Statistical Support for GLP Studies

Quantics is the only independent GLP-certified statistical provider

Quantics is an MHRA GLP-accredited Test Facility. Our expert team of statisticians provide GLP statistics for projects of any size or scope, from ecotoxicology to food safety and beyond.

We work as a test site under a multi-site arrangement, and appoint a PI for the study phase work.

Quantics has years of experience in providing statistical support for GLP studies, including:

  • Toxicity & Mutagenicity
  • Environmental Toxicity for Terrestrial and Aquatic organisms
  • Bioaccumulation & Pesticide residue
  • Non-clinical safety for pharamaceuticals, food additives, and more!
GLP-Certified-Icon

Quantics can provide bespoke analysis as well as routine statistical analysis of toxicology and ecotoxicology tests for contract testing laboratories and research organisations using fully validated analysis programs for all the standard OECD / ICH tests.

The common OECD guidelines can be accessed here: OECD guidance documents.

I just wanted to send a brief note to thank you for everything you did to help us with this regulatory response. Your excellent communication with us, timely provision of draft output tables, and a very high quality draft report that required only minimal input were key to our success. This was indeed a challenge to deliver under such a tight timeline, and you even managed to deliver ahead of schedule. We really appreciate your collaboration with us and your outstanding contribution to this team effort – thank you!!

Kevin LeinerSyngenta

I would like to thank you again for the great work you did for this SR & meta-analysis. This is a great achievement for Danone to get this work published in a good journal of gastroenterology

Denis GuyonnetDanone

Quality Mangement

Quantics’ robust, MHRA-approved quality management system ensures that we can support your project at every stage, whether that’s early development or approaching regulatory approval. We have extensive experience preparing GLP statistics for regulators in the UK, US, and around the world, meaning we can advise on study design for any set of regulations or guidances.

Our GLP certificate can be viewed online here

365 Days

Providing GLP & GMP statistics all year round

Same Day Reporting

Same day draft reporting for routine GLP and GMP statistical work

QA Report

Ready for use QA report within 2 days for all GLP and GMP routine work

QC Check

Guaranteed 100% QC check of every result

Customised Service

Fast, reliable service customised to your needs

Process Support

Full process control support / trending if required

Get in touch!

Want to find out more about how Quantics can support your GLP study? Book a 30 minute discovery call with our Customer Experience Manager, Andy Rust, using the form below!

OECD Guidences

OECD ref Title Latest guidance Link to guidance
201 Algal growth inhibition 2011 201 guidance
202 Daphnia acute immobilisation 2004 202 guidance
203 Fish acute toxicity 1992 203 guidance
207 Earthworm acute toxicity 1984 207 guidance
208 Seedling Emergence and Seedling Growth 2006 208 guidance
209 Activated sludge Respiration inhibition 2010 209 guidance
210 Fish Early life stage toxicity 2013 210 guidance
211 Daphnia reproduction 2012 211 guidance
212 Acute Fish Embryo 1998 212 guidance
213 Acute Honey bee 1998 213 guidance
214 Acute Honeybee (Contact) 1998 214 guidance
215 Juvenile Fish Growth 2000 215 guidance
216 Soil Nitrogen Transformation 2000 216 guidance
217 Soil Carbon Transformation 2000 217 guidance
218 Sediment Chironomid toxicity 2004 218 guidance
219 Water Chironmid toxicity 2004 219 guidance
221 Lemna growth inhibition 2006 221 guidance
222 Earthworm reproduction 2004 222 guidance
225 Sediment water Lumbriculus 2007 225 guidance
228 Determination of Developmental 2016 228 guidance
232 Collembolan Reproduction 2009 232 guidance
235 Chironomus sp 2011 235 guidance
238 Sediment-Free Myriophyllum Spicatum 2014 238 guidance
239 Water-Sediment Myriophyllum Spicatum 2014 239 guidance
305 Bioaccumulation in fish* 2012 305 guidance

Our Latest Blogs

May 13
Apr 22

USP 1033: A Validation Example

In the previous parts of our series covering the latest draft version of USP <1033>, we examined the goals of a bioassay validation study and the basics of accuracy and precision. Then, we discussed Probability of Out-of-Specification (Prob(OOS)) and how this can be used to inform the acceptance criteria... read more →
Mar 11
Feb 25

USP 1033: Bioassay Validation Acceptance Criteria

In the first part of our series examining USP <1033> in depth, we discussed the goals of bioassay validation – specifically, to demonstrate that an assay is suitable for its intended use. Part of this demonstration is a detailed quantification of the accuracy and precision of the assay. We... read more →
Feb 11