Clinical investigations & performance studies for in vitro diagnostics

DHS supports CROs conducting and finalising clinical and analytical performance evaluation studies of IVD devices. Not only do we function as a study site but also perform laboratory analysis at our laboratory, located on-site of Europe’s largest teaching hospital – the Charité Universitätsmedizin (ranked in the World’s Top 10 Best Hospitals of 2023).  

We act as the Investigator for your study

Our duties as an investigator include:

  • Detailed preparation for the study including document and device review;
  • Preparing and applying for ethics approval, including translation from English to German for the local ethics committee;
  • Working together with local practices and centres, including the Charité Universitätsmedizin, biobanks, and diagnostic laboratories for attaining samples and participants for prospective and/or retrospective studies;
  • Marketing strategies for recruiting study participants;
  • Recruiting study participants at our study site through interviews;
  • Performing the study in accordance with the study plan;
  • Correct and thorough documentation;
  • Performing laboratory analysis on point-of-care devices;
  • Performing validation studies on kits, e.g., PCR, ELISA, ECLIA.

We work according to ISO 20916:2019

The ISO 20916:2019 – In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice. This document defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic medical devices (IVDs).

All studies performed at the DHS are conducted in accordance with the requirements laid down in the ISO20916:2019 standard.

We can obtain ethics approval for your study

All prospective clinical studies involving human subjects are conducted in compliance with ethical standards. Prior to commencing any clinical performance studies, ethics approval is obtained. We work closely together with a Clinical Investigator (Physician).

We perform laboratory analysis for your IVD medical device

Our laboratory works in accordance with RiliBäk, the Guidelines (“Rili”) of the German Federal Medical Council (BÄK) and Good Laboratory Practice (GLP). Currently, we have applied to the DaKKS for ISO15189, which will be approved in the next few months.

We can write your Clinical Performance Study Report (CPSR)

The CPSR contains complete details about the clinical performance study protocol plan, results, statistical analyses, and conclusions, including performance evaluation.

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