Program Strategy and Design

The identification and design of the most cost-efficient, timely, and appropriate preclinical development program provides reassurance of the relevance and applicability of the data to the intended clinical trial protocol or product registration. Charles River’s comprehensive global consulting team can provide scientific and regulatory insight for both program strategy and design for INDs/CTAs, IDEs, NDAs/MAAs, and BLAs. This service is available to all of our clients and can be tailored to meet your needs at every stage of product development.

• Scientific direction
• Program strategy
• Needs/gap analysis
• Risk assessment
• Program/study design
• Pre-IND/IND or CTA/MAA text review
• Integrated summaries for INDs/CTAs or investigator brochures
• Timing layout, project scheduling and placement
• Regulatory advice

What's New

Charles River and DSI to Co-Host Second Annual Safety Pharmacology Symposium and Workshop

Charles River Preclinical Services Announces Dates of 15th Annual Biotech Symposium

On-line Registration for the 2008 Charles River Short Course Now Available

All news items

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