Nonclinical development plans and gap analysis

A Preclinical development plan and gap analysis report to support a clinical trial application (CTA / IND) in Europe and or in the USA will:

• Confirm or propose the regulatory classification of the candidate

• Evaluate available study reports and results from preclinical studies on a scientific and regulatory perspective 

• Identify preclinical studies needed to support clinical trials in Europe and or the USA, identify risks and propose countermeasures

• include, for each preclinical study to be performed, a study synopsis describing the study objectives, animal model, test and control articles, treatments and schedules, observations, readouts, terminal procedures and GLP requirements. These synopses will be sufficient to obtain precise quotations from Contract Research Organizations (CROs), identify studies critical parameters and establish a preclinical development schedule and budget.

based on regulatory requirements, available scientific literature and the clinical study synopsis