Clinical Research Certified Professional Course

Company Connect Consultancy is offering an opportunity to get certified and become a certified GCP Professional.  To enable the participant, clear the qualifying exam for obtaining the certification, the institute will be offering proper training materials which will be provided without any extra cost save for the cost for applying for the Certification Examination. This certification is aimed at improving the conceptual knowledge of the participant for Good Clinical Practices and resolving any dilemmas that a working professional may face regarding the application of GCP guidelines at his workplace. Successful performance in this exam implies that the participant has in-depth knowledge and clear understanding of industry guidelines and regulations. The study material has been carefully designed to introduce the attendee to various aspects and basics of GCP, its need and benefits in assuring the ethical and scientific integrity of clinical trials. GCP compliance provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible. Several specialized topics have been added to guide the participant through ICH GCP regulations, compliance needs, comparison of Indian GCP guidelines vs. ICH GCP guidelines etc.

The case study based approach in the training provided for the certification programme is designed for working professionals in full time employment who want to update their knowledge and gain required skills and attitude in the area in order to become a certified GCP professional in the domain. This certification is also beneficial for professionals from different streams to help them intensify their knowledge. An advanced training having rigorous case studies based methodology will be imparted to all participants for preparing for the Certifying Examination.

What is Clinical Research?

Clinical research is a branch of healthcare science which includes detailed study of human health and study. It
focuses to advance medical knowledge by studying candidates through direct interaction or through the collection and analysis of blood, cell, tissues or some other samples.

Scope of Clinical Research

Clinical Research determines the safety and effectiveness of medicines, equipment, and diagnostic products etc prior to release in the market. Sometimes, people get confused between clinical research and clinical practice. The difference is, one is to collect evidence to establish a treatment, while lateral is used to establish treatments itself. Clinical research is referred to the complete bibliography of a drug, device or a biological test. There is a huge requirements in Clinical Research in India.

Clinical Research Professional Courses

Company Connect Consultancy  is one of the well known Clinical Research training and placement firm which aims high quality  Job oriented training and placements. Clinical Research is an interesting career option with a great scope for professional career. We are comprises of highly qualified, dedicated and experienced faculty working
with the vision to provide best quality job oriented training to the candidates. The clinical trials market worldwide is worth over USD 26 billion and the industry has employed an estimated 2,10,000 people in the US & over
70,000 in the UK, and that form one-third of the total research and development staff. There are more than 2, 50,000 positions vacant globally & salaries vary in the region of approximately USD 40,000 per annum for a Clinical
Research Coordinator. A career in Clinical Research offers excellent job opportunities in USA, Europe (UK), Singapore & India. India is going to be the major hub of clinical trials.

Clinical Research Modules to be covered:

Module -1 : Clinical research
Module -2 :  Clinical Data Management
Module -3 : Pharmacovigilance
Module -4 : Medical Writing 

Career Opportunities in Clinical Research

Let’s explore the jobs in clinical research for freshers right from the entry-level to the managerial level. When you are a fresher in this field it is very important that you have a clinical research certification in your hand. This opens up multiple opportunities for you. There are multiple and exciting jobs available in Clinical research some of them are mentioned below:

  • Clinical Research Associate

  • Clinical Research Coordinator

  • Clinical Research Investigator

  • Clinical Research Manager

  • Medical Writer

  • Clinical Data Manager

  • Clinical Trial Auditor

  • Project Manager

Advanced Certified Program In Clinical Research & Operations Management

The pharmaceutical and biotech industry is experiencing a 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.

Certified Study Resources for Professionals

  • Introduction to Clinical Research Industry and Basics of Clinical Trials

  • Drug Discovery & Development Process

  • Pre-clinical studiesPre-clinical studies

  • Basics of Clinical Trials & Clinical Research

  • Terminology & Definitions in Clinical Trials

  • Ethics and Ethical Guidelines for Clinical Trials and Good Clinical Practice (GCP): ICH Good Clinical Practice E6 (R2)

  • Indian GCP and Schedule Y

  • Types and Phases of Clinical Trials

  • BA/BE Studies

  • Regulations Guiding the Clinical Research Industry- History and Basics of National and International Regulatory Bodies

  • Research Methodology & Clinical Trial Design

  • Essential Documents in Clinical Trials: Protocol, CRF, Inform Consent, Investigator's Brochure, Study Progress Report

  • Responsibilities of Clinical Research Professionals

  • 21 CFR PART 11

  • Clinical Data Management

  • Pharmacovigilance in India, US & UK

  • Medical Coding (MedDRA & WhoDrug)

  • Medical Writing

  • Informed Consent Document

  • Clinical Trials -Latest updates : New Drugs and Clinical Trials Rules, 2019

  • Intellectual property Rights (IPR) and Patent Laws

  • Industry Based Case Studies

Practical Training will be also provided on Oracle Argus Safety Database on the following topics:

  • Case processing

  • MeDRA coding & WHO DD coding

  • Duplicate Check and case initiation

  • SAE Narrative writing

Eligibility

Graduation/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Executive Diploma, Industry Certificate, and Certificate Programmes.

Upon Successful completion of Course our team will provide Following

  • Resume Preparation with Best templates

  • Live Project on Argus Data Safety Tools

  • Highest Placement record across all training institutes

  • Industry based SOP’s  training

  • Interview Preparation and Mock Interview Session.

  • Communication skills and personality development sessions

  • Placement Assistance

  • Free Soft skills training

  • 100% Money Back warranty 

  • Total 150 hours of exposure to theory, case studies and practicals

  • Hands on Training will be provided on Clinical Research Sites

  • Course Completion Certificate accepted across CROs and Industries. 

Registration

The registration will be carried out by contacting on Company Connect Consultancy. How to Apply

Programme Deliverables

A comprehensive study material for all the modules in Soft copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.

  • Assignments for all the programme modules for continuous evaluation and guidance.

  • Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.

  • Online classes for all the modules will be conducted on the weekdays or Weekend (as per batch you choose). Moreover, a doubt clearing session will also be scheduled before the examination.

  • All the efforts are made by faculty members to make the entire programme modules easily understandable.

  • Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.

  • At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.

  • All learning and training delivery initiatives shall be conducted in English.

Certification and Membership Fees

Contact on +91-9691633901 or Info@companysconnects.com for details of fees structure 

Assessment & Certification

All the participants are expected to appear for online assessment. After successfully qualifying the examination, the participants will be certified as GCP Professional by Company Connect.

Placement Assistance & Corporate Relations

The Institute has partnered with many organizations for providing with placement assistance to in its participants. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. 

In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare and food giants like IQVIA, Dr. Reddy's Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, IPCA Laboratories, Calyx, Mother Dairy, Bliss GVS Pharma, Al Rawabi, Almarai, Green Pastures, SeQuent, PepsiCo India, Mankind, Beryl Drugs, Allergy Therapeutics, CFTRI, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Ranbaxy , Biocon etc. The IGMPI's Corporate Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Pharmaceutical, Healthcare and Food industries on regular basis.