Multi-national companies in the pharmaceutical field are facing great challenges like spiraling research and development costs, pricing pressures, absence of blockbuster molecules and increased overheads. In this scenario, outsourcing of high end processes to third-party service providers is a viable strategic option adopted by them. The services that are being outsourced include:
- Pharma Clinical Trials
This service provides research support for Phase I-IV clinical trials across broad therapeutic areas.
A new drug is tested for the first time in a small group of healthy volunteers in Phase I trial. This is to determine the early safety profile as well as to gather information on the pattern of drug distribution and absorption, metabolism and other pharmacologic actions of the drug in human body.
In Phase II trial the drug is tested for the first time in patients with the actual disease condition of interest. Information on the initial efficacy, optimal dosage and further details concerning the safety of the drug is collected in this phase.
Phase III clinical trial is conducted in a large number of patients with the target disease to gather enough data to statistically demonstrate the efficacy of the drug.
Phase IV clinical trial is done after a drug has been approved. It involves clinical studies for gathering more information on the drug used in the general population.
- Clinical Data Management
In this service the data management and biometrics team supports data validation of Phase I-IV clinical trials.