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Clinical Research, Pharmacovigilance, Medical Coding & Data Management Courses | RCRM Nagpur
Eligibility
MBBS, BDS, BAMS, BHMS, B.Pharm, M.Pharm
Duration
3 months theory + 3–4 months CRC training at a clinical trial site
01

Executive Diploma in Clinical Research and Pharmacovigilance

A foundational track covering Good Clinical Practice, trial design and drug safety — built for graduates ready to start hands-on training quickly.

  • Introduction to Clinical Research
  • History behind the development of GCP and ethical guidelines of clinical research
  • Glossary of terms in CR and ICH-GCP principles
  • Drug development process
  • Stakeholders of clinical research and their responsibilities
  • Importance of monitoring and auditing in clinical research
  • Clinical trial design and its importance
  • Essential documents of clinical research
  • NDCTA guidelines in clinical research
  • Overview of clinical trial process and budgeting in clinical trials
  • Clinical data management
  • Pharmacovigilance
  • Basic pharmacology
  • BA/BE studies
  • Drug administration and drug dosage forms
Eligibility
B.Sc (all life sciences), B.Tech (Biotech, Genetic Engineering), B.Sc Nursing
Duration
6 months theory + 3–4 months CRC training at a clinical trial site
02

Post Graduate Diploma in Clinical Research and Pharmacovigilance

A deeper 6-month theory track for life-science graduates, with restricted batch strength for closer mentorship.

Restricted batch strength Job-role focused training Live learning environment
  • Introduction to Clinical Research
  • History behind the development of GCP and ethical guidelines of clinical research
  • Glossary of terms in CR and ICH-GCP principles
  • Drug development process
  • Stakeholders of clinical research and their responsibilities
  • Importance of monitoring and auditing in clinical research
  • Clinical trial design and its importance
  • Essential documents of clinical research
  • NDCTA guidelines in clinical research
  • Overview of clinical trial process and budgeting in clinical trials
  • Clinical data management
  • Pharmacovigilance
  • Anatomy and physiology (human organ systems)
  • Pharmacology — drug metabolism, pharmacokinetics, pharmacodynamics
  • Routes of drug administration, drug dosage
  • BA/BE studies and their importance
Eligibility
B.Sc (all life sciences), B.Tech (Biotech, Genetic Engineering), B.Sc Nursing
Duration
4 months theory + CRC training at a clinical trial site
03

Professional Course on Drug Regulatory Affairs

Regulatory affairs is one of the most dynamic roles in pharma and healthcare — professionals in this space keep a company compliant as regulations shift, across drug development, food and cosmetic industries alike. In India it's typically a postgraduate specialisation, though many organizations also hire M.Sc. (life sciences, chemistry) graduates with focused RA training like this course.

  • ICH guidelines
  • Introduction and general view of the pharmaceutical industry
  • Regulatory guidelines
  • Regulatory submissions — USFDA, EMA, Indian (domestic)
  • Preparing responses to deficiencies
  • Biologics guidelines
  • Project work
  • Resume preparation to industry standard and interview preparation
Eligibility
MBBS, BDS, BAMS, BHMS, B.Pharm, M.Pharm
Duration
3 months theory + 3–4 months CRC training at a clinical trial site
04

Diploma in Medical Coding

Medical coding converts healthcare diagnoses, procedures and other clinical information into standardized alphanumeric codes — the shared language physicians, administrators, insurers and government health bodies all rely on to communicate. Coders work across hospitals, insurance companies and health-tech firms.

A typical career path:

  • 1Jr. Medical Coder
  • 2Sr. Medical Coder
  • 3Quality Analyst (QA/QC)
  • 4Team Lead
  • 5Dy. Manager → Manager → Sr. Manager
Eligibility
MBBS, BDS, BAMS, BHMS, B.Pharm, M.Pharm
Duration
3 months theory + 3–4 months CRC training at a clinical trial site
05

Diploma in Clinical Data Management

Clinical data management covers the trustworthy handling and delivery of clinical trial study data, including modern Electronic Data Capture (EDC) processes and CDISC data standards, in strict compliance with CFR Part 11.

  • Quality control and data quality audits
  • Medical coding and SAE data reconciliation
  • Double data entry comparison and adjudication
  • Query management, database lock and export to SAS
  • Clinical data management report, database design and development
  • Data cleaning
  • Edit, validation and design-check programming
  • Data validation
  • Project-specific CDM plan
  • Delivery of clean data files and documentation
  • Project data archival and storage
  • Independent double data entry

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