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
NEWS & EVENTS
 
Bayer And Regeneron Report Positive Results For VEGF Trap-Eye In Second Phase 3 Study In Central Retinal Vein Occlusion

Bayer HealthCare and Regeneron Pharmaceuticals, Inc. announced positive top-line results for VEGF Trap-Eye (aflibercept ophthalmic solution) in the Phase 3 GALILEO study in patients with macular edema due to central retinal vein occlusion (CRVO). The positive results from the GALILEO study confirm the results of the similarly designed Phase 3 COPERNICUS study that were announced in December 2010.

Source: http://www.medicalnewstoday.com/articles/224558.php
 
 

MORE NEWS...

I5 launched it new division I5 Health Care
Updated: 20th May 2014

CDSCO issues diretion to Zonal Offices for conduction inspection of clinical trial site
Updated: 26th Mar 2013

Clinical trial industry is no killing machine: G.N. Singh - Livemint
Updated: 20th Mar 2013

Draft Guideline of FDA on Electronic Source Capturing
Updated: 1st Dec 2012

ICH makes progress on ongoing reforms and adopts Guidelines for safety reporting.

DCGI initiates surprise inspection drive on CROs across India

DCGI had released a new Ethics Notice on 16 Aug 12, which contains a check list of Essential elements that are to be included in the ICF.

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

Bayer And Regeneron Report Positive Results For VEGF Trap-Eye In Second Phase 3 Study In Central Retinal Vein Occlusion

FDA to amend trial investigator disqualification regulations

Clinical trial sites need a proactive compliance strategy

 

 

 
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