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Lactation studies

Trusted expertise for complex lactation research

The generation of reliable lactation data is essential for understanding drug transfer into breast milk, supporting regulatory requirements, and enabling informed treatment decisions for breastfeeding women. 

Successful lactation studies require effective participant recruitment, strong retention, scientific rigor, and regulatory confidence. Our proven experience in lactation research, combined with participant-centric study design, helps sponsors generate high-quality data while maintaining study timelines and minimising burden on mothers.

With one of the most experienced lactation research teams in the industry, ICON has completed multiple lactation studies across a range of therapeutic areas and study designs. Our Salt Lake City Clinical Research Unit (CRU) offers access to a highly engaged participant population, flexible study operations, and specialised equipment designed to support successful study execution. 

Delivering results in lactation research

  • Proven lactation study experience:  Nine lactation studies in the past three years
  • Participant-centric study design : Studies designed around the needs of lactating mothers, with flexible scheduling and home visit options for dosing and breast milk collection to minimise participant burden
  • Regulatory and scientific expertise: Guidance on FDA- and ICH-aligned study design, pharmacokinetic assessments, and infant exposure modelling, helping sponsors navigate regulatory expectations and generate robust evidence to support development programmes

Industry-leading recruitment capabilities

Our recruitment team combines deep expertise with access to a large proprietary participant database, including more than 14,000 women who meet key demographic criteria for lactation studies. Located in a region with one of the highest breastfeeding rates in the United States, we are well positioned to support rapid and reliable participant enrollment. Using targeted recruitment strategies and real-time performance tracking, we consistently exceed industry enrollment benchmarks while maintaining visibility into recruitment progress. 

Specialised clinical infrastructure

The postpartum period is an important period for the mother-baby bond which impacts long-term social-emotional development. ICON encourages mothers to bring their babies for any in-house stays needed for the lactation study. During these stays the CRU provides the mothers and their infants with private accommodation and facilities such as a crib. 

Participants are provided with dual electric breast pumps and collection supplies, while experienced lactation study teams ensure samples are handled using validated refrigerated and frozen storage processes (-20°C and -80°C) to maintain quality, integrity, and regulatory compliance.

The ICON advantage

Our approach combines operational flexibility, scientific expertise, and a deep understanding of the unique needs of breastfeeding mothers. By designing studies around participants while maintaining rigorous scientific standards, we help sponsors:

  • Accelerate enrollment and reduce screen failures
  • Improve participant retention and study completion rates
  • Generate high-quality breast milk pharmacokinetic data
  • Reduce operational and regulatory risk
  • Support product labeling and evidence-based prescribing recommendations
  • Deliver lactation studies on time and with confidence
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