Services

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Expertise

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

  • EU QPPV
  • 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
A businessman insures red dominoes and stops the collapse of the whole system. Insurance and risk management. Accurate forecasts and miscalculations. Financial support, subsidies and exemptions
KPI (key performance indicator) on wood background
How to deal with your vendor

CRO PILOTAGE

  • Vendor Management

Selection, Évaluation, Audit

  • CRO Oversight

Follow-up and indicator implementation