Expedited Review Process

Prior to their participation in clinical trials, the CBTC requires pharmaceutical sponsors or other interested parties to request an in depth Expedited Review of their protocols, drugs and projects. The CBTC will sign a blanket confidentiality agreement on behalf of Consortium (members, and employees), as all relevant information stemming from the Expedited Review will be centrally disseminated to all of its members. CBTC Headquarters organizes the Expedited Review after a mutually agreeable date has been set and develops the agenda along with the Sponsor. The Consortium provides Presentation Guidelines to assist the Sponsors to structure their presentation and the content of the Review. As Sponsors present their drug trials, a CBTC Review Team under the direction of the Head Reviewer prepares a draft Assessment Report which includes: project summary, comments, recommendations, budget details, and rank assignment. Final Assessment Reports are forwarded to the Sponsor within approximately 15 business days of the presentation.

The CBTC requests that the Sponsor submit a written Response to the Assessment Report. The CBTC then distributes a copy of both CBTC Assessment Report and Sponsor's Response to all members of the Consortium informing them of the content and status of the given project or trial.

A positive outcome of the Assessment Report and Company Response will likely result in a Call for Sites (clinical trial participation) which is centrally dispatched by CBTC Headquarters.

Expedited Review Charges: The Sponsor requesting a CBTC Expedited Review will bear all expenses relating to the Expedited Review at cost. Charges incurred may involve some of the following: transportation, parking, accommodation, reviewer honoraria, room rental, food and beverage, teleconferencing, audio-visual, administrative on-site fee, and 15% corporate surcharge. The CBTC makes every effort to keep these costs to a minimum.

Call for Sites: A Call for Sites, is the "Go Ahead - Signal" which signifies to all CBTC investigators that the clinical trial or project has been satisfactorily reviewed, all negotiations have been completed, and the project is ready for clinical trial participation. Investigators wishing to participate in the study, are required to communicate their interest to CBTC headquarters within 5-7 business days. The CBTC then forwards a "Short-List" of interested investigators directly to the Sponsor. The final selection of sites is made entirely at the Sponsor's discretion.