We are cooperating with leading Laboratories and clinical organizations in UK and Switzerland where are performed Phase I/II clinical trials and human mass balance studies using radiocompounds.
- International Regulatory recognition
- Fast study activation and Ethics approval
- In-house clinical and bioanalytical units
- Easy subjects recruitment and large volunteers database
- Drug or alcohol interactions
- Special population studies
- Food influence
- PK and statistical data processing
- Medical writing and clinical expertise support
We are cooperating with leading Laboratories and clinical facilities in UK and Switzerland where are performed clinical metabolism and excretion balance studies in human healthy volunteers.
The collaboration combines the skills sets from radiosynthesis through pre-clinical metabolism and onto the integrated final clinical report.
The integrated early clinical service includes:
- Preclinical exposure determination
- Efficient approval process
- Fast volunteer recruitment
- Dosing and sample collection
- Real-time recovery analysis
- Bioequivalences and bioavailability studies
- Bioanalysis and Pharmacokinetics
- Metabolic profiling and identification
- Independent audits
- Preparation of the final integrated report
- GMP synthesis of APIs and IMP formulation