Turnkey Clinical Program Support with a Unique Assay
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 over 100 clinical sites, 85,000 samples and rapid turn around reporting data within 7-10 days.
Proposal:
A comprehensive strategy was outlined, including a wide variety of products tobe validated.
Outcome:
A seamless bioanalytical program was established including shipping clinical supplies to sites, creation of customized training material and manuals for sample collection and analyses, consultation with FDA and international regulatory agencies and the construction of specialized databases and web-based portals for data reporting.
