SMO - SITE COORDINATION & MANAGEMENT

Site Management is the most critical component of the entire trial. Successful participation in a trial increases the likelihood of future trials. With our experienced trial coordinators you can be certain that your site performs flawlessly. We meticulously follow trial procedure in all aspects ensuring:

  • Proper budgeting and CTA (Clinical Trial Agreement) review that the time to site initiation is kept to the minimum
  • Ethical management of the informed consent process that the site follows the protocol and time between signing the informed consent to screening to randomization is kept to the bare minimum
  • Replacements for screening failures are quickly found
  • All documentation is duly completed with proper source documents and the documents are properly filed for easy accessibility any time
  • Drug accountability and temperature logs are scrupulously maintained
  • Blood/tissue samples are safely stored and their temperature logs maintained
  • Speedy resolution of queries
  • Participants are punctual for follow up visits and proactively addressing issues to minimize drop outs
  • Efficient coordination of all logistics involving courier dispatch of documentation as well as samples to external/central labs
  • Prompt IEC/IRB submissions and follow up for timely acknowledgements and approvals
  • prompt status reports as required by the IEC/IRB
ADVANTAGES OF OUR COORDINATORS

Coordinators from B.Sc Nursing background trained by industry experts in all the guidelines which includes ICH GCP, Schedule Y, US FDA, Indian GCP, ICMR and all other study related requirements/procedures.

Our coordinators are specially trained in patient counseling/communication, patient follow up, sponsor and IEC communication, IP accountability, query resolution and all other study related requirements which will help our clients to meet the needs successfully within the time limit