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Monitoring

Clinical Trials Phase II - IVNon-interventional StudiesMedical DevicesNutritional Supplements

Monitoring – Clinical Trials Phase II – IV

 

We at Winicker Norimed provide you with further measures of quality assurance for your project by performing clinical monitoring.

 

Apart from our in-house CRAs, we have a large number of qualified freelancer CRAs at our disposal. This allows us to operate highly cost-oriented and flexible.

 

We provide you with the following services:

 

  • On-site monitoring
    • qualifications visits
    • initiation visits
    • monitoring visits (risk-based)
    • close-out visits
  • Remote Monitoring
  • Training of the investigational sites for specific study requirements
  • Site management
  • Supporting investigational sites with safety reporting, and support with the management of queries
  • Support of the study sites in preparation for audits and inspections

Your contacts for Monitoring – Clinical Trials Phase II – IV

Sabine Dürnhöfer

Sabine Dürnhöfer

Dipl.-Biol.
Sabine.Duernhoefer@ winicker-norimed.com
+49 (0) 911 / 9 26 80 8730

Dr. Markus Hillgärtner

Dr. Markus Hillgärtner

Markus.Hillgaertner@ winicker-norimed.com
+49 (0) 911 / 9 26 80 8767

Monitoring – Non-interventional Studies

 

Quality assurance measures are gaining more and more importance in the area of non-interventional studies. Almost all studies are subject to monitoring whereby the extent of this quality assurance measure strongly depends on the study requirements and thus varies for each individual NIS.

 

We consult you on the selection of suitable quality assurance measures and conduct the monitoring of your study for you.

 

Our CRAs are trained specifically for the monitoring requirement of non-interventional studies.

 

We provide you with the following services:

 

  • Iinitiation visits, monitoring visits (risk-based) and close-out visits
  • Remote Monitoring
  • Training of study staff on study requirements and safety reporting
  • Site management during throughout all study phases
  • Supporting investigation sites with safety reporting

Your contact for Monitoring – Non-interventional Studies

Karin Blankenhorn

Karin Blankenhorn

Dipl.-Biol. 
Karin.Blankenhorn@winicker-norimed.com
+49 (0) 911 / 9 26 80 8932

Monitoring – Medical Devices

 

We provide you with further measures of quality assurance for your project by performing clinical monitoring. Our team of CRAS is specialized in monitoring clinical investigations with medical devices.

 

Our services in monitoring:

 

  • On-site visits: (in accordance with ISO 14155)
    • qualification visits
    • initiation visits
    • monitoring visits (risk-based)
    • close-out visits
  • Remote Monitoring
  • Training of the investigational sites for individual studies, tailored to the specific regulatory requirements of medical device clinical investigations
  • Supporting investigational sites with safety reporting, and support with the management of queries
  • Support of the participating investigation sites with the preparation for audits and inspections

Your contact for Monitoring – Medical Devices

medizinprodukte@winicker-norimed.com
+49 (0) 911 / 9 26 80 0

Monitoring – Nutritional Supplements

 

We provide you with further measures of quality assurance for your project by performing clinical monitoring.

 

Apart from our in-house monitors, we have a large number of qualified freelancer CRAs at our disposal. This allows us to operate highly cost-oriented and flexible.

 

Our services in monitoring:

 

  • Identification and selection of investigational sites
  • Implementation of: Qualification visits, initiation visits, monitoring visits (remote and on-site, on a risk-based) for Source Data Verification, Close-out visits
  • Training of the investigational sites for individual studies, tailored to the specific regulatory requirements of studies with nutritional products with health promoting properties
  • Screening for and management of protocol deviations
  • Site management
  • Supporting investigational sites with safety reporting

Your contact for Monitoring – Nutritional Supplements

Sabine Dürnhöfer

Sabine Dürnhöfer

Dipl.-Biol.
Sabine.Duernhoefer@winicker-norimed.com
+49 (0) 911 / 9 26 80 8730

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