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Quality Assurance

Bioclinica Laboratory is committed to providing clients with reliable and reproducible analytical methods for biomarkers while safeguarding patient care and achieving the highest standards in laboratory quality. Using a convergence of analytic pre-study and in-study validation across a wide range of assay formats, we deliver biomarker feasibility assessments and evaluation in a regulatory compliant environment. Our rigorous quality control combined with our experienced laboratory services translates into efficient analysis of biological samples from your clinical trials. All of Bioclinica Lab's procedures and training programs comply with current regulatory requirements.

Our key business operations are governed by a comprehensive Quality Management System implemented to reflect industry standards and best practices for study management, software development, IT infrastructure management, documentation, QC assessments, training, and CAPA.

The Molecular Markers Database System (MMDS)
The Molecular Markers Database System (MMDS) was developed by Bioclinica Lab for handling clinical trial data, from sample information through data analysis and transfer. The MMDS, based on an Oracle database and fully 21 CFR Part 11 compliant, supports each new study and provides a consistent user interface, regardless of the size or complexity of the clinical protocol. It has components for study team members to perform protocol information entry, sample receipt, data query, analysis, reporting, and other functions related to study data. Our analytical instruments and automated platforms are connected to the MMDS, and our data security procedures assure integrity, protection and backup of study data. Bioclinica Lab has a dedicated IT department that is responsible for the development, improvement, maintenance and validation of the MMDS.

As part of validation and QC, Bioclinica Lab regularly participates in Proficiency Testing of molecular markers by the College of American Pathologists (CAP) and the UK National External Quality Assessment Service (UK NEQAS). We continuously monitor and improve our quality to be in compliance with current regulatory guidelines.

ADDITIONAL RESOURCES

Biomarker Menu

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Molecular Marker Laboratory Services

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Alzheimer's Disease Biomarker Lab Expertise

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Leader in Clinical Trial
Management Solutions

Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

Attending CBI's IRT conf? Catch 10/27 @bioclinica GSK talk on bens of sponsor controlled #IRT. Here's the core tech… https://t.co/zFiQswIQFb
bioclinica (10 hours ago)
RT @Xtalks: #Cardiovascular Imaging for Monitoring Safety: Visualizing Outcomes @bioclinica https://t.co/5osqBkDFKm
bioclinica (10 hours ago)
Want stellar imaging acquisition & assessment in your #clinicaltrial ? Get tips in @bioclinica 's Tim Crowe's blog https://t.co/hzbV3Cmlyc
bioclinica (Yesterday)
Will you be at CBI's IRT conference in Philly Oct 26-27? https://t.co/C7vuxwnCH7
bioclinica (Yesterday)
Must-see live webinar packed w info for those who want to learn about CV safety from the leading experts.… https://t.co/4y5OaUNeIk
bioclinica (5 days ago)
Right at home near our Princeton offc is where to catch us talking all things #RTSM Oct.18-19.… https://t.co/h1OSFwiSFi
bioclinica (5 days ago)

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