Explore Wombat's Capabilities

SIMPLE | QUICK | ELEGANT | COMPLIANT

Data items for capturing patient information for vaccine trials can be built automatically from existing CDISC and/or EDC standards, resulting in draft or even fully complete daily diary forms depending on the suitability of the documented standards and specifications. Typically, the initial forms are built directly and instantly from the standards, and then refined using Wombat’s manual design tools (no programming required). Such form and item design editing is collaborative, and all design decisions during study development are archived, resulting in auditable evidence of a controlled process. 

Simple

The Wombat platform is built specifically to support eDiary data capture from patients, caretakers, and parents participating in vaccine trials.  A Wombat eDiary system plays nice with existing EDC and CTMS systems that sponsors and sites already know how to use. 

Design, development, testing and debugging, UAT, deployment, TCO’s, and archival site/ sponsor records for the eDiary are all in one, self-documenting system. 

Wombat designer supports implementation of instructions and contextual help for patients and site users.  Thus, completing the eDiary is a simple web experience since users see exactly what to do next.

Quick

Quick Design: With Wombat, screen content and sequence can be easily built and reviewed in real time even by remote team members - there is no need to wait days for review to ensure that agreed upon specifications written on paper have been properly implemented. Instead, specification and approval is collaborative, dynamic, and recorded in the archive of the functioning implementation.

-eDiary versions of sponsor-specific vaccine diary cards are available for review (and even editing) at the initial presentation.

Quick Operation: Patient ID’s and vaccination codes are validated to be unique and authentic (matching EDC values) at registration. 

-AE and SAE data are sent transactionally and immediately to EDC or CRO systems so that site staff are alerted and can quickly review and complete standard AE reports.

-Completion compliance information is current in real time so that patient performance can be managed quickly. 

Elegant

Ongoing changes in design take effect in real time, ready for review and approval worldwide.  Why mess with Word documents, WebEx sessions, semantic confusion, versioning of spreadsheets, matching schedules?

Users see only what they need in order to fulfill their roles in the study.  Hidden fields are supported so that sites can track individual patients by private identifiers that sponsors and unauthorized study staff cannot see.

Real-time transactional transmission of protocol data values to RAVE.  No manual entry or transcription needed; elegant simplicity.

Compliant

The eDiary implementations of PRO instruments used in vaccine trials are assessed for content validity, comprehension, and ease of use. 

Documented conformance to Part 11, Annex 11, ICH E6 [R2], HIPAA, CTR, and other relevant security and privacy rules and regulations applying to clinical trials.