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Post Graduate Diploma Advance Clinical Research | Clinical Data Management
STARTING SALARY PACKAGE

INR 3.5 Lacs to INR 5.5 Lacs PA

INDUSTRY SIZE

INR Over USD 261 billion

POSITION VACANT

25 lac position globally

ICRI Campus


Course Description

01.

This program is an award-winning programme and is India’s first & till date the most sought-after programme within the science fraternity

02.

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.

03.

The PG Diploma in Advanced Clinical Research offers an advanced study of the sub-disciplines of epidemiology, data management, and biostatistics. Along with the curriculum's theoretical components, this programme also focuses on teaching students how to use their knowledge and skills in the real world.

04.

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

05.

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.

Industry

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.

Curriculam

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

SEMESTER II

  • 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

SEMESTER III

    Module XI – Clinical Data Management Module XII – Clinical Trial Management Module XII – Drug Safety and Pharmacovigilance
    Module XIV – Soft Skills for a Clinical Research Profess

What You Will 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

What are the fantastic career Prospects of doing a PG Diploma in Pharmacovigilance?

Pharmacovigilance is a popular field of study these days. This field focuses on assessing, detecting, and comprehending harmful effects and preventing them. The postgraduate diploma in Pharmacovigilance is a well-known course that can be pursued at many reputable colleges in India and abroad. This course professionally prepares students to excel in this field and establish a solid career in pharmacovigilance course in Pune. Numerous colleges provide this course to students. Students can now take this course online, which is very advanced and convenient. The Pharmacovigilance course is becoming increasingly popular due to its numerous advantages

The Post Graduate Diploma in Pharmacovigilance has been designed by industry experts, ensuring comprehensive coverage and understanding of the industry and its functional areas. The Post Graduate Diploma Programme aims to familiarize participants with the most recent theoretical and practical aspects of the Course In Pharmacovigilance. The diploma program has the following enticing features to advantage all program participants:

Pharmacovigilance Training's Future Career Prospects ICRI provides professional and industry-oriented Pharmacovigilance courses in Pune, paving the way for entry into the industry. A PG Diploma in Pharmacovigilance course offers an advantage for those already in the sector as a badge of professional training, while those new to the industry feel at ease with the backing of appropriate and up-to-date information and training required for sustained growth in the industry.

The PG Diploma in Pharmacovigilance is a comprehensive program that provides candidates with knowledge and practical information about the industry type, working modalities, methodology used, quality control techniques, and drug development. Still, the overall emphasis remains on the course in Pharmacovigilance. This includes a thorough investigation of various types of adverse effects, serious adverse effects, adverse effects reporting regulations, documentation methods, and so on. After completing this program of Pharmacovigilance course, the candidate can choose from various job opportunities in the industry/sector of their choice. Additionally, for individuals seeking broader expertise, courses such as diploma clinical research, PG Diploma in Clinical Data Management, and Post Graduate Diploma Advance Clinical Research can be pursued alongside the Post Graduate Diploma In Pharmacovigilance for a well-rounded education in the field.

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, Mama earth

Why ICRI Why ICRI?
  • ICRI has been India’s first & most awarded institution in Clinical Research & Healthcare since 2004.

  • ICRI has 19000+ Alumni network working across the globe

  • Awardee of Presidential Award for contribution in Clinical Research & Healthcare sector along with 21 more industry specific awards such as India Today Awards, Star TV Awards, ET Now, Higher Education Excellence Awards, Saksham Education Award etc for contribution in Aviation, Healthcare & logistics Management

  • ICRI’s programs, ensure that its graduates are equipped academically and are professionally trained for the global job market.

  • India’s first book on clinical research and pharmacovigilance was launched by ICRI.

  • It is the first institute to launch a PhD in Clinical Research and the first international and national conference in clinical research.

  • ICRI is preparing next generation professionals in Clinical Research, Healthcare, Aviation & Logistics-Supply Chain, Psychology, Cyber Security, Allied Health, Data Sciences and Agriculture

  • ICRI’S Allied Health programs and professional PG Diploma are conducted through it's through its unique university - hospital partnership model to provide degree & the certification.

  • ICRI has 2500+ industry partners for internship programs and final placements.

  • ICRI is generating 100% placements every year with an average salary package of INR 4.5 Lac PA to INR 7.0 Lac PA
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