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Data Management at CTCC

Services at a glance

CTCC offers you, our client, complete services of GCP-compliant Data Management processes for clinical trials with electronic CRFs.

Our Clinical Data Management System is validated according to regulatory requirements. We have implemented quality assurance and quality control processes to produce secure and valid data for statistical analysis.

Our services include:

  • eCRF Design
  • Preparation of Data Management Manuals, Data Review Plans, Data Entry Guidelines, Reconciliation Manuals etc.
  • Study Database setup, validation and maintenance (including comprehensive plausibility checks)
  • User training comprising eLearning and help desk
  • Data cleaning and query management
  • Study specific reports online or through scheduled mailing
  • Email alerts on events, e.g. “new patient” or “new SAE”
  • Coding (MedDRA, WHO-DDE)
  • Management of lab data
  • SAE reconciliation
  • Database closure and data export
  • CDISC SDTM mapping

Team Data Management

Name

Titel

Function

Fon +49 221 478-

Fax +49-221-478-

Email

Bardach, Elena

Dipl.-Oecotroph.

Lead Data Management

88132

87887

elena.bardach[at]uk-koeln.de

Alexi, Pascal

 

Database Developer / Statistical Programmer

88391

87887

pascal.alexi[at]uk-koeln.de

Becker-Peters, Laura

Dipl.-Oecotroph.

Data Manager

85688

87887

laura.becker-peters[at]uk-koeln.de

Grünwald, Irene

 

Data Manager

84870

87887

irene.gruenwald[at]uk-koeln.de

Pfeiffer, Andrea

 

Data Base Developer

88133

87887

andrea.pfeiffer[at]uk-koeln.de

Scheckenbach, Frank

Dr. rer. nat.

Data Manager

88257

87887

frank.scheckenbach[at]uk-koeln.de

Schwartzkopff, Franziska

Dr. rer. nat.

Data Manager

84872

87887

franziska-maria.schwartzkopff[at]uk-koeln.de

Willms, Sandra

 

Data Manager

88134

87887

sandra.willms[at]uk-koeln.de