High value-added services

Clinical Studies and Biobank

Providing solutions from the early stages of product development right through to product manufacturing, including high value-added services such as clinical studies.

Striving for continuous improvement

Keeping our focus on excellent performance to manage time to market and uncertainty. 

Our state-of-the art facilities provide us with the necessary assets and capabilities for our operations to meet our customers’ needs while fulfilling the highest standards of quality, service and efficiency. 

CLINICAL STUDIES

Extensive Expertise in Europe and the USA

We have broad experience in clinical studies to support regulatory approvals and product validation across major markets, including:

  • Clinical studies for CE marking under IVDR
  • Clinical studies for FDA 510(k) and PMA submissions
  • Method comparison and performance evaluations

Comprehensive Clinical Study Management: We design and execute tailored clinical study plans to meet your product needs, supported by:

  • Clinical study managers integrated within cross-functional teams throughout reagent development, ensuring deep product knowledge
  • Strict adherence to Good Clinical Practices (GCP) across all study phases
  • Selection and qualification of clinical study sites worldwide
  • Development of Statistical Analysis Plans
  • Preparation of study protocols, associated documents, and reports compliant with Good Documentation Practices (GDP)
  • Negotiation of contracts and Statements of Work (SOWs) with clinical sites
  • Submission to Institutional Review Boards (IRB) and Ethics Committees (EC)
  • Patient recruitment, sample collection, informed consent processes, and management of leftover samples
  • Electronic capture of all data into Case Report Forms (eCRFs)
  • Site initiation, monitoring (both onsite and remote), and closeout visits
  • Data management and detailed data analysis
  • Clinical accountability for FDA pre-submissions and submissions

 

 

Biobank, a key asset

> 190,000 samples

Our extensive biobank supports all phases of assay development, biotechnology, and innovation by centralizing samples and their associated data.

  • Sample Types: Serum and plasma samples used for product development and verification studies, including sensitivity, specificity, sample stability, cross-reactivity, and matrix effect evaluations.
  • Source Diversity: Samples are sourced worldwide from multiple suppliers such as universities, hospitals, reference laboratories, blood banks, other institutions, and commercial providers, primarily across Europe and the USA.
  • Collection and Compliance: Samples are mainly leftover specimens, with prospective collections also performed. All collections are conducted under IRB/EC approvals and comply with Good Clinical Practices (GCP). Samples are stored frozen at -80ºC in access-controlled freezer rooms.
  • Advanced Sample Management: Our biobank employs dedicated sample management software ensuring security, traceability, data integrity, automatic data import, location hierarchy, and easy-to-use search functionality.
  • Quality Assurance: All Standard Operating Procedures are aligned with best practices in biobanking to maintain sample quality and regulatory compliance.