Bengaluru Centre

CLINIMINDS

CLINIMINDS -

SINCE 2004

(19+ YEARS NOW)

LSSSDC

Live eLearning PG Diploma
Clinical Research
Pharmacovigilance
Clinical Data Management
Fulltime - 4 Months Live eLearning


Weekend - 6 Months Live eLearning
9500+ Cliniminds Alumni

Eligibility - B.Pharmacy, M.Pharmacy, Doctor of Pharmacy, BSC, MSC, BDS, BHMS, BAMS, B.Tech / M.Tech Biotech, Biomedical, Life Sciences.

Recent Placements

LSSSDC
Live eLearning PG Diploma
Clinical Research
Pharmacovigilance
Clinical Data Management
Fulltime - 4 Months Live eLearning


Weekend - 6 Months Live eLearning
9500+ Cliniminds Alumni
Eligibility - B.Pharmacy, M.Pharmacy, Doctor of Pharmacy, BSC, MSC, BDS, BHMS, BAMS, B.Tech / M.Tech Biotech, Biomedical, Life Sciences.

Program Inclusions

  • Live Interactive eLearning Sessions
  • Hands on Software Training - Pharmacovigilance Safety Database, Clinical Data Management, eCTD Software.
  • Arranging Job Interviews - Campus Placements.
  • Dedicated Placement Cell - 360° Placement Support.
  • Pre Placement Training - CV Writing, Mock Interviews, English Communication, Aptitude Test Training
  • Access to LMS – 24x7 - Recordings, PPT, Notes, eBooks.

Certifications

  • 1
    Life Sciences Sector Skill Development Council, NCVET.
  • 2
    Advanced PG Diploma – Cliniminds - Program Accredited by Accreditation Council for Clinical Research Education, United States of America.
  • 3
    Internship Certification – www.thinki.in
  • 4
    ICH GCP Certificate – Cliniminds

Recent Placements

  1. Drug Discovery
  2. Overview of Clinical Research
  3. Regulations & Guidelines in Clinical Research
  4. Roles & Responsibilities of Key Stakeholders
  5. Preparation & Planning of Clinical Trials
  6. Essential Documentation in Clinical Research & Regulatory Submission
  7. Study Start Up Process
  8. Clinical Monitoring Essentials
  9. Compliance, Auditing & Quality Control in Clinical Research

  1. Overview of Clinical Research
  2. Pharmacology – General Principles
  3. Introduction to Pharmacovigilance
  4. Pharmacovigilance Regulations
  5. Hands on Training on Case Processing and Report Generation
  6. Safety Reporting and Processing ICSR
  7. Aggregate Reports, Signal Detection & Risk Management
  8. Documents in Pharmacovigilance
  9. Audits & Inspections
  10. Advanced Pharmacovigilance & Analytics

  1. Overview of Clinical Data Management
  2. Clinical Data Integrity
  3. Data Management Plan
  4. Design of Case Report Form
  5. CRF Tracking
  6. Electronic Data Capture
  7. Data Entry Guidelines
  8. Edit Check Creation, Validation, Programming
  9. Discrepancy Management
  10. Data Transfer in Clinical Data Management
  11. Medical Coding Dictionaries
  12. Laboratory Test in Clinical Trials
  13. Creating Reports
  14. Adverse Event Reporting & Reconciliation
  15. Audit Trail
  16. Database Lock
  17. Quality Assurance in Clinical Data Management
  18. QMS, Audit & Inspection, SOP Compliance
  19. Hands on Software Training

  1. Drug Development Process & Introduction to Clinical Research
  2. Introduction to Regulatory Affairs, Terms & Terminologies & Abbreviations
  3. Chemistry, Manufacturing & Controls (CMC)
  4. Drug Master File
  5. Regulatory, Filing System for DMF in Different Countries
  6. ICH – Introduction, Objectives & Guidelines
  7. CTD Introduction - Module 1 to 5
  8. Regulatory Filing Systems in Europe
  9. Regulatory Filing Systems in US
  10. Registration Procedures in Rest of the World
  11. Validations
  12. Audits & Compliances
  13. Regulatory Operations
  14. Pre Publishing
  15. Publishing
  16. Final Submission via Gateways
  17. Practical Approach towards Overall Dossier Preparation & Submission
  18. Pharmacovigilance Regulations
  19. Indian Pharmaceutical Regulations

  1. Introduction to Patent Regime
  2. Introduction to Patents
  3. Trademarks
  4. Copyright
  5. Industrial designs
  6. Trade Secrets
  7. Geographical indications
  8. Types of Patent
  9. Patentability criteria
  10. Patentable subject matter/Non Patentable subject matter
  11. Anatomy of Patent
  12. Term of a Patent Expiry calculation of patents.
  13. Inventor ship

  1. Duty of Disclosure
  2. Timelines
  3. Types of Searches
  4. Various Search Engines
  5. Performing a Search (Dummy Strategy) & Advantages of patent search
  6. International Patent classification Patent
  7. Introduction to patent drafting
  8. Specification and Description
  9. Written description, Enablement and Best mode requirement
  10. Claims

  1. SAS Introduction
  2. Infile option
  3. Methods to read data
  4. Import Export of data
  5. Set and where statements
  6. Libraries
  7. If then Else statement
  8. If then and Loop
  9. Addition of data
  10. Merging of data
  11. Functions in SAS
  12. Procedures in SAS
  13. SQL Overview
  14. Macro Overview
  15. ODS(Output Delivery System)

  1. Introduction to CDISC
  2. Overview of CT Protocol, SAP, CRF, TFL shell
  3. Sample CRF Annotation activity
  4. Overview of SDTM Implementation guide
  5. Overview of ADaM Implementation guide
  6. Preparation of Dataset specification (SDTM + ADaM)
  7. Sample SDTM creation
  8. Sample ADaM creation
  9. Creation of .XPT files for Regulatory submission
  10. Sample TFLs creation
  11. Overview of P21 tool for validation of data
  12. Overview of University free SAS version usage to perform above
  13. activities on dummy project
  14. Overview of define.xml and final regulatory submission package

For more information, please contact:

Cliniminds Bengaluru

+91-9902261347  , +91-9560102589, +91-9810068241  

C/O BHIVE Workspace Platinum Indiranagar, 271, 6th Main Rd, HAL 2nd Stage, Motappapalya, Indiranagar, Bengaluru, Karnataka 560038

Email us your queries : bangalore@cliniminds.com