Biotech and medtech: your projects advance quickly, with strong constraints (funding, deadlines, recruitment, regulatory requirements, clinical and medico-economic evidence).
At RCTs, we support you in full-service throughout the life cycle: pre-authorization studies, post-authorization, RWE (primary & secondary data), health economics, early/compassionate access, and clinical evaluation of medical devices.
Like human-sized CROs, we focus on agility, proximity and the ability to manage complex situations—while mobilizing specialized expertise (methodology, statistics, regulatory, market analysis).
From the study design to the drafting of deliverables, including monitoring and statistical analysis, RCTs can be used at each step.
We conduct interventional and non-interventional studies, and also carry out evaluations on secondary data (e.g. SNDS / RNIPH) according to the needs of the project.
Our medical devices team supports you on the strategy and clinical evaluation according to Regulation (EU) 2017/745, as well as the associated standards (MDCG, MEDDEV 2.7/1 rev.4).
We have a large network of partners, extended in Europe and worldwide for your international studies.
Biotechs need a partner capable of optimizing resources, timing, and methodology. At RCTs, we intervene notably on:
Clinical strategy & study design
Clinical operations (full-service or à la carte)
Biostatistics, data management, medical writing
Are you developing a medical device (implantable, software, AI, diagnostic, etc.)?
We accompany you from A to Z on the clinical evaluation and regulatory strategy, in coherence with the EU MDR 2017/745.
Clinical evaluation (CEP/CER): definition of the strategy (own data, equivalence, WET, Article 61(10)); Drafting of the Clinical Evaluation Plan (CEP) and the Clinical Evaluation Report (CER)
PMCF (Post-Market Clinical Follow-up): PMCF strategy, drafting PMCF Plan / Report
CE marking & medtech projects
+800
Projects carried out
+150
Studies conducted
98%
Regulatory success rate
50+
Partners
Each biotech faces unique challenges: limited resources, tight deadlines, complex regulatory requirements. The mission is simple: accelerate your clinical trials while ensuring quality, compliance and efficiency. RCTs offers complete management of clinical trials, adapted to biotechnology. From the design of the protocol to regulatory submission, our dedicated team ensures tailor-made support. We integrate the latest technologies, international best practices and transparent communication to ensure the success of each study.
With more than 150 clinical studies carried out in Europe and internationally, approved regulatory submissions (ANSM, EMA, FDA) and recognized expertise in more than 15 therapeutic areas (oncology, rare diseases, immunology…), you benefit from a reliable partner for your strategic projects.
Design & Conduct of Early Trials (Phase I/II, Phase III, First-in-Human)
Optimized study design, complete management of trials on healthy volunteers or patients, respect of critical deadlines for your milestones.
Complete Regulatory Support
Drafting of protocols, constitution and submission of files (CTA/IND), obtaining ANSM, EMA, FDA authorizations and ethical opinions.
Biostatistics & Data Management
Robust statistical analyses to validate your endpoints, CDISC compliant secure data management, eCRF and reliable reporting.
Rapid Recruitment of Patients & Centers
Access to a network of investigators and partner hospitals, targeted recruitment strategies to achieve your inclusion objectives.
Pharmacovigilance & Safety Monitoring
Continuous monitoring of adverse events, DSUR reports, proactive risk management to ensure the safety of participants.