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Biopharmaceutical consulting

  • Perfom portfolio and product assessments
  • Design product development strategies
  • Establish product safety profile and risk-benefit assessment
  • Generate operational plans for clinical research
Assurance that the data and reported results are credible and accurate 

Clinical Operations

  • Project Management
  • Investigator and Site Selection
  • Site monitoring
  • Country/Local Regulatory Affairs
  • Subject recruitment
  • Functional Service Provisions
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Sécurité du Patient  genexion
Making health care safer 

Patient Safety

  • Pharmacovigilance (Case management)
  • Risk management
  • Product surveillance
  • Medical Monitoring 
There is no clinical research without quality assurance

Quality Assurance

  • Regulations, mapping, SOPs,
  • Audit (PV, IT, Site)
  • Inspection readiness
  • Post inspection management (response writing, CAPA)
  • Training
  • Protection of personal data (RGPD; 21 CFR part 11)
  • Filing and archiving
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Writing of different types of scientific documents

Medical writing

  • Essential documents development (Protocol, ICF, IB)
  • Final Clinical study Report
  • Publication, poster
Dealing with a crisis

Crisis Management 

  • Digitalization
  • Filing
  • Archiving
  • Quality Control
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How to deal with your vendor


  • Vendor Management

Selection, Évaluation, Audit

  • CRO Oversight

Follow-up and indicator implementation