Icons: Standard: Uncontained: 3×3

Icons: Standard: Uncontained: 3×3
February 11, 2016 Eric Bosch

Data Management - Paper CRFs

Our DFdiscover data management system combines the best of both worlds, supporting traditional paper-based CRFs as well as providing full EDC capabilities. Paper CRFs can be completed and emailed or transmitted securely 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 participant 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.

Data Management - EDC

DFdiscover is fully EDC-capable. Sites can enter data quickly and efficiently, with interactive quality control checks in place, directly into the database using either the local app 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 through the use of 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.”

Data Management - Source Docs

Beyond paper and EDC, DFdiscover allows data worksheets, source documents, and other participant records 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.

CDISC Strategy

DF/Net utilizes CDISC standards including CDASH, SDTM, and ADaM in order to help our clients accelerate their product development. From Case Report Form design, database setup, preparation of analysis data sets and ultimate regulatory submission, DF/Net has experience in applying these standards in ways that not only streamline your research but do so in a cost-effective way.

CDISC Services We Offer:

  • CDASH-compliant CRF design
  • CRF annotations compliant with SDTM
  • Define.XML creation and validation
  • Legacy data conversions to SDTM
  • SDTM and ADaM mapping specifications, programming and validation
  • SDTM and ADaM transport data delivery

Whether you need legacy data converted to CDISC standards, or the application of CDISC standards to your studies managed at DF/Net, we will help you navigate the evolving world of clinical data standards.

WHODrug Coding

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.

MedDRA Coding

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 though 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

Edit Checks

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.

Biostatistics

Quality biostatistics support, from protocol review through the clinical study report, is an essential component of successful clinical research. DF/Net provides the full range of clinical research statistical services, including:

  • Study design
  • Protocol assistance
  • Sample size/power calculations
  • Randomization schema
  • Statistical analysis plan development
  • CRF review
  • Data Monitoring Committee Support
  • Interim and final statistical reports
  • Statistical consulting – our statisticians are happy to assist you with any statistical question that arises in your research

We believe that biostatistics should be based on the needs of the study and not on a ticking clock. We offer multiple pricing models designed to meet client budgets.

At DF/Net, we are part of our clients’ study team, helping clients perform efficient and ethically sound research that improves health outcomes the world over.

Statistical Programming

DF/Net specializes in cost-effective, customized statistical programming solutions that are designed to meet client needs. Our experts include SAS-certified programmers and are early adopters of the R language. We also have skills in other statistical software packages including Stata and SPSS and in conventional programming languages such as Java and Perl.

Statistical programming services DF/Net offers include:

  • Custom designed automated reports
  • Table, Listing, and Figure (TLF) programming
  • Data Quality Control and Data Cleaning Listings
  • Custom statistical programming to support your research

We offer access to all statistical deliverables through our secure and easy to use web portal. At DF/Net, we fully understand that clients need access to their data on demand. All dynamic programming deliverables are automatically updated on a schedule chosen by the client. We can add reports as a PDF, RTF, Excel, or in XML format, allowing out clients to incorporate them directly into presentations, clinical study reports, or other documents.

At DF/Net, our statistical programmers enable clients to smoothly interact with their data and provide solutions to statistical programming problems.

Integration via API

Use our API to integrate data sources.

Study Rescue

Do you have an ongoing study that is struggling to meet deadlines or quality objectives? We have great success bringing in new clients, understanding their challenges and  providing concentrated support to get their studies back on track.