Stragen Services
Consultancy and service provider focused on pharmacovigilance and clinical development strategy. Offers regulatory pharmacovigilance services (registration/updates to EU systems, QPPV responsibility, PV system documentation), safety database implementation and maintenance, pharmacovigilance operations (case processing, safety reporting, literature review, signal detection), and clinical affairs support including clinical development program definition, CRO coordination and compassionate use program coordination. Based in Lyon, France.
Industries
Nr. of Employees
small (1-50)
Stragen Services
Lyon, Rhone-Alpes, France, Europe
Services
Regulatory registrations and updates, QPPV responsibilities, PV system master file preparation, safety database implementation and maintenance, case processing, safety reporting, literature review, signal detection and quality control of PV activities.
Clinical development programme definition and implementation, CRO coordination and management, medical data review, clinical expert reports, and support for regulatory submission planning.
Client-specific solutions including coordination with client quality, regulatory and legal departments and management of compassionate use programs.
Regulatory registrations and updates, QPPV responsibilities, PV system master file preparation, safety database implementation and maintenance, case processing, safety reporting, literature review, signal detection and quality control of PV activities.
Clinical development programme definition and implementation, CRO coordination and management, medical data review, clinical expert reports, and support for regulatory submission planning.
Client-specific solutions including coordination with client quality, regulatory and legal departments and management of compassionate use programs.
Expertise Areas
- Pharmacovigilance (post-marketing and clinical trials)
- Clinical development and trial management
- Regulatory strategy and submission support
- Compassionate use / expanded access programs
Key Technologies
- ICH E2B adverse event data standard
- Safety database systems (validated PV databases)
- Signal detection methodologies for safety surveillance
- Regulatory reporting to EU pharmacovigilance systems