We want to help you and your site personnel conduct successful studies. Read below to learn more about our process.
Site Identification
These are the steps we usually take in identifying study sites:
- A specialist from our study team will contact you
- You may be asked to sign a confidentiality agreement
- We will send you a protocol synopsis and a brief questionnaire that will help us assess your interest and capabilities
- If your site is selected by Clinical Operations (see below), your next contact will likely be from Quintiles' Site Startup Unit.
Site Startup Unit
You will receive a regulatory document packet for completion, as well as a contract and budget.
A specially trained Site Startup Specialist will guide you through completion of these time-critical documents, including:
- Checking regulatory documents for accuracy
- Reviewing informed consent changes
- Negotiating a fair contract and budget
The Site Startup Unit will also handle contract amendments, if necessary.
Clinical Operations
Clinical team lead
We will dedicate a team lead to the study. This person will be responsible for managing all clinical aspects of the study, including:
- Site performance
- Qunitiles’ clinical research associates
Clinical research associate
After you return your questionnaire, a clinical research associate may visit your site. This is your opportunity to show in detail how you will successfully conduct the study.
Once your site is selected and you complete the startup process (see Site Startup Unit above), a clinical research associate will likely visit your site to go over study details with you.
Your clinical research associate will also conduct all other necessary monitoring visits and work with you to resolve data queries throughout the study.
Clinical Operations Staff Member
An in-house Clinical Operations staff member will also be assigned to assist the clinical team lead. This staff member, among other things, will be responsible for collecting any new or revised regulatory documents from you throughout the study.
Investigator Payment Administration
Upon sponsor request, we will appoint staff to process Investigator payments in accordance with your site contract.
These staff establish payment guidelines that are fair to sites, Quintiles, and the sponsor.
Generally, we pay our sites monthly based on patient visits completed and pass-through expenses incurred, with a small percentage held back until all study data queries are resolved.
Details about each payment are mailed with the check
- Protocol
- Sponsor
- Investigator
- Patient ID
- Visit numbers
- Dollar amounts
If your site is in North America and you have study-specific payment inquiries, please contact the payment analyst listed in your study contract @ (888) 267-2836.
If your site is not in North America, please contact your clinical research associate or designated Quintiles contact person.
Medical and Scientific Services
Upon sponsor request, we will assign a physician to act as medical monitor.
Our medical monitor will provide protocol clarifications for clinical research associates and investigative sites, including:
- Inclusion/exclusion determinations
- Any applicable waivers to the protocol
The medical monitor will be available by pager 24 hours per day for any urgent protocol-related issues you may have.
The medical monitor will also provide oversight to our pharmacovigilance staff, who may contact you to resolve queries on any severe adverse events you submit.
Project Management
The project manager has overall responsibility for the study and reports its progress to the sponsor.