A number of factors favour India as a clinical research hub. There are numerous government-funded medical and pharmaceutical institutions with state-of- the-art facilities, which can serve as ideal centres for multi-centred clinical trials. India has proven ability in generic drug production. India is the third largest producer of generic drug globally. India boasts of well-trained and qualified manpower, well versed in English. The research and the development process in India can be done at a more affordable price. More importantly, there is vast drug naive cases, which can be utilised, due to the prevalence of a large variety of diseases, including widespread cases of cancer and diabetes, India is viewed the world over as the ideal location for clinical research trials for the pharmaceutical industry.
All our training programs have been developed by the clinical research experts who have worked in the health care industry for many years. This course is an assortment of various modules of clinical research and Biopharma subjects. The course is especially for any graduates from health science and allied health science milieu. Hence, our training programs are medical industry oriented to an extent of preclinical testing, Good laboratory practice, and Good clinical practice and also immense of practical knowledge to impart in real-life scenario. Very nominal fee structure is also advantage for student from middle income family.
Padmashree having a well drafted unique quality assurance in teaching programme which well designed to benefit the students which will help them to develop conceptual and practical skill further in wide range of scenario. PICR having an assessment programme by having
- 1. PGI boast of centre of quality education.
2. Advisory board with Ten member team from all background.
3. All study modules are reviewed by Industry experts.
4. Students feedback programme are regularly practiced
5. Quality of teaching module is periodically reviewed.
6. Entire annual reports are systematically reviewed.
7. The course is affiliated to the Rajiv Ghandi University of Health sciences. Karnataka.
Yes there is specialization, after successful completion of two semesters the students will have to choose one optional subject along with the other two compulsory subjects.
- I - Pharmaceutical Biotechnology - Optional
II - Pharmacogenomics. - Optional
III - Statistical Operations & Advanced Analytics - Compulsory
IV - Regulatory affairs and Pharmacovigilance. - Compulsory
After completion of Course the various specializations that are available in clinical research field include Monitoring, Project Management, Quality Assurance, Data Management, Pharmacovigilance, Regulatory Affairs, Medical Writing, Research Physician, Site Management, Business Development Research and development etc.
- 1. A 30 acre Campus is fully covered by lush green environment,
2. Wi-Fi internet facility, Class rooms with LCD projectors.
3. Multimedia Room for audio and video classes.
4. CDM/ SAS analysis training Labs,
5. Digital Library with online access.
6. Students those who registers receive the course syllabus and printed material for all the aspects of clinical research.
7. Apart from the class room teaching, we have a unique teaching methodology in-built hands-on training through assignments, Presentation, Journal club, Case studies, Hands on training Workshops. Statistical analysis /Data Management software training.
8. Good infrastructure wet lab facility.
Padmashree Diagnostic Centre, Bangalore
- 1. SMO India, Bangalore
2. Kidwai Institute of Oncology
3. Bangalore Institute of Oncology (HCG Global)
4. Guest Lecture series from major Pharma industries personnel.
Most of the faculties in PICR are doctoral degree holders and proven expertise in Clinical research field. Like Preclinical testing (invitro and Invivo model), Good laboratory practice, Good Clinical Practice, They have 5-10 years of research and teaching experience in their relevant subjects and have 10-50 publications to their credit in both National and International journals. Industry working visiting faculties, to train our students in the field of clinical and preclinical project activities.
Dr. Suresh Babu .S.V, M.Sc., ADCR, PhD, Principal
His area of interest in Good Laboratory Practices (GLP) and Conduct of clinical studies with investigational agents. He also involved in coordinating with the development of preclinical testing and clinical agreements with collaborators. He also supervises a staff that files and manages a diverse and extensive collection and implements collaborative research and development agreements for these investigational drugs or agents. Before coming to Padmashree Group of Institutions, Dr. Suresh Babu spent 13years in National Institute of Mental Health and Neurosciences, Deemed University, Department of Neurochemistry, Clinical Biochemistry unit, Bangalore. His area of interest is particularly in Neurological disorders, inherited neurometabolic disorders and proven expertise in analysis of amino acids by HPLC in biological fluids. Dr. Suresh Babu is an Author and Co-author for more than 12 papers at national and international journals.
Dr. N.S.N. Rao, M.Sc., PhD, Professor, Dept. of Biostatistics
Dr. N.S.N.RAO, M.Sc, Ph.D., F.I.P.H.A., F.A.M.S. is presently Professor of Bio- Statistics at Padmashree Group of Institutions, Bangalore besides being Visiting Professor in various Medical Institutions at Bangalore. He has been teaching Research Methods to a vast number of students of Medical and Allied Health Sciences for over five decades, both in India and United Kingdom. He has been a visiting faculty at Liverpool School of Tropical Medicine, England. He has provided guidance for various Research projects and also Technical Consultancy to a large number of WORLD BANK, DANIDA, UNICEF, FORD FOUNDATION, UNFPA, ICMR funded programmes in different States of India. He was the full time Team Leader of Technical Support Unit of United Nation's Population fund at Delhi. He has to his credit awards like Fellowship of the National Academy of Medical Sciences (India), Fellowship of the Indian Public Health Association, Visiting Professorship with Indo_British University Collaboration programme, Golden Jubilee Award from Indian Public Health Association. His publications include a dozen Monographs, two text books, half a dozen Chapters in Monographs, 50 Technical reports and over 100 scientific publications in National and International journals.
Dr. Prabhu .B.M, M.Sc., M.Phil., PhD, Assoc. Professor, Dept. of Physiology
He obtained both his M Phil and Doctoral degree in Neurophysiology from National Institute of Mental Health and Neurosciences, Bangalore. Further he continued his postdoctoral research at department of Biological Sciences at Arkansas State University, AR, USA and University of Pennsylvania, PA, USA. His area of interest in Developmental neurotoxicity, Nanotoxicity, Nanomaterials and Neuron interaction and proven expertise in Animal cell culture and cell based drug induction studies. He is the Author and Co-author for more than 9 papers at national and international journals.
Ms. Malarkodi .S.M, M.Sc., M.Phil., Asst. Professor, Dept. of Molecular Biology
She did M.Sc., Biotechnology at Bharathidasan University. Her area of interest in the field of Bioinformatics – Drug designing (Study of pharmacokinetics, pharmacodynamics), Molecular diagnostic techniques, SOP writing, ISO certification, Documentation, Medical Writing, CDM, Assessment of SAEs. She has also developed many ELISA based assay kits/products and also proven expertise in protein purification.
R. Chinnadurai., M.Sc., M. Phil, PGDCA. Asst. Professor, Dept. of Biostatistics
Dr. Chinnadurai presently working as visiting Professor at Padmashree group of institutions. He has been teaching research methodology at various institutions. He has vast experience on research data analysis and processing through various software's like SPSS, EPI-INFO, EPISTAT and HG. He also has experience in field work data mining, structured tool, supervision of large scale data studies under the projects – Dept of Biostatistics, CMCH, and Vellore. He has conducted number of workshops on Biostatistics and Research methodology in many colleges for Post graduate students. His publication, a Monogragh No 33, House hold characteristics – 1998, Rural and Urban communities of Vellore district of Tamil Nadu, India. Under the project “Longitudinal study on child growth and development” – CMCH, Vellore.
Ms. Sumana Nayak A, M. Pharma. Lecturer, Dept. of Pharmacy
She did post graduation in M.Pharma - Experimental Pharmacology, RGUHS, and Bangalore. Area of interest: Preclinical Testing. She has one publication to her credit
Clinical Research Coordinator (CRC):
- 1. Clinical Research Associate (CRA)
2. Clinical Data Associate
3. Medical Monitor
4. Clinical Trial Analyst
5. Project Co-coordinator
6. Clinical Research Manager
7. Manager Scientific Writing
8. Data analyst
9. Basic Science Researcher
10. Medical writer
11. Study Coordinators (Pre Clinical Testing)
12. Drug safety associates
13. Principal Investigator (PI)
14. Regulatory affairs specialist,
15. Marketing Researcher
- 1. Industrial visits
2. Industry related project training
3. Industry –Academic sponsored Workshop training
4. Guest faculties from Biopharma Industries, Pharma, Basic Research, Bioethics.
Many various scientists and researchers are involved in the development of a new drug. For many years, traditional organic chemists, scientists, physiologists, and statisticians have been involved in the research process. In more recent years, they have been joined by new kinds of specialists. For example, biochemists study the chemistry of life processes. Molecular biologists study the molecules that make up living matter. Toxicologists investigate chemicals’ potential for harm. Pharmacologists look at how drugs work, and computer scientists apply the power of their sophisticated machines to analyze and assess new chemicals. Each of these individuals plays a critical and necessary role in new drug development.
It takes an average of 12 years for a drug to travel from the research lab to the patient. In addition, only five in 5,000, or 10%, of the drugs that begin preclinical testing ever make it to human testing. Only one of these five is ever approved for human usage.
The new drug development and approval process may be one of the d regulates the new drug development process. The regulatory bodies, like FDA, EMEA, ANVISA, CDSCO’s role in the preclinical research stage is minimal. However, once a company finds sufficient evidence that a drug is successful most difficult processes in the world. The regulatory body monitors the animals, human trials will begin. The FDA/CDSCO plays a much more crucial role during the various clinical trial phases. If the drug shows successful effects in humans and the FDA approves it to be prescribed by physicians to humans, the FDA will determine what information should be placed on the label including, directions for use, potential side effects, and other necessary warnings..
At any one time, thousands of new drugs are being researched and developed to treat and cure the diseases the effect both humans and animals. New drugs for diseases such as AIDS, Cancer, Diabetes, Arthritis, Asthma, Parkinson’s disease, Feline Leukemia, and other chronic diseases are continuously being researched and developed. That is why it is critical to support biomedical research. Continuous and ongoing research is important also to the discovery of new treatments and unexpected benefits. For example, the popular hair growth treatment gain begun but it’s existence in a research lab as a potential heart medication.
There are many steps researchers take when developing a new drug, steps that can be divided into different phases.
- 1. Preclinical Research 2. Investigational New Drug (IND) Application 3. Phase 1 Trial 4. Phase II Trials 5. Phase III Trials 6. Phase IV Approval
The first place researcher’s start is in the lab. Preclinical research is the process where scientists and researchers determine what germs, viruses, or bacteria cause a specific disease. Once this is accomplished, researchers and scientists will work to break down the different components that make up a disease to find out what abnormal events or processes are taking place in the body. Scientists then work to develop a drug that will treat these abnormalities by conducting experiments in test tubes where they will add various compounds to enzymes, cell cultures, or cellular substances. The goal is to determine which compound additions result in some sort of chemical effect on the disease. Whenever possible, scientists will use computer models to test different compounds; however, computers don’t provide any final answers. These compounds still have to be placed into a living biological system to see if they work. Therefore, after successes in the “Benchtop” process (test tubes and cell cultures), scientists then test these compounds that have shown some desired effects in living animals. The entire process of preclinical research can take up to three and a half years. Once the process is complete, a pharmaceutical company will then file an Investigational New Drug Application (IND) with the CDSCO/FDA.
The IND becomes effective if the CDSCO/FDA approves it within a stipulated periods in days. At this time a pharmaceutical company can begin to test the potential new drug in humans. This process includes three phases of clinical trials.
A new drug is administered to approximately 20 to 80 healthy volunteers, to study the activity and monitor potential toxicity in people. This process takes about one year and if successful, will lead to phase II clinical trials.
During the phase II trials, the drug is given to 100 to 300 volunteers with the disease being studied to determine the drugs effectiveness. Proper dosages are established during this time. This process can take about two years to complete before moving to phase III clinical trials.
This phase involves anywhere from 1,000 to 3,000 volunteers with the specific disease that are in clinics or hospitals. Physicians will monitor these patients closely to determine the effects of the drugs and determine if any side effects are involved. This phase confirms if the drug is effective and safe and can take about three years.
After all three phases of clinical trials have been completed successfully a pharmaceutical company must file a Application with the Regulatory bodies like FDA/ CDSCO. The pharmaceutical company must be able to clearly demonstrate the effectiveness and safety of the drug and must provide all of the scientific information the pharmaceutical company has collected on the specific drug. The Regulatory bodies can take up to six months to review the application. Often times, this process takes longer than six months.
If the CDSCO/FDA approves the drug, it is then made available for physicians to prescribe to patients. The pharmaceutical company is still responsible for submitting periodic reports to the Regulatory bodies like FDA/ EMEA regarding any unknown side effects that may occur after approval. For some medications, the FDA requires additional studies after approval. These are known as Phase IV Clinical Trials and serve to determine if there are any long-term side effects.