- Design and implementation of clinical trial programs considering immediate and long-term global development goals
- Protocol design, IB, IMPD, PIL and ICF
- Preparation, submission and maintenance of clinical trial applications
- Support for EU legal representation
- US Agent for INDs and IDEs
- Pre- and Post-marketing integrated Pharmacovigilance services
- Medical expertise provided by internal EU Qualified Person for Pharmacovigilance (EU QPPV)
- Constant monitoring and evaluation of the Risk/Benefit ratio of the product.
Drug Safety and Pharmacovigilance Services
- Preparation of customized drug safety and pharmacovigilance SOPs
- Registration of Sponsors in the EMEA EudraVigilance database
- Registration of medicinal products in the EVMPD
- Third Party Service Provider as a service
- Individual Case Safety Reports (ICSRs)
- EVMPD information to EudraVigilance via EV WEB
- SAE coding, management and Expedited reporting: Collection, Quality Control, Assessment, narrative writing, unblinding and management of ICSRs
- Periodic Safety Reporting: clinical trials Annual Safety Reports, IND reports, EAP Periodic Safety Reports and PSURs
- Preparation of MAA module 1.8.1 and 1.8.2: Risk Management Plans including Pharmacovigilance Plan, Pharmacovigilance System Description.
- Participation in global safety meetings with the Competent Authorities
- Review of safety sections of promotional material
- Safety training of Medical Science Liaisons and Sales Teams.
Medical Device Vigilance Services
- Pre and post-marketing vigilance services for all classes of Medical Devices according to the European guideline MEDDEV 2.12-1 rev. 5, including:
- Preparation of customized Standard Operating Procedures (SOPs) for Medical Device Vigilance system and Incidents / Near Incidents reporting procedures.
- Incidents/Near Incidents management: Cases reception, Quality Control Assessment, and preparation of narratives
- Incidents / Near Incidents Expedited Reporting: Preparation and submission of Manufacturer Incident Reports and Field Safety Notice (FSN) to multiple Regulatory Authorities where necessary.
- Periodic Vigilance Reports: Complete and submit Periodic Summary / Trend Reports to National Competent Authority