Clinical Trials

CLINICAL TRIALS AND SPECIAL SERVICES

Light Transmission Aggregometry is the gold standard for testing platelet function,

 

“Elucidation of these inhibitory mechanisms has made rapid progress, not only because platelets are advantageous models for other cell systems but also because it may result in important advances in drug treatment”

Professor Gustav V.R. Born,  Department of Pharmacology

Cambridge University

Hills Road, Cambridge

CB2 2QD England July 28, 1977

 PLATELET AGGREGATION:

You can now include platelet function tests as part of a clinical trial whether it is a single site or multi-national undertaking.

The PAP 8E platelet aggregometer and its companion Platelet Function Centrifuge, model PDQ, are simple to use, easy to standardize across sites, highly reliable, and require minimal operator training.

With Bio/Data support and guidance, the PAP 8E and PDQ have been used successfully in clinical trials, PDPK and vigilance studies  ranging from a single site to 73 sites scattered over 33 countries.

CLINICAL TRIALS:

Protocol Development * Study Design * Investigator Orientation *  Site Selection and Validation * Operator Training and Proficiency * Field Training, Service and Support * Platelet Function Testing Systems * Study Specific Specimen Collection Kits * Study Specific Reagents, Assays and Test Kits * Single Lots * Tools for Standardized Specimen Collection and Sample Preparation * Multi-site Performance Monitoring * Global Technical and Logistical Support and Consultation * Management Mechanisms for Data Transfer and Acceptability * FDA Mandated Safety Profile Studies

 

ROUTINELY AVAILABLE AGONISTS:

ADP, Arachidonic Acid, Collagen (Type 1) Epinephrine, Ristocetin (Ristocetin Cofactor Activity Assay, Ristocetin Induced Platelet Aggregation) TRAP 6, TX A2 (U 46619), Aspirin, Ticagrelor.  Others available upon request.

Single lots can be produced for study specific needs.

COMPOUND AND VEHICLE ASSESSMENTS/CONTRACT RESEARCH:

Multi-year known donor pool and library * Threshold Concentration Studies * Method and Test Kit Development * Vehicle Effects * Effects of other Medications on Compound or Vehicle * Compound Assessment *  All Reports prepared or approved by the Chief Scientific Officer

   

CONFIDENTIALITY AGREEMENTS:

One way * Two way * Multi-party

VETERINARY STUDIES:

PAP-8E Protocols for mice, rats, rabbits, dogs, non-human primates * Study Specific Reagents * Mechanism for System Performance Verification, Operator Proficiency 

 

QUALITY SYSTEMS:

Bio/Data Corporation is licenced as a manufacturer and distributor by the USFDA, and other countries' regulatory agencies.

All products are developed and manufactured at the Horsham (PA) facility

Bio/Data Corporation is an ISO 13485 registered company