Clinical data management
For almost 20 years, we have been dedicated to quality, high performance and flexibility.
Key factors of Metronomia's extraordinary performance in clinical data management are people, procedures and technology: Well-established standard operating procedures are put into practice by excellent teams of clinical data managers supported by high-end clinical data management solutions.
With more than 40 experienced data management systems users, Metronomia has proven to complete large phase III trials as well as demanding phase I trials in oncology, all with its own challenges with regard to efficiency, quality and flexibility.
Systems and services
- Set-up of clinical databases in Clintrial® 4.5 (PhaseForward) or clincase® 2 (Quadratek Data Solutions) using sponsor or CDISC-SDTM data dictionaries
- Capacity to process large number of paper CRF pages per month via independent double data entry
- Capacity to review and validate large number of paper CRF pages including query processing
- Scanning and indexing all paper CRF pages with scanTrace for immediate online access
- Medical coding and review expertise in such standard dictionaries as MedDRA®, WHO DDEnhanced, NCI-CTCAE
- CDISC-SDTM CRF annotation, definition of data management and data validation plan
- CRF design using Adobe Framemaker®, including CRF printing administration and shipment
- SAE and external data reconciliation
- clincase® 2 eCRF technology
CRF scan services
- CRF and query form scanning and workflow management
- Online review with scanTrace:
- CRFs and query forms
- CRFs, data and query forms linked for easy access
- Commenting functionality
- Fully flexible user administration and user rights
- Creating PDF files (including bookmarks) and DVDs with images for regulatory submissions