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- | |
---|---|---|---|---|---|
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 |
Dwivedi, Gaurav |
| Clinical Database Developer | 88142 | 88209 | gaurav.dwivedi[at]uk-koeln.de |
Grünwald, Irene |
| Data Manager | 84870 | 87887 | irene.gruenwald[at]uk-koeln.de |
Moshkova, Irina |
| Data Manager | 88139 | 87887 | irina.moshkova[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/Database Developer | 84872 | 87887 | franziska-maria.schwartzkopff[at]uk-koeln.de |
Willms, Sandra |
| Data Manager | 88134 | 87887 | sandra.willms[at]uk-koeln.de |