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EDC and EKG

Catalyst's specializes in planning and executing electronic data capture (EDC) programs. EDC programs require an in-depth knowledge of the technology's capabilities and a thorough understanding of the trial development process. The FDA's demanding new guidlines for centralized, digital cardiac monitoring and evaluation put an even greater burdern on the Sponsor wanting to leverage technology to keep their trial on track. Catalyst's realtionship with Medical Data and OmniComm Systems provide proven answers to both requirements.

EDC

OmniComm's core product, TrialMaster, allows for secure data collection, transmission, validation, monitoring and real-time administration of study data gathered at investigative sites, monitor locations, laboratories, and pharmacies. Its innovative features include easy-to-use tree navigation, a robust messaging system, and detailed data validation.

The benefits of this technology to Catalyst's clients include:

  • Dynamic architecture reduces trial development time
  • eCRFs are generated from a master database, permitting on-demand forms
  • Compliant with 21 CFR part 11, ICH-GCP and FDA's Guidance on Computerized Systems Used in Clinical Trials
  • Real-time data validation and cleaning, using customer-specific edits while ensuring data integrity
  • Easy data import/export in SAS, CDISC, XML, ASCII files and Excel spreadsheet formats
  • Instant messaging via robust alerts and messaging system
  • Online query resolution expedites monitor/ investigator issues
  • Real-time project management by sponsors, field managers and project managers through access to ongoing research data
  • Browser-based program permits you to manage your data on the web from anywhere, anytime

For more information about OmniComm visit www.omnicomm.com.

EKG

Medical Data's technology allows for the centralized collection, analysis and management of cardiac and blood pressure research data. This technology supports:

  • 12-lead ECG with thorough QT/QTc analysis
  • 12-lead and 3-channel Holter monitoring
  • Ambulatory blood pressure monitoring
  • Event monitoring

Since it was founded in 1985 as a division of Spacelabs Inc., Medical Data has conducted hundreds of thousands of cardiovascular procedures for virtually all of the major pharmaceutical companies, plus universities, CROs, biotech firms and medical device companies. In addition to offering "gold standard" digital 12-lead ECG technology, the company also offers the latest innovative ambulatory blood pressure monitoring (ABPM) devices, coupled with unparalleled secure data transfer technology for instant screening and turnaround, all within the budget constraints satisfactory to any client.

Visit Medical Data on the web at www.spacelabs.com/medicaldata.