Clinical Services

Clinical trials phase I-IV: ICH-GCP compliant clinical trials projects. International project management (ISO 9001:2000).

Study site management services: Pre-study. Initiation. Medical and scientific consultation throughout the study. Clinical Monitoring. Close-out. Experienced Clinical research coordinators.

Contract and Finance management for Clinical trials: Review of the proposal and budget, Institution/Investigator contract negotiation. Lawyer consultancy. Changes management. Study payment management

Clinical monitoring

Medical monitoring

Feasibility studies: Country and region-level feasibility assessment in advantageous timelines. Legislation and regulatory requirements, availability of the particular study population, treatment guidelines in operating countries, interest of potentially involved parties, and any specific details are discovered and included in the feasibility report.

Selection of Sites and Investigators: dynamic sites/investigators data base.

Biotechnology studies (medical devices)

Non-interventional studies: Full scope services from protocol to final report.

Post marketing studies  

Data management and Biostatistics: Study design, CRF and source data form design. Data management and medical coding: both paper-based and electronic data capture processes. Planning, sample size, statistical analysis, reporting and documentation.

Trainings: GCP trainings for investigators. Local study-specific trainings. Organization of investigator meetings.