Simply put a CRO stands for a Clinical Research Organization that is a medical organization specializing in drug development, disease treatment, medical trials, researches and various other studies. In the past few years, India has gained prominence in Medical science, treatment and Medical tourism. The reasons are numerous. One of the important reasons is the development of eminent CROs, especially in the southern part of the country.
A standard
CRO in India would offer their clients with an extensive service portfolio that would include Bio Studies, Clinical Trials, Bioanalytical Research, Biometrics, Medical Writing and Regulatory Services and many others. The service portfolio is impressive and is a comprehensive mix of late and early development studies and is characterized by reliability and quality. There are experienced medical professionals who make the best use of the new age technology and applications.
CROs and Phase I Studies
Phase i studies form an essential aspect and it is supported by the vast experience of the CRO in clinical trials. Apart from this, the infrastructure is state-of-the-art and healthy volunteers to conduct the studies. Some of the components include the following:-
1. First-in-human
2. Single Ascending Dose studies
3. Multiple Ascending Dose studies
4. New Chemical Entities
5. Dose Escalating studies
CROs and Regulatory Compliance Services & QA
Regulatory Compliance Services & QA is an integral component of a CRO and has a dedicated team for regulatory services and other allied audit compliance. This is further supported by in-depth awareness of local regulatory processes and association with multiple regulatory agencies that leads to an efficient clinical trial approval process. The service portfolio includes the following as listed below:-
1. Formulation of regulatory strategies
2. Compilation of the clinical trial application
3. Submission and follow-up of the application
4. Response to regulatory agency queries
5. Procurement of drug import licenses
6. Procurement of NOC for export of biological samples
7. Tracking of applications and approvals
8. Safety Reporting
9. Submission of Clinical Safety Report (CSR)
10. Renewal of Import License
CROs and Therapeutic Research
Eminent CROs in India also offer their expertise in Therapeutic researches. This is marked by numerous medical studies done and submitted to the USFDA and includes the following areas:-
1. Dermatology
2. Oncology
3. Diabetes
4. Cardiology
5. Anti-Retroviral
6. Gastroenterology
7. Infectious Diseases
8. Neuro-Psychiatry
9. Biologics
10. Immunoglobulin
Drug development leading to efficient disease diagnosis and treatment has been the motto of the CROs so far. This apart, they act as a center for clinical researches for various Indian as well as International sponsors.
