Clinical Research Scenario
Pharmaceutical Industry worldwide has witnessed lots of paradigm shift so far in the entire industry. Previously considered as just a secondary market in India, Pharmaceutical Industry has acquired the major place.With years to come, clinical research and trials holds manifold promises to reach all the nook and corner of the country thus creating further horizons for the upcoming and existing clinical research organization and contract research organization (CRO).
Subsequent to these developments, the Pharmaceutical industry tends to promise a bright future for India. Whereby, the aura has already settled into the vibes, information technology recognizing its potential, has taken a major step to revamp the current status of clinical trials. A simple example can be in terms of current paper system that encounters several drawbacks (such as Lack of standards, incredibility, mishandling of data etc) can easily be wiped by electronic entries and Electronic Data Capturing popularly known as EDC. Another technology entry into present Clinical Research set up is IVRS (Interactive Voice Response System). IVRS in Clinical Research helps in data tracking of Patient Randomization, Drug details, Clinical Trial Logistics management etc .Yet another concept is online drug dictionaries that helps Researchers and medical professional a big deal. These are just fewer concepts with many more facets to be added by the technology in India’s pharmaceutical Industry. India’s open and existing resources and the all time expanding scope of Clinical Researches will be refurbished once the fully dedicated technology aspect gets into the functioning. Present Scenario of Clinical Research and Clinical Trials can be explained in following terms-
Existing Resources with India
- Site availability
India is a hub of world’s best super speciality hospitals well equipped with the most advanced technologies and well trained doctors. Hospitals like AIIMS, Apollo, PGI-Lucknow, KGMC Lucknow, RP eye care center-Delhi, SMS Jaipur, PGI-Chandigarh, Rajiv Gandhi Cancer hospital,Max hospital, Fortis hospital lead the que.
- Data credibility
The elements comprising data credibility include completeness, accuracy, precision, timeliness, integrity and independent verifiability. India promises accuracy with smallest unit of difference detectable and integrity that ensures that the information content is not alterable except under authorised guidance.
- Prevalence of disease
The another factor that makes India an attractive destination for clinical trials is the prevalence of diseases . The large population of India increases the probability for diseases. Hence increasing the prevalence of disease. This in turn manages fast recruitment of patients available for clinical trials.
- Cheap cost
India is a place for cost effective yet quality oriented clinical trials. The same clinical trial conducted in US or any other part of the world may cost four to ten fold as compared to India. India gives a low cost advantage with high quality fast output.
- Infrastructure
Presence of Indian based CROs that are ready to extend a helping hand to the perplexed sponsors is an added cherry to the cake. The CRO business in India ranges between $100-$120m per year. This factor is making the pharmaceutical countries flock towards India. CROs manage many functions of a sponsor, monitoring the work in phase II-IV. Currently, there are almost 30 CRO in India. India holds a market of $300 to $500 million in the field of Clinical Research Organization(CRO). Where Northern India constitutes ten percent of it and generates revenue of $40 million out of it.
- Technical support
Development of softwares for electronic case report forms, data mining and management, SAS programing are often outsourced to India owing to its cost effectiveness as the same effort in US may require far more investment
- Late stage clinical trials in India
- India is already into partnership with a number of countries for Phase II and phase III trials.
Succeeding with latest Trends
After adopting the major changes of IT industry in Pharmaceutical Industry, India is all set to define new parameters for Global markets. Added to it, India is also coming up with Central Drug Authority(CDA) and will empower it with autonomous powers and decision making body . The change in models defining Pharmaceutical Industry along with existing resources that India holds in terms of successful clinical research will prove that even India can adopt the current changes and can be as versatile as others.