Clinical CRO

Our CRO is a key partner in the evaluation of healthcare products, offering comprehensive clinical research services, including data collection and analysis.
We offer support in the form of technical assistance, management of all or part of clinical projects, or training in compliance with regulatory standards and GCP, covering scientific affairs, clinical operations, data management, biostatistics and clinical evaluation.
Benefiting from extensive experience in the field (CRO founded in 1992), our organization has adapted to regulatory and technological developments to meet the growing needs of laboratories and manufacturers.
Our clinical offer perfectly complements Efor group’s portfolio of services by offering expertise in the collection, analysis and valorization of clinical data essential for placing and maintaining health products on the market.

Scientific and medical knowledge, and the ability to research, understand and communicate this knowledge, are the cornerstones of clinical research – and the Scientific and Medical Affairs department plays a crucial role in these activities. Structured around three main activities, notably conception, support and synthesis, this department is involved at every stage of a clinical research project.
• Drafting or proofreading of synopses, protocols, CRFs, newsletters, etc.
• Support throughout the study:
Clinical operations teams (review of documents);
o Data Management teams (medical coding, data review);
o Statistical teams (SAP review, interpretation of results).
• Clinical study report writing.
Our teams can also support you in your efforts to disseminate and communicate your study results by writing articles for peer-reviewed journals, popularized content for blogs and websites, posters, in-house medical or sales training content, etc.

The Clinical Operations team coordinates, supervises and executes clinical studies on behalf of sponsors, ensuring that each study is conducted in accordance with established protocols, Good Clinical Practice (GCP), and local and international regulations.
Our teams are involved in:
• Drafting or proofreading the study’s essential documents (synopsis, protocol, CRF);
• Preparing and submitting the necessary files to regulatory authorities and ethics committees;
• Identifying, qualifying, contracting and opening sites;
• Coordination of the study (planning, follow-up, etc.) and third parties (centralized laboratories or other service providers) and management of study sites and documents (TMF, etc.)
• Monitoring (on-site, remote, risk-based) and management of data collection by Clinical Research Associates (CRAs).

Clinical data management is a complex process, involving three crucial phases to ensure the integrity, quality and usefulness of the data collected. Our teams can support you in the following activities:
• Drafting essential documents (Data Management Plan, Data Validation Document, etc.) ;
• Design, validation and maintenance of eCRF (Electronic Case Report Forms), ePRO (Electronic Patient Reported Outcome), and other data collection and transfer interfaces;
• Adaptation to CDISC format (CRF CDASH and SDTM) if necessary;
• Quality analysis (management of inconsistencies) and medical coding;
• Data review and “base freezing”.

Biostatisticians are the CRO’s data analysis experts. Their skills are called upon at various critical stages of a clinical study, and their work is fundamental to the reliability and credibility of the conclusions drawn. They are involved in various fundamental stages of a clinical project, notably:

• Calculation of the sample size required for the study and description of analysis methods in the protocol;
• Creation of randomization lists;
• Drafting of a Statistical Analysis Plan (SAP) and Tables Listings Figures (TLFs) mock-up;
• Adaptation to CDISC (ADaM) format for studies, if necessary.
• Statistical programming and analysis;
• Drafting of statistical reports.

Clinical evaluation is an essential process for placing and keeping MD on the market (IVDDs require a “performance evaluation”). Our methodical and rigorous approach, which complies with European regulations (Regulations 2017/745 and 2017/746), guarantees an in-depth, objective analysis of the data available on the device under evaluation.
• Conducting the evaluation: strategy development, definition of safety and performance claims, systematic analysis of non-clinical and clinical data, demonstration of compliance of evaluated devices with General Safety and Performance Requirements (GSPR), identification of gaps and actions to be implemented by the manufacturer;
• Post-market clinical (MD)/performance (IVDD) monitoring;
• Response to non-conformities issued by notified bodies;
• Critical review, signature (after validation of conformity) as an independent assessor of evaluations written by our clients.