, implementation timelines would depend on your organization's size, but the educational platform enables rapid onboarding.

How does this integrate with our existing lab systems?

EQIPD developed a working prototype of a quality reporting module with an information exchange protocol designed to connect study design assistants, electronic lab journals, and lab-based research software. The specifications enable integration with existing research infrastructure rather than requiring replacement.

Consortium

Who built it

This is a heavyweight consortium with 31 partners across 9 countries, and a striking 61% industry ratio — 19 industry members including 7 SMEs alongside 11 universities. Funded through IMI2 (Innovative Medicines Initiative), which means major pharmaceutical companies co-funded this alongside the EU's EUR 4,495,523 contribution. The geographic spread across Belgium, Switzerland, Germany, Finland, France, Israel, Netherlands, UK, and the US gives it global credibility. For a business buyer, the fact that nearly two-thirds of the consortium are industry players — not just academics — means this system was built by people who understand real pharma R&D operations. The University of Edinburgh coordinated, providing academic rigor, while the industry majority ensured practical applicability.

How to reach the team

The project was coordinated by The University of Edinburgh (UK). SciTransfer can help you reach the right person.

Next steps

Talk to the team behind this work.

Want to implement the EQIPD quality system in your preclinical R&D? SciTransfer can connect you directly with the consortium team and help you evaluate fit for your organization.

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