|
CPC has served as a core laboratory for several different measurements and in the context of several different clinical trials.
Core Lab Services are offered in the following:
ECG Core Lab Profile
The Colorado Prevention Center is committed to cardiovascular safety in new drug development by providing timely, rigorous, high-quality interpretation and analysis of study-related ECG variables.
CPC is an academic research organization that provides full-service clinical trial management, and our specific capabilities as an ECG core lab include:
- Utilization of state-of-the-art Mortara E-Scribe and GE Muse systems to support ICH-E14 concordant analysis of a wide array of ECG data.
- Timely analysis and interpretation of digital 10-second 12-lead ECG strips
- Extraction of 10-second ECG strips from 12-lead digital Holter data
- Expert study reports for thorough QT and arrhythmia trials
- 21 CFR Part 11 compliant data acquisition and processing
- Quarterly or study-specific inter- and intra-reader variability (IIRV) reports
- Rigorous QA/QC processes
- Continuous interpreting cardiologist training program
- Full service biostatistical and data management capabilities facilitating integrated and timely analysis of clinical, pharmacokinetic, and ECG data
- Protocol design and scientific input
Through an established partnership with ICON Development Solutions (Healthcare Discoveries), a state-of-the-art Phase I unit in San Antonio Texas, CPC provides seamless implementation of ECG studies from bedside to expert report and FDA ECG warehouse submission. This partnership features:
- Instantaneous automated transmission of digital ECG data via an established, secure and dedicated connection
- Customized web-based reporting system, empowers exceptional communication between study site, core laboratory, and sponsor to track progress on enrollment and number of ECGs interpreted
- Ability for a cardiologist to remotely view ECG strips identified by the site for immediate safety interpretation
- Jointly developed SOPs and cross-institutional team meetings ensure quality ECG data acquisition, processing, and enhanced workflow
- Seamless digital data flow validated from start to finish - patient acquisition to SAS® to regulatory authorities
For more information Contact Us
<TOP>
Treadmill Testing Core Lab
The Treadmill Testing Core Lab employs a simple logic: find errors in endpoint collection quickly to decrease the potential for invalid endpoint data. As evidenced by our article in the Journal of Vascular Medicine (add hyperlink to our article), many PAD studies have been plagued by significant and costly errors in treadmill testing due to factors such as a failure to properly run treadmill tests per protocol and inappropriate equipment. We developed our Treadmill Testing Core Lab to help ensure better control over these detrimental factors.
The process is quite simple: treadmill tests are conducted at the sites and the copies of the associated ECG/treadmill printouts are sent immediately to CPC for review. Errors are identified and corrective action plans are implemented to minimize or eliminate the impact of the error. The site personnel are quickly notified of any errors and a retrained on the appropriate method of conducting treadmill testing for the protocol. We have found the sooner errors in treadmill testing can be addressed, the better and more valid the data is for the endpoint thus, improving the ability of detecting a treatment effect of an investigational product or treatment.
For more information Contact Us
<TOP>
Wound Measurement Core Lab
Many ischemic limb clinical trials with wound measurements as primary and secondary endpoints have shown significant variability in the collection and assessment of the wound area. Typically, wounds are measured and assessed inconsistently among the clinical trial sites.
At CPC, we have developed our Wound Measurement Core Lab to decrease the potential for error and variability. Wounds are measured by the site in a standardized method and then sent to CPC for assessment. These measurements can be made using the traditional wound tracing method and/or standardized photographic measurements. The wound area and wound type are then assessed by qualified personnel at CPC. Each wound is put through a secondary review to ensure accuracy and consistency. By standardizing the collection and measurement of wounds, CPC has developed a unique solution for minimizing the variables which can cause errors, thus, improving the ability of detecting a treatment effect of an investigational product or treatment.
For more information Contact Us
<TOP> |
