| |
|
 |
| |
Our 50,000 square feet Phase I Unit
provides a wide range of services under the management
of highly trained and knowledgeable team of professionals.
All studies are conducted in accordance with Good Clinical
Practices, ICH, Federal Regulations and rigorous Standard
Operating Procedures. |
| |
We offer |
| |
- Experienced research team of physicians, CRAs, nurses
and technicians
- Rapid subject recruitment
- Healthy volunteers as well as special populations
- A focus on volunteer and patient safety
- Regulatory compliance
- Strict adherence to the protocol
|
| |
Services Overview |
|
Protocol development and review |
| |
- Bioavailability studies/bioequivalence studies
- Safety and tolerability studies
- First-in-human studies (proof of concept)
- Drug-Drug interactions studies
- Ascending dose studies
- QTc studies
|
|
Clinical Execution of the Protocol |
| |
- Extensive database of healthy male and female volunteers
- 3 independent mixed-gender 48-bed units (144 beds)
capable of short-term & long-term confinement plus a 14-bed FIM clinic.
- Experienced physicians, nurses, phlebotomists and
technicians dedicated to subject safety and data integrity
|
|
Clinical Data Management |
| |
- Document development and design of case report forms
- Project management and monitoring
|
|
Partner with bioanalytical laboratory |
| |
- Method development, validation and transfer
- High throughput analysis of biological specimens
- Electronic data transfer and interim reporting
|
|
Pharmacokinetic/Pharmacodynamic statistical
analysis |
| |
- Analysis and interpretation of analytical and statistical
data
- Pharmacokinetic modeling
- Population pharmacokinetics
- Analysis of clinical endpoints
|
|
Integrated Report Writing and Electronic Submissions
|
| |
- USA, EMEA and TPD regulatory agencies
- Post-submission regulatory follow-up
|
|
Quality Assurance auditing with independent
reporting to Management |
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
