Clinitec operates a co-located clinical pharmacology unit and regulated bioanalytical laboratory, alongside a global network of investigator sites. This co-location removes transport lag between dosing and analysis, supporting rapid PK turnaround for BA/BE and early-phase studies.
Clinical pharmacology unit
Our clinical pharmacology unit supports early-phase and BA/BE studies with 24/7 medical supervision, continuous cardiac monitoring, and biological sampling capability. Healthy-subject and patient populations are recruited from a vetted database.
- Beds with continuous monitoring capacity
- 24/7 qualified physician coverage
- Biological sampling and processing suite
- Volunteer database and recruitment desk
Bioanalytical laboratory
Our regulated bioanalytical lab is equipped with state-of-the-art LC-MS/MS and ligand-binding assay platforms. All methods are validated to ICH M10 and run under 21 CFR Part 11-compliant systems with full audit trails.
- UPLC-MS/MS systems (pg/mL sensitivity)
- Ligand-binding platforms (ELISA, MSD, Gyrolab)
- Automated 96-well sample preparation
- 21 CFR Part 11-compliant data systems
Data and technology
We deploy validated EDC, CTMS, eTMF, IWRS/IRT, ePRO, and pharmacovigilance systems integrated into a sponsor-facing dashboard. Near real-time visibility into enrollment, queries, and safety thresholds is standard.