Study Monitoring

Xyzagen’s scientists and monitors provide knowledgeable and detailed oversight of your nonclinical studies. Based on our extensive contract research organization (CRO) experience, we understand the complex details and timing of program critical and in vivo studies required by the science and the regulatory agencies. Our monitors and scientific staff work with our senior consultants and management to bring an understanding of your specific scientific and regulatory needs to the daily management of your preclinical program.

We offer

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Xyzagen FORMULATION DEVELOPMENT​

Nonclinical Study Management and Monitoring

Protocol development

Bid solicitation and laboratory selection

Data and report review

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Nonclinical Project Management

ON-SITE STUDY MONITORING

preparation of study monitoring reports

Development and maintenance of timelines and budgets for preclinical programs

Phase 1 Study Monitoring

A large number of phase 1 units offer also bioanalytical support. In the case of bioequivalence studies for ANDAs this approach is a very logistics efficient approach. However, this leads to a problem that traditional trial monitors are not capable of monitoring the bioanalytical component. Xyzagen’s scientists and staff are experienced in Phase 1 trial monitoring and the technical monitoring of the bioanalytical lab

We offer

Phase 1 Bioanalytical Monitoring
Phase 1 Unit Monitoring