Company Profile: Catalyst Clinical Services Pvt. Ltd.
Catalyst Clinical Services Pvt. Ltd. is a contract research organization with a prime focus on clinical research training and development activities.
With regards to clinical research training Catalyst has made pioneering initiatives such as:
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· Professional Diploma in Clinical Research (PDCR );
· Advance Certificate Program(s) in Clinical Research;
· Professional Certificate in Pharmacovigilance (PCPV);
· Professional Diploma in Clinical Research (ASU&H);
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· Oncology Clinical Trials Training (OCTT );
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· Advance Certificate in Clinical Research (ACCR );
· GCP Training Workshop(s)
· 21 CFR Part 11 Training
Program Director
Sanjay Gupta (M.B.A., M.Pharm) is a well known clinical research expert having over 22 years of extensive clinical research experience. He has personally
conducted and supervised over 100 clinical trials (Global registration trials, Exploratory Phase-II trials, Phase-I trials, Investigator initiated trials etc.)
across a wide range of therapeutic areas including Oncology, Endocrinology, Psychiatry, Critical Care, Infectious Diseases, Andrology, Ophthalmology
etc.
He has presented his research work in various International Journals and Conferences including American Society of Clinical Oncology (ASCO), Seminars
in Oncology, British Journal of Cancer (BJC), Gastric and Breast Cancer (GBC) and British Journal of Radiology (BJR). He has authored 9 books and written
thought provoking articles on clinical research field for periodicals Chronicle Pharmabiz and Express Pharma Pulse. His recent books “The Big Book of
Clinical Research” and “All You Need to Know about Clinical Research” has been widely acclaimed by key stakeholders across the clinical research
industry.
He is the founder member of Society for the Promotion of Ethical Clinical Trials (SPECT) in India and also the Network Coordinator for a cancer trials
network set-up by University of Oxford, London (India and UK).
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PDCR Program Curriculum
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All the students enrolling for PDCR program are committed to uphold the highest standards of personnel and professional ethics. The PDCR program
consists of four modules in all. The components of four modules are as follows:
Module No.
Module Title and Components
Introduction to Pharmaceutical Medicine
· The Drug Development Process
· New Drug Discovery
· Clinical Development of Drug
· Essential Clinical Trial Documents
· Clinical Trials Terminology
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2
3
Good Clinical Practice (GCP) Foundations
· History of GCP - milestones in the evolution of GCP
· Principles of GCP
· Applicable GCP Guidelines
· Declaration of Helsinki
· Clinical Study Process
· The Management of Clinical Studies (Sponsor)
· Ethics in Clinical Research
· Informed Consent
· Serious Adverse Event (SAE)
· Challenges in the Implementation of GCP Guidelines
· Biostatistics
Drug Regulatory Affairs (Clinical Trials)
· Overview of Regulatory Environment in USA, Australia, Europe and India
· Clinical Trial Application Requirements in India
· Import- Export of Clinical Trial Drugs in India
· Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule.
· IND/ANDA/New Drug Application