Our Services

Observational studies

    • Post Marketing Survey (PMS)
    • Post Approval Safety Studies (PASS)
    • Implementation and monitoring of TUA (Temporary Use Authorization)
    • Epidemiological studies
    • Pharmacoepidemiological studies
    • Retrospective / prospective observational studies
    • Establishment and monitoring of registers

Data Management

    • Creation of databases and input masks
    • Hosting databases
    • Development of the Data Validation Document (DVD)
    • CRF: Reception, Annotation Registration and Entry + Double Entry Confrontation
    • Data Clarification Form (DCF) :
      • Programming consistency tests for transmission, test execution
      • Issuing and entering answers
      • Quality edition and review
    • Codification of medical data (Whodrugs and MedDRA)
    • Realization of validation programs
    • Editing individual data listings by subject
    • Data management report
    • Preparation of data review meetings
    • Gel and base transfer
    • CDISC format
    • Data management report

Statistics: SAS software, MedDRA dictionary (medical-surgical history), WHODRUG dictionary (concomitant processing)

    • Development of statistical methodology
    • Development of statistical rationales
    • Workforce calculation
    • Writing the statistical part of the protocols
    • Randomization list
    • Drafting of the statistical analysis plan
    • Programming of statistical analyzes
    • Calculation and statistical analysis
    • Statistical reports
    • Mock report
    • ICH report

Consulting in Medical Development, Registration and Medical Writing

    • Clinical Development Plan
    • Request Analysis for Product Registration
    • Risk Management Plan
    • Bibliographic research and analysis
    • Synopsis of studies
    • Consent and patient information
    • Study protocol
    • CRF
    • Pharmacovigilance report
    • Clinical report
    • Writing of abstracts, articles, posters …
    • Systematic review of the literature and meta-analysis

Market Study of Health Products

    • Management of diseases in different countries
    • Products on the market
    • Prescribed volumes
    • Market share by product
    • Exposed populations
    • Registration modalities

Consulting in Regulatory Compliance and Management of Pharmacovigilance

      • Implementation of Regulatory Compliance Plan
      • Adaptation of RCPs to local requirements
      • Proposal for Risk Management Plan projects
      • Annual Safety Report
      • Price and reimbursement files
      • Constitution of registration and marketing authorization files
      • Files monitoring
      • Response to authorities

Patient Education Program

    • Provision of programs
    • Implementing programs
    • Provision of a Call Center with trained staff and coordinated by doctors
    • Program analysis and report

Management of Scientific Boards

      •  Selection of experts
      •   Signature of experts’ agreements and follow-up of declarations
      •   Logistical organization of meetings
      •   Preparation of meeting documents
      •   Animation of meetings
      •   Data follow-up after expert meetings
      •   Interface with the sponsor
      •   Legal fee payment of experts

Market Access

  • Market studies
  • Assessment of regulatory constraints
  • Provision of local partners
  • Constitution of registration dossiers
  • Constitution of price records
  • 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

Training

    • Training in Clinical Research (GCP-ICH)
    • Training in Pharmacology Epidemiology and Observational Studies
    • Training in Medical Writing and Critical Analysis of Articles
    • Specific trainings adapted to the needs of each employee or customer