In a context of increasing protocol complexity and heightened regulatory requirements, Corelabs and clinical investigations are becoming closely interconnected. Core laboratories are now recognised as key partners in clinical research, particularly in trials involving medical devices (MDs) or innovative medicinal products.
According to a recent feature published in DeviceMed, co-authored notably by Dr Maurice Bagot D’Arc, founder of BluePharm, Corelabs represent a critical link in ensuring the homogeneity, robustness and traceability of data derived from specialised assessments such as imaging, ECG, pathology and biomarkers.
But what are the real strengths of Corelabs in clinical investigations? And how do they fit into the current European regulatory environment?
Corelabs and clinical investigations: definition and scope
A Corelab (Central Laboratory) is an independent structure specialised in the centralised analysis of technical data generated during clinical trials. Unlike local assessments performed at investigator sites, a Corelab standardises interpretation through harmonised and validated procedures.
In clinical investigations of medical devices governed by Regulation (EU) 2017/745 (MDR), the demonstration of clinical benefit and control of methodological bias have become major regulatory requirements. Independent and centralised evaluation of efficacy or safety endpoints directly strengthens the robustness of the CE marking dossier.
For medicinal products, Regulation (EU) No 536/2014 frames clinical trials with reinforced requirements regarding data quality and participant protection. Within this context, Corelabs contribute to generating reliable and auditable data.
It is important to note, however, that there is no explicit regulatory requirement mandating the use of a Corelab in clinical investigations. Their involvement is strategic rather than compulsory.
The main advantages of Corelabs
Standardisation and bias reduction
Inter-observer variability represents a major methodological risk in trials involving imaging endpoints (cardiology, oncology, neurology and beyond).
Corelabs implement:
- harmonised reading criteria;
- trained and certified readers;
- double-reading or blinded reading procedures.
International actors such as Medpace Core Laboratories or Clario have developed integrated platforms combining imaging, ECG and electronic data systems to reduce variability in interpretation.
By centralising assessments, Corelabs significantly enhance data consistency across multicentre trials.
Scientific independence
One of the key challenges in clinical investigations—particularly for Class III medical devices—is the objective demonstration of clinical benefit.
An independent Corelab provides:
- a clear separation between investigators and evaluators;
- enhanced data security in the event of audits;
- increased credibility vis-à-vis notified bodies.
This independence is particularly strategic in comparative trials or in Post-Market Clinical Follow-up (PMCF) studies, where the robustness of endpoints is closely scrutinised.
Regulatory robustness and traceability
European authorities expect documented, traceable and reproducible data.
The Clinical Trial Information System (CTIS), implemented by the European Medicines Agency (EMA), strengthens transparency requirements for medicinal product trials.
In this context, the structured documentation provided by Corelabs—standard operating procedures (SOPs), archiving systems, validation of analytical platforms—facilitates:
- preparation for inspections;
- compliance with Good Clinical Practice (GCP);
- consistency of statistical analyses.
The contribution of Corelabs to regulatory robustness is therefore not limited to technical interpretation, but extends to full lifecycle documentation.
Corelabs and medical devices: heightened stakes under the MDR
The MDR requires reinforced clinical demonstration and thorough justification of the benefit–risk balance.
In medical device clinical investigations, Corelabs are particularly involved in:
- interventional imaging analysis;
- validation of angiographic endpoints;
- assessment of functional performance.
Specialised companies such as NAMSA or Eurofins Biomnis combine regulatory expertise with centralised analytical capabilities to support manufacturers in their clinical evaluation strategies.
The centralised approach strengthens the quality of the dossier submitted to notified bodies, whose requirements have significantly intensified since the MDR entered into application in 2021.
Towards increased digitalisation of Corelabs
Digital transformation is also reshaping Corelab operations through:
- secure cloud-based platforms;
- artificial intelligence tools for image pre-analysis;
- integration with eCRF and electronic data capture (EDC) systems.
Publications in specialised journals such as Nature Reviews Cardiology highlight the growing use of algorithm-assisted interpretation in cardiovascular imaging, complementing human expertise.
However, artificial intelligence does not replace expert evaluation. AI tools must be validated, documented and integrated within a robust quality framework, particularly in regulated clinical environments.
Corelabs: a strategic differentiating factor
In a competitive environment where time-to-market is critical, Corelabs and clinical investigations are increasingly seen as strategic assets.
Corelabs allow sponsors to:
- improve methodological quality;
- reduce inter-site variability;
- anticipate questions from authorities or notified bodies;
- secure the demonstration of clinical benefit.
They therefore represent a significant strategic lever for both industrial and academic sponsors.
Conclusion
Today, Corelabs are inseparable from a robust development strategy, whether for medicinal products or medical devices.
In a European regulatory landscape shaped by Regulation (EU) 2017/745 (MDR) and Regulation (EU) No 536/2014, data quality, independence and traceability have become decisive criteria.
More than a technical service provider, the Corelab now positions itself as a high-value methodological partner, directly contributing to the scientific and regulatory credibility of clinical investigations.
From a recent publication in Device Med : https://www.devicemed.fr/dossiers/sous-traitance-et-services/etudes-cliniques/les-atouts-des-corelabs-dans-les-investigations-cliniques/53211
