R&D support

With more than 6 years of experience, BluePharm offers a complete range of services through its five areas of expertise
  • Project management
  • Clinical operations
  • Data management and biostatistics
  • Medical writing
  • Pharmacovigilance and Materials Vigilance, with over 25 years of experience
  • Training of investigators and healthcare teams on site or in e-learning

Advice and methodological expertise

  • Methodological and regulatory advice,
  • Qualitative survey of opinion leaders to support your strategies and achieve your objectives,
  • Documentary research and definition of target populations.

Vigilance monitoring

  • Specific monitoring in support of pharmaco/materiovigilance services,
  • Optimal management of the detection, collection and evaluation of adverse events,
  • Adjudication of serious adverse events for clinical trials.

Medical writing

  • Writing of synopses, protocols, case reports, clinical reports, following international regulations,
  • Writing of scientific articles in local and international journals, and communication documents for congresses, symposiums, scientific committees, investors, … (abstracts, posters, slideshows, …)

Professional training activities in the human health field

  • Training of investigator teams on the study product
  • Human Health training for sales teams

The quality of our services is guaranteed by our concern for quality, our commitment to ISO 9001-2015 certification and our Qualiopi certification for training activities.

Clinical Investigations - Non-interventional / Pharmacoepidemiological Studies

BluePharm accompagne les industries de santé

  • Preparatory phase: elaboration of the study documents, regulatory and ethical submissions, selection and validation of centers.
  • Study launch: creation of monitoring dashboards, administrative and scientific set-up of centers, monitoring of therapeutic units and samples, etc.
  • Study monitoring: centralized monitoring in most cases from the selection of participating physicians to the closing of the centers,
  • Data management: collection, control and validation according to the specificity of your project: paper CRF or e-CRF, written correction requests with or without telemonitoring, provision of CRA, quality control visits
  • Biometric management with data managers and statisticians
  • Data analysis, statistical reporting

Our teams’ expertise covers all health products and therapeutic areas as well as all types of studies (interventional and non-interventional), prospective or retrospective:

  • Pre-authorization study
  • Post-authorization study on primary or secondary data
  • Study on secondary data (RNIPH)

BluePharm has developed a specific expertise in non-interventional studies to offer studies specifically designed and managed to meet the demands of health authorities.