Clinical Research Industry is a bridge between the lab and market for new Medicines and the market is growing rapidly. India is rising as a global hub for clinical research. According to projections from McKinsey & Company, the Indian clinical research industry could create a center of attention from US $1.5 billion of revenue from U.S. and European sponsors by 2020, creating a demand for more than 10,000 investigators skilled in good clinical practice (GCP) and supported by nearly 50,000 clinical research professionals. With enhanced outsourcing from the U.S. and Europe to India, global pharmaceutical companies and Indian business executives have set up contract research organizations (CROs) in India. They are in need of highly experienced professionals, both in the clinical research profession and the knowledge process Outsourcing sector. Programs Clinical Research Training – Resolve Group of Companies offers a Certification in Clinical Research, handy Training Program in Clinical Research & Certificate course in Clinical Research which are carefully planned by qualified clinical research professionals for individuals who wish to enter this thrilling world. This course offers full wide-ranging education and “hands-on” training of the entire process as well as GCP (Good Clinical Practice). Clinical research is a scientific study of the effects, risks, efficacy and benefit of a medicinal product. These are carried out prior to the release of the medicine in the market. These trials are undertaken at various stages and studies are conducted after the launch of a new product to monitor safety and side effects during large-scale use. Clinical trials are conducted by Pharmaceutical companies or Contract Research Organization (CROs) / Site Management Organization (SMOs) on their behalf. It is this sector that is driving the growth in Clinical Research in India.
Depending on the type of product and the stage of its development, investigators enroll healthy volunteers and/or patients into small pilot studies initially, followed by larger scale studies in patients that often compare the new product with the currently prescribed treatment. As positive safety and efficacy data are gathered, the number of patients is typically increased. Clinical trials can vary in size from a single center in one country to multicenter trials in multiple countries
Drug Development
Drug development is a blanket term used to define the entire process of bringing a new drug or device to the Market. It includes Drug discovery / product development, pre-clinical research (microorganisms/animals) and Clinical trials (on humans).
Our Clinical Research Training Modules are recent industry oriented curriculam
Program Summary
Certification in clinical research (CCR) is designed to provide candidates with an prospect to acquire and develop the knowledge necessary for efficient clinical research. The program is planned to meet the high demand for trained employees for human clinical trials.
The program enable you to master practical aspects of clinical trial conduct and administration counting clinical trial phases and design, planning, execution, data analysis, regulatory and practical guidelines and ethical considerations.
Certification in Clinical Research (CCR)
3 months (60 hours)
COURSE MODULES
- Clinical Pharmacology and Drug Discovery Process
- Clinical Phases of Drug Development
- Drug Regulations and Ethics in Clinical Research
ELIGIBILITY CRITERIA
- Graduate or Postgraduate in Life Sciences
- Microbiology / Biotechnology / Biochemistry / Bioinformatics
- Molecular Biology / Zoology/Chemistry
- Pharmacy / Medicine
- Bioinstrumentation / Nursing
- Physiotherapy/Dentistry
- Homeopathy / Ayurveda and Veterinary Science
PROGRAM OUTLINE
- Introduction To Clinical Research
- Basic Pharmacology & Pharmacy in CR
- New Drug Development
- Guidelines For Clinical Trials (ICH – GCP)
- Ethics in Clinical Research
- Regulations in Clinical Research
- Biostats & Clinical Trial Designs
- Clinical Trial Documents
- Quality in Clinical Trials
- Clinical Trial Management -Project Management
- Drug Safety & Pharmacovigilance
- Clinical Data Management
PROGRAM OUTLINE
- Be trained the process of drug development
- Gain an perceptive knowledge of the clinical trials process through a operations-focus approach
- Get your hands on synopsis of Pharmacology & Biostatistics
- Gain a global point of view on clinical trials management to better counter to the growing industry
- Learn how to act in response to ethical issues inherent in clinical trials
- Look through real-world case studies discussions
- Gain knowledge of about Quality control/ Auditing of Clinical Trials
- Appreciate the process of pharmacovigilance and Safety exposure.