Calypse Consulting
Calypse is a France-based contract research organisation and consulting firm (est. 2016) that provides regulatory, clinical research, data and quality services to pharmaceutical, biotechnology and medical device organisations across Europe. Core activities include clinical trial design and operations, regulatory dossier preparation and authority interactions, clinical data management and biostatistics, pharmacovigilance, medical writing, quality system support and consultant resourcing. The company reports ISO 9001 and ISO 27001 certification and publishes corporate social responsibility commitments including an EcoVadis Gold rating and adherence to international responsible-business charters.
Industries
Nr. of Employees
medium (51-250)
Calypse Consulting
Paris, Ile-de-France, France, Europe
Services
Study conception, operations, monitoring (on-site/remote/centralized), site feasibility and management for Phase I–IV and device investigations.
Preparation and coordination of regulatory dossiers, submissions to national authorities and ethics committees, CE marking support and notified-body interactions.
eCRF design, DMP/DVP development, data validation, SDTM mapping, statistical analysis planning and execution, and final statistical reporting.
Safety case management, adverse event reporting, reconciliation between clinical and safety databases, and post-market follow-up studies.
Writing and review of protocols, informed consent, clinical study reports, publications and patient materials; pre-submission review by experienced medical writers.
Supply of qualified consultants for temporary or long-term placements across regulatory, quality, pharmacovigilance, production and clinical functions, with integration and follow-up processes.
Study conception, operations, monitoring (on-site/remote/centralized), site feasibility and management for Phase I–IV and device investigations.
Preparation and coordination of regulatory dossiers, submissions to national authorities and ethics committees, CE marking support and notified-body interactions.
eCRF design, DMP/DVP development, data validation, SDTM mapping, statistical analysis planning and execution, and final statistical reporting.
Safety case management, adverse event reporting, reconciliation between clinical and safety databases, and post-market follow-up studies.
Writing and review of protocols, informed consent, clinical study reports, publications and patient materials; pre-submission review by experienced medical writers.
Supply of qualified consultants for temporary or long-term placements across regulatory, quality, pharmacovigilance, production and clinical functions, with integration and follow-up processes.
Expertise Areas
- Clinical trial management
- Regulatory affairs (EU)
- Pharmacovigilance and safety monitoring
- Clinical data management and standards
Key Technologies
- Electronic case report form (eCRF) platforms
- SDTM data mapping
- MedDRA and WHO-DD coding
- Electronic patient-reported outcomes (ePRO)
News & Updates
Company reports ISO 9001 certification for quality management.
Company reports ISO 27001 certification for information security management.
Company reports EcoVadis Gold rating and placement in the top 5% of assessed organisations for corporate social responsibility.
Company reports an index score of 93/100 for the gender equality index.
Company indicates adherence to the United Nations Global Compact on its corporate information pages.
Company indicates adherence to a digital-responsibility charter for sustainable and ethical digital services.
Company reports ISO 9001 certification for quality management.
Company reports ISO 27001 certification for information security management.
Company reports EcoVadis Gold rating and placement in the top 5% of assessed organisations for corporate social responsibility.
Company reports an index score of 93/100 for the gender equality index.
Company indicates adherence to the United Nations Global Compact on its corporate information pages.
Company indicates adherence to a digital-responsibility charter for sustainable and ethical digital services.