Clinical trials involving drug therapies or surgical techniques to treat endometriosis, uterine fibroids, or menorrhagia require a menstrual blood loss endpoint to confirm efficacy. Two approaches commonly used are a qualitative visual scoring system (pictograms, e.g., PBAC) or a quantitative assessment that calculates hemoglobin conversion to alkaline hematin. Using a quantifiable, evidence-based endpoint actually reduces screen failure rates so you’re enrolling the right patients and positions your drug product or device for unencumbered regulatory approval and commercial success.
Why KCAS? No other lab has as much recent and relevant experience.
- Experience: Since 2006, KCAS has measured 137,129 samples from 5,422 menstrual cycles across 2,131 patients and worked with 166 clinical sites in multiple countries. Our method is validated to the FDA’s Guidance for Validations, has been audited by both device and pharma clients, and the test procedure is filed in the FDA Master File. [Data Updated Dec. 2012]
- Logistics: With this much experience we’ve learned what to do…and what not to do. We consult with you early to design your study and once you have the green light, we facilitate all aspects of the process, including providing all products and supplies to clinical sites, training and support to insure everything goes smoothly.
- Client Service: We make it easy for you. Our project managers and scientists are available 24/7 for questions and support.
- Quality Assurance: KCAS’ Alkaline Hematin assay, instruments, database and analysis software are all validated to provide you with the highest quality results.
- Proven Record: KCAS is the ONLY lab that has supported an NDA submission for a product that met FDA approval and is currently on the market. KCAS is currently supporting several programs for both drugs and devices that are ongoing or under review.
KCAS facilitates all aspects associated with the Alkaline Hematin component of your clinical trial, including:
- Study design consulting and preparing pre-IND and IDE documents related to the assay, including the laboratory manual
- Responding to FDA questions related to Alkaline Hematin
- Site and patient training – either at Investigator Meetings or web-based
- Global core lab services – shipping feminine supplies and kits to clinical sites, navigating Customs requirements for international shipments and making sure samples get back to KCAS for analysis
- Coordinating re-orders and available for on-demand clinical site support
- Preparing the custom data report(s) with the information you need as frequently as you want
- Learn more about KCAS’ Clinical Sample Logistics Department
KCAS continues to explore our proprietary techniques’ application in other areas. Be sure to contact us if you have a novel use for this assay that we can investigate together.
View the Alkaline Hematin Assay Performance Sheet, which provides a summary of the method type, analytical range and stability data.