The data management includes the layout design of the CRF, the programming of the clinical databases and the query management. As part of the query management, the data are validated with edit and plausibility check, encoded and reconciled with external data sources, e.g. SAE reconciliation.
At the request of our customers the data can be provided compliant to CDISC (SAS programming).
The Dr. Notghi Contract Research GmbH employs experienced data managers and SAS programmers with different emphases in setting up and editing database systems and clinical data. For 19 years the Dr. Notghi Contract Research GmbH is a flexible and competent partner in this field
What we offer in the field of data management:
⦁ Creation of data management and data validation plans (DMP, DVP)
⦁ Design and programming of CRFs (eCRF, pCRF),
⦁ User trainings and help desk
⦁ Query Management
⦁ Data reconciliation of external data (e.g., laboratory) and AEs
⦁ Medical coding according to MedDRA and WHO-DDE
⦁ Preparation and moderating of Data Review Meetings
⦁ Electronic data transfer
What we offer in the field of SAS programming:
⦁ Edit- and plausibility Checks
⦁ SDTM (CDISC) datasets
⦁ AdaM datasets
⦁ Creation of tables, listings and figures (TLFs)
You benefit from:
⦁ Years of experience in Phase I and II studies
⦁ Experience with different databases
⦁ Established processes between individual departments
We help you conserve your valuable resources and reduce costs.
We offer a broad spectrum of services in the field of medical writing for full- and part-service solutions.
Our experts will gladly advice you personally. We look forward to your call or your message