Conducting clinical trials in children can involve many clinical, scientific, technical and logistical challenges. Most, if not all, pediatric conditions can be classified as rare diseases, and drugs developed for pediatric indications usually fall within the definition of an orphan drug. The comparatively low numbers of pediatric patients can pose significant logistical challenges for enrollment. This often necessitates use of multiple trial sites, across wide geographic regions, a feature of pediatric trials that requires careful planning, coordination and management in order to ensure the timely completion of studies and quality data.
KinderPharm has aligned with Worldwide Clinical Trials to create KinderPharm-Worldwide.
“Combining our talent with cutting edge approaches to pediatric trial design through the use advanced computer-based modeling and simulation together with access to a global clinical trials infrastructure is of immense benefit for our clients and patients alike.” Martin Graham, CEO, KinderPharm
Phase I-IIA Clinical Trials
Whether you’re testing dose ranges in healthy volunteers or cancer patients, conducting pilot studies to investigate dose-response or dose frequency, or pursuing numerous other safety and efficacy characteristics, our clinical experts can help.
Phases I–IIa are critical for determining next directions as well as satisfying regulators and reassuring stakeholders. Our significant early-phase experience and teamwork culture provide consistency and continuity. Dedicated staff keep their skills current with ongoing training.
Worldwide’s clinic in San Antonio, Texas, was designed specifically for early-phase trials. It is ICH-GCP* compliant, accommodates 300 study participants, and includes all essential facilities for storing and dispensing study drugs and maintaining investigator site files and study data. Specimens are seamlessly transferred for analysis to our bioanalytical lab or a lab of your choice.
Phase I-IIA Therapeutic Portfolio
- Alzheimer’s disease
- Anxiety disorders
- Bipolar disorder
- Cardiovascular disease
- Mild cognitive impairment
- Parkinson’s disease
- Women’s health
*ICH-GCP: International Conference on Harmonisation: Good Clinical Practice
Phase IIB – III Clinical Trials
Worldwide Clinical Trials has customized phase IIB-IIIB clinical trial services, which can be deployed on a stand-alone basis or as a full-service solution, creating scalable, flexible programs based on experiences with other programs ― across therapeutic areas — that help avoid pitfalls. Phase II-IIIB is often scrutinized for opportunities to shorten timelines or reduce levels of investment by dosing across the fewest number of patients with disease characteristics to optimize signal detection. Proceeding with Phase II programs that neither define a clinically useful dose range nor patient characteristics predictive of response enhances the possibility of Phase III failure.
Planning Early for Market Success
The planning process for commercialization now begins in the early stages of most clinical investigations. We can help you supplement or complete trials to better define product characteristics, investigate quality of life or healthcare utilization issues, explore marketing strategies which acknowledge differences in standards of care internationally, or plan for Phase IV evaluations which are either mandated as part of post-marketing commitments, or envisioned as part of a line extension.
Global Experience, Local Expertise
In today’s highly international clinical trial environment, an ability to use regional differences in standard of care and thus improve patient access to clinical trials is an asset for any CRO. Because of our highly differentiated geographical footprint, characterized by “in country” clinical experts who are familiar with language, culture, and standards of care, our ability to operationalize clinical studies for “difficult to find, difficult to treat patients” is exceptional.