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
SERVICES - CRO

 

As a continuation of the evolution process I5 has established a Full-fledge Contract Research Organization (CRO) as an independent division to handle Phase studies, which includes Pilot studies, Pivotal Studies, Phase Studies and Therapeutic Equivalent studies. With its unparalleled experience of managing hundreds of studies as a SDMO and as a SCRO, I5 has future extended its service to clients as a Contract Research Organization where I5 will provide full-fledged service starting from designing till reporting of studies to Pharmaceutical, Biotechnology and Medical device industry.

I5’s CRO was established with an aim to build a full-fledge CRO offering end to end service with respect the phase studies, with system and process in compliance with global regulatory standards ( including ICHGCP, ICMR, EMEA and FDA Standards). I5 with the back-up of its extended working experience with many renowned global pharmaceutical companies as a SDMO and also in various indications starting from infectious disease to Oncology, is committed to offer the best service with respect to study design, management, conduct and reporting.

With its customized systems and infrastructure I5 would be a unique service provider, who can give the best quality and on-time service in most economic cost. Considering the advantage having one of the well established networks of investigators through the SDMO division and customized systems and resources to handle multicentre long term PMS studies with huge patient pool through SCRO division; I5 CRO will be able to give you most cost effective, highly complain and timely service.

 

SERVICE

 

  • Regulatory Affairs
  • Clinical Operations
  • Quality Assurance
  • Clinical Data Management
  • Biostatistics
  • Pharmacovigilance
  • Medical Writing
  • Project Management

 

COMPANY HIGHLIGHTS

 

  • Having an unparalleled experience of handling hundreds of Global phase studies as SDMO
  • Having an experience of handling hundreds of PMS studies as SCRO.
  • Having an experience of simultaneously handling 25 exclusive sites with around hundred activate projects.
  • Ability to conduct Phase I to Phase IV studies, IITs, MMSs, PMSSs and Therapeutic equivalent studies.
  • Full time experienced Clinical Research Coordinators through India, to have complete control over the site.
  • Well accepted by all clients as one of the most cost effective and quality assured CRO
  • Worked with many renowned global pharmaceutical companies.
  • Had developed a customized system to handle small budget studies without compromising the quality.

 

 
 
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