We are affiliated to Center For Advancement In Health Sciences (CAHS), Mumbai.CAHS is the first ISO 9001:2000 institute offering unique professional courses in clinical research in India Introduction
Clinical Research is a systematic study for new drugs in human subjects to generate data for discovering or verifying the Clinical, Pharmacological or adverse effects with the objective of determining
safety and efficacy of the new drug. It has opened up new avenues of employment for a large number of trained professionals. In recent years, Clinical Research outsourcing to India has been increasing. This has largely been due to the availability of a huge talent pool of investigators and Clinical Research professionals. Also, India has several prized attributes for clinical trial development, some of which are:
1. Availability of Medical, Pharmacy and Science graduates
3. Excellent infrastructure facilities
4. Comparative cost advantage
5. Changes in the regulatory framework
Many pharmaceutical and Clinical Research organisations have already come forward to unlock the vast potential that India has, and are conducting Clinical Trials in India. Thus, there is expected to be a huge demand for qualified and trained Clinical Research professionals. Salaries start at Rs. 1.5 lacs p.a. and go to over Rs. 15 lacs p.a. for professionals with less than 5 years’ experience. Clinical Research, therefore, promises to be an interesting career option in India. OUR MISSION
Provide an education, training and exchange of information for Clinical Research Professionals and to nurture professional excellence in design and ex*****on of clinical research, thereby contributing to enhancing the Clinical Research culture in India. OUR OBJECTIVES
# Be a recognized as a center of excellence and become a pioneering institution in promoting ethical Clinical Research in the country.
# Fill the vacuum created due to lack of skilled manpower in Clinical Research industry by imparting innovative and intellectually challenging education in the segment.
# Collaborate with organizations at national and international levels in areas of research, training, seminars and conferences.
# Synthesize the highest academic standards with relevance to the needs to present business and commercial policies. COURSE WE OFFER
Post Graduate Diploma in Clinico-Regulatory and Patents
Considering the complex and challenging environment in pharmaceutical industry, we have designed a 6 months “composite” course in Clinical trials, Regulatory Affairs and Patents that not only offers academic training but also provides practical experience in the areas related to:
# The fundamentals of Clinical Trials
# Clinical Trial Protocol
# Management of Clinical Trial
# Indian Drug Regulations
# Pharmacovigilance
# Common Technical Document
# WTO, GATT, IPR, TRIPS
# Data Management
# Medical writing
# Audits and QC of clinical trials.
# Intellectual Property Rights (IPR)
# Communication and business development. Eligibility
Minimum eligibility criteria for application to the course would be either of the following:
# A postgraduate or graduate in Bioscience/Life Sciences (with any of the following subjects: Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotech) with at least 50% marks in aggregate.
# A postgraduate or graduate with Chemistry as a subject with at least 50% marks in aggregate.
# A postgraduate or graduate in Pharmacy or Pharmaceutical Sciences.
# A postgraduate or graduate in Medicine.
# A graduate or equivalent degree/diploma in Nursing. Career Prospects
Career prospects include a professional career in Clinical Research industry either as a clinical investigator, site coordinator in at a hospital conducting clinical investigations or CRO (Clinical Research organization).Jobs are also available in Biopharmaceutical industry. The Clinical Research 6 month weekend course is useful for:
# Doctors – Principal Investigator, Co-Investigator, Medical Advisor, Drug Developers, Regulatory Affairs Manager, Clinical Research Physician.
# Pharmacists, Life Science graduates, Science postgraduates in Biochemistry- Medical writers, Clinical Research Associate, Site Coordinator, Clinical Research Manager and
Drug Development Associate, Biostatistician, Quality assurance
# Management Graduates (MBA) – Business Development, Clinical Project Management, Clinical Research Management, Regulatory Affair Management.
# IT professionals, Biostatistician, Engineers, postgraduates in Maths, Applied Maths, operational Research, Statistics – Clinical Data Manager, Drug Development Associate. Course Objectives
# Have better understanding of Good Clinical Practice and Standard Operating Procedure for Clinical Research and Clinical Data Management.
# Contribute more effectively in their profession pharmaceutical/ biopharmaceutical companies in drug development, CROs offering clinical research and clinical data management services, in bio-IT life science industry, or academic research institution or as clinical investigators at hospitals/ medical sites conducting trials on subjects.
# Support overall clinical trial process electronically by implementing Electronic Data Capture (EDC) system and Project Monitoring.
# Participate in design, conduct and management of global clinical trials conducted at multicentric sites in India and Overseas.
# Have an understanding of evolving regulatory process standards and practices of ICH GCP in conduct of different therapeutic trials for preparing the submissions made to the regulatory authorities for seeking market authorization in India, US, EU, Japan etc.
