Service Offering
Our end-to-end service offering comprises regulatory consulting, IP import and sample export, protocol design, ethics committee submissions, safety screening, and bio analytical testing. In addition, we have proven expertise in clinical study management, method development and validation, data management with Oracle Clinical, PK analysis using WinNonlin, statistical analysis using SAS, and report writing, amongst others.
Clinical Research Centres and Facility
BABE and intensive PK/PD studies are conducted in clinical research centres (CRCs) located at selected specialty hospital campuses in India ensuring highest standards of safety. In India, our state of the art BA/BE centre with the 116-bed Clinical Pharmacological Unit (CPU) is located at Manipal and Mangalore and is designed for first-in-man and mixed gender studies.
Equipped with an advanced ICU to handle emergencies, our CPUs are centrally air-conditioned with dedicated areas for screening, counselling, phlebotomy, access-controlled pharmacy, and recreation & dining rooms with state-of-the-art monitoring. The ICU beds are equipped with defibrillators, ventilators, cardiac monitors, oxygen supply, a crash cart and all emergency medicines.
In addition, we have access to the 60-bed Human Pharmacological Unit at the Vydehi Institute of Medical Sciences, Bangalore, which is designed for large pivotal studies. All our facilities are designed to meet high standards of volunteer safety and comply with DCGI specifications.
We have an in house GLP compliant analytical lab with a bank of LCMS/MS and a library of methods.
Study Team and Volunteer Base
Screening samples are tested at our ISO-certified Clinical Testing Laboratories accredited by the College of American Pathologists; hence we are able to ensure volunteer inclusion with protocol compliance.
We have a database of over 4,500 volunteers including female volunteers and special populations for studies focused on post-menopausal women, geriatric volunteers, oncology, psychiatry and dermatology, as well as diabetes. |
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Regulatory Submissions and Quality Assurance
Underwriters Laboratory has certified our processes as compliant with ISO 9001 and, for information security, with ISO 27001. College of American Pathologists have accredited our Safety Lab, which is also ISO 15189 certified. Computer system validation and 21 CFR Compliance is audited by Lachman Associates. Protocols are reviewed by an Institutional Ethics Committee, which is registered with the Office of Human Research Protection, US Dept of Health & Human Services. Our regulatory submissions include EMEA, MHRA, Health Canada.
Our study data is part of drug dossiers filed with various regulatory authorities in India, EU and US.
Studies offered
The studies include:
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Dosage forms - tablets, capsules, suspension
- Immediate and modified release formulations
- Inhalation devices, topical emulsion, sprays
- Transdermal patches
- Light-sensitive compounds
- Food effect studies, apple sauce studies
- Multiple dose steady state studies
- Double-blind, multiple arm design
- Dose escalation studies
- Repeat ‘first-in-man’ studies
- Clinical end point studies
- Proof of concept and exploratory studies
Key Differentiators
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Studies conducted with the highest standards of safety in compliance with international guidelines
- Early slotting of study with volunteer bank and method library
- Breadth of expertise in patient PK/PD studies, biosimilars and early development studies
- Qualified by reputable sponsors from the UK, USA, Switzerland, Finland, Canada and India
- Personalized service to sponsor
- Audited by FDA and WHO
Link to PIR on WHO audit
WHO PIR Mangalore
WHO PIR Manipal
FDA EIR |
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