Protocol, CRF, ICF design;
CTA submission and close following the approval process;
Communication with Ethics Committee and Regulatory Authority;
Subjects recruitment, selection;
Investigational Medicinal Product administration;
Biological samples drawing;
Subjects' release and follow-up.
Bioanalytical method development and validation;
Analytical report release.
Pharmacokinetic and statistical services:
Study protocol design;
Sample size, randomisation etc.
Site specific monitoring;
Study specific monitoring;
Source data verification, query rezolution;
Monitoring reports release to the Sponsor.
Quality system services:
Site, study specific auditing;
Good Laboratory Practice statement release;
Good Clinical Practice statement release.
Data management services:
Pharmacokinetic and statistical Database;
Final Report release.