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ClinFact is a Contract Research Organization (CRO) that can provide extensive support in carrying out clinical trials in which the Medis software is used. ClinFact is a successor of HeartCore bv, a core lab in cardiovascular imaging( 1996-2004). Our threshold for starting clinical studies is low, and continuity and quality is guaranteed at very affordable price levels. We support various sizes of trials, from very small studies through medium-sized studies including hundreds of data sets. Based upon our 25+ years of experience in developing post-processing solutions in medical imaging, we can very well judge what the proper SOPs should be, what is important and what less, and how to minimize any variabilities in the image analysis procedures. Our experiences are extensive in the fields of cardiovascular MRI, QCA, IVUS, OCT, as well as in the field of pulmonology for densitometric analyses of CT data sets. ClinFact has worked with a significant number of partners.

Our services include the typical cardiovascular multi-modality core-lab services:
  • Carrying out phantom studies
  • Quality assurance on QCA acquisitions and analyses
  • Quality assurance on MRI acquisitions, in particular for myocardial classifications
  • Support of protocol design
  • Carrying out quantitative image analyses according to our Standard Operating Procedures (SOPs)
  • Organization of Instructional Courses, e.g. QCLA and QCMR courses.

Over the past years we have carried out data analyses of several major clinical trials, such as the HEBE and EXPLORE MRI clinical trials.

List of Publications

Schuttersveld 9
2316 XG Leiden

P.O. Box 384
2300 AJ Leiden
the Netherlands

Tel. +31 (0)71 522 32 44
Fax +31 (0)71 521 56 17

ClinFact's mission is to provide pharmaceutical and medical device industries with expert medical consulting and efficient high-quality clinical trial management services, by working only with state-of-the-art quantitative image analysis software. Its aim is to reduce the time to market of new medical devices and therapeutic treatments that improve patient quality of life.