Problem:

A customer needed a specialized assay developed involving the quantitation of menstrual blood on feminine hygiene products. Essential to the success of the program was the ability to handle the complicated logistics involving more than 100 clinical sites, 85,000 samples and rapid turn around of reporting data within 7-10 days.

Proposal:

A comprehensive strategy was outlined, including a wide variety of products to be validated.

Outcome:

A seamless bioanalytical program was established that included, shipping clinical supplies to sites, creation of customized training material and manuals for sample collection and analyses, consultation with the FDA and international regulatory agencies and the construction of specialized databases and web-based portals for data reporting.

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