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CTASC-Clinical Trials Management System

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
89447
Program Year/Program:
2009 / SBIR
Agency Tracking Number:
RR024945
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
CLINICAL TRIALS AND SURVEYS CORPORATION
CLINICAL TRIALS AND SURVEYS CORPORATION 10065 Red Run Blvd. Owings Mills, MD 21117
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Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: Yes
 
Phase 2
Fiscal Year: 2009
Title: CTASC-Clinical Trials Management System
Agency: HHS
Contract: 4R44RR024945-02
Award Amount: $750,000.00
 

Abstract:

DESCRIPTION (provided by applicant): The business of developing, testing, and approving new medical treatments for use in the U.S. has changed dramatically over the past 10 years. In recent years we have observed declining approvals, increasing costs, incr easing regulatory process complexity, doubling of the number of new treatments being tested, and slowing of U.S. based recruitment. Together these forces have contributed to a significant increase in time to market for needed therapies. We believe that the current regulatory requirements for conducting clinical trials are preventing small companies from testing many potentially beneficial therapies due to a lack of resources to conduct this testing. A new, simplified, cost effective technology solution is needed that will allow small research organizations to setup and conduct a clinical trial at an affordable price. If this new technology is based on time-tested standard computer driven processes, it will significantly increase the acceptability of data submissions to the FDA and file transfers to partner organizations. Small researchers also tend not to have IT departments or large data centers to run these types of systems. To ensure the solution can be economically deployed, configured and integra ted it should be provided through a Web browser using a Software as a Service (SaaS) model with a data model based on Clinical Data Interchange Standards Consortium (CDISC). C-TASC is in a strong position to deliver this technology with a sustainable competitive advantage due to the experience and intellectual capital we have gained through years of managing these types of studies, our experience in developing Web-based technology to manage clinical trials, and our recent addition of technology leaders hip that has developed similar Web-based SaaS solutions for other large markets. Creation of this technology will enable small research organizations to affordably conduct studies in a manner consistent with FDA standards, would speed many therapies to market and, in some cases, allow a therapy to come to market that would not have been affordable in the past.

Principal Investigator:

Joseph J. Valeri
4104350663
JVALERI@C-TASC.COM

Business Contact:

Chris Donhauser
cdonhauser@c-tasc.com
Small Business Information at Submission:

CLINICAL TRIALS AND SURVEYS CORPORATION
CLINICAL TRIALS AND SURVEYS CORPORATION 10065 Red Run Blvd. Owings Mills, MD 21117

EIN/Tax ID: 152163220
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No