MultiHealth Group – An integrated CRO specializing in clinical research and regulatory affairs, in France and internationally

Q: How does MultiHealth Group ensure the quality of its services?

Quality is based on compliance with GCP, GLP, and MDR guidelines, which are applied at every stage of a project. The group draws on more than 30 years of experience, multidisciplinary teams covering monitoring, biostatistics, regulatory affairs, and digital solutions, as well as proprietary tools such as Clinfile for data digitization and EcoClin for tracking the carbon footprint of clinical trials.

From study design to regulatory submission, MultiHealth Group supports public and private companies at every stage of their healthcare product development.

Our expertise

Years of experience

Specialized companies

therapeutic areas

Industry Expertise

Our areas of expertise

Medical and Scientific Writing

Methodology, protocol, articles, posters, BI, PSUR, CER, CSR, literature review

Regulatory Affairs

Submissions, regulatory strategy, marketing authorization applications

Quality assurance

Audits, QMS, ISO 9001, product quality

Project Management

Interventional Clinical Trials (Phases I–IV), Real-World Evidence (RWE) Studies, Early Access and Compassionate Use Programs, Care Pathways, SNDS

Monitoring

International, Implementation, Follow-up Visits, Data Quality Control

Biometry

ECRF, Data Management, Biostatistics

Safety

Multivigilance, Clinical Trial Safety, Post-Market Vigilance

Training

Careers in Clinical Research via FORMATIS

Digital tools

EDC, rSDV, CTMS, Early Access

Consulting and Recruitment

Outsourcing and Life Sciences Consulting through TempoPHARMA

An integrated group—
—with a global vision

MultiHealth Group brings together under one roof all the expertise needed to manage your healthcare projects: from regulatory strategy to statistical analysis, and from monitoring to recruitment.

This integrated approach allows us to offer a level of consistency and seamless coordination that specialized service providers cannot guarantee on their own.

Multidisciplinary expertise

Project management, recruitment, training, biometrics, digital tools—all handled in-house.

Proprietary tools

Digital solutions developed specifically to address the challenges of clinical research.

Customized support

Flexible model: Full-service, single-service, or on-demand resources, depending on your needs.

Guaranteed regulatory compliance

Expertise in EMA, ANSM, FDA, GCP, and MDRrequirements at every stage of your projects.

Our specialized companies

Contract Research Organization (CRO) specializing in clinical trial management

CLINACT supports sponsors and CROs in managing and monitoring their clinical trials—from setting up the trial site to on-site monitoring—while ensuring compliance with Good Clinical Practices (GCP) in France and internationally.

MONITORING – PROJECTS

Digitization of Clinical Trials

Clinfile develops digital tools (eCRF, ePRO) that simplify the collection and monitoring of clinical data in real time, resulting in studies that are more reliable, faster to conduct, and easier to audit.

DIGITAl – ECRF

Statitec Take control of your clinical data

Biostatistics & Clinical Data Management

Statitec provides statistical analysis of clinical trial data—from designing the analysis plan to drafting reports—to ensure the quality and regulatory compliance of the results produced.

BIOMETRICS

Outsourcing & Specialized Healthcare Recruitment

TempoPHARMA provides healthcare companies with specialized professionals in clinical research—whether for temporary assignments or permanent positions—to quickly meet the needs of project teams requiring additional staff.

RESOURCES – HR

Clinical Research Training Center

FORMATIS designs and delivers training programs for industry professionals to develop the skills of in-house teams and support new employees as they build their expertise.

TRAINING – CERTIFICATION

They trust us

Frequently Asked Questions

What is an integrated CRO, and why should you choose MultiHealth Group?

An integrated CRO brings together all the expertise needed to conduct a clinical trial under one umbrella, rather than spreading it across multiple independent service providers. MultiHealth Group brings together CLINACT ( monitoring), Clinfile ( digitization), Statitec (biostatistics), TempoPHARMA (recruitment), and FORMATIS ( training). This structure ensures a single point of contact, consistency across teams, and greater responsiveness to unforeseen events during a trial, from study initiation through regulatory submission.

What types of projects can MultiHealth Group handle?

MultiHealth Group provides services for Phase I through IV clinical trials, observational studies, and real-world evidence (RWE) studies, as well as for the preparation of regulatory dossiers and marketing authorization applications. The group also supports the digitization of clinical trials through Clinfile and meets both short-term and long-term needs for specialized clinical research personnel through TempoPHARMA.

Does MultiHealth Group operate only in France?

No, MultiHealth Group operates in France and internationally. The group supports multicenter trials that comply with EMA, FDA, and ICH guidelines for sponsors seeking to conduct their studies beyond France. The website is also available in English to facilitate communication with international sponsors and partners, from study design through regulatory monitoring.

How does MultiHealth Group ensure the quality of its services?

Quality is based on compliance with GCP, BPC, and MDR guidelines, which are applied at every stage of a project. The group draws on more than 30 years of experience, multidisciplinary teams covering monitoring, biostatistics, regulatory affairs, and digital solutions, as well as proprietary tools such as Clinfile for data digitization and EcoClin for tracking the carbon footprint of clinical trials.

Does MultiHealth Group offer one-time assignments or only full-service contracts?

MultiHealth Group offers three service models tailored to the sponsor’s needs: a full-service approach that covers the entire project, a single-service approach focused on a specific area (biostatistics, monitoring, regulatory affairs, etc.), or the provision of ad hoc resources through TempoPHARMA to bolster an in-house team for a defined period.

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MultiHealth Group – An integrated CRO specializing in clinical research and regulatory affairs, in France and internationally