Clinical Trial Supply & Investigational Product Management

Download the Syllabus to view sample certificates and course details for your professional growth.

CLINICAL RESEARCH & PHARMACOVIGILANCE

Global Institute of Health Science is a pioneer in health science education, especially in distance and online learning. The institute is ISO 21001:2018 certified and globally acclaimed, with copyright approval from IPR Government of India and international certification from UASL UK for Quality Control Management Systems.

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Bringing Excellence to Health Professionals
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Internationally Acclaimed with ISO & Government Approval
Lifetime Free Personalized Tutoring for Student Success

GIHS Clinical Research and Pharmacovigilance courses online program is designed to provide total overview and skill globally in the field of clinical research. It would help professionals to upgrade & develop their knowledge about ICH GCP Guidelines, regulatory issues and other major aspects of clinical research & trial management. It is designed to provide total overview and skill globally in the field of clinical research, and pharmacovigilance. It would help professionals to upgrade & develop their knowledge about clinical trials, data management, pharmacovigilance, regulatory issues and other major aspects of pharmacovigilance. to understand the key concepts in the responsible conduct of research and that conforms to the highest standards for the protection of human research subjects. It can be able to critically appraise the medical scientific literature, including the methodology of published and proposed investigations.

Syllabus

Table of Content

Introduction of Clinical Research
Clinical Trial Phases / Pharmacological Principle of Clinical Research
Drug Development and Launch
Indian Regulation (Domestic Regulation)
- ICH GCP
- Schedule Y
- ICMR
- Indian GCP
Key Stakeholders in Clinical Research
- Ethics Committees and Institutional Review Board
- Responsibilities of Sponsor
- Responsibilities of Investigator
- Responsibilities of Sponsor – Investigator
- Responsibilities of Sponsor – Vendor
Clinical Trial Design and Project Management
- Clinical Trial Design
- Vendor Selection and Management
- Project Planning
- Project Management
Principles of Good Clinical Practices
- Protocol Design
- CRF Design
Essential Documents in Clinical Research and Regulatory Requirements
- Essential Documents
- IND Application
- Clinical Study Report
- NDA Application
- Informed Consent Process and Documentation
Study Setup Process
- Site Selection and Pre-Study Visits
- Site Initiation
- Subject Recruitment and Retention Planning
- Site Contract and Budgeting
QC, Compliance & Auditing in Clinical Research
- 21 CFR Part 11
- Site Auditing
- Sponsor Compliance and Auditing
- SOP for Clinical Research
Clinical Monitoring
- CRF Review & Source Data Verification
- Drug Safety Reporting
- Drug Accountability Work
- Routine Site Monitoring
- Site Close-Out Visit
Introduction of Pharmacovigilance
Overview of Pharmacovigilance
- Standard Terms and Terminology in Pharmacovigilance
- Medical Evaluation of Adverse Events in Pharmacovigilance
- Adverse Event Reporting System and Form
- Diagnosis and Management of ADRs
- Medical Evaluation of Adverse Events (AE)
Case Processing
- Global Perspective of Pharmacovigilance
- Single Case Processing
- Case Narrative Writing
Pharmacovigilance Reporting Database, Signal Detection, Management and Risk Assessment
- Quality System in Pharmacovigilance
- Expedited Reporting Criteria
- PSUR & PBRER
- PV Database and Signal Detection
- Risk Assessment & Management
Medical Dictionary for Regulatory Activities (MedDRA)
- MedDRA
Pharmacovigilance Laws and Guidelines
- Regulatory Guidelines & Laws in PV
- SOPs in PV
- PV Auditing and Inspection
- Regulatory Aspects in PV

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Clinical Research Courses

Clinical Trial Supply & Investigational Product Management

The GIHS Clinical Trial Supply & Investigational Product Management course aims to develop essential knowledge and practical skills in managing investigational products throughout the clinical trial lifecycle. The program focuses on clinical trial supply planning, procurement, packaging, labeling, storage, distribution, inventory management and drug accountability in compliance with global regulatory standards. Students gain an understanding of ICH-GCP, GMP, USFDA, EMA and CDSCO guidelines, including investigational product handling, temperature-controlled logistics, cold chain management and quality assurance. The course enables professionals to understand clinical supply chain operations, minimize supply risks, maintain product integrity and ensure timely availability of investigational medicines at clinical trial sites. It also develops competencies in regulatory documentation, supply forecasting, product reconciliation and return or destruction procedures. The GIHS online training program supports professional career advancement in clinical research and pharmaceutical supply management through flexible learning, certification and placement assistance.

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Clinical Trial Supply & Investigational Product Management

Clinical Trial Supply & Investigational Product Management is a specialized field of clinical research that focuses on the planning, procurement, storage, distribution, accountability and management of investigational medicinal products used in clinical trials. The GIHS Clinical Trial Supply & Investigational Product Management Program is designed to provide comprehensive industry-level knowledge and practical skills in clinical trial supply chain operations. The program covers investigational product (IP) handling, packaging, labeling, randomization, cold chain management, inventory control and drug accountability. It helps healthcare, pharmaceutical, biotechnology and clinical research professionals upgrade their knowledge of ICH-GCP guidelines, USFDA, EMA and CDSCO regulatory requirements, Good Manufacturing Practices (GMP), temperature-controlled logistics and clinical trial supply compliance. The course prepares professionals for career opportunities in clinical trial supply management, investigational product coordination, clinical logistics and pharmaceutical supply chain operations across global clinical research organizations.

Career-Relevant Skills You Will Develop

Clinical supply planning and forecasting
Investigational product lifecycle management
Labelling, packaging and blinding concepts
Cold-chain and distribution management
Import, export and customs documentation awareness
IRT / IWRS supply configuration concepts
Drug accountability and reconciliation
Temperature excursion and deviation handling
GMP–GCP interface awareness
AI-enabled clinical supply literacy

Career Options

Clinical Trial Supply Associate / Specialist
Investigational Product Coordinator
Clinical supply chain and logistics support
Depot and distribution coordination
IRT / IWRS supply configuration support
Site pharmacy and dispensing support
Drug accountability and reconciliation support
Cold-chain and quality-support roles

Eligibility

Mode or Methodology

Certification

Eligibility

Placement Assurance

Fees, Payment & Program Duration

Certificate Program

Foundation-level program
Industry awareness focus
Expert-designed syllabus
Research-based curriculum
Academic & tech support
Skill development course
Global accreditation & Govt-recognized

₹22,999

*Fees subject to taxes & exchange rates.

Post Graduate Diploma Program

Advanced-level professional course
Research-based modules
Lifetime expert support
Job & career assistance
Free Career Boost (www.TopCVCoach.com)
High employment potential
Global accreditation & Govt-recognized

₹32,999

*Fees subject to taxes & exchange rates.

Fast Track PG Diploma Program

Accelerated PG-level program
Flexible learning format
Lifetime expert support
Research-driven curriculum
Free Career Boost (www.TopCVCoach.com)
Job-oriented training
Global accreditation & Govt-recognized

₹36,999

*Fees subject to taxes & exchange rates.

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Sarah Lilly-MBA

7 months ago

From the day 1 to till date Chethan assisted very well and had a smooth journey till I had received my certificates through courier. And the studies are very detailed and made interesting. Thank you😊

Brandon SJ

7 months ago

I took an EEG course through GIHS that I really enjoyed. The course expanded my mind and pushed me in a lot of ways to capture complex nuances to the process and machinations of EEG and how it works giving me the confidence needed when as I embark on this field. In addition to the learning materials - the communication was exceptional from officials and anything that you needed help with they were there willing and ready able to assist. Thank you so much GIHS!

Kirti Saxena

8 months ago

"Great experience! The faculty is knowledgeable and approachable. The resources and facilities are top-notch. Would definitely recommend."

Andrea Del Pilar

8 months ago

They have a very good independent study methodology and the subject matter is really good; in my personal case, since this specialization is not available in my country, the Institute of Health was a wise choice.

Vinitha Siva

8 months ago

Assistance is good 24/7 , the content of the course can be improved slightly, other than that it was great . Thanks for the support

Samridhi Sharma

11 months ago

The PG Diploma in Nutrition course covers the basic concepts clearly. Teaching is satisfactory and the study material is useful for understanding nutrition fundamentals. Overall, it is a decent course for those looking to gain knowledge in this field.

A V

1 year ago

One of the best institutions. I have recently completed my PG Diploma in Clinical Research and Pharmacology. Course is carefully structured and detailed. Management is very well organised and prompt in assistance. I would highly recommend this institution.

Akram Sabiq

1 year ago

"I'm impressed with the comprehensive coverage of international standards and laboratory skills, which were not adequately addressed in my previous academic programs. This course has been a game-changer for me, providing the knowledge and skills necessary to succeed as a lab technician on a global platform."

susigarans

1 year ago

My Experience with GIHSS and the PG Diploma in Health Informatics & Management I am grateful for the opportunity to pursue the PG Diploma in Health Informatics & Management at GIHSS. Throughout the course, I learned a wealth of knowledge that has significantly enhanced my understanding of the healthcare industry and the role of technology in improving patient care. The curriculum was comprehensive, covering essential topics such as health information systems, data management, healthcare analytics, and health policy. The faculty were highly experienced and supportive, always ready to clarify doubts and encourage practical learning. The program also emphasized real-world applications, which helped me develop critical skills needed in the healthcare sector. Thanks to GIHSS, I now have a solid foundation in health informatics, enabling me to contribute effectively to healthcare organizations. Overall, this course has been a valuable stepping stone in my professional development, and I highly recommend it to anyone interested in bridging healthcare and technology. Wishing everyone success in their learning journey! Best wishes to all future students. Sincerely Denis

Dr Fatema Ebrahim

1 year ago

I recently completed my Post Graduation in Pregnancy and Child Care from GIHS and it was a wonderful experience. The course was well-structured, and the faculty was supportive and knowledgeable. I gained in-depth knowledge about all the aspects of pregnancy and childcare, that have prepared me to confidently support mothers and babies. Highly recommended .

Frequently Asked Questions

How is clinical trial management different from clinical practice?

In practice you use established treatments. In a trial you collect the evidence that establishes one — which brings
protocol, GCP, regulatory and documentation obligations that ordinary practice does not carry.

Does the programme cover project management as well as GCP?

Yes. Trial design, project planning, project management, vendor selection, contracts and budgeting are all part of the
curriculum.

Does it include pharmacovigilance?

Yes. The syllabus gives drug-safety exposure — AE evaluation, case processing, signal detection, MedDRA and PV laws —
for a fuller view of participant protection.

How can AI help a clinical trial manager?

With feasibility, recruitment planning, timeline forecasting, vendor KPIs, risk identification, document review and
monitoring support. Accountability for GCP compliance stays with qualified professionals.

Does it cover the Trial Master File?

Yes — essential documents and TMF review concepts, including identifying missing, inconsistent or overdue
documentation.

Does the course cover monitoring and source-data verification?

Yes. CRF review, source-data verification, drug accountability, routine monitoring and site close-out are covered in a
dedicated module.

Can this programme lead to a Clinical Project Manager role?

It supports the pathway. Project-management roles normally also require demonstrated operational experience, and
appointment remains an employer decision.

Can working professionals enrol?

Yes. The programme is delivered online and by distance learning, with a Fast-Track option.

What is included in the programme fee?

Course material with the latest updates, online access within 48 hours, printed books shipped with your enrolment, a
personal subject expert for life at no cost, the online examination and project assessment, and two international
certificates on successful completion. There are no hidden charges.

Is the TopCV Coach access really free?

Yes. Every GIHS enrolment now includes complimentary TopCV Coach access worth ₹9,999 for professional resume
building and interview skills, and your profile is posted on the TopCV website where a large recruiter network is active.

Can I use this programme to start my own practice or venture?

Yes, within your lawful professional scope. The Business & Entrepreneurship section of this brochure sets out the nonclinical services, education and consulting work the knowledge supports. Regulated clinical services require the
appropriate qualification and authorisation.

I am not from a clinical background. Can I still enrol?

Yes. Any graduate from any discipline may enrol, as can working professionals with relevant experience, entrepreneurs
and managers of healthcare or allied organisations.

Where Our Graduates Are Making an Impact

Request More Information

Want to know more about our programs or find the right course for you? Fill out the form below and our academic counsellors will connect with you shortly.

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Still deciding? Get the brochure on WhatsApp

Our experts will reach out within 24 hours to assist you.

Clinical Trial Supply & Investigational Product Management

CLINICAL RESEARCH & PHARMACOVIGILANCE

The GIHS Advantage

Syllabus

Clinical Trial Supply & Investigational Product Management

Talk to a career counsellor — free

Clinical Trial Supply & Investigational Product Management

Career-Relevant Skills You Will Develop

Career Options

Eligibility

Mode or Methodology

Certification

Eligibility

Placement Assurance

Fees, Payment & Program Duration

Certificate Program

₹22,999

Post Graduate Diploma Program

₹32,999

Fast Track PG Diploma Program

₹36,999

Learn the AI skills employers now expect, included free in your course

"We Teach What the Job Requires"

Frequently Asked Questions

In practice you use established treatments. In a trial you collect the evidence that establishes one — which brings protocol, GCP, regulatory and documentation obligations that ordinary practice does not carry.

Yes. Trial design, project planning, project management, vendor selection, contracts and budgeting are all part of the curriculum.

Yes. The syllabus gives drug-safety exposure — AE evaluation, case processing, signal detection, MedDRA and PV laws — for a fuller view of participant protection.

With feasibility, recruitment planning, timeline forecasting, vendor KPIs, risk identification, document review and monitoring support. Accountability for GCP compliance stays with qualified professionals.

Yes — essential documents and TMF review concepts, including identifying missing, inconsistent or overdue documentation.

Yes. CRF review, source-data verification, drug accountability, routine monitoring and site close-out are covered in a dedicated module.

It supports the pathway. Project-management roles normally also require demonstrated operational experience, and appointment remains an employer decision.

Yes. The programme is delivered online and by distance learning, with a Fast-Track option.

Course material with the latest updates, online access within 48 hours, printed books shipped with your enrolment, a personal subject expert for life at no cost, the online examination and project assessment, and two international certificates on successful completion. There are no hidden charges.

Yes. Every GIHS enrolment now includes complimentary TopCV Coach access worth ₹9,999 for professional resume building and interview skills, and your profile is posted on the TopCV website where a large recruiter network is active.

Yes, within your lawful professional scope. The Business & Entrepreneurship section of this brochure sets out the nonclinical services, education and consulting work the knowledge supports. Regulated clinical services require the appropriate qualification and authorisation.

Yes. Any graduate from any discipline may enrol, as can working professionals with relevant experience, entrepreneurs and managers of healthcare or allied organisations.

Other Related Courses

Where Our Graduates Are Making an Impact

Request More Information

Request More Information

Still deciding? Get the brochure on WhatsApp

Clinical Trial Supply & Investigational Product Management

Clinical Trial Supply & Investigational Product Management

Clinical Trial Supply & Investigational Product Management

Enter Details To Get Syllabus

In practice you use established treatments. In a trial you collect the evidence that establishes one — which brings
protocol, GCP, regulatory and documentation obligations that ordinary practice does not carry.

Yes. Trial design, project planning, project management, vendor selection, contracts and budgeting are all part of the
curriculum.

Yes. The syllabus gives drug-safety exposure — AE evaluation, case processing, signal detection, MedDRA and PV laws —
for a fuller view of participant protection.

With feasibility, recruitment planning, timeline forecasting, vendor KPIs, risk identification, document review and
monitoring support. Accountability for GCP compliance stays with qualified professionals.

Yes — essential documents and TMF review concepts, including identifying missing, inconsistent or overdue
documentation.

Yes. CRF review, source-data verification, drug accountability, routine monitoring and site close-out are covered in a
dedicated module.

It supports the pathway. Project-management roles normally also require demonstrated operational experience, and
appointment remains an employer decision.

Course material with the latest updates, online access within 48 hours, printed books shipped with your enrolment, a
personal subject expert for life at no cost, the online examination and project assessment, and two international
certificates on successful completion. There are no hidden charges.

Yes. Every GIHS enrolment now includes complimentary TopCV Coach access worth ₹9,999 for professional resume
building and interview skills, and your profile is posted on the TopCV website where a large recruiter network is active.

Yes, within your lawful professional scope. The Business & Entrepreneurship section of this brochure sets out the nonclinical services, education and consulting work the knowledge supports. Regulated clinical services require the
appropriate qualification and authorisation.

Yes. Any graduate from any discipline may enrol, as can working professionals with relevant experience, entrepreneurs
and managers of healthcare or allied organisations.