Human Pharmacology Unit
Clinigene has a state-of-the-art Human Pharmacology Unit [HPU] spread over 15,000 sq. ft. with 54 beds. HPU services include planning and conducting bioequivalence studies and Phase I studies. Studies are conducted in accordance with ICH-GCP and Indian GCP guidelines.
The HPU has the instrumentation, experience and expertise to conduct different clinical studies like bioequivalence, PK/PD, Drug interaction, Phase I and Dose escalation studies. The clinical facility has a fully equipped Intensive Care Unit [ICU], Pharmacy and separate subject screening and blood sampling areas.
HPU is committed to offering professional and technical expertise for the timely execution of all studies. The Clinigene Central Laboratory provides clinical laboratory services to HPU.
The HPU team has research professionals who are experienced and trained in all aspects of conducting early phase clinical development programs and is committed to ethical, accurate, reliable and quality services extended to sponsors. HPU has a dedicated QA team to ensure conduct of all studies in compliance with protocol, SOPs and GCP principles.
Infrastructure
- Dedicated facilities for housing male and female volunteers
- Pharmacy with dispensing area
- Dedicated area for documentation
- Counseling area
- Screening area
- Blood sampling areas
- Volunteer dining and recreation areas
- ICU
- Volunteer database
Expertise
- Pilot and Pivotal BE studies and PK/PD studies for various dosage forms - tablets, capsules, extended release preparations, gels, inhalations, nasal preparations, suspensions and solutions
- Phase I clinical studies
Services
- Protocol design and review
- Screening and recruitment of healthy volunteers
- Approval of protocols by Independent Ethics Committee (IEC)
- Study execution
- Report preparation
Advantages
- DCGI approved facility
- Quick turn-around time
- Studies submitted to TDP [Health Canada], EMEA, DCGI
- Experienced staff well versed with various regulatory audits like ANVISA Brazil, WHO, UK MHRA, US FDA.
- Facility and expertise on par with world’s best CROs
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