MediQuest Therapeutics Chooses TranSenda to Deploy Clinical Trial Portal; Solution Provides a Clinical Data Management Portal and eCRF Submission for MediQuest Study.

BELLEVUE, Wash. -- TranSenda International, LLC announced today the deployment of a clinical trial data portal for MediQuest Therapeutics. The portal is enabled by the deployment of TranSenda's Clinical EDC Manager application, which provides data capture through electronic case report forms (eCRFs). The application has been implemented for MediQuest and the clinical sites participating in their Phase III trial of a topical gel formulation for the treatment and prevention of Raynaud's phenomenon. Raynaud's phenomenon is a disorder that affects the blood vessels in the fingers, toes, ears, and nose, afflicting more than six million people in the United States.

TranSenda's Clinical EDC Manager -- a secure, modular web-based application for capture, storage and tracking of clinical trial data -- facilitates efficient communication between MediQuest employees, clinical research associates (CRAs), third-party labs and the clinical sites participating in MediQuest's study. The MediQuest portal allows participating site staff to create patient records, submit eCRF data, and resolve queries generated by the site monitors. Once forms are ready, Investigators are able to sign them electronically according to regulatory guidelines. The application also includes intuitive filter, sort, and search functionality, which enable site staff and CRAs to spend less time in front of a computer and more time attending to their study responsibilities.

The TranSenda application is built upon TranSenda's Clinical Trial Process Manager (CTPM) platform, which enables Clinical EDC Manager to be easily modified to fit the dynamic needs of any trial. Use of the process-platform-based application also enables much of the application to be re-utilized for subsequent trials that MediQuest conducts in the future, which will allow the company to leverage its initial investment -- providing significant incremental cost savings over the paper-based system previously utilized.

"MediQuest is very pleased with the TranSenda Clinical EDC Manager system," stated Fred Dechow, Ph.D, President and CEO of MediQuest. "Equally important, the TranSenda team has been very professional in guiding our organization in this transition to EDC for clinical information. They have also been responsive to the inevitable changes that occur with the deployment of such a system. We anticipate that the utilization of this system will save significant time in our clinical development program."

"We are excited to have the opportunity to collaborate with MediQuest and to help further their study of Raynaud's phenomenon," said Bob Webber, President and CEO of TranSenda. "The deployment of our Clinical EDC Manager application for this purpose demonstrates the value that TranSenda's modular software solutions can provide to life sciences organizations."

Historically, one of the most common challenges of EDC applications is acceptance at participating trial sites. While allowing Investigators and Study Coordinators to submit trial data electronically reduces a trial sponsor's data collection and management costs, the implementation of EDC systems can generate confusion and inefficiencies for clinic personnel. TranSenda recognizes and overcomes these obstacles by designing intuitive, trial-specific web screens tailored to fit the particular protocol and trial processes. The flexibility of TranSenda's CTPM platform allows TranSenda to quickly and efficiently design and develop software solutions that are the result of collaboration with their clients and fit the exact needs of the trial, as opposed to rigid off-the-shelf systems in which the trial processes must conform to the software.

"Working with TranSenda has eliminated any anxiety about submitting trial data electronically," stated Dr. M.E Csuka, Associate Professor of Medicine at the Medical College of Wisconsin in Milwaukee, one of the twenty-one clinics participating in the trial. "I anticipate the system will increase our efficiency in conducting the trial. While the system is logical and transparent, TranSenda's support staff is extremely courteous and helpful in resolving any issues first-time users may have when getting started. Questions are always answered and addressed promptly."

While working with MediQuest, TranSenda established partnerships with the other industry-leading companies also participating in the trial, including LabConnect, which is providing lab services, and Ockham Development Group Inc., whose personnel are using the Clinical EDC Manager application to streamline the fulfillment of their clinical data monitoring, review and analysis responsibilities. Ockham's Site Monitors are able to review data remotely prior to visiting trial sites in order to identify and resolve eCRF completion issues, thereby optimizing time on site to source verify, generate and resolve queries for identified issues, and lock completed eCRFs on an expedited, rolling basis. By providing Ockham with instant access to Investigator-signed eCRFs and generating industry-compliant XML data exports seamlessly uploaded to SAS(R), the TranSenda application enables the trial database to be locked quickly and securely, which reduces the overall cost of the trial for MediQuest.

"The deployment of TranSenda's Clinical EDC Manager for this trial has demonstrated TranSenda's ability to develop powerful solutions that fit the specific needs of a trial. Our ability to view virtually real-time data to monitor enrollment and CRF completion for this pivotal Phase III trial has enabled us to expedite measures that ensure that this cold weather-related trial will be completed on schedule," stated Kathy Burruss, Ockham's Senior Director of Clinical Data Management. "Moreover, by using TranSenda's system, we have maximized our site visits by reviewing eCRF data and addressing issues in the office as well as timing our site visits based on the availability of eCRF data."

About TranSenda

TranSenda collaborates with life sciences organizations to develop modular software solutions which provide a single collaboration portal to integrate and manage all applications and data. TranSenda's modular clinical trial products leverage a common, process-based platform designed specifically to optimize the connectivity of all applications and data. TranSenda International, LLC is a Microsoft Gold Certified Partner headquartered in Bellevue, Washington, USA. For more information, visit www.transenda.com.

About MediQuest Therapeutics

MediQuest Therapeutics is a privately held specialty pharmaceutical company headquartered in Seattle, Washington. Discovery and development efforts focus primarily on inflammatory/infectious skin diseases and conditions. For more information, visit www.mqti.com.

About Ockham Development Group

Ockham Development Group Inc. is a privately held corporation with 50+ employees headquartered in Cary, North Carolina, near the university-biotech-pharmaceutical sciences nexus known internationally as Research Triangle Park. Ockham represents an aggregate of both its leadership and the various experiences of its personnel within the drug development sector. These diverse experiences span the spectrum from service provider-derived to sponsor-derived. For more information, visit www.ockham.com.

About LabConnect

LabConnect provides global centralized bioanalytical, safety, genotyping and biostorage laboratory services for the biopharmaceutical industry. LabConnect is committed to delivering high quality central laboratory services by providing specialized customer service, innovative data management and reporting systems, and competitive pricing structures. For more information, visit www.labconnectllc.com.