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| Biotechnology |
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In the wake of immense success of the information
technology (IT) industry and with a foundation of
knowledge-based industry now firmly established,
biotechnology and clinical research has emerged
fast in India. Although a relatively young market
segment, India is looked at as a favored destination
for clinical trials and clinical validation studies
for a number of key factors:
- Abundance of patients with ethnic diversity,
- Highly trained and experienced medical staff,
- IT-enabled infrastructure, and
- Low cost.
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There is a significant economic advantage in conducting
clinical trails in India compared to the developed
countries. Recognizing this potential, Qualtran
has setup facilities for research in India.
India has been a part of the many FDA and EMEA registration
studies. India became a member of WTO in 1995 and
agreed to adhere to the product patent regime by
2005. This has led to a significant growth in Pharmaceutical
Industry (> 15%) and increased stakes of MNCs in
Indian operations.
Qualtran at present is capable of contributing to
the following areas of Clinical Research and Drug
Discovery: Bio-availability, Bio-equivalence Studies,
Clinical Trial Site Management, Clinical Operations
management, Multi Centric Clinical Trials, Central
Bioanalytical Lab Facilities, Data Management, Bio-statistics,
report writing and Global Clinical Trials in Phase
I, II, and III. The conduct of simultaneous successful
multi-center global clinical trials with Indian
sites leading in patient recruitment, retention
and completion of all trial related activities,
have proved beyond doubt the choice of India as
destination for Clinical Trials. The advent of reputable
bioanalytical laboratory facilities, their certification
and accreditation by national and international
agencies and CAPC (College of American Pathologists)
has added an important crucial dimension to conduct
of clinical trials. No longer there is need to rush
trial samples for analysis to international laboratories
and no longer have time consuming formalities for
sample export and import. |
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