My clinical research services

Consultants who are available quickly, responsive, autonomous and versatile: that is what sponsors, CROs, hospitals and investigators look for. I offer six areas of cooperation to bring flexibility and efficiency to your trials.

For pharmaceutical and biotech companies, medical device manufacturers, CROs, university hospitals, cancer centres and other healthcare professionals.

Clinical monitoring (CRA)

A Clinical Research Associate since 2000, I give sponsors rigorous oversight of their sites, from phase I to phase IV, in line with the protocol, procedures and source documents.

  • Site selection, initiation, monitoring and close-out visits, on site or remote, as defined in the monitoring plan.
  • Informed consent and eligibility review.
  • Source data verification and review (SDV/SDR) against the eCRF, query management.
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Clinical project management

I coordinate and oversee your clinical studies from protocol to close-out, in line with regulations, timelines and budget. You get a single point of contact who knows the field.

  • Operational protocol review: feasibility, visit flow, burden for sites.
  • Design and writing of study documents: CRF, monitoring plan, guidelines, study-specific procedures, SAE and device deficiency forms.
  • Feasibility studies, site selection and approval.
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Regulatory affairs

I prepare, submit and follow up authorisation requests for interventional and non-interventional studies and medical device investigations, within the timelines set by EU and French regulations.

  • Collection and review of regulatory and essential documents (protocol, investigator’s brochure, information sheets, insurance, CVs, agreements).
  • Medicinal product trial applications in CTIS under EU Regulation 536/2014, parts I and II, and follow-up of requests for information (RFIs).
  • Ethics committee (CPP) submissions through the French SI RIPH platform for research involving human participants (Jardé law, categories 1, 2 and 3).
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Site coordination

Increasingly complex protocols take up a lot of medical staff time. Under the principal investigator’s responsibility, I take care of most logistical and administrative study tasks.

  • Help with patient screening and enrolment, attending tumour boards when needed.
  • Scheduling of visits, appointments and tests across departments.
  • eCRF data entry and real-time query resolution with sponsor CRAs.
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GCP audit

Auditing drives improvement in clinical research. A qualified auditor since 2013, I check that your studies protect participants’ rights and safety and produce credible data.

  • On-site investigator site audits.
  • Trial master file (TMF) and investigator site file (ISF) audits.
  • Audits of dietary supplement and medical device studies (ISO 14155).
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Training

I run initial and continuing training for everyone involved in clinical studies: investigators, CRAs, study coordinators, nurses and pharmacists. Practical content drawn from 25 years in the field.

  • Good Clinical Practice and what changes with ICH E6(R3).
  • Clinical research for principal investigators, CRAs and coordinators.
  • Regulatory affairs: CTIS, ethics committees, ANSM, CNIL.
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A study to start, a site to take over, an audit to prepare?

Tell me what you need: I reply within 2 business days with my availability and a first estimate.