Our Services

Clinical study conception & Management:

    • Development of “Concept” protocol
    • Medical Writing
    • Project Management/coordination
    • Investigators selection
    • Site feasibility
    • Submission and obtention of regulatory approvals
    • Organization and animation of investigator meetings
    • Site initiation, periodic monitoring and site close-out visits
    • Data entry/support visit (Tecking)
    • Management of study vigilance
    • Management of health products: TUs, MDs,…
    • Management of study materials: tablets, connected devices, questionnaires…
    • Data Management
    • Statistics
    • Payment of investigator and hospital’s fees

Early Access Program (EAPs):

    • EAP strategy development
    • Conception and submission of EAP request file
    • Medical Writing
    • EAPs Management/Coordination
    • Monitoring of vigilance
    • Data Management
    • Statistics

Patient Education Program (PSP):

    • Proposition of programs
    • Implementing programs
    • Provision of a Call Center with trained staff coordinated by doctors
    • Program analysis and report
    • Management of pharmacovigilance in the context of a patient education program

Medical Writing & Publication:

    • Bibliographic research and analysis
    • Study synopsis
    • Consent and patient information
    • Study protocol
    • Therapeutic Use Protocol (TUP) for Early Acces Program
    • Case Report Form (CRF)
    • Pharmacovigilance report
    • Clinical Report (ICH/Non ICH)
    • EAP synthesis report
    • Meta-analysis
    • Presentation of results: Writing of summaries, articles, posters

Management & animation of Scientific Boards:

      • Selection of experts
      • Signature of experts’ agreements and follow-up of declarations
      • Logistical organisation of meetings
      • Preparation of meeting documents
      • Animation of meetings
      • Data follow-up after expert’s meetings
      • Interface with the sponsor
      • Payment of expert’s fees

Education & training:

    • KAP survey (Knowledge, Attitude, Practice) in clinical research
    • Clinical Research Training (GCP-ICH)
    • Training on the new European regulations
    • Training in Interventional Studies Methodology
    • Training in the methodology of Pharmacoepidemiology studies and Observational studies
    • Pharmacovigilance training
    • Training in Medical Writing and critical analysis of articles
    • Training on the medical environment of the studied pathology
    • Specific training adapted to the needs of each employee or customer

Data Management:

      • Development of database for paper CRF & e-CRF with web access and hosting (In compliance with 21 CFR Part 11)
      • Development of the Data Validation Document(DVD)
      • CRF Annotation
      • Data entry of paper CRF (simple or double.
      • Data Clarification Form (DCF) edition
      • Codification of medical data (Whodrugs and MedDRA)
      • Import of external data
      • Vigilance data reconciliation
      • Preparation of data review meetings
      • Freezing and transfer of database
      • Data management report
      • CDISC format (on demand)

Statistics:

  • Development of statistical methodology and rational
  • Size calculation
  • Writing the statistical part of protocols
  • Randomization list
  • Drafting of the statistical analysis plan
  • Mock report
  • Programming of statistical analysis
  • Calculation and statistical analysis (edition of tables and figures)
  • Statistical reports : tables and figures only, with statistical interpretation of results

Market Study :

    • Disease Management
    • Prescribed volumes
    • Market share by product
    • Exposed populations
    • Registration modalities

Market Access:

    • Market studies
    • Assessment of regulatory constraints
    • Provision of local partners
    • Constitution of registration dossiers
    • Constitution of price records (pricing)
    • Provision and management of Biosimilar projects
    • Provision of Bioequivalence Centers and coordination of studies on behalf of the sponsor (price negotiation on behalf of the client)
    • Access Program

Product Development Advice:

    • Medical, methodological, clinical and statistical expertise in order to draw up a development plan according to objectives defined in terms of therapeutic indication and country
    • Regulatory advice on country requirements for registration of health products and proposal of an adequate development plan
    • Development of risk management plans in line with legal expectations
    • Analysis of key elements allowing the negotiation of better reimbursement conditions and / or prices of health products
    • Constitution of renegotiation / maintenance of price and reimbursement rate files

Regulatory affairs:

    • Summary of Product Characteristics (SmPC) adaptation in order to ensure the conformity of your product Marketing authorization with local regulatory requirementses
    • Support in the submission of your Marketing Authorization file and adaptation to local regulations in the targeted countries
    • Update of MA Module 3 of mature drugs regarding the evolution of regulations and manufacturing processes

Management of Vigilance:

    • Management of Vigilance
    • Case report writing (CIOMS form)
    • Writing of PSUR or DSUR
    • Advice on health product vigilance regulations