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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.

 

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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
 
DCGI initiates surprise inspection drive on CROs across India

With the view to ensure patient safety, the drug controller general of India (DCGI) has initiated a surprise inspection drive in he clinical research organisations (CROs) across India for examining various activities undertaken at CROs. Through this initiative, the DCGI plans to auge on the clinical trial situation in India, to see on whether they are patient centric and conducted as per the rules.

This is the first ever initiative taken by the DCGI's office wherein, he will be personally assisting the officials on random basis to verify CRO's commitment in following the good clinical practices (GCP) and various other regulatory provisions as per Drugs & Cosmetics (D&C) Act and Rules for protecting the rights, safety and well being of the subjects involved in clinical trial.

This is also expected to keep the DCGI personally updated on all the reports of the investigation submitted by the inspectors and other Central Drugs Standard Control Organization (CDSCO) officers about the clinical trial along with verifying information of the investigators, sponsor and CROs about procedures of inspection and follow up of their action.

Dr G N Singh, DCGI who has already inspected couple of CROs in and around Delhi stressed that the centre will henceforth take all the possible measures to ensure and verify the credibility and integrity of clinical trial data generated with in the country. “Our vision is to ensure safety of all our patients and to let them know that we are striving our best towards ensuring their welfare and safety by reaching out to them for that we will be conducting routine surveillance for any specific cause and will make sure that all the laws are properly enforced throughout the country.”

He further added that in the coming years one of the main agenda of the CDSCO will be to ensure effective enforcement of all the relevant rules in the country by frequent monitoring the activities of CROs.

Interestingly, the DCGI along with select officials from the CDSCO has already visited couple of CROs in and around Delhi anonymously to check on compliances and patient conditions. While on the drive, their main focus was to interact with the subjects directly and get information from them on clinical trials. They also investigated on the practices that are followed by the CROs while carrying out clinical trials.

 
 

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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