Clinical Services
Quintiles India is a full-service CRO, or clinical research organisation. We have established a leading position with a track record of conducting clinical studies involving tens of thousands of patients in a variety of therapeutic areas.
Key Services in India
- Project management
- Clinical trial monitoring and site management
- Regulatory affairs
- Drug safety and Pharmacovigilance
- Quality assurance
- Medical and scientific services
Quintiles India brings together quality, speed and low cost through:
- Client-centered project management and innovative study strategies
- Clinical staff who know the investigators and the local environment
- Regulatory staff who have built credibility with Indian investigators and regulatory authorities
- Exceptional therapeutic and technical skill sets that enable management of complex global programs
- Low employee turnover
We are the only global CRO in India whose study sites have been inspected by the U.S. FDA multiple times. In addition, we adhere to Quintiles Global Standard Operating Procedures and conduct studies that conform to ICH GCP requirements. We have participated in FDA Pivotal and Supportive studies with patient contribution from India accounting for between 8% and 75% of the data. 98% of the studies conducted by Quintiles India are for FDA or European regulatory bodies.
Trained Staff
In addition to therapeutic expertise, our responsive and flexible staff uses:
- Lessons learnt from past studies
- Exceptional communication process
- Issue resolution processes
- Novel risk management tools
- Industry leading technology tools
We offer GCP workshops for investigators and site staff.
Therapeutic Expertise
- Oncology
- Central nervous system (neurology and psychiatry)
- Cardiovascular diseases
- Endocrinology
- Gastroenterology
- Respiratory
- Anti-infectives
- Ophthalmology
- Respiratory
- Vaccines
- Rare diseases
- Medical devices and non-interventional studies
To Complete the Full Service Offering India Provides for Clinical Research Excellence
- World-Class Data Management Solutions in Bangalore – The largest of Quintiles’ Data Management units, it offers world-class end-to-end data management solutions in two shifts, for paper as well as electronic CRFs, and the capabilities to work on a variety of platforms. Quintiles also offers biostatistical and medical writing services from Bangalore.
- Centralized ECG Services – Quintiles offers global Central Cardiac Safety Laboratory services from Mumbai and Bangalore. With our medically qualified staff, the Quintiles Cardiac Safety Lab provides 24 x 7 x 365 days digital ECG reading services to sites in any corner of the globe. Read a compilation of research findings generated by Quintiles Cardiac Safety Services or learn more about the services.
- Central Clinical Laboratory – Since 2007, Quintiles has operated a CAP-accredited central clinical laboratory in Mumbai, which offers central lab services for Indian sites in global studies. This lab is a part of Quintiles global central lab network. All labs are connected through the proprietary Quintiles Laboratory Information Management System, helping customers operate and report seamlessly across the world.
- SiteAssist Programme – This programme employs qualified social workers in major cities where we have clinical sites. They follow up with patients, either by phoning or by paying personal visits, to help ensure patient compliance with patient diaries and specimen collection. If necessary, they will accompany patients to hospital or transport specimens for storage in hospital. This service also helps in reducing dropout rates.
- Innovative Partnerships – Quintiles is working with a number of customers globally and in India where Quintiles is a Functional Service Provider offering flexible resourcing. In India, we also operate two custom-built Functional Service Provider units for global customers. In these units, 100% of the staff is dedicated to that customer. One unit is for data management, another for pharmacovigilance services.
