Investigational New Drug (IND) Studies | Preclinical Development | Charles River

accelerating IND study timelines 

In response to the evolving needs and expectations of our clients for accelerated IND timelines, Charles River has adopted new standardized reporting timelines. We now offer a fully compiled, audited draft report at 10 weeks post-necropsy for studies up to and including 13 weeks of treatment across all Charles River preclinical facilities. With these globalized processes optimized, a typical IND-enabling program conducted at Charles River is on an accelerated timeline, where all required final reports are delivered at a maximum of 26 weeks from test article receipt (given standard program parameters). This includes allotted time for analytical and bioanalytical method development and validation, repeat dose toxicology in-life and reversal phases (in this example with treatment up to 28 days with a 28-day recovery), standard safety pharmacology battery and genetic toxicology tests.

For your IND guide and full access to our accelerated reporting timelines, including a full-size Gantt chart, please log in to The Source. If you are not a member of The Source, our new online scientific and educational information center, please click here to register. 

Gantt chart

 

For more information about our preclinical capabilities, contact us at askcharlesriver@crl.com.

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For more information, contact us at:

+44 (0) 1875 614545
askcharlesriver@crl.com

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Scientist I Wilmington, MA, US

Charles River Laboratories, Inc.