Clinical Operations

Enovalife provides clinical trial services in over 20 countries. Our team of experts—pharmacists, doctors, and scientists—participates in clinical trials across the pharma, biotechnology, medical device, cosmetics, and food processing industries.

Our assets

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Broad and international coverage

Support for clinical studies from FIH/Phase I to Phase IV, whether interventional or non-interventional.
Involvement in both local and international studies across a variety of therapeutic areas, including oncology, neurology, rare diseases, vaccines, and more.

End-to-end expertise

Medical writing for essential documents (study protocol, ICF, CRF or eCRF, patient consent, etc.): Link to our centers of excellence to be added.
Start-up of clinical trials, including regulatory submissions in France and abroad (CPP, CNIL, CNOM, ANSM, EMA, FDA, etc.), contract establishment, and cost negotiation (single agreement, hospital agreement, or ad-hoc grids).
Definition and management of budgets and guidelines.
Comprehensive management, planning, and monitoring of the study, from feasibility, selection, and implementation to follow-up and closure, with monitoring carried out by our ARCs (Risk-Based Monitoring, remote monitoring, and on-site visits).
Selection, management, and oversight of vendors and logistics for clinical studies (IVRS/IWRS, routing of therapeutic units and biological samples, central laboratory, translation services, etc.).
Laboratory study management: from protocol review to clinical study report, operational set-up, and follow-up of clinical lab-related activities, collaboration with central labs, third-party labs, and sponsor laboratory networks, as well as clinical lab budget management and planning.
Administration and management of clinical trial documentation (eTMF, TMF, and CTMS).
Writing of Clinical Study Reports (CSRs).

Quality assurance support

Preparation and support for sponsors during audits and inspections (ANSM, FDA, EMA, etc.).
Management of deviations and implementation of CAPAs.
Assistance with remediation projects.

Why choose us?

Over 20 years of experience in clinical operations

With a strong expertise and longstanding trust from our clients, we effectively support clinical trials for partners ranging from start-ups to Big Pharma.

International network and local proximity

Our structure enables us to operate on an international scale while maintaining close proximity to our clients.

Partner in innovation

As Orange Group's CRO, Enovalife is your ideal partner for the digitalization of clinical trials.

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Clinical Operations