Features Of Clinical Research Organizations
Most often a clinical research organization (CRO), is termed as a contract research organization. Simply put, it is a service organization that provides help to the pharmaceutical and biotechnological sector in the process of drug development through non-clinical and clinical trials.
With the increase of medical tourism in India, leading clinical research organizations have set up in the country. These CRO’s are proactively involved in Clinical trials in patients, special population studies accompany by medical volunteers. In India, the renowned and leading CRO’s are located in the southern part that includes places like Bangalore and Chennai. Amidst their wide portfolio of services there is advanced Phase I to III studies with biotechnology companies. Furthermore, the CRO’s have created a positive name for their extensive service portfolio and expertise in areas such as:
* Bio Studies
* Bioanalytical Research
* Biometrics
* Medical Writing
* Regulatory Services
This apart, the CRO’s have a specialized department for QA and regulatory services that constitute an important part of their service portfolio. A dedicated team is allocated for the same that conducts audits and are supported by in-depth local regulatory procedures and effective coalitions with various regulatory agencies. Some of the essential services that are offered includes:
* Formulating regulatory strategies
* Compiling a clinical trial application
* Follow up and submission of the application to DCGI
* 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
Keeping in mind the present day chronic ailments CRO’s also conduct medical studies such as the Phase I study and other medical researchers in their bio clinical laboratories. These laboratories are equipped with state-of-the-art infrastructure that helps in drug development processes and other treatments. Important components here are:
* Single Ascending Dose studies
* Multiple Ascending Dose studies
* New Chemical Entities
* Dose Escalating studies
* Capabilities
Therefore CRO’s provides advanced services for Phase 1 studies for instance First-in-Man for new chemical entities (NCEs) as well as new biological entities (NBEs). Simultaneously, they also offer services for a suite of clinical pharmacology studies that comprises 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.
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