Consulting

   
Q-Trials provides consulting sevices based on our senior staff experience. These are some of our most established consulting packages. However, you can always ask for our opinion and we will be happy to help or refer you to an expert.    

Clinical Contract Overview
Medical Writing Consultancy
Audits and Inspections

Clinical Contract Overview

Q-Trials offers a new service, providing the full assurance that your study reaches its optimum. In essence, we are hired to overlook the execution of a study by a hired CRO. Is your CRO delivering? Q-Trials will perform for you an internal inspection, while taking a close look at the contract you have with the CRO of your choice and comparing it against actual performance. We measure by three parameters: Quality, Time, Budget.

All these and more are questions often raised by clients, who would like to be assured that all is well:
  • Is the CRO performing all activities agreed upon?
  • Is the CRO performing the activities within the agreed timelines?
  • Were the recruitment and treatments goals achieved?
  • Were all sites initiated? If not, flat rates can be reduced.
  • Are all monitoring visits performed on schedule?
  • Are reports submitted and finalized in a timely manner, authorized by appropriate personnel?
  • How is the study overseen? Are teleconferences performed, and if so – are meeting minutes written?
  • Are major issues escalated and resolved?
  • Are major contract milestones met, is budget adhered to?
Why us?  It takes one to know one. We know the ins and outs of how a CRO works. And you benefit from our objectivity as a third party. This is a service provided worldwide.
 

Medical Writing Consultancy

Q-Trials provides medical writing such as protocol development, study documents, SOPs,  summaries and reports.

 

Audits and Inspections

Audits and inspections are an essential tool in ensuring patient safety above all, site compliance with local and international regulations, and quality data. Q-Trials selected staff members perform Clinical Quality Assurance Audits in client offices and at clinical sites, and have participated in inspections by local and international authorities. Internal Sponsor-initiated audits are best performed by an independent auditor. We provide our clients with this service by certified, experienced auditors.