- QPS in India is a GLP/GCP-compliant Contract Research Organization (CRO) that specializes in clinical drug development research.
- Established in 2004 and located in Hyderabad, India, with 36,000 square feet of facility space and 150+ employees.
- Bioavailability / bioequivalence (BA/BE) studies to support new and generic drug registrations for Drug Controller General of India (DCGI) , US Food and Drug Administration (US FDA), European Medicines Association (EMA) , Therapeutic Products Directorate (TPD), World Health Organization (WHO) , and Medicines Control Council (MCC)
- Early Phase clinical development (Phase I → Phase IIa), including PK/PD.
- Late Phase clinical development (Phase III → Phase IV) studies to support new and generic drugs.
- Bioanalysis for small molecules using LC-MS/MS.
- Clinical data management, including eCRF design, data entry, query management, data cleaning, SAS programming, SDTM and ADaM datasets to meet current CDISC standards.
- Pharmacokinetics and biostatistics using WinNonlin and SAS.
- Medical writing, including study synopsis, protocol, investigator’s brochure, informed consent forms, case report forms, ICH E3 integrated clinical reports, and eCTD publication.
- Project Management services.
- Quick turnover-time to support first-to-file studies.
- 92 beds across 3 clinics.
- 4 bed emergency unit to handle adverse events (AEs).
- 3 wet laboratories.
- 10 triple quadrupole mass spectrometer (TQMS).
- Over 1,000 bioanalytical, validated assays.
- Capacity to analyze over 250,000 samples per year.
- On-site pharmacy and ISO 15189-accredited clinical laboratory.
- On-site canteen for study participants’ meal preparation.
- Automated temperature monitoring for freezers and refrigerators.
- Dual-level power backup system for the facility.
- A network of over 500 hospital locations for patient studies in oncology, dermatology, ophthalmology, metabolism, gastroenterology, neurology, and respiratory diseases.
- Volunteer tracking system.
- A database including over 12,000 healthy-volunteers
- 29 regulatory inspections in 10 years.
- 11 successful US FDA inspections (latest in February 2018).
- 9 US FDA inspections with no 483s.
- 6 consecutive 483-free inspections since 2014.
- 9 successful DCGI inspections (latest in April 2018).
- 2 successful WHO inspections (latest in October 2017).
- 1 successful EMA inspection (latest in April 2015).
- Highly experienced management staff with over 200 combined years of clinical BA/BE experience.
- Highly experienced team, including GMP, GCP, GLP, and GEP areas.
- Created and executed over 1,500 generic drug study designs.
- Over 1,200 clinical studies conducted both in healthy volunteer and patient populations (including BA/BE, food effects, and drug interactions).
- Submitted 800+ studies to various regulatory agencies.
- Over 200 first-to-file studies.
- Expertise in multi-drug administration routes: oral, intravenous (IV), intramuscular (IM), subcutaneous (SC), and topical.