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Site Management

Services and tools at a glance

Foto: Uniklinik Köln

Site Management supports trial conduct throughout clinical departments, and identifies and addresses unmet needs across the clinical research community.

Services and staff we provide are Flying Study Nurses, Feasibility Management, the Site Management System clinicalsite.org, a special Study Budget Calculation using Studget™ as well as cross-clinic Trial Conduct Management Meetings.

In addition to many years of expertise in conducting clinical trials, all Flying Study Nurses are trained in

  • Study assistance (according to Curriculum of KKS-Netzwerk)
  • Study coordination
  • IATA (Cardio-pulmonary resuscitation)
  • Medicinal product & medical device trial legislation (AMG & MPG)

 

 

Tasks

Site Management

  • Feasibilities
  • Flying Study Nurses
  • Trial-specific personnel training
  • Site Management System (SMS) for recording and management of trials
  • Document management, CV database and researcher portfolio (via SMS)
Personnel Support for external sites

Flying Study Nurses

Andrea Pelzer und Beatrix Burmeister; Foto: Uniklinik Köln

The Flying Study Nurses of the CTCC are qualified, ready and able to perform the following tasks in the conduct of clinical trials:

  • Cost calculation
  • Contract tracking
  • Adjustment of trial specific documents
  • Preparation of trial sites
  • Checking study documents for completeness
  • Trial site set-up and preparation
  • organisational implementation of study protocols
  • Organisation and coordination of trial conduct on site
  • Recruitment, screening and care of study participants
  • Patient support and home visits
  • Preparation and support of patient visits
  • Documentation of patient treatment course according to protocol and eCRFs
  • Collection and documentation of all study-related data, including editing queries
  • Drug accountability (incl. drug storage, documentation and application)
  • Sample Collection, proper processing, storage and shipment
  • Management and handling of investigational drugs
  • Preparation of monitor visits
  • Preparation of audits and inspections by local, national and international authorities

We provide experienced Study Nurses not only for the University of Cologne, but also for external sites at hospitals or practices for a limited duration.

Are you experiencing or anticipating a staff shortage at your site? Please inquire about personnel support possibilities to keep your trials running!

Studget TM - Calculation Software for Clinical Trials

Computer software for the calculation of fees required to properly conduct a clinical trial within a hospital or medical practice, namely, for estimating the expected cost of a clinical trial so that the user can negotiate with the contracting sponsor of the Trial. The solution: the Study Site Budgeting Tool Studget TM!

Calculated Total

Payments

Detailed payment schedule

  •              Payments per trial visit
  •              Start-up fee 
  •              Payments for continuous activities
  •              Payments for single activities

Case payment          

Required staff hours

  •              Time for preparation
  •              Time per visit
  •              Average time needed per month of trial duration