Role of CRO’s in Phase I Studies Medical researches include clinical trials as well as various medical studies. A prominent one is know as the Phase I studies and trials that centers around a new treatment or drugs used in humans. The main objective of these studies is to learn and study about the best dosing schedule. The study includes objectives such as the manner is which a drug is given, the amount of the drug and the frequency at which the drug is given. Medical researchers concentrate on the learning about the drug and its toxic or any other harmful effects. Eminent Clinical Research Organizations in India conducts Phase I studies, that are in turn supported by their experience in Clinical trials. These organizations are equipped with advanced state-of-the-art infrastructure and have volunteers that assist in the studies. Some of the component includes the following:
First-in-human Single Ascending Dose studies Multiple Ascending Dose studies New Chemical Entities Dose Escalating studies Capabilities
In addition to the above mentioned services, the CRO’s also provide Phase I Studies for instance First –in-Man for the New Chemical Entities (NCE’s) and also the New Biological Entities (NBEs). In addition to that, there are a diverse range of medical pharmacology studies that comprise Drug Inspection studies, Proof of Mechanism & Proof of Concept, Food Effect, TQTc studies, Pharmacokinetic / Pharmacodynamic studies as well as explanatory studies for multiple biomarkers and Special Popular studies.
Importance of Infrastructure in Phase I Studies Infrastructure plays an important part in Phase I studies and various other researches that are associated with it. Most CRO’s have well equipped bed units that are managed efficiently by a team of expert professionals having the required medical experience and equipped with state-of-the-art clinical devices. This apart there are also well trained nursing staffs and experienced physicians. These staffs have hands on experience in carrying on First-inhuman and other clinical Pharmacology studies. In India, there are eminent CRO’s in the southern part of the country where Phase i Studies are conducted. These CRO’s have vast experience in conducting medical researches and trials in patient and special populations. Their service portfolio covers Phase I to III studies for various global biotechnology and pharmaceutical companies. They also help in end-to-end Clinical trials. This apart some of the other services that they provide include Bio Studies, Regulatory Compliance Services, Biometrics, Medical Writing and Bioanalytical Research and have an impressive track record and client feedback. Click here for more on clinical laboratory services
Published on Jan 30, 2012
Medical researches include clinical trials as well as various medical studies. A prominent one is know as the Phase I studies and trials tha...