Quorum Review’s Quick Step™ service is designed to streamline the submission and review processes for clinical trials with over 50 planned North American sites* (or over 80 planned North American sites** for two or more related protocols submitted simultaneously). The service features a full spectrum of efficiencies for every stage of the IRB approval process. Some of the unique features include:
Pre-Assigned Study Manager
A dedicated Quorum representative will act as your concierge through the entire Quick Step™ process. They will assist with completing sponsor and site forms (as necessary), as well as coordinating your communication with our Regulatory Attorneys and the Quorum Board’s decisions.
Regulatory Consultation Service
As an added benefit of this service, you will be provided with 5 hours of complimentary consultation by one of our industry-renown Regulatory Attorneys. These hours are intended to assist with any regulatory area you desire from assistance with international country selection for research sites to advice on protocol design or consent form issues.
Consent Form Editing
Would you like help building your consent form before you formally submit protocol to go for review? Quorum’s highly experience Consent Form Development Team can assist you. This service still requires a draft protocol to verify study information, however Quorum can edit your form(s) so that your expectation of our review are known well before your protocol and consent are brought before the Board. Later, if your protocol requires changes, simply supply your study amendment and our editors can track the relevant changes on your behalf.
In addition, this service gives you the opportunity to provide custom citations for study documents.
Ad & Recruitment Processing
Quorum can prepare the administrative paperwork for your advertising or participant recruitment material prior to review, helping to minimize (or eliminate) the time between IRB approval and the start of your participant outreach efforts.
No need for you to complete the CSQ (Central Study Questionnaire)! Your Pre-Assigned Study Manager can migrate the data on your behalf (if the information is available from a related study already in-house), or complete it with you via conference call.
Submitting related studies? Our teams can cross-coordinate similar consent changes or special handling requests for sites that provide a uniform solution for your entire study plan.
Site Identification & Outreach
Via our new Site Directory, Quorum can help you identify potential investigators for your study based on geographic area or therapeutic expertise. Our database is constantly growing with new investigators willing to be contacted for new clinical trials, so you can be sure to have the most updated contact information. Upon request, Quorum can also reach out to select members of our institution list and tailor targeted campaigns to find new researchers interested in performing your research.
Data Migration Service
Transferring a large study to Quorum from another IRB? No problem. We can assist with transfer efforts and migrate the study data from another IRB’s documents to our own. When completed, you will have the opportunity to give your final sign-off on the submission materials. Your Pre-Assigned Study Manager can also schedule a teleconference to resolve any outstanding questions or issues surrounding the transfer.
This service is also beneficial to sponsors and CROs who currently have studies overseen by Quorum and would like to begin an extension or sister study using similar data from their current study file. Quorum can migrate the relevant, parallel information from your first study into your new study documents – saving you the time and effort.
Site Enrollment Service
Once sites have been identified for enrollment, Quorum can reach out and help walk each site through the application process.
Want to see how much time you saved on study start-up with our process? Upon request, Quorum will assist you with defining goals and metrics that communicate how the Quick Step™ service improved your clinical trial launch. A quarterly report will be provided to show you hard data about gains in your efficiency.
* Studies may have research sites outside of the U.S. and Canada but must have a minimum of 50 planned sites in those two countries.
** Two or more related studies may have research sites outside of the U.S. and Canada but must have a minimum of 80 in those two countries.