OUR ADVANTAGE

Clinical trials require strict adherence to protocol, extensive documentation, complete accuracy, compliance to ICH-GCP and other regulatory norms, an ethically sound patient recruitment strategy, and efficient site management.

 

QUICK LINKS          
 
CRP Course I5 Site List
Scheldule Y CDSCO Website
GCP E6 Guideline FDA Guidance
 

 

LATEST NEWS
  • CDSCO issues diretion to Zonal Offices for conduction inspection of clinical trial site
  • Clinical trial industry is no killing machine: G.N. Singh - Livemint
  • Draft Guideline of FDA on Electronic Source Capturing
  • ICH makes progress on ongoing reforms and adopts Guidelines for safety reporting. Press Release - ICH Steering Committee, San Diego, California, USA, November 2012
  • DCGI initiates surprise inspection drive on CROs across India
  • Recent draft guidelines release by DCGI for public review and opinion
  • I5 Clinical Research launches FREE GCP Accreditation Test (GAT) for Clinical Research Professionals
  • I5 Clinical Research launches Clinical Research Professional (CRP) Course
  • INC Research to acquire Kendle International
  • Nautic purchase of Omnicare Clinical Research part of recent acquisition trend of mid-sized CROs
I5 ACADEMIA

I5 Academia is an internal part of I5 clinical research Pvt limited which focuses on the the development of innovative way to increase the skill set of Clinical research professionals. Pres ently we are offering two set of programmes for clinical research Industry:

1. GAT - GCP ACCREDITATION TEST (FREE)

Almost every aspect of pharmaceutical medicine is subject to regulation and for many years it has been a requirement of regulatory authorities that clinical trials performed to support licensing of new medicines be conducted in compliance with a set of standards known as Good Clinical Practice (GCP). Therefore pharmaceutical physicians, clinical research scientists, research nurses and others employed within the industry are required to have a good working knowledge of GCP. Many companies provide training courses for their personnel either in-house or externally. However, for the most part training has not extended to clinicians, research nurses, technicians and other personnel serving as investigators and support staff involved in the conduct of clinical trials. Furthermore, there has been no qualification in GCP widely recognized as evidence of attaining a satisfactory standard of knowledge. As we all understand GCP being the 'backbone' of CR industry and people's health at large, this FREE GAT is our humble offering to clinical research industry.

All the professionals, Investigators, students and others can take benefit from this course and keep themselves accredited for GCP all the time. You would require filling a simple registration form and can take the test. If you pass, you will get your GCP accreditation certificate as a PDF copy.

Click here for entering to our GCP Test Page and get yourself accredited NOW!

If you want to support this programme in any form please contact us at academia@i5clinicalresearch.com.

 

2. CCRP - CLINICAL RESEARCH PROFESSIONAL

Certified Clinical Research Professional (CCRP) is a skill development program ( through correspondence/class room training) of 6 months duration with a primary focus on Drug discovery and clinical trial processes, Good Clinical Practices (GCP) guidelines, Drug regulatory affairs, Roles and responsibilities of various clinical trial stakeholders. The prime objective is to provide a high-end training thereby enhancing the employment prospects of the participants.

Please click below to get Information Brochure and Application of this course.

For more details on the course, please contact:
Dr. Divya, Course Coordinator: +91-9176990133
Landline: +91-44-22760117

You may also write to academia@i5clinicalresearch.com for any additional information.

USEFUL LINKS

Kindly find below links to some of the most commonly used web pages. Keep on visiting this page in future as we will keep on adding new site and tools in this page.

CLINICAL SERVICES

A site including listings of industry and government-sponsored clinical trials, as well as new drug therapies in research or recently approved by the FDA. Information on how to sign up for a clinical trial.
http://www.centerwatch.com

CLINICAL TRIALS

ClinicalTrials.gov is a registry of federally and privately supported clinical trials conducted in the United States and around the world. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations, and phone numbers for more details.
http://clinicaltrials.gov/ct2/home/

DAILY MED

DailyMed provides high quality information about marketer drugs. Drug labelings on this web site is the most recent submitted to the Food and Drug Administration (FDA) and currently in use; it may include, for example, strengthened warnings undergoing FDA review or minor editorial changes. These labels have been reformatted to make them easier to read.
http://dailymed.nlm.nih.gov/dailymed/about.cfm

DRUGS @ FDA

Drugs@FDA is an official site of US FDA. It provides current and accurate information like FDA Application No., Active Ingredient(s), Approval Details, TE Code, RLD and Patent details.
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/

ELECTRONIC ORANGE BOOK

Electronic Orange Book is an official site of US FDA. It provides most important information related to the drug and most importantly related to Patent and Exclusivity.
http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm

CLINICAL TRIAL INDUSTRY - INDIA

The Clinical Trials Registry- India (CTRI) has been set up by the ICMR's National Institute of Medical Statistics (NIMS) and is funded by the Department of Science and Technology (DST) through the Indian Council of Medical Research (ICMR). The mission of the Clinical Trials Registry-India (CTRI) is to encourage all clinical trials conducted in India to be prospectively registered before the enrollment of the first participant and to disclose details of the 20 mandatory items of the WHO International Clinical Trials Registry Platform (ICTRP) dataset.
http://www.ctri.in/Clinicaltrials/index.jsp

CGPGP.NET

Worldwide information for Clinical Trial participants, including the current clinical trials being conducted and their locations.
http://www.gpgp.net/

DRUGS.COM

Prescription Drug information for consumers & professionals including information on new Drugs and their progress through the FDA.
http://www.drugs.com/new-drug-applications.html

CLINICAL CONNECTION - CLINICAL TRIALS

Receive notification when a new US clinical trial that you are interested in becomes available.
http://www.clinicalconnection.com/

 
 
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