QPS India

Core Competencies

• North American standard Covid-19 safety measures in place in the lab and the clinic to protect our staff and all study subjects
• Global generic drug assay method development and validation team
• 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
• Sample receipt from any global location
• Project Management
• Dedicated, full-time Clinical Research Associates (CRA) for clinical monitoring.
• Clinical Data Management; including eCRF design, data entry, query management, data cleaning, SAS programming, SDTM and ADaM datasets to meet current CDISC standards.
• Medical writing; including study synopsis, protocol, investigator’s brochure, informed consent forms, case report forms, ICH E3 integrated clinical reports, statistics, and eCTD publication.
• Pharmacokinetics and biostatistics using WinNonlin and SAS.
• Quick turnover-time to support first-to-file studies.
• Successful recruitment of healthy volunteers and patient study subjects across numerous GCP sites.
• Ability to successfully recruit study subjects for partial-replicate and replicate designs with long washouts and ensure subject panel completion, even with stringent Covid-19 safety procedures in place.

Facility

• 138 clinic beds
• Designated ICUs (with fully inventoried crash carts) in every clinical dosing area to protect study subjects against unforeseen AEs and SAEs.
• 4 bed emergency unit to handle adverse events (AEs)
• 3 wet laboratories
• 10 LC MS/MS systems (triple quadrupole mass spectrometers – TQMS)
• Over 1,000 bioanalytical, validated assays
• Capacity to analyze over 250,000 samples per year
• On-site, access controlled pharmacy
• 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
• 500 hospital network locations for patient studies in oncology, dermatology, ophthalmology, metabolism, gastroenterology, neurology, and respiratory diseases
• Study subject tracking system
• A database including over 12,000 healthy potential study subjects

Achievements

• 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)
• Additional inspections by UK MHRA and NPRA

People

• Highly experienced management staff with over 200 combined years of clinical BA/BE experience.
• Highly experienced team, including GMP, GCP, GLP, and GEP areas.

Experience

• Created and executed over 1,500 generic drug study designs.
• Successfully completed over 1,600 clinical PK studies (80% of which advanced to regulatory approval).
• Submitted 800+ studies to various regulatory agencies.
• Over 200 first-to-file studies.
• Expertise in multi-drug administration routes; including oral, intravenous (IV), intramuscular (IM), subcutaneous (SC), and topical.
• Experience across a broad range of patient populations; including, CNS (Neuropsychiatry), Cardiology, Endocrinology, Gastroenterology, HIV/Infections Diseases, Nephrology, Oncology, Opthalmology, Pulmonology, etc.
• Ability to dose controlled substances at the QPS Missouri USA site, while catering to all the back end services out of QPS India.