InfantRisk Center: We specialize in lactation research
Clinical Lactation Research Partner for Industry
Clinical Lactation Studies for Drug & Biologic Sponsors
The InfantRisk Center designs and executes clinical lactation studies aligned with FDA's Clinical Lactation Studies: Considerations for Study Design guidance — generating the human milk data your Lactation labeling and postmarketing requirements demand.
Why sponsors run lactation studies
Human milk data is now an expectation, not an afterthought
Under the Pregnancy and Lactation Labeling Rule, the Lactation subsection of your label needs real human data — the amount of drug in milk, its effect on milk production, and the risk to the breastfed infant. FDA increasingly asks sponsors to produce it.
The bottleneck we remove
Studies fail on recruitment. Ours don't.
FDA notes that lactation studies frequently fail because sponsors cannot identify potential subjects — often terminating after substantial start-up costs.
The InfantRisk Center is the trusted source of breastfeeding medication information for tens of thousands of nursing mothers. Our apps and national call center connect us directly to women taking the exact medications you need to study — so we recruit and finish. We have never terminated a study for lack of subjects.
Direct-to-patient reach. MommyMeds & InfantRisk apps put us in front of 20,000+ nursing mothers every month.
National call center. 3× the lactation-exposure call volume of U.S. Poison Control Centers combined.
Human Milk Biorepository. A growing, nationwide bank of deidentified milk samples in dedicated research freezers, ready for drug analysis.
Enrollment certainty. A national network that protects your start-up investment and your timeline.
Study designs we execute
The full range of FDA-described lactation study designs
We design each study around your drug's pharmacokinetics and dosing — from a simple milk-only screen to a full mother-infant pair study — using the study types and sampling strategies described in FDA's guidance.
HOW WE WORK WITH YOU
Engagement models to match your program
Turnkey execution, sample generation for your own analysis, or lower-touch consultation, customizable to any level, working directly with pharma or alongside your CRO.
Interventional trials
Full turnkey studies at the TTUHSC Clinical Research Unit, with IND support, or we run the trial and deliver samples to you for analysis.
6–24 months
Non-interventional
Observational "registry"-type data and direct milk-sample collection from women already taking the medication of interest.
3–18 months
Pediatric safety
Any design augmented with long-term observation of pediatric events in exposed infants.
12+ months
Consultation
Study-design and lactation-pharmacology expertise through our Sponsorship program for lower-touch needs
Flexible
CONTACT US
Start a conversation
Tell us about your drug and your regulatory need — our research team will follow up directly.
Correct interpretation. Having run more medication-in-lactation studies than any lab in the world, we know how this data behaves. Other labs can produce the numbers but draw the wrong conclusions — our experience is in how the data gets read.
Independent validation. We review and validate lactation data produced by other labs, so you can trust the analysis behind a submission.
Specialty depth. Through TTUHSC we bring in clinical experts in the disease state at hand, alongside our lactation-pharmacology core.