A New Jersey, USA based Contract Research Organization
ClinTech Research LLC
Through its subsidiary
ClinTech Research India pvt. Ltd
Summer Special Hands-on Clinical Trial Operations Training
at Biotechnology Park, Lucknow
Clinical Research Industry is expanding at phenomenal rate with an expected market of US $ 1.5-2.0 Billion by 2010 according to several reports. Global Pharmaceutical companies and CROs are setting up their R&D bases in India leading to more number of job opportunities in Clinical Research. Be a part of upcoming boom.

Summer Special Hands-on Workshop/Project Dissertation Training package Offer @ 40% Off (Offer valid till July 2010)
(Batches started from 10th May 2010., 7th June 2010. & 5th July 2010.)

Course Duration Offer Fee Regular Fee
Clinical Trial Overview, Good Clinical Practices, & Clinical Data Management Including Project/ Dissertation Training(30 days)7,500/-12,500/-
Integrated Clinical Trial Research & Operations(45 days)9,000/-15,000/-
Integrated Clinical Operations including Project/Dissertation Training(45 Days)12,000/-20,000/-
Integrated Clinical Trial Research & Operations including Project/Dissertation Training(60 Days)15.000/-25,000/-
Integrated Clinical Trial Research & Operations including Project/Dissertation Training(90 Days)18,000/-30,000/-

Program Highlights:
  • A unique workshop emphasizing hands-on practical learning - supplemented with self-paced practice.
  • Training conducted by working professionals from India and USA.
  • Program coordinated from ClinTech Research, New Jersey USA.
  • Certificate of Participation will be awarded upon successful completion
Program Features:
  • Guidance by the competent and experienced Clinical Research Professionals.
  • Special lectures on drug development topics by leading scientists.
  • Internet and computer facility for students to support their learning.
  • Assistance in preparation of Project Report, and presentation / seminar.
  • Opportunity to work closely in real projects of the company for selected candidates.
Eligibility:
Students of B.Pharm/M.Pharm, B.Tech/M.Tech and other pharmacology & biological sciences. 		Career Avenues:
  • Pharmaceutical Companies
  • Biotechnology Companies
  • Contract Research Organizations (CRO)
  • Site Management Organizations (SMO)
  • Investigator Sites, Clinics, and hospitals
  • Pharmaceutical BPOs
  • Academic Institutions
Career Opportunities in Clinical Research:
  • Clinical Research Associate (CRA)
  • Clinical Data Associate
  • Safety Data Associate
  • Clinical Trial Coordinator
  • Clinical Quality Assurance Executive
  • Quality Assurance Auditor
  • Business Development Executive
  • Regulatory Affairs

Program Director - Sri P. Srivastava Ph.D., ClinTech Research, New Jersey, USA
Dr. Sri P. Srivastava has more than 24 years of extensive hands-on experience in drug development including clinical & IT Systems Operations (e.g. Oracle Clinical, IVRS, CRF Tracking etc.) within the US industry. Dr. Srivastava has held progressive management responsibilities in Clinical Operations Department at multinational pharmaceutical companies like Parke-Davis, Pfizer, Purdue Pharma and Organon Pharmaceuticals.

Our Integrated Training Content Outline
Clinical Research Overview
  • Phases & Types of Clinical trials
  • The Clinical trial Activities
  • Roles & Responsibilities of Key Players
  • Investigators, IRB/IEC, Sponsor
  • Essential Documents Checklist
  • Regulatory Agencies
  • Regulations & Guidelines

Clinical Data Management
  • Hands-on Training using mock protocols
  • Database Design
  • Data Acquisition
  • Data entry and verification
  • Data Cleaning
  • Discrepancy Management
  • Extract dataset and Database lock
  • Data security and Safety
 Site Management & Study Monitoring
  • Initiation of the Trial
  • Pre-Study Qualification
  • Clinical Research Coordination
  • Types of Monitoring Visits & Reports
  • Review of Site Documentation
  • Adverse Event Reporting
  • Study Close-out

Regulation, Validation & QA
  • ICH - Good Clinical Practices (GCP)
  • GCP Evolution (GCP: History and Regulations)
  • GCP: Roles and Responsibilities
  • GCP Processes and Expectations
  • FDA 21 CFR Part 11 Guidelines
  • Computer Systems Validation
  • Concepts & Tool of Quality in pharmaceutical
  • Role & importance of Quality Assurance (QA) in Clinical Research
Location:
#201, Biotechnology Park, Sector-G, Jankipuram Lucknow, UP 226021, INDIA Tel.: +91 (522) 4045207, +91 (522) 3230131 or more information mail us at training@ClinTechResearch.com or contact: Training Counselor, ClinTech Research India Pvt Ltd
Download Brochure and Registration Form