Cardiometabolic Diseases

How new medicines effect prevention or treatment

CRS offers exceptional research competence in obesity, metabolic syndrome, diabetes, and cardiovascular disease with a huge scope of well-established and up-to-date clinical investigations for the pharmacodynamic evaluation of new molecules. These methods range from a broad spectrum of metabolic clamp investigations and tests, over several biomarkers, up to high resolution imaging techniques and tissue biopsies.

We hold exceptional competence in pharmacodynamic assessments of metabolic diseases under new medicines

The dramatic growth of obesity in association with its metabolic, cardiovascular, and mutagenic comorbidities has inspired basic and clinical research and increased our understanding of the molecular pathways driving these diseases.

CRS is a highly experienced, strong, and reliable partner in the early and advanced clinical assessment of investigational drugs or medical devices for the prevention or treatment of obesity, metabolic syndrome, diabetes mellitus, non-alcoholic fatty liver disease (NAFLD), etc., – in brief: in the indication of cardiometabolic and cardiovascular diseases.

Through our in-house medical and regulatory specialists, CRS offers a comprehensive service starting from preparing a powerful and reliable study design, throughout a high quality conduct of the trial in our own or external study sites, up to data management, statistical analysis and medical writing. Our continuous efforts to grow our volunteers and patients database, as well as an established network of collaborating supportive medical specialists and office based doctors are the guarantee of a powerful study recruitment.

Our experienced scientists can provide particular support in the preparation of manuscripts to be placed in high ranked scientific journals, or for the presentation at international scientific meetings. Several hundred papers published in international peer reviewed journals are proof of our outstanding expertise in this therapeutic area.

Below please find some details about the disease course and about our huge armamentarium of pharmacodynamic assessments:

Obesity, metabolic syndrome, and diabetes mellitus are complementary components and major drivers of a worldwide growing pandemic of cardio, vascular, and metabolic morbidity and mortality. In 2014 nearly 2 billion adults were considered overweight and more than 600 million were found obese presenting with a Body-Mass-Index (BMI) > 30 kg/m².

Decreasing physical activity, sedentary lifestyle, unhealthy food consumption, stress, and a lower socioeconomic status were identified as the main components associated with obesity and the metabolic syndrome. An increase in intraabdominal visceral fat mass and especially accumulation of ectopic and perivascular fat in organs such as liver, skeletal muscles, heart, and kidneys are predictors of several comorbidities such as non-alcoholic steatohepatitis (NASH), diabetes mellitus, cardiovascular or renal complications. Numerous cytokines released from visceral adipocytes trigger inflammation, lipid disorders, an increase in blood pressure, and a decline of insulin sensitivity. All together expediting the risk for myocardial infarction, stroke, cardiovascular death or cancer.

  • Oral / Intravenous Glucose Tolerance Assay
  • Continuous Glucose Monitoring
  • Standardised Test Meals
  • Glucose Clamping
  • Insulin Resistance Measurements
    (HOMAIR; Quicki Index; i.v.-Glucose Tests; Glucose Clamp (M-value)
  • Alpha and Beta Cell Function Assessments
    (Arginin-Test; Glucagon-Test)
  • Endocrinological Tests
    (Dexamethasone; ACTH; LH-FSH; TRH; Pentagastrin)

  • Intima Media Thickness (IMT)
  • Flow Mediated Dilatation (FMD)
  • Skin Laser Doppler
    (Acetylcholin Iontophoresis, Nitric Oxide Iontophoresis, Postischemia)
  • Laser Speckle Imaging
  • Arterial Tonometry
    [Pulse Wave Velocity – PWV; Augmentation Index (AiX@75)]
  • 24 Hour Blood Pressure Monitoring
  • 24 Hour Holter Monitoring
  • Retinal Microvascular Function
  • Retinal Endothelial Function (Flicker)

  • Liver Elastography (FibroScan®)
  • MRI (Liver; Fat; PDFF)
  • Body Fat Distribution (DEXA)
  • Tissue Biopsies
    Subcutaneous adipose tissue; Muscle; Liver

We are consistently extending our medical diagnostic armamentarium to offer highly reliable scientific methods for the assessment of pharmacodynamic effects of new treatments.

In recent years, important breakthrough medical device techniques were achieved in the area of drug application and biosignal monitoring. CRS has a profound regulatory and clinical experience in the performance of medical device studies.

Studies performed at CRS cover the assessment of drug application devices, point of care testing, continuous biosignal monitoring, as well as the implantation of subcutaneous application systems or biological sensors.

REACHING OUT IS EASY AND FAST – LET’S TALK

Martin Mulder

Senior Vice President Corporate & Business Development


LET’S TALK BUSINESS

BACK TO OVERVIEW

CRO Leadership Awards 2019

CRS is proud to be recognised again by pharma companies worldwide as a leading CRO with regard to: capabilities, compatibility, quality and reliability.

European Biotechnology Guide

Find CRS’s company profile in the European Biotechnology Science Industry Guide, volume 9 2019.

EcoVadis – CSR Rating

Based on the CSR rating by EcoVadis in 2022 CRS has been granted Silver Recognition Level.