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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 divided into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging and Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Biomarker Laboratory. Our eHealth segment comprises an eClinical Solutions Division along with Safety and Regulatory Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

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