Studien, Kooperationen & Innovationsmanagement

We believe IVDR drives the need for performance studies and market surveillance studies in a clinical laboratory setting. We believe better products can be developed if creators of future IVDs get early feedback from end-users and lean access to clinical samples.

Our customers:

In-vitro diagnostics industry (IVD)
Contract research organization (CRO)
Research institutions (RUO testing)
Pharmaceutical industry
Life science companies

Our offerings
- Study implementation in a variable testing environments (core lab, satellite lab, POCT setting)
- Study design support
- Compilation of IRB application, contact point for all queries for the IRB
- Co-development of new biomarkers with industrial collaboration partners
- Reference method development
- Performance study services in a clinical laboratory setting
- Bio statistical analysis
- Result presentations
- Dedicated project leaders, research scientists and technicians for your project
- Dedicated lab space with different levels of confidentiality
- Recruitment of healthy volunteer and patient groups
- Full spectrum of laboratory diagnostics across 9 diagnostic fields
- Compliance with the current quality specifications
- ISO 20916 compliant study environment
- ISO 15189 accredited laboratory

Common types of studies and collaborations

Performance of studies in regulated environment with frequent audits in our clinical routine laboratory in rooms with restricted access.
Lean and fast access to clinical samples to guide product development planning and planning of performance studies.
System requirements and specifications, assay development, clinical and laboratory assessment, comparative evaluation of novel diagnostic platforms to current methods (“gold standard”), Center of Excellence.
PD- and PK-assessments, patient screening, study-specific routine testing.
Access to clinical experts and end-users of IVDs to deliver input e.g. for design control processes and access to real world data on throughput, clinical performance of current test, cost-structures and reimbursement to help building business models and defining benchmarks for new products.