Early Drug Development

CRC staff members have conducted hundreds of Phase I clinical trials in the United States and Europe. CRC has assisted sponsors with preparing protocols and obtaining IRB approval for the majority of these studies. Responsibilities have included site selection and placement of trials at large and small Phase I commercial facilities and academic settings, monitoring of the clinical trials and assurance of subject safety, data analysis and reporting of the data, as well as independent auditing of the site, when required.

Phase I study designs have included:

• First in man
• Pharmacokinetic
• Pharmacokinetic/Pharmacodynamic profiling
• Bioequivalence/Bioavailability
• Assessing age, gender and ethnicity concerns
• Addressing QT concerns
• Dose proportionality
• Drug/drug interaction
• Selected populations: Pediatric and adolescent PK
• Renal- and hepatic-impaired patients

Proof-of-Concept Studies
CRC has particular expertise in the design and implementation of Proof-of-Concept studies, based on extensive experience-based knowledge of pharmacology, regulatory strategy and methodology for assessing therapeutic effect.

Sleep Disorders Studies
CRC has conducted trials in a variety of sleep disorders including sleep apnea and insomnia. In addition, we have worked with wakefulness promoting compounds, assessed the residual affects of sleep promoting compounds and the potential for sedation in compounds designed for other indications.

Pharmacology and Imaging Studies
During the development of certain CNS compounds, it may be advisable to address the question of whether a compound penetrates the blood-brain barrier and, if so, what is the extent of the penetration and where is the compound distributed within the brain. Imaging studies can be powerful tools for answering these questions as well as for contributing to the examination of the relationship between a compound’s pharmacokinetics and pharmacodynamics. In addition to the standard CRO services for these trials, CRC can provide guidance in the development of study design and interpretation of results.