Pharmacovigilance Services

Comprehensive PV Solutions

SanaClis operates exclusively compliant PV systems, aligned with the European Medicine Agency Guidelines on Good Clinical and Good PV Practices and 21 CFR part 11 regulatory requirements.

Our seasoned team of experts have a deep understanding of all facets in the provision of complex PV-related medicinal product life cycle management, commencing with clinical trial phase I-IV and continuing to post marketing surveillance.

We provide custom-tailored trainings, drug and device vigilance relevant project management, safety reporting intelligence covering multiple countries of the world and consultancy services

Comprehensive SAE/SUSAR Management and Case Processing

Receipt, review and processing of MedDRA coded adverse events, incorporation of medical history, concomitant medication, relevant laboratory tests to the ICSR, comprehensive narrative writing
Electronic and/or paper-based reporting to authorities (including EudraVigilance) and other relevant recipients

Safety Database Hosting

Using Pharmacovigilance Safety Database system which is validated and fully E2B (R3) compliant, with output of reported ICSRs in xml format or as a CIOMS-I or MedWatch Form 3500
Possibility to create line listings and export relevant entered data in several formats
Automatic re-coding with new MedDRA versions

Preparation and Submission of Periodic Safety Reports

DSUR prepared in accordance with the International Council for Harmonisation (ICH) Guideline E2F

Involvement in Data Safety Monitoring Board Activities

Drafting of a DSMB Charter,
Preparation of PV and medically related data for DSMBs, moderation of the venue
Participation in DSMB conventions on behalf of a client
Availability for expert DSMB Membership

Clinical Trial Planning PV Activities

In depth review of all relevant clinical trial related documentation
Organization of kick-off meetings
Preparation of safety management plans based on individual expectations of the client and workflow setting
Subsequent review of the EDC system and respective set-up of Safety Database for the given project
SAE Reconciliation Plan

Registration of Sponsor/MAH and the medicinal product in EudraVigilance (including the XEVMPD module) as well as in other relevant authority reporting systems, as applicable

Clinical Trial Sponsor and Site Support

Provision of comprehensive PV-related trainings to investigators and corresponding site personnel
Site consultancy services focusing on the correct implementation of all pharmacovigilance-related requirements and correct report form completion
Provision of expertise on safety-specific national regulatory requirements for most worldwide countries