Learn Clinical Research, Pharmacovigilance, Clinical Data Management Training in Hyderabad. (CDM) Clinical Data Management Online Classes for Life Science graduates
Advance Certification Program in Clinical Research & Management
About This Course:
The pharmaceutical and biotech industry is experiencing a sea change worldwide with more impetus on innovation and personalized medicine. The business models are maturing to the next level of niche busters and towards a coexistence of novel and the age old blockbuster strategies.
With the economic drift and emerging economies like India, China, Brazil and Russia, the pharmaceutical and biotech industry is shifting research and development towards these regions especially in the phases of clinical development. Further, indigenous pharmaceutical and biotech companies in these regions are increasing their R&D efforts both for innovative molecules as well as the generic market.
Consequent to this scenario, a large number of clinical research organizations have recently developed which include a range of full service CROs, early phase CROs, SMOs, companies with selective specialized services like data management, clinical research consultancies, KPOs etc. This has created a demand for skilled workforce in the clinical research industry.
This course will provide extensive training in the niche domain of clinical research. It incorporates end-to-end theoretical & practical training.
What you’ll learn in this course:
- Drug discovery and development
- Preclinical studies
- Basics of Clinical Trials & Clinical Research
- Terminology & Definitions in Clinical Trials
- Types and Phases of Clinical Trials
- Good Clinical Practices (GCP)
- BA/BE Studies
- Research Methodology & Clinical Trial Design
- Clinical Trial Regulatory Affairs
- Preparations & Planning for Clinical Trials
- Essential Documentation in Clinical Trials & Regulatory Submissions
- Clinical Trial Operations and Monitoring
- Responsibilities of Clinical Research Professionals
- 21 CFR PART 11
- Informed Consent Document
- Schedule Y
- Protocol Development
- SOP development for Clinical Trial Operations
- Compliance, Auditing & Quality Control in Clinical Research
- Pharmacovigilance, Risk Management & Compliance to Clinical Safety.
- Pharmacovigilance Regulation to Clinical Safety.
- Adverse Drug Reactions, Reporting & Signal Detection System.
- Bio-statistical Analysis of Clinical Trials Data.
- Clinical Trials & Regulation Analysis.
- Clinical Trials Data Management.
- ICH-GCP Guidelines for Clinical Trials.
- Contract Research.
- Assurance & Control of Pharmaceutics.
- Medical Writing & Documentation.
Design, Development and UAT testing for Pharmaceutical product:
- Review and understand study protocol and the study timelines
- Accurately review case report form (CRF) for completeness, accuracy and consistency in accordance with all applicable procedures.
- Create data listings for manual checks
- Create data listings from CRF data
- Responsible for various other activities including testing of Validation Procedure, Database testing and handling discrepancies in Database as per protocol.
- Perform external checks to handle manual discrepancies and action the same.
- Performing User Acceptance Test. (Using Edit Check Specifications and other Checklist’s)
- Issued and managed clinical data queries to closure.
- SAE Reconciliation.
- Proficient in working on Oracle Clinical Database and EDC/RDC tools.
- Basic knowledge in Inform.
- To freeze and lock data as appropriate in time for statistical review blinded interim quality review, interim and final database lock.
- Build data extract views in OC well versed knowledge of FDA and ICH regulations applicable to the design, analysis and reporting of clinical trials.
- Good comprehension of FDA guidelines, ICH-GCP Guideline esp. E3, E6, E9
- Dedicated and trustworthy team worker with excellent analytical skills.
- Highly energetic person committed to achieve goals set forth.
GRATISOL LABS ADVANTAGE:
- Complete Course Material will be provided including detailed information about the entire work flow of Clinical Research Associate.
- 2 months internship available after rigorous training in Pharmacovigilance.
- Own CRO live Projects
- Highest Placement record across all training institutes
- Industry based SOP’s training
- Trainers with minimum of 7+ years of experience
- Comprehensive teaching by Medical Doctors
- Total 150 hours of exposure to theory, case studies and practicals.
- Hands on Training will be provided on Clinical Research Sites
Certificate will be provided for this Course on successful completion of Assignments & Projects.
Certificate would be awarded at the end of the program by Gratisol Labs. A fast track weekend course will also be conducted for employees & aspirants of Clinical Research Industry.
For more information, please contact Gratisol Labs at firstname.lastname@example.org