Our Part Time PG Diploma in Clinical Research & Pharmacovigilance typically focuses on providing specialized knowledge and skills related to conducting clinical trials and managing clinical research projects.
An interactive program providing distance and classroom training for the clinical research professional, begins with the history of legislation and regulations that govern clinical research and an overview of drug, biologic, and device development. Course participants develop a thorough knowledge base of Good Clinical Practices and International Conference of Harmonization guidelines (E6, E2A), gaining a solid understanding of clinical trial development and management.
A six-month clinical research diploma program typically provides foundational knowledge and practical skills essential for conducting clinical trials and working in the clinical research industry.
Our programs are designed for the professional who wants to transition into a Clinical Research Associate/ Clinical Research Investigator/ Study Coordinator/ Data Manager/ Biostatistician/ Regulatory Affairs Managers/ Clinical Trials Auditor/Clinical Project Manager/Clinical Research Manager/ Business Development Manager/ Drug Safety Associate/Medical Writer or enter the clinical research industry. It offers a comprehensive Education and “Hands-On” Training of the clinical research process, the FDA regulations, GCP (Good Clinical Practice) and the International Conference of Harmonization (ICH) guidelines. Over 15000 people have successfully completed our program
Indian Institute of clinical research & Management has expanded to provide individuals with additional training options via class room / distance learning system providing flexible and affordable clinical research training via comprehensive training programs, education modules and interactive Webinars.
On-site services for institutions in need of clinical research training
Introduction to Clinical Research
- Overview of the clinical research process.
- Understanding the roles and responsibilities in clinical research teams.
Clinical Trial Design and Methodology
- Basics of designing clinical trials.
- Different phases of clinical trials and their objectives.
Data Management in Clinical Research
- Principles of data collection, entry, and management.
- Data quality assurance and validation.
Patient Recruitment and Informed Consent
- Strategies for recruiting and retaining participants.
- Understanding informed consent procedures.
Safety Monitoring and Adverse Event Reporting
- Methods for monitoring participant safety during trials.
- Reporting adverse events according to regulatory requirements.
Clinical Research Documentation
- Writing and maintaining essential documents (e.g., protocols, case report forms, study reports).
Career Development in Clinical Research
- Overview of career paths and opportunities in clinical research.
- Professional development skills (e.g., CV preparation, interview techniques).
Skills Developed
- Understanding of Clinical Trial Processes: Ability to comprehend the lifecycle of clinical trials and the regulatory framework guiding them.
- Practical Research Skills: Hands-on experience with tasks like data collection, analysis, and documentation.
- Ethical Awareness: Knowledge of ethical considerations and patient rights in clinical research.
- Communication Skills: Ability to effectively communicate research findings and collaborate with multidisciplinary teams.
Career Opportunities
- Clinical Research Coordinator (CRC): Assists in conducting clinical trials, manages study activities, and ensures compliance with protocols.
- Clinical Data Coordinator: Handles data collection, entry, and management for clinical trials.
- Clinical Research Assistant: Provides administrative and operational support to clinical research teams.
- Documentation specialist: The ETMF (Electronic Trial Master File) or document specialist role is crucial in clinical research and involves managing the electronic documentation and records associated with clinical trials.
Eligibility PG diploma in Clinical Research & Pharmacovigilance
- Life Science and Health Care Graduates or Diploma in any Discipline
- B.Sc/M.Sc.,Biotechnology, Microbiology, Genetics, Biochemistry, DMLT, MLT
- M.B.B.S.M.D., MS.
- B.D.S., M.D.S., B.V.SC, M.V.Sc, B.PTh, M.PTh, OPTh, ANM, GNM.
- B.H.M.S., B.A.M.S, B.U.M.S, B.Sc Nursing
- B. Pharma, M.Pharma, D.Pharma
- For SAS: B.C.A, B.com, BCCA, B.E. Any Other Graduates.
- Highly interested participate in the final year can also apply.
Conclusion
A six-month clinical research diploma program offers a condensed yet comprehensive introduction to the field, providing students with essential knowledge and practical skills required to start a career in clinical research. It’s suitable for individuals looking to enter the industry quickly or for those seeking to enhance their existing qualifications with specialized training.
