gratisol.com Labs Hyderabad : Clinical Research Training

Name Of The Training Institute : Gratisol Labs( gratisol.com )
Training Offered : Clinical Research Training
Location Of The Training Institute : Hyderabad

Website : gratisol.com/index.php/compon…2013-new-delhi

Clinical Database Design and Data Management :
About this training :
This course will provide extensive training in the niche domain of clinical data management. It incorporates end-to-end theoretical & practical training sessions on Oracle Clinical, Remote Data Capture (RDC) & Oracle Inform Central Designer.
Following Course Content will be covered during the training :
** Welcome and Introduction to Clinical Data Management
** Drug Development and Clinical Trial Phases
** Fundamentals of Clinical Research & Roles in a CRO
** Clinical Data Management Process & Life cycle
** ICH – GCP guidelines
** GCDMP guidelines
** Paper Vs Electronic Data capture
** Data Management Plan document
** Introduction to CDISC SDTM Standards
** Application of SDTM Standards.
** Clinical Study Documentations Setup
** CRF Annotation
** Creation of SDTM annotated CRF
** Creation of Database Structure Document
** Creation of Edit Check Specification Documents
** Study User Acceptance Test (UAT) documents
** Project Initiation
** CRF Design/ eCRF design
** 21 CFR Part 11 Regulations
** Questions and Discussions
Details :
ELIGIBILITY :
Minimum Eligibility Criteria For Application To The Course Would Be Either Of The Following :
Applicants are recommended to have one of the following life Science degrees: Bachelor’s, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / M.Tech (Biotechnology), B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical companies, CROs and Hospital.**
SELECTION PROCEDURE :
To Maintain High Academic Standard, Gratisol Labs Gives Due Importance To The Quality Of Students Enrolled.
To Ensure This, The Selection Of Individual Student Will Undergo The Following Procedure
** Personal Interview
** Screening And Selection Of Students
CERTIFICATION :
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.

Pharmacovigilance- 2 Months :
About this training :
The focus of the training will be mainly on the following topics :
** History and over view of pharmacovigilance
** Introduction and responsibilities: USFDA, EMA and CDSCO
** Pharmacovigilance in India
** Clinical Development process
** Different phases of clinical Trials
** Adverse events and its types
** Drug Safety in clinical trials and post marketed drugs
** Different sources of Adverse events reporting
** Different types of AE reporting Forms
** Expedited reporting and its timelines
** Different departments working on Pharmacovigilance
** Roles and responsibilities of case receipt unit
** Roles and responsibilities of Triage unit
** Four factors for the reportable case
** Seriousness criteria of adverse event
** Expectedness or Listedness of adverse event
** Causality assessment of the adverse event
** Introduction to safety databases and different types
** Importance and procedure of duplicate check
** Case bookin or initiation
** Introduction to MedDRA and WHODD
** Narrative writing
** Case quality check, Medical review and its submission.
** The Qualified Person for Pharmacovigilance (QPPV) in the European Economic Area
** PSUR and its submission timelines
Practical Training will be also provided on Safety Database on the following topics :
** Data Entry
** Case Processing
** MedDRA & WHODD coding
** SAE narrative writing.
Details :
Mode of training- Instructor Led Class room/ Online Training
Note : Industry Experts from Novartis, Parexel, TechMahindra, Infosys, HCL, MakroCare, Aurobindo Pharma, Natco Pharma, Dr Reddys will deliver the classes.
Our candidates employed in Mahindra Satyam, GSK, Quanticate, ICMR, Global Hospitals, Apollo Hospitals, NIMS, Quintiles, Novartis, Glenmark Pharmaceuticals Ltd, Parexel International (India) Pvt Ltd, AstraZeneca-UK and many more…
To reserve the seat immediately, send a DD of Rs.500/- in favour of Gratisol Labs payable at Hyderabad along with your resume by courier or registered post. You can also reserve the seat by doing cash payment at Gratisol Labs Premises.
Tenure : 2 month
Eligibility :
Applicants are recommended to have one of the following life Science degrees: Bachelor’s, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical companies, CROs and Hospitals.

Contact Details :
Gratisol Labs India(Andronovo Labs Training Partner)
Plot No. 70, 3rd Floor,
Road No. 10, Banjara Hills
Landmark : Star Hospitals/Mandir Showroom
Hyderabad – 500034