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    Wombat Clinical Systems Platform

    Wombat is a web-platform that is optimized for design and implementation of the patient diaries used in vaccine trials. The Wombat Clinical Systems Platform is browser based, so patients truly can participate in a vaccine trial with the phone, tablet, and/or computer that they already own and know how to use. Wombat implements BYOB (Bring Your Own Browser) eDiaries - nearly any device with an internet browser and access to the internet serves for entry and transmission of data by patients about their experience following vaccination.
    SKU: PHIWB001
    Interest categories: Vaccines
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    Familiar ePRO systems are not well suited for vaccine trials. Over the last 20 years ePRO providers have developed complicated platforms for programming, validating, shipping, and servicing specific devices that rely on worldwide telecommunications providers for trial level data transmission.  Such provisioned ePRO systems can support eSource data capture in complex clinical trials, but the interaction required to specify the content and scheduling for programming eDiaries into such systems is unnecessarily slow and expensive, particularly so for vaccine trials.


    The Wombat Clinical Systems Platform is enough and not too much. If you have previous experience with paper diaries and existing data standards, Wombat supports creation of compatible items and forms for eDiary data capture that are instantly ready for review.  With an hour or so of collaborative refinement using Wombat, our team will provide a trial sponsor with a working eDiary system ready for use by sites, study staff, and subjects. Wombat needs no training or domestication to integrate with EDC and IVR systems.


    Explore Wombat's Capabilities



    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. 


    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 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. 


    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.


    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.

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