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Clinical Trials

clinical_trialsSpecific Areas of Expertise:

Bio/Data Corporation is a leader in clinical trials and clinical studies. Because of their accuracy and reliable results, our platelet aggregation profilers have been selected for use in many significant studies including:

  • Anti-Platelet Trialists Collaborative
  • ARICA
  • CAPTURE
  • COMPARE
  • EPIC
  • EPISTENT
  • GUSTO IV (aka SPEED)
  • GUSTO V
  • IMPACT II
  • ISAR-REACT 3
  • PCI CURE
  • PLATO
  • PURSUIT
  • RESTORE
  • TIMI 12
  • TRITON

Our experience is unrivalled and our expert project managers and our interdisciplinary teams draw upon their state of the art knowledge and therapeutic expertise to anticipate every challenge your trial faces.

We offer:

  • Platelet function testing systems, equipment and supplies
  • Reagents specifically packaged to the needs of the study
  • Software designed to the exact needs of the study
  • Databases designed for the collection, review and dissemination of the data
  • Training for the operational testing and management of the data
  • Installation, training and validation of operators and site coordinators
  • Field support of the trial and data management
  • Study design
  • Phase I through post market experience and expertise

With service experts worldwide, Bio/Data Corporation has one of the most experienced teams devoted exclusively to clinical trials. We are an FDA regulated company and ISO 9001:2008, ISO 13485:2003 registered and hold numerous international certifications.

Please refer to our Quality Systems and Standards for more information on how we ensure that our products meet the most stringent standards.

 

Platelet Function

Examining the role of platelets and platelet function is critical in the evaluation of therapies that target cardiovascular, diabetes and metabolic disorders. Platelet aggregation, the gold standard for platelet function tests, has sometimes been considered too complex and time consuming for the typical trial site to perform. That is no longer the case.

Bio/Data has developed a total testing system, complete with software and standardized procedures based on its PAP-8E Platelet Aggregometer, PDQ® Platelet Function Centrifuge, and system performance verification test protocols suitable for use by trial site personnel in diverse and busy settings.

In just one recent trial, Bio/Data’s PAP-8E platelet aggregometer and the PDQ platelet function centrifuge were deployed to trial sites in 33 countries. Data from the validated trials sites was reviewed by a third party technical expert and found to be suitable for inclusion in the study database.

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Instrument Management

We make it easy and cost-effective to integrate the very best instrumentation in your study. Our instrument management programs include site assessment, delivery, installation, training and validation, support, post trial preventative maintenance, storage and verified hard drive data removal.

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System Performance Verification

Bio/Data has developed a unique test system that verifies instrument performance and operator competency each day subjects are tested. This information is captured in a segregated portion of the database and can be reviewed by a third party to determine the acceptability of the data prior to inclusion in the study database. This unique test system also provides assurance that data from multiple trial sites are comparable.

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Customized (Study Specific) Software

System software can be customized for the study reagents as well as for the procedures for conducting the tests, study time points, subject/sample identification and automated collection of required information and test results. All data is captured and maintained in a hardened Access® database.  Data transfer is tightly controlled in accordance with study specifications.

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Study Specific (Custom) Reagent and Test Kits

We provide sequestered lots of standard platelet function reagents (agonists). Study specific concentrations, custom kits and reagents are also available.

All reagent kits include reconstituted solutions and diluents in order to minimize site to site variation in reagent preparation. Kits are sized for single day of testing use to eliminate storage and improper use of previously reconstituted reagents.

Examples include:
Standard reagents: ADP, Arachidonic Acid, Collagen, Epinephrine, and Ristocetin
Specialty reagents: Thrombin, TRAP, and Fibrinogen Inhibited Thrombin Aggregation Kit

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Consultation and Program Development

Our experienced technical and administrative staff will work with you to develop a comprehensive program that meets your platelet function PD requirements from the laboratory through Phases I – IV.

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Standardized Sample Preparation

Bio/Data pioneered a method that assures consistent sample preparation at all trial sites, and reduces specimen processing time to about five minutes per subject sample. Our PDQ Platelet Function Centrifuge has been validated for this purpose and has been used at trial sites around the world. It is an integral part of a successful test system ensuring accuracy and providing speed and convenience.

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Specimen Collection Kits

Individual specimen collection kits specifically designed for platelet function tests eliminate compromised samples and data resulting from the use of inferior general purpose specimen collection supplies or kits.

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Technical and Logistical Support

Bio/Data Corporation can also perform trial site qualification and assessment. We offer technical and procedural support internationally via phone, email and fax for both instrumentation and software. We also provide a simple email based mechanism for managing study related reagent, supply inventory, and resupplying trial sites.

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Global Training and Site Validation

We develop and deliver on site training for trial site or central laboratory staff in specimen collection, sample preparation and analysis, data management, and control. At the completion of training, site/operator validation testing occurs, and site qualification is determined. Third party review and acceptance of validation testing is also available.

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Investigator and CRA Orientation

Bio/Data Corporation can also provide expert introduction, overview and documented orientation to platelet function technology, system components, technical, and logistical requirements, and procedures to be used at trial sites.

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Quality Systems

All products and services are produced and provided in accordance with ISO 9001:2008 and 13485:2003 standards.

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FDAAA's Reform

FDAAA's Most Comprehensive Reform of Prescription Drug Regulation in Decades

Regulatory agencies are responsible for approving important new therapies while ensuring the safety of the public. Agencies may require additional platelet function testing during your clinical trials to evaluate specific safety concerns for marketing approval. Bio/Data has specialized skills and systems to provide and manage the challenges that agency mandated Platelet Function Testing programs may require.

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Drug Agency Mandated Programs

On September 27, 2007, President Bush signed into law H.R. 3580, the Food and Drug Administration Amendments Act of 2007 (FDAAA). The FDAAA constitutes the most comprehensive reform of prescription drug regulation in four decades. There are few areas of drug and device development and commercialization that are not touched by this reauthorization, and the new authority granted to the FDA is noteworthy.

The new regulations indicate platelet function studies are now required for drugs that are designed for cardiovascular, biological, diabetic and anti-platelet drugs or for therapeutics’ such as Factor VIII and von Willebrand Factor.

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