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Mumbai Campus

PG Diploma in Advance Clinical research & PVCDM

Duration - 10 Months

Admissions 2023

Scope of The Course

INR 3.5 Lacs to INR 5.5 Lacs PA

Starting Salary Package
INR Over USD 261 billion

Industry Size
25 lac positions globally

Positions vacant

PG Diploma in Advance Clinical Research & PVCDM

ICRI’s PG Diploma in Advance Clinical Research is an award-winning programme and is India’s first & till date the most sought-after programme within the science fraternity.

The program consists of various human experiments and studies. It is a broad concept with various components, such as clinical research activities, drug management research, drug manufacturing, determining the right dosages of medications for human consumption, and effects of particular medications on the human body, among others.

The comprehensive curriculum enhances the avenues available to students when they step into the industry for faster career scope in Clinical Research.

The mix of Clinical Research, Clinical Data Management, Medical Writing and Pharmacovigilance curriculum along with Management Module and Soft Skills in the course ensures a head start to move up the corporate ladder faster.

Course Objective

To provide participants with a broad understanding of the basic principles employed in diploma clinical research both domestically and internationally.

Why ICRI?

India’s first & largest institute in healthcare management

Real time exposure in hospital facility for hands on practical training in industry partners & hospitals

Additional certifications from CII and ICRI upon completion of training

Industry trainings embedded in course curriculum with practical training at leading hospitals

19000+ alumni network working across the globe

Learn and explore the best of both worlds with India’s top ranked university

Awardee of Presidential Award for contribution in clinical research & healthcare

ICRI has partnered with leading healthcare organizations such as Singhealth

What will you study?

SEMESTER I

Module I – Introduction to Clinical Research
Module II – Basic Pharmacology and Pharmacy in Clinical Research
Module III – New Drug Development
Module IV – Ethical Guidelines in Clinical Research
Module V – Ethics in Clinical Research
Module VI – Regulations in Clinical Research
Module VII – Biostatistics in Clinical Research
Module VIII – Specialist Clinical Trials and Clinical Trial Designs
Module IX – Clinical Trial Documentation
Module X – Quality in Clinical Trials
Module XI – Clinical Data Management
Module XII – Clinical Trial Management
Module XII – Drug Safety and Pharmacovigilance
Module XIV – Soft Skills for a Clinical Research Professional

What Will You Become

For Doctors: Principal Investigators / Co-investigator / Medical Advisor / Drug Developers / Regulatory Affairs Manager / Clinical Research Physician.
For Paramedics, Pharmacists & Life Science Graduates: Medical Writers / Clinical Research Associates / Site coordinators / Clinical Research Manager / Drug Development Associates / Clinical Data Management / Pharmacovigilance Executive / Clinical Trial analyst / Drug Reviewer / Drug Safety Physician & many more
For Management Professionals: (with Life Science/Health Science background) Business Development / Clinical Project Management / Clinical Research Management / Regulatory Affairs.
Clinical Research Associates: To monitor clinical trials, ensure compliance with the clinical trial protocol, checks clinical sites activities, make on-site visits, CRFs.
Clinical Research Investigators: Conduct BA/BE studies, writing / revising SOP, review of protocols, investigators brochures, ICF & CRFs Protocol, CRF & ICF preparations plans and conduct of BA/BEIEC/IRB affairs-GC.
Study Coordinators: Provides safety & protection while collecting & managing the study data.
Data Manager / Biostatistician: Design, study & predict the seriousness of the disease, seriousness of the disease, evaluate new treatment and effectiveness of medication, participate in research design, data collection, choosing & implementing appropriate methodologies, interpreting the results.
Regulatory Affairs Managers: Review & registration of documents, evaluation of technical data, liaison with regulatory authorities.
Clinical Trials Auditors: Conduct audits for regulatory function within the trial department to assure compliance with GLP/GCP in accordance with established FDA regulations and company policies & standard operating procedure.
Clinical Research Managers: Manage, supervise, train, mentor clinical research staff, approve investigator’s study, budget & contract, review & approve regulatory documents, develop a protocol, approve CRFs, review study data.
Business Development Manager: Identify potential clients, establish business relations, responsible for meeting new clients, following up on leads, market research.
Drug Safety Associate: Manage & relay drug safety information, maintain current knowledge of global drug safety regulations, summarize clinical safety data, write narratives with medical input, report SADRs to Regulatory Authorities, participate in training on drug safety issues & another task under drug safety.
Medical Writer: Documentation, manuscripts, abstracts, external communication tools Clinical Data Manager: Ensures the accuracy & consistency of data prepared for regulatory bodies for reporting purpose.
Others: Auditors, Quality Assurance, Patents & IP Related position

Where will you work:

Bioengineering companies- Serum Institute Of India, Panacea Biotech Ltd, GlaxoSmithKline, Bharat Serums
CROs - Excel Lifesciences, Clinigene, IQVIA, PARAXEL, Panacea
Hospitals – Apollo, Max, Fortis etc
Life-Division of IT Companies – Accenture, TCS, Cognizant etc
Pharma Company – Cipla, Novartis, Ranbaxy
Medical device companies- Abbott Laboratories, Johnson & Johnson, Novartis AG, Siemens Healthineers, General Electric
Medical Colleges- AIMS, BAMC, Maula AZAD, Mahavir Medical College,
Cosmetic Companies- Biotique, Lakme, Sugar Cosmetics, Mamaearth

Industry Exposure

Industry

Clinical research Industry: Global & Indian perspective

The global clinical trials market size was estimated over 50.0 billion in 2022 and is expected to reach to USD 84.43 Bn by 2030 with a registered CAGR of 5.7% during the forecast period 2022 to 2030.
The market was further driven by COVID-19 pandemic and the importance of making India as a hub for conducting clinical trials. The large number of patients also highlights the growing demand for treatments and immunizations. Currently, 288 medicines and 106 vaccines are in various stages of development, with almost 7.0% of therapeutics in Phase IV, 21.0% in Phase III, and 43.0%, 13.0%, and respectively, Phase II and Phase I.
These rules have brought India's regulatory framework on par with U.S. Food and Drug Administration (FDA) norms and now India is among the top choices for global clinical trials. India's clinical trials market is expected to reach $3.15 billion by 2025 with a compounded annual growth rate of 8.7%.
A new set of rules in place since 2019 is beginning to make India an attractive destination for big pharma to conduct clinical trials in India.
Today, around 50,000 clinical research professionals are required in the clinical research industry.

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