GLP & SEND Reporting

GLP and SEND Reporting

Built on more than 50 years of experience, Sinclair Research offers fully GLP-compliant  research capabilities to support biopharmaceutical, animal health and medical device development programs. Sinclair offers expertise in all research models and is a pioneer in miniature swine research.

An established leader in fully GLP-compliant services, Sinclair offers Sinclair is fully GLP-compliant and our personnel have many years of GLP experience. Sinclair has an independent Quality Assurance Unit that audits the facility, protocols, in-life critical phases, raw data, and reports for GLP studies. Sinclair is inspected by the FDA on a regular basis.

Sinclair Research Center is proud to offer GLP data sets in SEND (Standard for Exchange of Nonclinical Data) format for submission to the FDA, which supports faster and better quality regulatory review. We use Xybion’s suite of programs, notably Pristima® and SEND Savante™ for quality data acquisition, reporting and dataset creation.

Our dedicated study data team works in-house to ensure your data, from collection to submission, is accurately converted to SEND format. Systems are validated and have been assessed for 21 CFR Part 11 compliance. Data capture using the Xybion suite of programs allows Sinclair to provide cost effective and compliant management and oversight of studies.

Why partner with Sinclair Research?

As one of the largest nonclinical CROs in North America, Sinclair Research’s scientific and technical expertise can provide you with the fully GLP-compliant services you need, the data you expect, and the customer experience you deserve! Contact our team to discuss your upcoming research and meet with our scientific experts to discuss how to reach your next development milestone.

Our GLP-compliant research utilizes the following
data capture and SEND dataset creation systems:

  • Pristima® Version 7.1 or newer
  • SEND Savante ™ 7.4.0 BUILD 16

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