Human Pharmacology Unit
Clinigene has 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. Recently, the facility was successfully inspected by US FDA, UAE Ministry of Health and Austrian Regulatory Agency (AGES) with no critical findings.
Our HPU has a fully equipped ICU and a strategic contract with a tertiary care hospital for managing medical emergencies.HPU uses Clinigene’s Central Laboratory for screening and safety evaluations helping reduce transport and turn-around time.HPU team comprises of experienced research professionals trained in different aspects of early phase clinical development programmes. 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
- Comprehensive database of healthy volunteers (3000+) with biometric identification
- Dedicated areas for
- Housing male and female volunteers
- Volunteer dining and recreation
- Pharmacy with dispensing area
- Counseling
- Screening
- Sampling
- Documentation
- Document archival
- ICU – equipped with telemetry, defibrillator, ECG, infusions pumps, glucose analyzer, pulse oximeter
Expertise
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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
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Phase I clinical studies [Single dose, multiple dose, dose escalation, food interaction, drug-drug interaction studies]
- Support and conduct patient PK/PD studies off-site
Services
Flexible services module include:
- Protocol design and review
- Local regulatory approvals, where required
- Protocol approvals by Independent Ethics Committee (IEC)
- Recruitment and screening of healthy volunteers
- Execution of complex study designs
- AE monitoring and reporting
- Report preparation
Advantages
- World-class facility inspected by USFDA, UAE Ministry of Health, AGES and DCGI
- Studies submitted to TPD [Health Canada], EMEA, MHRA, USFDA and DCGI
- Experienced in conducting PK studies for small molecules and biologicals
- Quick turnaround time
- Database of healthy volunteers for faster recruitment
- Experienced staff, well versed with various regulatory audits like ANVISA, WHO, UK MHRA, US FDA
- Organize and conduct patient PK/PD studies off-site
- Flexibility in offering services as stand-alone service or as a part of the full service study
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