Clinical Operations

Life Sciences Expertise

Business & Decision Life Sciences provides clinical trials in more than 20 countries. Our team of experts (pharmacists, doctors & scientists) take part in clinical trials for Pharma, Biotechnology, Medical Devices, Cosmetics and Food processing Industries.

Our assets:

  • Clinical studies support for our partner laboratories, from Phase I to Phase IV, whether they are interventional or non-interventional, ATUs / RTUs, ISS, surveys, cohort studies, registers, market studies, RWE, etc...
  • Involvement in local and international studies in various therapeutic areas (oncology, neurology, rare diseases, vaccines, etc.).
  • Medical writing for essential documents (study protocol, ICF, CRF or eCRF, patient consent, etc...)
  • Start-up of clinical trials, including regulatory submissions in France and abroad (CPP, CNIL, CNOM, ANSM, EMA, FDA, etc.), contracts' establishment and costs' negotiation (single agreement, hospital agreement or ad-hoc grids).
  • Budget and guidelines definition and management.
  • Management, planning and monitoring of the study from feasibility, selection and implementation to follow-up and closure, thanks to the monitoring carried out by our ARCs (Risk based monitoring, remote monitoring, On-site visit).
  • Vendors selection and management and supervision of clinical study logistics (IVRS/IWRS, routing of therapeutic units and biological samples, central laboratory, translation company, etc.).
  • Clinical trial administration and management of eTMF, TMF and CTMS.
  • Clinical Study Reports (CSR) Writing
  • Sponsors preparation and support during audits and inspections (ANSM, FDA, EMA, etc.). Managing deviations and implementing CAPAs. Assistance during remediation projects.

Why choose us?

Proven Expertise
Based on our strong expertise and the lasting trust of our clients in the support of clinical trials, we know how to accompany our partners in their next challenges from Big Pharma to start-ups.

International Network & Local proximity
Our structure allows us to have an international dimension while maintaining proximity to our clients.

Partner of choice
As the Orange Group's CRO, Business & Decision Life Sciences is your ideal partner to support you in the digitalization of your clinical trials.

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