Human Pharmacology Unit
Clinigene has a state-of-the-art infrastructure, expertise and experience to conduct early phase clinical development programs at its Human Pharmacology Unit [HPU] which is spread over 22,500 sq. ft. with 86 beds and 8 Intensive Care Unit [ICU] beds. The clinical facility has a fully equipped ICU and a strategic contract with a tertiary care hospital for handling medical emergencies.
The HPU uses Clinigene’s Central Laboratory for screening and safety evaluations.
The HPU team comprises of experienced research professionals trained in different aspects of early phase clinical development. The team offers professional and technical expertise for timely execution of studies and is committed to provide ethical, reliable and quality services.
The HPU has a dedicated Quality Control team to ensure that all studies are conducted in compliance with protocol, SOPs and GCP principles.
Our Quality Assurance team independently monitors quality of all deliverables.
The early phase services include planning and conducting:
- Bioavailability/bioequivalence studies
- Pharmacokinetic/pharmacodynamic studies
- Phase I / First-in-Human studies
- Proof of Concept studies
These studies are conducted in accordance with national and international GCP guidelines and regulatory requirements.
Infrastructure
- Volunteer database with biometric identification
- Dedicated areas for
- Housing male and female volunteers
- Volunteer dining and recreation
- Pharmacy with dispensing area
- Counseling
- Screening
- Sampling
- Documentation
- Document storage
- ICU – equipped with telemetry, defibrillator, ECG, infusions pumps, glucose analyzer, pulse oximeter
Expertise
- Pilot and Pivotal BE and PK/PD studies for various dosage forms and routes of administration - tablets, capsules, extended release preparations, transdermal gels, inhalations, nasal preparations, subcutaneous injections
- Phase I clinical studies [Single dose, multiple dose, dose escalation, food interaction, drug-drug interaction studies]
Services
Flexible services module include:
- Protocol design and review
- Recruitment and screening of healthy volunteers
- Protocol approvals by Independent Ethics Committee (IEC)
- Execution of complex study designs
- AE monitoring and reporting
- Report preparation
Advantages
- State-of-the-art DCGI [Drug Controller General of India] approved facility
- Studies approved by TPD [Health Canada], EMEA and DCGI
- Experienced in conducting studies for small molecules and biologicals
- Quick turnaround time
- Database of healthy male volunteers [3000+] for faster recruitment
- Experienced staff, well versed with various regulatory audits like ANVISA, WHO, UK MHRA, US FDA
- Flexibility in offering services as stand-alone service or as a part of the full service study
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