Your expert partner in clinical research
Our vision of clinical research
At BluePharm, clinical research is not just a regulatory step. It is a strategic lever for accelerating access to therapeutic innovation.
We support industrial and academic sponsors in the rigorous, ethical, and efficient implementation of their research projects on drugs and medical devices.
BluePharm offers comprehensive expertise in clinical research, from design to commercialisation of clinical trials, through its five areas of activity:
- Methodology of Clinical Trials and Clinical Investigations
- Clinical operations
- Medical writing
- Pharmaco/Medical devices vigilance
- Training in good clinical practices and regulations in clinical research
- Specific areas of expertise
Our expertise at every stage of clinical research
Methodology of Clinical Trials and Clinical Investigations
- Clinical feasibility investigations, confirmatory studies
- Clinical studies phase II, IIIB, IV
- Regulatory advice :
Documentary Research and Definition of Target Populations
Medical Writing
- Clinical Study Documents:
Synopsis, protocols, case report forms, and clinical reports in compliance with international regulations.
Pharmaco/Medical devices vigilance
- Clinical trials vigilance:
Support for sponsors for optimal management of serious adverse events and serious incidents (notifications, reports, MedDRA coding)
- Preparation of annual safety reports
- Post-marketing pharmaco/materio vigilance
Training in products, pathologies, GCP, and clinical research regulations
- Training for Investigator Teams:
Sessions dedicated to the products being studied, regulations, and good clinical practices (GCP qualification)
- Sales Team & MSLs Training:
training on the product and related pathologies.
Clinical Investigations
- Preparatory Phase:
Development of study documents, regulatory and ethical submissions, selection and validation of sites.
- Study Launch:
Administrative and scientific setup of sites, creation of monitoring dashboards, management of therapeutic units and sample collection.
- Monitoring and Data Management:
Centralized monitoring, data collection, control, and validation (paper CRF or e-CRF), data correction, remote monitoring, and provision of CRAs.
- Biostatistics:
Data management and analysis by a specialized partner.
Specific areas of expertise
- Post-Authorization Studies SCAC (PMCF):
Specific expertise to meet the requirements of health authorities.
- Qualitative Studies:
Through semi-structured interviews with opinion leaders or patients, and thematic analysis of the results. - Retrospective studies
Study based on secondary data
