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Clinical Monitoring

Interface between study team and sponsor

Through clinical monitoring not only the rights and well-being of patients is monitored but also the integrity of the data collected.

Via on-site monitoring, our CRAs ensure that your clinical trial is conducted at the trial sites according to protocol, GCP and all applicable legal and regulatory requirements. At the same time, they are available to site staff for study-specific and/or organizational questions. Thus, our CRAs represent an essential link between the trial sites and you as sponsor and enable targeted communication with your trial sites.

 

Our range of services includes:

  • Individual agreement on the appropriate monitoring strategy for your study, based on a study-specific risk assessment
  • Preparation of a study-specific monitoring plan
  • Preparation, execution, documentation and follow-up of
    • Qualification Visits
    • Initiation Visits
    • Regular monitoring visits and
    • Close Out Visits
  • Support of trial sites in the preparation of audits and inspections
  • Professional site management, i.e. our CRAs are the primary contact person for the trial sites for all study-specific issues:
    • Management of confidentiality agreements
    • Obtaining, reviewing, and filing of site specific documents.
    • Conducting regular structured phone calls to monitor study progress at the trial site.
    • Providing telephone guidance to trial site personnel
  • Management of the trial site specific part of the TMF at the CTC Cologne

Team Monitoring

Name

Title

Function

Tel +49-221-478-

Fax 478-

Email

Staß, Angelika

Dr. rer. nat.

Monitoring & FSN Service Lead

88137

88209

angelika.stass[at]uk-koeln.de

Brüggen, Annika

M.Sc.

Clinical Research Associate

84920

88209

annika.brueggen[at]uk-koeln.de

Hayn, Birgit

M.A.

Clinical Research Associate

88124

88209

birgit.hayn[at]uk-koeln.de

Helfer, Gabriele

Dipl.-Biol.

Clinical Research Associate

88146

88209

gabriele.helfer[at]uk-koeln.de

Kienes, Ioannis

Dr. rer. nat.

Clinical Research Associate

88206

88209

 

Montada, Angelika Anna Maria

Dr. rer.nat.

Clinical Research Associate

88206

88209

 

Paus, Martin

M.Sc.

Clinical Research Associate

88210

88209

martin.paus[at]uk-koeln.de

Semm, Sarah-Maria

 

Clinical Research Associate

88149

88209

sarah-maria.semm[at]uk-koeln.de

Wicharz, Margarete

 

Clinical Research Associate

88253

88209

margarete.wicharz[at]uk-koeln.de

Wuestenberg, Hauke

M.Sc.

C

88150

88209

hauke.wuestenberg[at]uk-koeln.de

Yilmaz, Selma

Dipl.-Biol.

Clinical Research Associate

88258

88209

selma.yilmaz[at]uk-koeln.de