subject: Importance And Growth Of Phase I Studies In India [print this page] With medical innovations and discoveries, India today is the most favored destination for clinical researches and trials.Clinical trialscomprise 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 studiestoday have become very popular in India. Famous CROs 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-
1. Multiple Ascending Dose studies
2. Dose Escalating studies
3. First-in-human
4. New Chemical Entities
5. Single Ascending Dose studies
CROs 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.
