Clinical Research & Biostatistics

Biostatistics is the application of statistical principles to a wide range of topics in medicine and biology. The areas of application include, but not limited to, epidemiology, environmental health, and design and analysis of clinical trials in medicine. Biostatistical methodologies are being incorporated into other areas such as medical informatics, public health informatics and bioinformatics. The discipline of biostatistics is a pivotal instrument used in the process of decision making in all areas of biomedical research that affect patient care. The most important of all activities in medical research is the analysis and interpretation of medical data.

Research plays a crucial role in the creation of evidence to practice Clinical Medicine. Globalization has brought research in medicine to a new frontier. Clinical research owing to its in-depth knowledge-based practices and drive for life-changing results has spawned novel opportunities at various levels. In this scenario, the need for knowledgeable experts cannot be less overemphasized. It is necessary that the upcoming experts be well versed in the field of clinical research. Hence, it is of paramount importance to upgrade the skills of investigators so as to make them self-reliant and competent at designing their clinical studies, creating their data collection tools, analyzing data and interpreting the results for publications and promotion of science.

Globalization is an increasing phenomenon in the pharmaceutical industry. It is imperative that the clinical research and operations personnel follow all required global and local rules related to cGCP (current Good Clinical Practice) as specified by their regional/global drug approval agencies. In this regard, the company makes an effort to keep up with global and local cGCP regulations and directives. These include the ICH (US), EMEA (Europe) and JPMA (Japan). The company has programs to impart cGCP knowledge through workshops conducted by its clinical research faculty and staff who are experienced in local and global regulations.

From this perspective, a clinician or any other health research professional’s training in clinical research and biostatistical methodologies are most often used in drug development and medical research. Of paramount importance is a research professional's training in a statistical software package, SAS (Statistical Analysis Software) to perform highly intensive computations. Such training will enable clinical investigators to design their research studies that have a solid scientific and statistical foundation, and be able to make suitable and meaningful conclusions using appropriate statistical methodologies.