Home -> Medical Colleges In Telangana -> International Drug Discovery And Clinical Research -> Under Graduate Courses -> International Drug Discovery And Clinical Research Clinical
Courses Offered
- Project Management
- Study conduct as per GCP guidelines on-time and on-budget
- Assist in regulatory affairs and approvals
- SOP preparation
- Site management
- Drug Accountability and Clinical Supplies
- Protocol/CRF Design
- Monitoring and Auditing
- Investigator meetings
- Registry Studies
MEDICAL WRITING
Medico-regulatory
- Regulatory dossiers for USFDA, EU (CTD)
- Medical Literature search and support
- Package Inserts & Labelling
Medico-marketing
- Product Monographs
- Product Manuals
- Field force training & training materials
Clinical Research Communications Support
- Clinical protocols, Case Record Forms, ICF, PIS documents
- Investigator’s Brochure
- Ethics committee documents
- Clinical trial forms- Screening, Enrolment, Monitoring, Informed Consent
- Clinical trial reports
- BA/BE protocols and reports
- Clinical trial applications for India (Sch – Y), EU (Eudra CT), USA
- Literature/Journal & Presentations
REGULATORY AND e-CTD SUBMISSION
- Submissions (IND/IDE, NDA/PMA/BLA, 510K) & Electronic Filings
- Pre-IND/IDE meetings / End of Phase II meetings / Pre-NDA/PMA/BLA Meetings
- Focused Clinical Data Interchange Standards Consortium (CDISC) consulting practice