Partners

Healthcare Discoveries, providing Phase I services

Getting your product into the clinic quickly is our primary goal as well as yours. We can speed both the initiation and completion of your Phase I research because our Phase I facility is part of a strategic alliance with Healthcare Discoveries (an ICON plc company). Together, Healthcare Discoveries and Catalyst provide the perfect foundation for accelerating clinical development and a smooth transition from Phase I to Phase II clinical studies.

With over 10 years experience in complex pharmacology clinical research, across the spectrum of medical science, Healthcare Discoveries was designed to provide the most professional, confidential, and secure environment possible to protect both subjects' and clients' interests. Healthcare Discoveries is:

110+ bed facility in San Antonio, TX
A wide range of Phase I-IIa trial experience
Proven performance in over 15 therapeutic areas
Focused on recruitment and rapid enrollment
An extensive database of healthy and special populations
Rapid study initiation
Certified laboratories on-site
On-site quality assurance team

At Healthcare Discoveries, our goal is to smooth the typical "speed bumps" in the Phase I execution and provide our clients with quality data in record time.

Colorado Prevention Center (CPC): ECG core laboratory services

Catalyst Pharma Group Inc. (CPG) looked for cardiovascular services partner that could meet the very special requirements of the FDA's demanding new guidelines for centralized, digital cardiac monitoring and evaluation. You will find the Colorado Prevention Center (CPC), together with Healthcare Discoveries Inc, provide the innovative central electrocardiography (ECG) laboratory services with the technology and experience to provide centralized cardiac analysis specific to the new FDA guidelines and still be capable of tailoring the project management to each protocol's unique needs.

Importantly, the CPC has achieved Mortara Certified Partner status after successfully implementing Mortara's 12-lead Surveyor Telemetry System in Phase I studies. The Mortara Certified Partner Program recognizes cardiac central laboratories and academic institutions engaged in the analysis and annotation of digital ECG data. In collaboration with the U.S. Food and Drug Administration (FDA), Mortara has developed the E-Scribe ECG Warehouse, to receive, store and analyze cardiac safety data submitted in standardized data formats in support of New Drug Applications (NDAs). ECG data must pass a validation step in the E-Scribe ECG Warehouse system, to ensure adherence to the Health Level 7 (HL7) XML standard. FDA reviewers use the data warehouse system to process ECG data with advanced tools and viewing technologies.

As a result of the certified partner status and the HCD's 12-lead Surveyor Telemetry System, we now have a system designed to significantly advance cardiac safety in drug development through a seamless integration of service and technology, that acquires and optimizes workflow and real-time monitoring of ECG signal quality. Sponsors now have a complete turn-key solution for cardiac monitoring that streamlines the management of ECG data from site acquisition all the way to FDA submission.

OmniComm Systems leverages Electronic Data Capture to Streamline Clinical Trials

The product of clinical research is data. The speed, accuracy and reliability of data collection is not only of paramount importance for safety and clinical decisions, it also influences operational costs of clinical development. Catalyst's partnership with OmniComm Systems leverages their TrialMaster Ph. It's internet-based electronic data capture (EDC) system that is rapidly becoming the industry standard to address this process. Catalyst's full integration of EDC technology saves our sponsors time and money.

By harnessing the latest Internet technology, we have created a near-paperless system for clinical trial management. Our Internet-based applications integrate the essential trial elements - data collection, data validation and reporting - into a seamless process that is both faster and more accurate than wasteful paper-intensive methods of conducting clinical research.

You can find OmniComm systems on the web at http://www.omnicomm.com