Clinical Research

Advanced Certified Program in Clinical Research & Operations Management

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.

Following Course Content will be covered during the training:

The focus of the lectures is mainly on:

  • 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
  • Intellectual property Rights (IPR) and Patent Laws
  • SOP development for Clinical Trial Operations
  • Compliance, Auditing & Quality Control in Clinical Research

 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) 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

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

Our Team of Experienced Drug Safety Specialists also provides the following upon successful completion of training:

  • Resume Preparation 
  • Interview Preparation with real time questions and answers
  • Mock Interview Sessions
  • Communication Skills and Personality development Sessions
  • Placement Assistance
  • Placement Assurance

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.

For more information, please contact Gratisol Labs at This email address is being protected from spambots. You need JavaScript enabled to view it.

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Contact

GRATISOL LABS – HYDERABAD
KVR Enclave, 2nd Floor, 207, Gurudwara Lane,
Beside Satyam Theater, Above ICICI Bank,
Ameerpet, Hyderabad– 500016,
Cell: +91 9705790302 / +91 8885198390
E-mail: training@gratisol.com