Contract research organizations (CROs)
Contract research organizations (CROs) provide/serve specialised clinical trial services and other research support services for the pharmaceutical, biotechnology, medical device industries and also serve government institutions, foundations, and universities.
One of the main reason why organisations and businesses that enter into a contract with CROs, do so to acquire specific expertise without the need for hiring permanent staff and hence save employee costs and time.
A contract/clinical research organization are extending such helping hand in biopharmaceutical development, clinical research endeavours, clinical trials conduct, product commercialization, biologic assay development and pharmacovigilance.
A contract with an outside company means that the hiring organization does not need the infrastructure, office space or manpower to run these trials themselves. and they hence save time from getting into direct job recruitment process.
Some CROs manage almost all aspects of a clinical trial, from site selection and patient enrollment through final regulatory approval from the Food and Drug Administration and European Medicines Agency.
Although a trial sponsor may transfer all trial functions to a third-party CRO, the sponsor remains responsible for the integrity of the trial data and to ensure it is all factual and backed by good science.
As pharmaceutical companies and medical devices organizations face increasing pressure on high drug costs, they are looking for ways to lower prescription drug costs without losing profits. Outsourcing clinical trial management is a way for these companies to significantly lower overhead costs, helping them make up for the dollars lost for lower medication prices.
Types of Services Provided by CROs
Contract research organizations offer comprehensive services, including:
- Project management
- Database design & build
- Data entry & validation
- Clinical trial data management
- Medicine and disease coding
- Quality and metric reporting
- Statistical analysis plans and reports
- Validation programming
- Safety and efficacy summaries
- Final study report
These are some of the top and best list of CRO’s in India: