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.
- 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.
- 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
- 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.