Our services
From study design
to communicating results.
Structured, clear and flexible support for RIPH, RNIPH and clinical investigation projects.
Project pathway
Eight stages, one commitment to quality.
01
Study design and launch
Study protocol development, including literature review, methodology and sample size calculation. Preparation of patient information sheets, consent forms, case report forms and financial agreements. Coordination of expert committees.
02
Regulatory submissions
Preparation and submission of applications to the relevant health authorities and ethics committees.
03
Investigator site selection
Selection of investigator sites and feasibility assessment.
04
Site initiation
Negotiation and signature of financial agreements, fee management and investigator site opening.
05
Site monitoring
On-site or remote monitoring, provision of clinical study technicians, treatment management, pharmacovigilance / medical device vigilance and a dedicated hotline.
06
Data Management
Paper or electronic CRF implementation, with or without randomisation, using a certified health data hosting server based in France. Query management and collected data quality control.
07
Biostatistics
Statistical analysis of collected data.
08
Medical writing and dissemination
Clinical reports, abstracts, posters and publication manuscripts.
AAP / AAC
Early and compassionate access
Management of early access, compassionate access and compassionate prescribing frameworks, according to their specific requirements.
GRP
Patient reimbursements
Patients’ out-of-pocket expenses and payments to service providers: taxis, ambulances, hotels, laboratories and specialist physicians, in France and across Europe.
Our commitments
Quality at
every stage
Timelines & budgets
An agreed framework, carefully monitored.
Compliance
Ongoing regulatory monitoring.
SOP
Established, consistent procedures.
Let’s talk
A clinical research project ?
Our team explores your needs and works with you to identify the right approach.