Metabolon has invested in developing and implementing internal processes and data governance polices that adhere to U.S. federal and international standards and regulations. Our rigor, established over 20 years, is especially critical for biopharma companies as they prepare data packages to support Investigational their New Drug (IND), Biologics License Application (BLA), and Marketing Authorisation Application (MAA) on the road to FDA or EMA regulatory approval.

We have the most comprehensive assortment of quality certifications among metabolomics providers to meet the diverse needs of our clients. Learn more about our certifications and quality standards:

ISO 9001:2015 – Quality Management Standard

ISO 9001:2015 is an international quality standard focused on maintaining good business practices with an emphasis on continuous improvement and customer satisfaction.

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CAP – College of American Pathologists

Authorized by Center for Medicare and Medicaid Services (CMS) to inspect clinical laboratories and decide on accreditation to CLIA.

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CLIA – Clinical Laboratory Improvement Amendments

These regulations focus on laboratory testing performed on specimens from humans for the purpose of diagnosis, prevention, or treatment of disease, or the assessment of health.

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GCP (ICH E6) / GCLP (WHO GCLP/08) – Good Clinical Practice / Good Clinical Laboratory Practice

GCP standards support the conduct of clinical trials for any IND, BLA or MAA application. The International Council for Harmonisation (ICH) guidelines are focused on ensuring all GCP standards are followed for clinical trials across the globe. GCLP guidelines focus specifically on analytical testing performed on laboratory samples for clinical trials, which are not the focus of the ICH standards.

HIPAA – Health Insurance Portability & Accountability (45 CFR 160, 164)

These U.S. National standards protect individuals’ medical records and other personal health information.

EU General Data Protection Regulation (GDPR) (2016/79)

Data protection and privacy for all individual citizens of the European Union (EU). It also addresses the transfer of personal data outside the EU.

Metabolon incorporates quality control steps at every stage of testing to ensure the highest quality data. Several types of analytical controls are utilized in concert with your study samples to ensure adequate assay and instrument performance. The type of controls used depends on the method employed. Metabolon also incorporates various quality control review steps to detect errors at all stages of data analysis and reporting to ensure the rigor and reproducibility of your study.

“We need to be able to stand behind the data because they are what will allow us to make claims on labels and go to regulators to support that these therapies are working in defined ways.”

– Christopher Ford, Ph.D., Seres Therapeutics

Data Governance provides a plan to ensure data is available, usable, consistent, and secure.

Metabolon is committed to protecting all personal data we receive or collect to prevent misuse and unauthorized access and to complying with applicable data security and privacy laws and regulations. Metabolon’s Data Governance Program exists to establish risk-based safeguards that protect information while not impeding its appropriate use. You can find our full Privacy Policy here: https://www.metabolon.com/legal/

As part of our protection of data, Metabolon complies with regulatory mandates for handling personal data including the Health Insurance Portability Accountability Act (HIPAA), General Data Protection Regulation (GDPR), and California Consumer Privacy Act (CCPA). We have also implemented a comprehensive information security program based on the NIST Special Publication 800-53 Revision 4 that is fulfilled through various policies and procedures alongside physical and logical security controls.

Metabolon’s Data Governance Program

With more than 20 years of experience in metabolite-based biomarker discovery and validation, Metabolon is equipped to assist companies to de-risk decision making and increase the success rate of their research efforts, including drug discovery and development.

Metabolon provides guidance to clients to ensure compliance with regulations and quality standards to support study integrity and high-quality data generation through all phases of the drug discovery and development process, from target selection to biomarker validation. We are here to ensure your study reaches its potential with the highest quality standards. This guidance is essential for biopharma supporting their need to accelerate pipelines and generate quality data for clinical trials founded in improving patient lives and outcomes. Our thousands of published studies, experience with hundreds of diseases and commitment to quality and data protection provide the rigor and confidence you need in your next study.

“Metabolon communicates at all stages, prompting me with the right questions to ensure we have a qualified process,” says Meaghan Sutton Bryant, Vendor Manager at Seres Therapeutics. “Even when we have encountered changes on our end, they showed they can be flexible while still keeping us on time. Communication is key with a vendor to take things off your plate that you do not need to be worrying about.”

Beyond the fact that our labs are ISO 9001:2015 certified, CLIA-certified and CAP-accredited for diagnostic testing on human specimens, our institutional knowledge will guide you through a successful metabolomics study from the start by ensuring your study is properly powered, properly controlled and properly aligned to your research & clinical objectives.  The assay developed at Metabolon for your GCP study may also be available to support your patient testing in your post-approval commercialization phase.

Properly Powered

• Supported by the knowledge of our Ph.D. Discovery and Translational Science experts including our in-house biostatisticians, we begin with a study design to chart the best course for your study.

Properly Controlled

• The quality of your sample is everything and that’s why our team works with you to ensure that the guidelines for handling, storage and volumes are met.

Properly Aligned

• If you want the highest biological insights from your metabolomics study, you need the highest quality metabolite annotation. Our integrated bioinformatics solution makes it possible to efficiently and accurately mine the world’s most biologically relevant, validated metabolomics compound library for every study to ensure consistently reliable results every time. Learn more about Metabolon’s Tier 1 identification workflow.

Learn more about our process that helps to ensure you have the highest quality and reproducible data for your study.