Pharmacovigilance & Safety

Excelya>Capabilities>Pharmacovigilance & Safety
Our deliverables

Excelya's active reach

Excelya reviews medical data relating to all phase I, II and III clinical studies in various therapeutic fields (oncology, cardiology, rheumatology, etc.) from the protocol review to freezing the database.

These activities include coding medical data (using the MedDRA and WHODD dictionaries), the weekly review of adverse event severity, the review of deviations occurring during the study or the medical consistency of the data entered in the electronic notebook (eCRF).

The Excelya advantages

  • Ability to integrate new team members and swiftly develop their skills.
  • Choice of candidates fully meeting client expectations (profiles).
  • Ability to improve existing processes, quality and/or speed of execution.
  • Excellent working atmosphere, team spirit with low turnover since the collaboration began.
  • Excelya’s ability to keep pace with client changes and ways of leading activities over time, while maintaining a constant level of quality and performance.
  • Implementation of ISO 9001 & ISO 27001 to meet client satisfaction.
  • Digitalization.
  • YEP – Your Exalting Project – An innovative project to involve team members and share knowledge in a variety of fields.

 

Why & how Excelya is already

Shaping an innovative future

  • By attaining complete mastery of tools currently used by the client as a platform on which to continue maintaining, improving and achieving a consistently high level of expertise over time.
  • By setting up workshops during which consultants can present subjects or processes involving great expertise to a selected audience or the entire department, on a subject or process on which the speaker has become an acknowledged expert.
  • By working with the client to develop new tools which are not scheduled to be used throughout the company for several years.
  • By inviting some pharmacist consultants to write their exercise thesis on the client’s premises (process redesign, e-health, etc.)