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Pharmacovigilance Services

Patient safety and subsequent reporting are at the forefront of our Pharmacovigilance activities



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

Medical Device Vigilance & Reporting

SanaClis Pharmacovigilance department additionally provides end-to-end PV related support for Medical device studies. Medical Device Vigilance & Reporting is performed in line with the requirements of the Regulation (EU) 2017/745 – Medical Device Regulation (MDR)

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

Speak to an Expert

Reach out to our team of Pharmacoviligance experts to discuss your project needs or more obtain update guidance.

Contact Us

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