Online Training - Clinical Research, Pharmacovigilance (Oracle Argus), Clinical Data Management (Oracle Clinical), Medical Devices Regulatory Affairs & Medical Writing Course with Course Certification, Internship Experience Certification & Job Placement Assistance
BioMed Informatics Medwin Hospitals, Hyderabad is a leading Clinical Research Institute in India offering the best Clinical Research Fully Integrated Course for BPharm, MPharm, and PharmD students, imparting job-oriented skills that are useful for entering IT companies, Pharma, Biotech, and CRO industries since 2000.
"An excellent opportunity for college students to enhance industry-demanded skills and boost career prospects. According to the Indian Pharmaceutical Association (IPA), 4 lakh pharma students graduate each year, emphasizing the need for job-ready skills."
Who Can Enroll?
This course is ideal for:
- BPharm, MPharm, PharmD students
Career Opportunities After Completing This Course
Upon completion, eligibility for career paths such as:
- Clinical Research Associate (CRA)
- Clinical Research Coordinator (CRC)
- Clinical Trial Coordinator (CTC)
- Pharmacovigilance Associate (PVA)
- Pharmacovigilance Data Case Processor
- Drug Safety Associate (DSA)
- Drug Safety Data Case Processor
- Pharmacovigilance Data Analyst
- ICSR Processor
- Medical Reviewer
- Narrative Writer
- Clinical Data Associate
- Clinical Research Data Analyst
- Clinical Data Coordinator
- Medical Device Regulatory Affairs Associate
- Medical Device Safety Associate
- Medical Device Regulatory Affairs Specialist
- Regulatory Writer
- Clinical Regulatory Analyst
- Medical Writer
Average Salaries (Entry-Level to Mid-Level)
- USA: $60,000 – $110,000 per year
- UK: £28,000 – £55,000 per year
- Canada: CAD 55,000 – CAD 100,000 per year
- Australia: AUD 70,000 – AUD 120,000 per year
- India: ₹3.5 LPA – ₹15 LPA
Module 1: Clinical Research
Advance Your Career in Clinical Research
Clinical research is a rapidly growing industry with global demand for skilled professionals. This field offers excellent career opportunities in pharmaceutical companies, Contract Research Organizations (CROs), and healthcare institutions. If you're looking to build a high-paying career in healthcare and life sciences, enrolling in a clinical research course is a strategic move.
Why Choose Our Clinical Research Training?
- Globally recognized certification for jobs in the US, UK, Canada, Australia & India
- ICH-GCP, USFDA, EMA, MHRA, Health Canada, TGA & CDSCO regulations
- Industry-focused curriculum covering clinical trial studies
- Certificate of completion, Internship Experience Certification & job placement assistance
Key Topics Covered
- Drug Development Process
- Clinical trials
- CRO Industry
- Clinical trial team
- Evolution of Ethics
- Regulatory Authorities: USFDA, MHRA, Health Canada, EMA, TGA, ICMR, CDSCO
- IRB (Institutional Review Board) / IEC (Independent Ethics Committee)
- ICH-GCP Guidelines
- Informed Consent Process
- SOPs (Standard Operating Procedures)
- IB (Investigator’s Brochure)
- IP (Investigational Product)
- Protocol
Module 2: Pharmacovigilance (Oracle Argus)
Advance Your Career in Pharmacovigilance
Are you looking to build a successful career in Pharmacovigilance? Our comprehensive training program provides in-depth knowledge of drug safety, clinical trials, and regulatory compliance, preparing you for a rewarding career in the pharmaceutical industry.
Why Choose Our Pharmacovigilance Training?
- Industry-relevant curriculum with Oracle Clinical
- Oracle Argus Safety Database work flow
- In-depth knowledge of ICH-GCP, FDA, EMA & CDSCO regulations
- Case processing, MedDRA& WHODD coding
- Certificate of completion, Internship Experience Certification with job assistance
Comprehensive Drug Safety Training
- Gain expertise in global pharmacovigilance regulations
- Oracle Argus Safety Database work flow
- Master adverse event reporting, case processing, and regulatory submissions
Key Topics Covered
- SAE reconciliation & Adverse Events classification
- Spontaneous & Cohort Event Monitoring
- Expedited Reporting & Seriousness criteria
- Causality assessment & Signal Detection
- MedDRA& WHODD coding
- PSUR preparation & submission timelines
Oracle Argus work flow
Argus Console
- Safety database setup & management
- Study creation & Workflow Configuration
- Expedited Report & Case priority configuration
- LAM (Local Affiliate Module) management
Argus Safety
- Case intake, validation & duplicate check
- Case processing & regulatory reporting (PSUR, IND, NDA)
- Medical review & Narrative writing
- Global adverse event database management
Module 3: Clinical Data Management (Oracle Clinical)
Advance Your Career in Clinical Data Management
Looking to excel in Clinical Data Management (CDM)? Our industry-recognized training program covers Oracle Clinical, data validation, case processing, and regulatory compliance, preparing you for high-paying roles in pharmaceuticals, biotech, and contract research organizations (CROs) across the US, UK, Canada, Australia, and India.
Why Choose Our CDM Training?
- Industry-focused curriculum with Oracle Clinical
- Aligned with FDA, EMA, ICH-GCP & 21 CFR Part 11 regulations
- Learn CRF design, data entry, validation, and database locking
- Discrepancy management & audit readiness
- Certificate of completion, Internship Experience Certification & job placement assistance
Key Topics Covered
- Overview of CDM, Regulatory Compliance & 21 CFR Part 11
- Roles & Responsibilities of a CDM Professional
- Clinical Data Management Process & Life Cycle
- CRF (Case Report Form) Design & Annotation
- Data Capture Methods (EDC & Paper-based)
- Edit Checks & Data Validation Procedures
- Discrepancy Management & Data Clarification Forms (DCFs)
- Database Locking, Freezing & Archival
Oracle Clinical Work Flow
Study Plan & Study Design
- Defining Programs, Projects & Planned Studies
- Creating Study Intervals & Treatment Patterns
- Investigator, Site & Patient Assignments
GLIB (Global Library)
- Creating & Maintaining Questions, Question Groups & DVGs
- Designing Data Collection Modules (DCMs) & Data Collection Instruments (DCIs)
- Implementing Validation & Derivation Procedures
Data Entry & Study Conduct
- First Pass & Second Pass Data Entry
- Comparison Reconciliation & Discrepancy Management
- Batch Validation & Data Cleaning
- Remote Data Capture (RDC) & Site-Based Data Entry
Module 4: Medical Devices Regulatory Affairs
Advance Your Career in Medical Devices Regulatory Affairs
Are you looking to specialize in Medical Devices Regulatory Affairs? Our comprehensive training program equips you with expert knowledge in global regulations, compliance, and approval processes required by the US FDA, EU MDR, and other international regulatory bodies.
Why Choose Our Medical Devices Regulatory Affairs Training?
- Comprehensive curriculum covering FDA, EU MDR, CDSCO & TGA regulations
- Device classification, PMA, 510(k), and risk management
- Regulatory submissions, compliance & post-market surveillance
- Certificate of completion, Internship Experience Certification & job placement assistance
Key Topics Covered
- Overview of Regulatory Requirements for Medical Devices
- FDA / CDRH Functioning
- Medical Device Classification
- Devices / Device Panels / Regulation Product Codes
- 21 CFR Parts 800-1299
- Product Classification Database: 21 CFR Parts 862-892
- Distinct Product Code Identification Procedure
- Total Product Life Cycle (TPCL) / TPCL Product Code Report
- General controls and Special controls
- Pre-market approval – PMA
- Adulteration and Misbranding
- Electronic Establishment Registration
- Pre-market notification submission 510(k)
- 510(k) Marketing clearance process
- Medical Device Exemptions 510(k)
- FDA Clearance
- Medical Device Reporting – MDR
- Special labeling and Establishment Registration
- Reserve Devices and Special 510(k)
- Abbreviated 510(k) & Substantial equivalence
- Medical device labeling & Post-market studies
- Medical device tracking
- Comparative study of Medical Device Regulations in the USA, EU, and India
Module 5: Medical Writing
Advance Your Career in Medical Writing
Are you looking to build a successful career in Medical Writing? Our industry-focused training program provides expertise in clinical, regulatory, and scientific writing, preparing you for high-demand roles in the pharmaceutical, biotechnology, and healthcare industries across the US, UK, Canada, Australia, and India.
Why Choose Our Medical Writing Course?
- Comprehensive curriculum covering Clinical & Regulatory Writing
- CSR, IB, ICF, PSUR, and IND submissions
- Expert guidance on FDA, EMA, MHRA, TGA, and ICH-GCP regulations
- Certificate of completion, Internship Experience Certification & job placement assistance
Key Topics Covered
- Clinical Study Reports (CSRs) & Protocol Development
- Clinical Study Protocol & Amendments
- Clinical Trial Reports & Patient Safety Narratives
- Narratives for Adverse Drug Reactions & Adverse Events
- Regulatory Documents & Submission Guidelines
- US FDA Guidelines, EU & Other Foreign Regulations
- Global Regulatory Submissions & Quality Reviews (QC & QR)
- New Drug Application (NDA) & Investigational New Drug (IND) Submissions
- Abbreviated New Drug Application (ANDA) Compliance
- Institutional Review Board (IRB) & Independent Ethics Committee (IEC)
- Electronic Code of Federal Regulations (eCFR) Compliance
- Investigator Brochures (IBs) & Informed Consent Forms (ICFs)
- Data Collection Documents & Source Documents
- Investigational Medicinal Product Dossier (IMPD)
- Standard Operating Procedures (SOPs) & Case Report Forms (CRFs)
- Electronic CRF (eCRF) & ICH-GCP Guidelines
- Regulatory Submission Documents
- Aggregate Safety Reports & Development Safety Update Reports (DSURs)
- Periodic Safety Update Reports (PSURs)
- Periodic Benefit-Risk Evaluation Reports (PBRERs)
- Periodic Adverse Drug Experience Reports (PADERs)