The healthcare sector now experiences the vital need for data collection and to understand the power of data and analyses in order to suggest “value-based care” to doctors, patients, payers and other stakeholders. Our Medical Affairs team responds to this need by supporting the customer’s development plan and research project with an all-round view to demonstrate and enhance the added value of the investigational product.
All members of our Medical Affairs team have a strong scientific background and global experience, having developed a deep understanding of international guidelines and standards. The team also ensures high scientific standards in the support provided to other key functions (regulatory, biometrics, pharmacovigilance, market access, etc.).
The team counts consultants with consolidated experience in the quality and regulatory fields, moreover acquired by operating in medical device manufacturers. It is undoubtedly able to offer excellent service that meets the customer's needs.
To be successful, a new healthcare technology must be cost-effective with proven value for all stakeholders involved, namely customers, suppliers, regulators, healthcare professionals (HCPs), payers, and patients. Our Medical Affairs team plays a key role in this regard. We help the client clearly underscore the new product’s added value by interacting with the various stakeholders to identify the most appropriate development plan that meets their different needs.
With expertise and scientific rigor, besides a keen eye for innovation and sensitivity to the needs and demands of the various stakeholders involved, we provide guidance for clients in identifying the best development strategy. Our plans are studied to generate high quality patient-centred evidence throughout the product’s lifecycle. This also meets all the needs of each stakeholder.
Excellent and clear communication targeting the many stakeholders in healthcare lays the foundation for scientific understanding, which creates value for the product, for healthcare professionals and for patients.
- Medical and diagnostic devices
- Food supplements
- Identification of medical needs and data gaps
- Research, analysis and interpretation of biomedical literature (publications, guidelines, systematic reviews, meta-analyses, etc.).
- Development of the study’s concept sheet focused on defining study endpoints, to define eligibility criteria, and identify appropriate outcomes (including Patient Reported Outcomes) and study design options.
- Identification and selection of the most suitable and qualified Contract Research Organisation (CRO) to support the execution of the study
- Protocol (Phase I, II, III, IV, observational studies, Real Word Evidence) / Clinical Investigation Plan
- Informed Consent, Dear Doctor Letter, Patient Card
- Investigator’s Brochure (IB)
- Investigational Medicinal Product Dossier (IMPD)
- Clinical Study Report (CSR)
- Scientific publications, abstracts and posters
- Training the study team: CRA, clinical operations, etc.
- Training for the Sponsor’s staff: MSLs, marketing, sales
- Training for medical staff: Investigators, Paramedic Staff, Pharmacists, etc.
- Mapping and managing Key Opinion Leaders
- Design and supervision of Advisory Boards, Study Steering Committees and Data Monitoring Boards
- Interaction with Scientific Societies and Patients’ Associations
- Quality System in accordance with Standard ISO 13485, 21CFR 820 and with Medical Device Regulation, (MDR) 2017/745 and (IVDR) 2017/746
- Quality System in accordance with MDSAP (Medical Device Single Audit Program)
- Development of Technical Documentation for CE marking of Medical Device in accodance with Regulation (EU) 2017/745 (MDR) and 2017/746 (IVDR)
- Dedicated Training