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Cr

Clinical Research

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  • Calypse offers support for clients in carrying out their national and international phase I to IV clinical studies, in compliance with good clinical practices / ICH and the regulations in force
    • Management of interventional studies
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– Clinical Research involving medical devices, medicines, cell therapy, etc.
• which involve an intervention on the person not justified by their usual care
• “which do not relate to drugs and involve only minimal risks and burdens”.
– Randomized trials.
    • Management of non-interventional studies
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– Pharmacoepidemiological, retrospective, prospective, cross-sectional and longitudinal studies.
– Data research.
– Biological collections.
– Observatories of pathologies.
– Post-MA studies requested by Health Authorities.
– General population surveys.
– Pharmaco-economic studies.
– Studies of use and practices.

    • Project design
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– Bibliographic search.
– Call for tenders from subcontractors (printing, phoning, etc.) and quality control.
– Creation of the graphic charter and logo.
– Creation of documents (Protocol, CRF/eCRF, patient questionnaires, TMF, ISF, PPT presentations).
– CNIL, CNOM, CPP, ANSM, CCTIRS regulatory submissions.
– Organization, management and animation of expert boards.
– Preparation of investigator/expert contracts.
– Feasibility / pre-selection of centers (creation of mailing/phoning script).
    • Implementation and monitoring of projects
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– Study protocol and eCRF training
– Preparation and dispatch of study kits.
– Management of the investigation centers and regular communications (emails, phoning, newsletters).
– Study follow-up via Access database or Internet.
– Problem identification and fast resolution in a transparent way.
– Centres and pharmacies monitoring.
– Managing queries and eCRF updates.
– Management of pharmacovigilance and transmission to the dedicated PV service on time.
– Management of fees and payments.
– Audits of investigation centers and ARCs.
– Regular reporting to the client (progress reports).
– Management of monitoring reports.
– Collaboration with the international team and participation in telephone meetings.
– Compliance with the provisional timetable.
– Update of the TMF and ISF of the study
– Management of the closure of centers and pharmacies.
    • Exploitation and scientific valorization of data
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– Collaboration with biometrics
– Writing statistical and clinical reports (ICH format), abstracts and posters
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