A Clinical Research Organization (CRO) is also called as a Contract Research Organization and is a service organization that offers assistance to the biotechnology and the pharmaceutical industries to conduct clinical studies including BA/BE studies. CRO’s generally vary from huge, international full service units to small, niche specialty groups. Today with the increase in the medical tourism in India, eminent Clinical Research Organizations has emerged in the country. They are extensively engaged in Clinical Trials in special populations, patient populations and healthy volunteers.
Renowned CRO’s are stationed and well developed in the southern part of the country, for instance Bangalore (for ex. Lotus Labs Pvt Ltd) and Chennai, provides a diverse portfolio of services that includes the Phase I to III studies with biotechnology enterprises. These CRO’s are known for their expertise in various aspects of Clinical Research and other areas such as:- * Bio Studies * Bioanalytical Research * Biometrics * Medical Writing * Regulatory Services CRO’s have a department dedicated to regulatory services & QA that consist of essential components of the service portfolio.
There is a dedicated group for the same as well as audit compliance that are backed up by an in-depth expertise of local regulatory processes and efficient alliance with multiple regulatory agencies. Selected services that are provided are listed below:- * Formulating regulatory strategies * Compiling clinical trial application * submission and Follow up of the application * Being responsive to regulatory agency queries * Procuring drug import licenses * Procuring NOC for export of biological samples * Tracking of approvals and applications * Safety Reporting * Submission of Clinical Safety Report * Renewal of Import License Furthermore, CRO’s also facilitate in Phase I studies that are in turn backed up by the clinical trails. The CRO’s are equipped with the state-of-the-art infrastructure that aids the process. Selected components of the same are listed below:- * Single Ascending Dose studies (SAD) * Multiple Ascending Dose studies (MAD) * New Chemical Entities (NCE) * Dose Escalating studies * Capabilities Hence we see that the CRO’s offer specialized services for Phase 1 studies for instance First-in-Man for new chemical entities (NCEs) as well as new biological entities (NBEs). In addition to that, they also provide services for a host of clinical pharmacology studies that consists of Food Effect, Drug Interaction studies, Pharmacokinetic / Pharmacodynamic studies Proof of Mechanism & Proof of Concept, TQTc studies, exploratory studies for special Population studies and multiple biomarkers.