Distance Learning Clinical Research Training Programs

James Lind Institute:
James Lind Institute is a collaborative effort of experts and stakeholders within the clinical research industry. The faculty members at JLI are senior clinical research professionals who bring in the best of their experiences to help students to establish a career in the field. This leads to the best pragmatic approach towards clinical research education.

Post-Graduate Diploma in Clinical Research (PGDCR)
The PGDCR course provides students with an extensive knowledge of the fundamental areas of clinical research. It strengthens skill, knowledge, proficiency and expertise to the standards expected of a clinical research professional.

The PGDCR course curriculum has been completely analyzed and recommended both by the clinical research industry and the academia. PGDCR offered by James Lind Institute imparts students the edge that they require to set foot in the clinical research industry. It also empowers the professionals working in the clinical research industry to move to senior positions in the management hierarchy.

Course Structure :-

MODULE 1 GENERAL INTRODUCTION
MODULE 2 EPIDEMIOLOGY AND EVIDENCE BASED MEDICINE
MODULE 3 PHARMACEUTICAL MEDICINE
MODULE 4 THERAPEUTIC AREAS
MODULE 5 ETHICS IN CLINICAL RESEARCH
MODULE 6 ROLES AND RESPONSIBILITIES
MODULE 7 CLINICAL TRIAL PREPARATION
MODULE 8 ESSENTIAL DOCUMENTS AND REGULATORY SUBMISSION
MODULE 9 STUDY START-UP
MODULE 10 CLINICAL TRIALS MONITORING
MODULE 11 REGULATORY AFFAIRS IN CLINICAL RESEARCH
MODULE 12 COMPLIANCE AND AUDITS
MODULE 13 DATA MANAGEMENT AND BIOSTATISTICS
MODULE 14 MEDICAL DEVICE TRIALS
MODULE 15 PROJECT AND VENDOR MANAGEMENT
MODULE 16 FINANCIAL MANAGEMENT OF CLINICAL TRIALS
MODULE 17 PERSONALITY DEVELOPMENT AND COMMUNICATION SKILLS

The later part of the course would involve mock exercises concerned with a real-time role review of a Clinical Research Professional in different capacities.

Duration : Self-paced 6-8 Months

Eligibility :
MBBS/BHMS/BAMS/BPT/MPT/BDS/Bachelor in Naturopathy & Veterinary Science /MD/MS.
Graduate/Postgraduate degree in Pharmacy/ Pharmaceutical Sciences.
Graduate/Postgraduate degree in Life Sciences (Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotechnology).
Graduate/Postgraduate degree in Chemistry/Biostatistics/ Bioinformatics.
Graduate or equivalent degree in Nursing/Allied Health.
Students in their final year of graduation for the above courses may also apply.
Fees : 17,500

Advanced Post-Graduate Diploma in Clinical Research and Pharmacovigilance (APGDCR-P)
The APGDCR-P is a consolidated course that provides students with a precise understanding of the fundamental areas of the clinical research as well as Pharmacovigilance methodologies. It enhances skill, knowledge, proficiency and expertise to the standards expected of a clinical research and Pharmacovigilance professional.

Other than clinical research management, this integrated course trains students to collect, analyze and archive data related to adverse drug reactions in order to make regulatory decisions related to marketed drugs. Both these sectors of the clinical research industry are now creating large number of new job opportunities.

Course Structure :-

CLINICAL RESEARCH :-

MODULE 1 GENERAL INTRODUCTION
MODULE 2 EPIDEMIOLOGY AND EVIDENCE BASED MEDICINE
MODULE 3 PHARMACEUTICAL MEDICINE
MODULE 4 THERAPEUTIC AREAS
MODULE 5 ETHICS IN CLINICAL RESEARCH
MODULE 6 ROLES AND RESPONSIBILITIES
MODULE 7 CLINICAL TRIAL PREPARATION
MODULE 8 ESSENTIAL DOCUMENTS AND REGULATORY SUBMISSION
MODULE 9 STUDY START-UP
MODULE 10 CLINICAL TRIALS MONITORING
MODULE 11 REGULATORY AFFAIRS IN CLINICAL RESEARCH
MODULE 12 COMPLIANCE AND AUDITS
MODULE 13 DATA MANAGEMENT AND BIOSTATISTICS
MODULE 14 MEDICAL DEVICE TRIALS
MODULE 15 PROJECT AND VENDOR MANAGEMENT
MODULE 16 FINANCIAL MANAGEMENT OF CLINICAL TRIALS
MODULE 17 PERSONALITY DEVELOPMENT AND COMMUNICATION SKILLS

PHARMACOVIGILANCE :-

MODULE 1 PRINCIPLES OF PHARMACOVIGILANCE
MODULE 2 PHARMACOVIGILANCE AND SELECTED SYSTEM ORGAN CLASSES
MODULE 3 PHARMACOVIGILANCE SYSTEMS
MODULE 4 GLOBAL PHARMACOVIGILANCE AND SAFETY STANDARDS
MODULE 5 PHARMACOVIGILANCE REGULATIONS AND GUIDELINES
MODULE 6 PHARMACOEPIDEMIOLOGY

The later part of the course would involve mock exercises concerned with a real-time role review of a Clinical Research Professional in different capacities.

Duration : Self-paced 8-10 Months

Eligibility :

MBBS/BHMS/BAMS/BPT/MPT/BDS/Bachelor in Naturopathy & Veterinary Science /MD/MS.
Graduate/Postgraduate degree in Pharmacy/ Pharmaceutical Sciences.
Graduate/Postgraduate degree in Life Sciences (Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotechnology).
Graduate/Postgraduate degree in Chemistry/Biostatistics/ Bioinformatics.
Graduate or equivalent degree in Nursing/Allied Health.
Students in their final year of graduation for the above courses may also apply.
Fees : 22,500

Advanced Post-Graduate Diploma in Clinical Research and Medical Writing (APGDCR-MW)
The APGDCR-MW is an integrated course that provides students with an explicit methodical understanding of the fundamental areas of clinical research and medical writing. It enhances skill, knowledge, proficiency and expertise to the standards expected of clinical research professional and medical writer. The APGDCR-MW course offered by James Lind Institute imparts extensive medical writing training to develop professional expertise of high caliber.

Course Structure :-

CLINICAL RESEARCH :-

MODULE 1 GENERAL INTRODUCTION
MODULE 2 EPIDEMIOLOGY AND EVIDENCE BASED MEDICINE
MODULE 3 PHARMACEUTICAL MEDICINE
MODULE 4 THERAPEUTIC AREAS
MODULE 5 ETHICS IN CLINICAL RESEARCH
MODULE 6 ROLES AND RESPONSIBILITIES
MODULE 7 CLINICAL TRIAL PREPARATION
MODULE 8 ESSENTIAL DOCUMENTS AND REGULATORY SUBMISSION
MODULE 9 STUDY START-UP
MODULE 10 CLINICAL TRIALS MONITORING
MODULE 11 REGULATORY AFFAIRS IN CLINICAL RESEARCH
MODULE 12 COMPLIANCE AND AUDITS
MODULE 13 DATA MANAGEMENT AND BIOSTATISTICS
MODULE 14 MEDICAL DEVICE TRIALS
MODULE 15 PROJECT AND VENDOR MANAGEMENT
MODULE 16 FINANCIAL MANAGEMENT OF CLINICAL TRIALS
MODULE 17 PERSONALITY DEVELOPMENT AND COMMUNICATION SKILLS

MEDICAL AND SCIENTIFIC CONTENT WRITING :-

MODULE 1 BASICS OF GOOD MEDICAL WRITING
MODULE 2 COMPUTER SKILLS
MODULE 3 OVERVIEW OF THE REGULATORY, MARKETING, AND DRUG PROMOTION PROCESSES
MODULE 4 CLINICAL STUDY REPORT
MODULE 5 SENTENCE CONTROL
MODULE 6 WRITING FLOW AND COHESIVENESS
MODULE 7 PUBLICATION WRITING
MODULE 8 DOCUMENTS IN MEDICO-MARKETING
MODULE 9 MANAGING THE REVIEW PROCESS

The later part of the course would involve mock exercises concerned with a real-time role review of a Clinical Research Professional and Medical Writer in different capacities.

Duration : Self-paced 8-10 Months

Eligibility :

MBBS/BHMS/BAMS/BPT/MPT/BDS/Bachelor in Naturopathy & Veterinary Science /MD/MS.
Graduate/Postgraduate degree in Pharmacy/ Pharmaceutical Sciences.
Graduate/Postgraduate degree in Life Sciences (Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotechnology).
Graduate/Postgraduate degree in Chemistry/Biostatistics/ Bioinformatics.
Graduate or equivalent degree in Nursing/Allied Health.
Students in their final year of graduation for the above courses may also apply.
Fees : 22,500

Advanced Post-Graduate Diploma in Clinical Research and Business Development (APGDCR-BD)
Business development is about bringing, doing or developing new things an organization didn't do before. The students of the APGDCR-BD course at JLI develop the skills necessary to find business leads, mature them into prospects and finally closing the deals with sponsors or vendors. This course develops students to enter this exciting, challenging and highly rewarding discipline as a “Scientific business development associate / manager” in the pharma-biotech or clinical research industry.

Course Structure :-

CLINICAL RESEARCH :-

MODULE 1 GENERAL INTRODUCTION
MODULE 2 EPIDEMIOLOGY AND EVIDENCE BASED MEDICINE
MODULE 3 PHARMACEUTICAL MEDICINE
MODULE 4 THERAPEUTIC AREAS
MODULE 5 ETHICS IN CLINICAL RESEARCH
MODULE 6 ROLES AND RESPONSIBILITIES
MODULE 7 CLINICAL TRIAL PREPARATION
MODULE 8 ESSENTIAL DOCUMENTS AND REGULATORY SUBMISSION
MODULE 9 STUDY START-UP
MODULE 10 CLINICAL TRIALS MONITORING
MODULE 11 REGULATORY AFFAIRS IN CLINICAL RESEARCH
MODULE 12 COMPLIANCE AND AUDITS
MODULE 13 DATA MANAGEMENT AND BIOSTATISTICS
MODULE 14 MEDICAL DEVICE TRIALS
MODULE 15 PROJECT AND VENDOR MANAGEMENT
MODULE 16 FINANCIAL MANAGEMENT OF CLINICAL TRIALS
MODULE 17 PERSONALITY DEVELOPMENT AND COMMUNICATION SKILLS

BUSINESS DEVELOPMENT :-

MODULE 1 MARKETING INNOVATION AND SERVICE
MODULE 2 ADVANCED FINANCIAL MANAGEMENT
MODULE 3 INTERNATIONAL BUSINESS DEVELOPMENT
MODULE 4 BUSINESS LAWS
MODULE 5 CORPORATE COMMUNICATIONS

The later part of the course would involve mock exercises concerned with a real-time role review of a Clinical Research Professional in different capacities.

Duration : Self-paced 8-10 Months

Eligibility :

MBBS/BHMS/BAMS/BPT/MPT/BDS/Bachelor in Naturopathy & Veterinary Science /MD/MS.
Graduate/Postgraduate degree in Pharmacy/ Pharmaceutical Sciences.
Graduate/Postgraduate degree in Life Sciences (Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotechnology).
Graduate/Postgraduate degree in Chemistry/Biostatistics/ Bioinformatics.
Graduate or equivalent degree in Nursing/Allied Health.
Students in their final year of graduation for the above courses may also apply.
Fees : 22,500

Advanced Post-Graduate Diploma in Clinical Research and Regulatory Affairs (APGDCR-RA)
The APGDCR-RA is a practically oriented course based on the tasks expected of a regulatory affairs expert in the clinical research industry. Students enrolled for the APGDCR-RA course are provided with the knowledge of the global regulatory structure and develop skills that are needed for regulatory strategic planning throughout the product lifecycle. Students in this course learn the methods of critical evaluation for risk/benefit analysis by analyzing the economic, societal, regulatory and corporate demands.

Course Structure :-

CLINICAL RESEARCH :-

MODULE 1 GENERAL INTRODUCTION
MODULE 2 EPIDEMIOLOGY AND EVIDENCE BASED MEDICINE
MODULE 3 PHARMACEUTICAL MEDICINE
MODULE 4 THERAPEUTIC AREAS
MODULE 5 ETHICS IN CLINICAL RESEARCH
MODULE 6 ROLES AND RESPONSIBILITIES
MODULE 7 CLINICAL TRIAL PREPARATION
MODULE 8 ESSENTIAL DOCUMENTS AND REGULATORY SUBMISSION
MODULE 9 STUDY START-UP
MODULE 10 CLINICAL TRIALS MONITORING
MODULE 11 REGULATORY AFFAIRS IN CLINICAL RESEARCH
MODULE 12 COMPLIANCE AND AUDITS
MODULE 13 DATA MANAGEMENT AND BIOSTATISTICS
MODULE 14 MEDICAL DEVICE TRIALS
MODULE 15 PROJECT AND VENDOR MANAGEMENT
MODULE 16 FINANCIAL MANAGEMENT OF CLINICAL TRIALS
MODULE 17 PERSONALITY DEVELOPMENT AND COMMUNICATION SKILLS

REGULATORY AFFAIRS :-

MODULE 1 REGULATORY STRATEGIC PLANNING
MODULE 2 PRE-MARKETING REGULATORY AFFAIRS
MODULE 3 POST-MARKETING REGULATORY AFFAIRS
MODULE 4 INTERFACING
MODULE 5 CORPORATE COMMUNICATIONS

The later part of the course would involve mock exercises concerned with a real-time role review of a Clinical Research Professional in different capacities.

Duration : Self-paced 8-10 Months

Eligibility :

MBBS/BHMS/BAMS/BPT/MPT/BDS/Bachelor in Naturopathy & Veterinary Science /MD/MS.
Graduate/Postgraduate degree in Pharmacy/ Pharmaceutical Sciences.
Graduate/Postgraduate degree in Life Sciences (Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotechnology).
Graduate/Postgraduate degree in Chemistry/Biostatistics/ Bioinformatics.
Graduate or equivalent degree in Nursing/Allied Health.
Students in their final year of graduation for the above courses may also apply.
Fees : 22,500

Professional Diploma in Pharmacovigilance and Pharmacoepidemiology
The professional diploma course in pharmacovigilance and pharmacoepidemiology introduces students to the principles and operations of pharmacovigilance. The curriculum for this certificate course is fully reviewed by experienced pharmacovigilance professionals.

Course Structure :-

MODULE 1 GENERAL INTRODUCTION
MODULE 2 PRINCIPLES OF PHARMACOVIGILANCE
MODULE 3 PHARMACOVIGILANCE AND SELECTED SYSTEM ORGAN CLASSES
MODULE 4 PHARMACOVIGILANCE SYSTEMS
MODULE 5 GLOBAL PHARMACOVIGILANCE AND SAFETY STANDARDS
MODULE 6 PHARMACOVIGILANCE REGULATIONS AND GUIDELINES
MODULE 7 PHARMACOEPIDEMIOLOGY

Duration : Self-paced 4-6 Months

Eligibility :

MBBS/BHMS/BAMS/BPT/MPT/BDS/Bachelor in Naturopathy & Veterinary Science /MD/MS.
Graduate/Postgraduate degree in Pharmacy/ Pharmaceutical Sciences.
Graduate/Postgraduate degree in Life Sciences (Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotechnology).
Graduate/Postgraduate degree in Chemistry/Biostatistics/ Bioinformatics.
Graduate or equivalent degree in Nursing/Allied Health.
Students in their final year of graduation for the above courses may also apply.
Fees : 15,000

Professional Diploma in Medical Writing
The Professional diploma course in medical and scientific writing provides in-depth understanding about regulatory and medico-marketing writing. The curriculum for this professional course is fully reviewed by experienced medical writers.

Course Structure:-
MODULE 1 GENERAL INTRODUCTION
MODULE 2 PHARMACEUTICAL MEDICINE
MODULE 3 BASICS OF GOOD MEDICAL WRITING
MODULE 4 COMPUTER SKILLS
MODULE 5 OVERVIEW OF THE REGULATORY, MARKETING AND DRUG PROMOTION PROCESSES
MODULE 6 CLINICAL STUDY REPORT
MODULE 7 SENTENCE CONTROL
MODULE 8 WRITING FLOW AND COHESIVENESS
MODULE 9 PUBLICATION WRITING
MODULE 10 DOCUMENTS IN MEDICO-MARKETING
MODULE 11 MANAGING THE REVIEW PROCESS

The later part of the course would involve mock exercises concerned with a real-time role review of a Clinical Research Professional and Medical Writer in different capacities.

Duration : Self-paced 4-6 Months
Eligibility :

• MBBS/BHMS/BAMS/BPT/MPT/BDS/Bachelor in Naturopathy & Veterinary Science /MD/MS.
• Graduate/Postgraduate degree in Pharmacy/ Pharmaceutical Sciences.
• Graduate/Postgraduate degree in Life Sciences (Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotechnology).
• Graduate/Postgraduate degree in Chemistry/Biostatistics/ Bioinformatics.
• Graduate or equivalent degree in Nursing/Allied Health.
• Students in their final year of graduation for the above courses may also apply.
Fees : 15,000