Clinical Trial Support

With its broad breadth of service platforms and industry most experienced scientific team, Avance Biosciences offers our clients worldwide custom solutions to support their preclinical safety studies and clinical trials.  Whether you are looking for a reliable genetic testing partner for patient stratification or an experienced GLP qPCR laboratory for your gene therapy safety study, Avance Bioscienes can offer you our experience and expertise to ensure the success of your project.  We are committed to full adherence to GLP and GMP regulations and guidelines promulgated by US FDA (21 CFR Part 58 and 21 CFR Part 210/211), OECD, European Commission (EC), and Japanese agency, as applicable to the service provided.

Services

Application Description
Genetic Testing for Clinical Trials Avance Biosciences offers Sanger sequencing, qPCR, and other  “Gold Standard” methods for clinical trial samples (such as for SNP detection) or to validating assays to be used in clinical trials.
Validation of in vitro DNA-based Diagnostic Devices Sanger sequencing is utilized as the “Gold Standard” to validate nucleic acid based diagnostic tools/devices for PMA or 510K clearances.
Companion Tests Validation With its strong experience in DNA-based assay development and validation, Avance Biosciences offers a series of “Gold Standard” methods to help validating companion tests for Premarketing approval.
Gene Expression Analysis The expression levels of specific genes, Small RNA, Micro RNA, and any RNA species of different samples are analyzed using Relative Quantitation Assays predesigned by Applied Biosystems Inc. or custom designed.
SNP Genotyping by Real-Time qPCR Avance Biosciences assesses single nucleotide polymorphisms (SNPs) by conducting allelic discrimination assays using TaqMan® probes. Assays may be predesigned by Applied Biosystems, Inc. or custom designed using ABI’s SNP Genotyping Assay Design Software.
Custom Assay Design and Validation Target specific assays of any species are routinely designed, qualified or validated at Avance Biosciences.
Validated Assay Transfer and Testing Technology transfer of clients’ validated qPCR assays to Avance Biosciences for the purpose of testing a large number of samples in a cost-efficient way

Experience

Our experienced technical and quality staff have worked together for more than a decade offering GLP/GMP level genomic services for regulatory submissions.

  • Experienced with GLP/GMP project management
  • Experienced with international clients
  • Experience with all major pharmaceutical companies
  • Strong technology and assay transfer capability
  • Assay and project reports readily accepted by regulatory authorities
  • Facility frequently audited by clients

Compliance

Our quality system is well designed and maintained to meet the most stringent requirements from regulatory authorities worldwide.  This system is well tested in many on-site client quality audits and is highly accommodated by our customers.

  • cGMP compliance per FDA 21 CFR Part 210/211
  • GLP compliance per FDA 21 CFR Part 58
  • 21 CFR Part 11 compliance
  • Methods/assays validated per ICH guidelines
  • Regularly equipment maintenance and calibrations.
  • Routine internal quality audits and in-process audits
  • Documented change control and review program
  • Incident report, OOS, and CAPA program
  • Vendor assessment program and raw material quarantine and release program
  • Optimized laboratory design and rigorous cross-contamination prevention measures
  • Ongoing employee training and proficiency test program
  • Complete documentation of laboratory procedures
  • Project archive and storage procedures

When you partner with Avance Biosciences, we give you undivided attention, share our experience and knowledge, and respond to your needs in a timely manner. Contact our technical staff to discuss how we can support you in your clinical trial project!

Contact Us

TaqMan® is a registered trademark of Roche.