Pediatric Studies

Clients benefit from our experience in planning and implementing pediatric Phase I-IV and pharmacokinetic protocols. Our pediatric study teams are experienced in using the validated tools and measurements needed to gather safety and efficacy data from pediatric patients. We have expertise also in pediatric clinical research techniques, such as making oral formulations taste better.

We have managed and monitored studies that use a variety of administration routes, including injections, inhalants, oral solutions, tablets, sprays, topical creams and ointments. 

Unique Approach to Trials

We use a multidisciplinary approach to help our clients anticipate, identify and address strategic pediatric drug development planning issues. We evaluate market potential; identify regulatory opportunities and obligations; develop an overall clinical strategy for new and marketed drugs that incorporates pediatric data; and design studies that take into account the specific challenges of the pediatric population. We also use analyses that maximize data for small sample-size studies as well as identify and facilitate funding and support from the government, industry and nonprofit organizations.

Extended Marketing Exclusivity in the United States

Our experts understand the evolving regulatory environment for pediatric products and the necessity of timely study implementation, data management, analysis and report preparation. We also help clients gain extended marketing exclusivity of drugs in the United States by developing and submitting data packages for the medicines' pediatric use.

Tailored Recruitment

Our recruiters, investigator service teams and clinical staff work together on using integrated media and patient support groups to identify appropriate sites for Phase I-IV protocols. We evaluate patient population requirements; assess sites to ensure the personnel and facilities meet high-quality standards; create a customized plan to access difficult-to-recruit patients; and identify sites with available patient populations.

We have successfully recruited from neonatal to adolescent subjects for protocols ranging from single-dose outpatient studies to complex neonatal pivotal trials.

Reduced Need for Samples

To minimize sample requirements from pediatric subjects, we employ the latest, most sensitive technologies available to provide pharmacokinetic analyses from the bioanalytical data obtained from small-volume samples.