Certificate Program in Clinical Research and Clinical Data Management









Clinnovo Research Labs offers top quality courses in clinical research courses with strong emphasis on practical training and projects.

Clinnovo aim to provide an efficient integration of academic expertise and industry oriented clinical research objectives. We ensure to render assistance for fresher to enter into the professional field of clinical research as well to the professionals who wish to excel at their work places by exceeding the stringent and knowledge based demands of industry.

All clinical research and clinical data management courses offered by Clinnovo are of the highest quality and reflect industry articulated goals. The certificate program in clinical research and clinical data management provide students greater opportunity to shape their career.

To make studying Clinnovo a unique and delightful experience, we are introducing the concept of blended learning and providing a number of unique services to students which include practical trainings. Providing study materials , handouts etc. with an opportunity to work on ongoing clinical trials, placement etc.

Course Modules for Certificate Program in Clinical Research and Clinical Data Management:

  • Module 1: Introduction to Clinical Research

  • Module 2: Drug Discovery and Development

  • Module 3: Bioinformatics and Drug development

  • Module 4: Introduction of ICH-GCP

  • Module 5: Roles and Responsibilities of Study Team

  • Module 6: IRB and IEC

  • Module 7: Introduction to Protocol Elements and Development

  • Module 8: Informed Consent Form and Investigator Broucher (IB)

  • Module 9: Introduction to HIPPA

  • Module 10: Essential documentation in Clinical Research

  • Module 11: Clinical Trial Process

  • Module 12: 21 CFR 11

  • Module 13: Introduction to CDISC

  • Module 14: Regulatory Submissions

  • Module 15: Introduction to Databases

  • Module 16: Datamanagement Plan

  • Module 17: Clinical Data Management Process

  • Module 18: CRF Design

  • Module 19: EDC ( Electronic Data Capture)

  • Module 20: MedDRA

  • Module 21: Pharmacovigilance

  • Module 22: Adverse Drug Reactions(ADR)

  • Module 23: EudraVigilance

  • Module 24: Open Clinica (Comprehensive)

  • Module 25: Rave(overview)