CRO - Clinical Affairs

Adopting a Proactive Approach

We understand the challenges you face and help you make informed decisions that facilitate market access and ensure the continued compliance of your medical device. Far more than a traditional CRO, we offer tailored strategies that make sense for you.

➜ Defining the Clinical Strategy

Support in developing a clinical strategy aligned with regulatory requirements (MDR 2017/745 and IVDR 2017/746) and market access objectives.

Demonstrating the potential of your product and justifying its value

We take an integrated approach tailored to the strategic challenges of early development phases. Our goal is to help you mitigate risks surrounding your product and clearly demonstrate its clinical benefit. We design and conduct clinical evaluations aimed at proving the clinical performance of the device, fully meeting the requirements of notified bodies.

➜ Critical analysis of clinical data requirements

Evaluation of existing clinical data

➜ Implementation of clinical evaluation

• Clinical evaluation / regulatory document

• Clinical Evaluation Plan (CEP) / Performance Evaluation Plan (PEP)

• Clinical Evaluation Report (CER) / Performance Evaluation Report (PER)

• State of the art : literature review

➜ Design and conduct of clinical investigations

• Clinical investigations (pre-market and post-market clinical follow-up)

• Observational studies and/or real-world data studies

• Development of the methodology for the Clinical Investigation Plan (CIP)

• Drafting of the Clinical Investigation Plan (CIP) and associated regulatory documents (information sheets, consent forms, etc.), excluding QARA-dependent technical documentation

• Drafting of the Clinical Investigation Report

➜ Execution of the Clinical Investigation Plan

Leveraging field experience to meet regulatory requirements

We design and conduct post-market studies that enhance the value of your product by providing essential data for your regulatory, medico-economic, or marketing strategy.

➜ Post-Market Clinical Follow-Up Plan

• Support in strategy and methodology for collecting clinical data post-commercialization
• Drafting sections of the PMCF/PMPF plan and PMCF/PMPF report
• Documentation updates: CEP, PEP, PER, and state of the art
• Development of the post-market clinical follow-up (PMCF) process
• Conduct and management of observational studies and/or real-world data studies

Identify existing care models adapted to
the pathway of your CE-certified medical device

➜ Advice and strategy for integration into standard care: early access reimbursement, LPPR (list of reimbursable products and services), LATM (list of telemedical monitoring activities)

• Clarifications on the eligibility conditions for your product, financing solutions, and guidance on the pathways to follow
• Mapping out the steps required to achieve reimbursement and anticipate the optimal dissemination of your product across the French market

➜ Argumentative studies required for the evaluation and pricing of your product

• Medico-technical argumentative study (SA/ASA) for evaluation by CNEDIMTS
• Medico-economic argumentative study for evaluation by CEEPS