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 - SDMO

 

Site Management is the most important component of the entire human research. As a Site Development and Management Organization (SDMO) our aim is to provide you clinical trial sites with highest standards of Quality and with the availability of skilled; GCP trained and experienced clinicians across varied therapeutic areas. With our experience we will help you to speed up the site identification, qualification, initiation, and start up process.

All our sites are equipped with standard operating procedures which ensure ethical conduct of the trial and adherence to international and local standards of good clinical practice. We recommend only those sites which meet your study specific needs, which help to significantly reduce the time and resources in trial conduct.

We do contractual discussions in a centralized manner, which minimize the lengthy negotiations for each site.

We appoint dedicated staff like CRCs, QA Executive, Site administration manager for your study to ensure centralized and smooth communications and quality work at site.

We ensure that the site is prepared and trained to conduct the study with international standards. We place an enormous amount of responsibility for the success of your study on our CRCs and hence we ensure that they have the skills and capabilities to manage it appropriately.

Sites, which are new to clinical trials, are trained extensively on ICH-GCP, Schedule Y, ICMR guidelines and other local regulatory requirements. This enables site study team to gain a better perspective of their contribution and avoid pitfalls that new teams may get into.

All the I5 sites are well equipped with basic infrastructure like refrigerators, freezers, centrifuge machines, fax, scanner, printer, photocopy machine, cupboards, ECG machines, computer, etc. This saves time and efforts spent on building the basic infrastructure at site.

 

I5 COMPANY HIGHLIGHTS

 

  • Ability to provide GCP trained clinical research.
  • Sites equipped with standard operating procedures.
  • Huge database of highly skilled, experienced and enthusiastic Investigators having access to large patient population.
  • Dedicated and experienced Clinical Research Coordinators.
  • Nationwide coverage.
  • Efficient and centralized contract and budget resolution.
  • Strong working relationships with local and central IRBs.
  • Stable, effective and mutually beneficial working relationships with Investigative sites.

 

SERVICES FOR SITES

 

I5 is dedicated towards “Clinical Trial Site Development” throughout India. To achieve our aspiration, we are involved in development of quality and standard clinical trial sites through our various business models. I5 provides a variety of services to the Medical Institutes/Hospitals/Clinics (Clinical Trial Sites) interested to take part in Clinical Research and keen to convert their Medical Institutes/Hospitals/Clinics to a potential Clinical Research Centre.

Depending on the business needs we have developed different business models for our partners.

I5 is dedicated towards “Clinical Trial Site Development” throughout India. To achieve our aspiration, we are involved in development of quality and standard clinical trial sites through our various business models. I5 provides a variety of services to the Medical Institutes/Hospitals/Clinics (Clinical Trial Sites) interested to take part in Clinical Research and keen to convert their Medical Institutes/Hospitals/Clinics to a potential Clinical Research Centre.

Depending on the business needs we have developed different business models for our partners.

To know more about our Business Models and to avail our services, please click here.

To get a list of current exclusive sites of I5, please click here.

 

 
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