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Sample Management

Proper sample management is a vital aspect of today's clinical trials.

  • Chain of custody is maintained throughout the complete life span of each sample
  • Your samples are safe and protected in our State-of-the-art cryopreservation and storage system. Our Brooks BioStore™III Cryo -190°C Storage System ensures specimen integrity, and accessibility for prompt retrieval. Our biorepository also preserves cell viability, functionality and chain of custody for regulatory compliance.
  • Storage services and fail-safes
  • Cold storage
    • Ultra low-temperature storage (-70C to -80C)
    • Liquid nitrogen vapor phase storage (-190C)
    • Backup generators and redundant HVAC systems
    • Temperature monitoring system for all freezers and refrigerators
    • Redundant whole building and biorepository security systems with 24/7 support
science vials

Project Management

Your dedicated Project Manager provides seamless communication while acting as your primary study contact. As a member of your team, our Project Managers find solutions to facilitate your project objectives (scope, resources, time, budget, quality and satisfaction) from contract signature through project closure. To address questions and requests promptly, your Project Manager will liaise between both external and internal project teams. Your Project Manager takes the scope of work objectives for all phases of the trial to join them with systematic efficiencies to help facilitate the success of your project.

  • Capable of rapid study set-up to fulfill critical timelines
  • >250 studies performed in the last three years spanning Phase I through Phase IV testing supported by project management with global clinical trial experience
  • Adherence to contracted budgets and turnaround times*
  • Collaboration with sponsor, CRO, clinical sites and others at the direction of the sponsor

In cooperation with your Project Manager, a dedicated project Data Coordinator can provide a number of services to help accelerate and simplify your secure data transfer and laboratory reporting needs. Each study is unique, and we want to ensure your data is received in a format that complies with your specific needs. We support standard electronic data transfer formats (EXCEL, CSV, ZIP) in addition to non-standard data transfer formats (SAS, CDISC).

project manager

Data Management

Viracor Eurofins provides a dedicated Data Manager in conjunction with a dedicated Project Manager to provide our clients with a complete package, integrating lab work with data delivery. Each client is unique in their needs. We cater to clients with very specific and detailed data requirements as well as clients that would like us to provide our standardized data delivery.
 
The final Viracor Eurofins data product follows industry standards for client specific formats, CDISC or the Viracor standardized format. Data can be delivered as an ASCII flat file, SAS dataset and SAS Transport file.
 
We make it our business to make sure the data delivered is thoroughly reviewed and QC’d ensuring a seamless process for our clients to prepare their final product.

data manager

Quality

Commitment to Quality

Viracor Eurofins BioPharma Services’ commitment is to become a trusted partner to our clients ensuring sample and data integrity. We constantly strive to assure facilities, equipment, personnel, methods, practices, records, and controls are in conformance with regulations.

 

Viracor Eurofins BioPharma Services operates its facilities in compliance with:

  • Applicable Good Clinical Laboratory Practice (GCLP) standards
  • 21 CFR Part 11 where applicable
  • Applicable International Committee Harmonization (ICH) Good Clinical Practice (GCP) E6
  • CAP/CLIA

 

Viracor Eurofins BioPharma Services follows several guidance documents and white papers including, but not limited to:

  • Guidance for Bioanalytical Method Validation, May 2018
  • Data Integrity and Compliance With Drug cGMP Questions and Answers Guidance for Industry, December 2018
  • Guidance for the Immunogenicity Assessment for Therapeutic Protein Products, January 2019

 

Commitment to Sample and Data integrity

It is our mission to provide reliable and defensible data. Our ability to provide review of procedures, training, facilities, methods, equipment, systems, data and reports in a timely manner is what sets our QAU department apart. To meet our quality standards and those of our clients, we regularly monitor Key Performance Indicators (KPIs). These are readily displayed for all employees to see so that quality is always on their minds.

 

Quality Team

The Viracor Eurofins BioPharma Services quality team specializes in Pharmaceutical, BioPharmaceutical, and Biomarker activities with over 20 years of industry experience. The QAU and lab quality departments work closely together to ensure the quality of the results from constant monitoring of training, environmental conditions, equipment needs, and CAPA effectiveness.

 

Certificates

CLIA

CAP

NY

 

Links

Society of Quality Assurance https://www.sqa.org/

American Society for Quality https://asq.org/

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