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Need a clinical trial in breastfeeding mothers?

In the last few years, pharmaceutical firms are increasingly being asked by the FDA to complete Phase III trials on breastfeeding mothers prior to release of their new pharmaceuticals.  This includes many older drugs that may be commonly used in breastfeeding mothers. 


The InfantRisk Center team is highly experienced in clinical trials in breastfeeding mothers and we are available for consults and/or actual management of the clinical trial itself.  Our team has published extensively in the transfer of pharmaceuticals into human milk and we know all the clinical requirements for a good trial in this population that would meet FDA requirements. 


With more than 1.5 million breastfeeding mothers visiting our website annually,  and >10,000 calls annually, we can recruit almost any kind of subject (drug, syndrome, age, etc) your trial may require. 


We have a highly experienced scientific staff with 3 Ph.D., 1 M.D. , numerous Clinical Research nurses, and other highly experienced clinical research staff.  We have a highly experienced Clinical Research Unit and Institutional Review Board available at our University facility.  We have a clinical trial facility available in our teaching hospital, which meets all medical/FDA requirements. 


Please complete the form below and let us know if we can help your organization with a clinical trial in breastfeeding or pregnant mothers.


Thomas W. Hale R.Ph., Ph.D.

Teresa  Baker. MD, OB/GYN

Texas Tech University School of Medicine

Department of Pediatrics and OB/GYN

Last Modified 2 July 2020