Clinical Trial Services and Support
Bio/Data Corporation is your platelet function expert. We offer a
complete line of products and services that will provide you with a
complete package to perform the clinical trails for all phases of your
study. The services that may be provided are extensive, a list of typical
services are:
- Platelet Function Testing System, equipment and supplies
- PAP-8E Platelet Aggregometer
- Simple to operate and reliable operation
- Includes all devices to perform the platelet function tests
- PDQ™, Platelet Function Centrifuge to prepare the samples
- Two electronic pipettors for precise measurements
- Reagents specifically packaged to the needs of the study
- Complete line of standard and specialty aggregation reagents and
diluents
- Single use and blinded packaging, study specific
- Functional controls to verify operation
- Specimen Collection Kits for platelet specimen collection
- Software designed to the exact needs of the study
- Preset study days
- Regulation and control
- Customized test menus
- Simplifies and streamlines the operation
- Reduces errors
- Databases designed for the collection, review and dissemination of the data
- Databases designed to exactly the needs of the study
- Specialized software allows for expert review of the data prior to
acceptance
- Master databases to receive and correlate the data from all sites
- Secure and hardened
- Training for the operational testing and management of the data
- Installation, training and validation of operators and site coordinators in:
- Sample collection and preparation
- Analysis
- Data transmission
- Training of second party data review staff and trial administrators
- Field support of the trial and data management
- Training and implementation of the review and master database
- Study design, pre-clinical
- Develop test protocols based on the study requirements
- Verification and control schemes
- Data management system design
- Phase I through post market
- Prepare sites
- Supply equipment and consumables
- Install and train site personnel
- Monitor methods and test panel
- Complete logistical support throughout the trials
- Bio/Data has experience in North American and international site
management.
- We can also provide site selection criteria
- Site pre-qualification
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