Data Management Services
Being the only person of the company in clinical operations with no in-house data management, I rely heavily on DF/Net's expertise and trust them. DF/Net is truly considered as a partner.
The DFdiscover data management system we feature combines the best of all worlds, supporting traditional paper-based CRFs as well as providing full EDC capabilities. Paper CRFs can be completed, scanned and securely transmitted to DF/Net where they are received and processed by DFdiscover and the DF/Net data team. The power of Intelligent Character Recognition (ICR) software for paper studies reduces data entry time, and a one-to-one relationship of CRF image and data entry screen makes data review intuitive. Entire subject binders directly linked to the data are readily available for review at any time by authorized study personnel, both at DF/Net and at your organization. DFdiscover CRF-based studies combine the simplicity of paper with the efficiency of EDC data entry.
DFdiscover is fully EDC-capable as well. Sites can enter data quickly and efficiently, with interactive quality control checks in place, directly into the database using either the local application or web-based tools. DFdiscover is 21 CFR Part 11 compliant and its use has been fully validated and documented to FDA standards. Data queries are reduced by DFdiscover’s powerful edit check features. Sites know which form to enter when, and are reminded when forms and visits are overdue. The quality control process doesn’t stop at data entry – all data are reviewed for completeness and accuracy at DF/Net. Human review can detect patterns, problems, and data that “just doesn’t seem right.
When data collection on a tablet makes more sense, our Android and iOS app supports data collection in both online and offline mode. In offline mode, data can be collected in the field and synced back to the central database.
Beyond EDC, DFdiscover allows data worksheets, source documents, and other participant records such as X-ray images to be scanned and securely attached to any data record, allowing key documents to be linked to your data and available for monitors, statisticians, and other key study personnel to view.
The DFdiscover data management system features an exhaustive edit check language that is used to validate data, calculate and insert values into data fields, and perform other actions across field, page, visit and subject logic. There is almost no clinical trial condition or scenario that cannot be coded, or verified, using the DFdiscover edit check language. Extensive documentation of the edit check language, with many examples, is included with the software.
For users of version 2016.0.0 and newer, a global library of edit checks (and user guide) is available for client use. Current clients can download this (free) global library from the support page.
DF/Net subscribes to the WHODrug Global dictionary to provide our clients with the industry-standard in drug coding.
Drug coding is increasingly becoming important as drug interactions are becoming more of a research concern. Many of our researchers are asking more and more questions about which drugs are being taken and why. As with MedDRA coding, DF/Net can provide WHODrug coding of your concomitant or other medications, either as a service integrated into the management of your study, or as a separate or retrospective coding project.
DF/Net Research can provide MedDRA coding of adverse events, medical history, and other medical terms as needed, either as a service integrated into the management of your study, or as a separate or retrospective coding project.
DF/Net fully follows MedDRA standards to meet your goals of harmonizing data, including providing services to:
- Code terms using MedDRA versions 10.0 through the current release
- Up-version your existing coding to the latest version of MedDRA
- Provide independent review of your existing MedDRA terminology to ensure that it meets your study, protocol, and regulatory needs
Is your current data management solution not performing as expected? DF/Net has extensive experience helping our clients through difficult transitions from their existing systems and vendors. Every case is different, but we approach all with empathy, integrity, and attention to detail, not only at the technical level, but at the personal level as well. Our systems are flexible and adaptable to allow any new database structure to match the previous one as closely as needed. We can help with data migration, site training and transition, documentation, and archiving of existing data.
Our motto is “building relationships with people and their data”. We are willing to invest and go the extra mile to make sure that your needs are met.