CRO’s and Clinical Research in India
India is presently at a state of medical boom. New methods of treatment and medicines are being discovered and various medical studies are being conducted. Decades back for any critical disease diagnoses one had to think about relocating abroad. Today the scenario is just the reverse. Most critical ailments can be detected at an early state and can be diagnosed too. All this is possible with the help of state-of-the-art medical equipments along with a team of expert medical professionals. However, the basis of all these developments roots from clinical research and trials.
What is a Clinical Research?
Clinical research is an indispensable part of drug discovery and development. The modern day ailments have been increasing worldwide. As a result, the methods of treatment and diagnosis too needs to effective and new age, so that patients receive maximum benefits. Researches that are carried on various hospitals and other medical institutions, in order learn about the medical dynamics is what is known as clinical research. It highlights all the trends of ailments, recovery process and the medical behavior of patients.
CRO’s and Clinical Research in India
The southern part of India has excelled in medical innovations the most in the past few years. It is a key center for medical research and trials owing of the availability advanced equipments and able doctors. Chennai, Vellore and Bangalore houses eminent Clinical Research Organization (CRO) providing a wide array of services that covers Phase I to III studies for pharmaceutical and global biotechnology companies. These CRO’s specialize in the following sections:-
- Medical Writing
- Regulatory Services
- Biometrics
- Bioanalytical Research
Fields of Clinical Research in India
Medical writing became important as soon as the industry recognized the requirement special skills to be able to come up with comprehensive medical documents where the data needs to be presented in a concise yet clear manner. Eminent CRO’s in India possess an experienced Medical Writing department, that guarantee all submission documents are medically and scientifically accurate, concise and complies with all regulatory and ICH guidelines. The submission reports are generally in CTD and eCTD formats. The services consist of Investigation Brochures, Case Report Forms, Study Reports, Scientific Papers for publication, Med Xview for e filing and many more.
Regulatory Services along with QA form the key constituents of service portfolio at the top CRO’s. They have a distinguished group for audit and regulatory compliance that is backed by an extensive understanding of regulatory methods and the successful connection with separate regulatory agencies ensures competence in the clinical trial approval process. A few selected services are listed below-
- Compiling the clinical trial application,
- Formulating regulatory services,
- Responding to regulatory queries
- Safety reporting
Most CRO’s In India have Bioanalytical Services as their forte and they comprise a diverse range of activities such as
- Serum
- Blood
- Urine
- Plasma
- Analyze intricate modules for Phase I plasma sample from Oncology assignments
Similarly, CRO’s comprise a Biometrics group helping clients at every level of the Clinical Trial along with the expertise to set up an analysis method, interpretations, study designs and assist in clinical development program. Selected upgraded software used by the team includes SAS and Winonline for their research and studies.
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