Importance and Growth of Phase i Studies in India
With medical innovations and discoveries, India today is the most favored destination for clinical researches and
trials. Clinical trials comprise certain methodologies that have an essential part to play in medical research. This in
turn enables efficacy and security of data that is collected for health interventions.
Clinical trials can be conducted only when there is sufficient information gathered from various studies and
researches. The Phase i Studies form an important part here. Numerous Clinical research organizations (CRO) in
India facilitate these studies.
Importance of Phase I Studies
Phase I studies today have become very popular in India. Famous CRO's provide assistance in clinical trials and
possess state-of-the-art bioanalytical infrastructure to adequately support these studies. Apart from this, there are
volunteers who contribute for the same. Selected components are listed below-
Multiple Ascending Dose studies
Dose Escalating studies
New Chemical Entities
Single Ascending Dose studies
CRO's in India today offers specialized services for First-in-Man studies for a completely new range of chemical and
biological entities. Few other services that on offer comprise a diverse range of medical pharmacology studies that
comprises Proof of Mechanism & Proof of Concept, Food Effect, Pharmacokinetic and Pharmacodynamic studies,
Drug Interaction studies, and TQTc studies. In addition to this, there are other elaborate studies for various
biomarkers and special population studies.
What plays an essential role in Phase i Studies?
Infrastructure plays a very essential role while conducting Phase i studies. Furthermore, there is a group managed
by expert professionals with profound knowledge in the field. There are state-of-the-art medical devices, trained
physicians and experienced nurses to aid the process.
Analyzing from an overall perspective on medical trials and Phase I studies owing to a sizeable expense that a full
series trial may incur, the responsibility of paying for all the required services and professionals is generally done
by the sponsor. There are cases when these sponsors range from being a biotechnology organization,
pharmaceutical company, or a governmental organization.
Furthermore, there is also a possibility, that these varied roles might exceed the accessible resources offered by
the sponsor. As a result, Phase i studies along with clinical trials are generally organized and handled by outsourced
agency, for example a clinical trial unit in the academic sector or a contract research organization.
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