Biological E Limited's Clinical research is that part of the continuum of health research which is conducted in human beings. This discipline combines discoveries from the basic science laboratory with the observations and insights of clinicians. It then delineates the mechanisms of human health and disease, develops potential preventive, diagnostic and therapeutic measures and finally evaluates their effectiveness for improving health. It also focuses on making rigorous comparisons among current diagnostic, therapeutic and preventive approaches and developing new ones, to determine which are most effective and safe. Clinical research merges with the closely related fields of health systems and population health research. Biological E Limited believes that the maximal benefits to the nation's health and its economy will be achieved by supporting a continuum from basic to clinical to health services to population health research.
Its mission is to engage in challenging Phase-II to Phase-IV clinical research programmes for a growing portfolio of domestic and internationally based pharmaceutical clients.
The CRA team consists of young, dynamic, passionate and enthusiastic research professionals. They are capable of meeting and delivering robust results to all study requirements through experience and commitment. CRA respects and values the relationship it shares with associated organizations, right from understanding the study requirements to designing the study and tracking it to completion.
Globally clinical research is mainly focused on -
- Patient-oriented research - Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects.
This area of research includes:
- Mechanisms of human disease
- Therapeutic interventions
- Clinical trials
- Development of new technologies
Clinical trials :
Clinical trials are research studies which try to answer scientific questions and find better ways to treat or prevent diseases. A clinical trial is conducted to determine whether a new drug or treatment is both safe and effective in people. These research studies rely on Healthy subjects / patients who volunteer to participate and try a new drug or treatment.
Most clinical trials that involve the testing of a new drug follow a series of steps, called phases. This process allows researchers to ask and answer questions in a way that results in reliable information about the drug and protects the patients. Clinical trials are usually classified into one of four phases:
In Phase I trials
Researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase II trials
The study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase III trials
The study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase IV trials
Post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
Biological E Limited currently conducts only Phase-III and Phase-IV studies in accordance with ICH Good Clinical Practice (GCP) guidelines. Biological E Limited also complies with the Drug and Cosmetics Act 1940, Indian regulatory guidelines, laws and standards governing the development and manufacture of Pharmaceutical products.