Clinical trials

Pharmassist Ltd has a well-developed Clinical Operations Department with proven successful record in conducting a wide range of clinical studies with medicines and medical devices. The Department consists of 14 full time employees with long experience in conducting clinical research. The Head of Department (M.D., qualified internist) has over 20 years of continuous experience in a wide spectrum of therapeutic areas and in several clinical research roles. The project managers and the majority of CRAs, apart from their typical qualifications, also possess long experience in the field. Personnel turnover rate is low. Pharmassist in clinical research has established collaborations with big multinational pharmaceutical companies, but also with smaller to medium size innovative and startup companies.

Feasibility and planning

  • Concept development and evaluation
  • Feasibility studies
  • Planning, resourcing and logistics
  • Trial files compilation
  • Regulatory and IRB submissions

Study documents

  • Protocol writing
  • Patient documents development
  • Statistical Methodology
  • IB and IMPD compilation
  • CRF design

Site preparation

  • Study manual development
  • IC documents writing, editing, review
  • Study-specific and ICH, GCP training of investigators

Site management

  • Site preparation and trial initiation
  • On-site coordination
  • Site monitoring
  • Site closing