Clinical trials data collection during patient care using a novel technology solu

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Department of Health and Human Services
Award Year:
Phase I
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Small Business Information
ADVANCED DIGITAL SYSTEMS, INC., 4601 Creekstone Drive Ste 130, Durham, NC, 27703
Hubzone Owned:
Minority Owned:
Woman Owned:
Principal Investigator:
(919) 485-4819
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() -
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DESCRIPTION (provided by applicant): The offeror propose to develop and test a novel hardware and software combination solution composed of the Livescribe Pulse Smartpen with Mi-Forms data collection software, for use in clinical data collection during pat ient care documentation at the bedside. The Livescribe Pulse Smartpen is a new commercial off the shelf hardware product providing both handwriting and speech capture, and Mi-Forms data collection software is the flagship product of the offering small busi ness. Physicians continue to have a strong preference for recording patient information and care progress notes via pen and speech dictation. Until now, there have been no devices capable of providing electronic handwriting capture, conversion to text and speech capture in a single integrated platform. Today's Pulse Smartpen from Livescribe, not much larger than a standard ballpoint pen, is such a platform. This current proposed research is to test the simultaneous speech and pen-on-paper handwriting captur e capability of the Pulse Smartpen, coupled with Mi-Co's unique software for processing pen and speech data, in a novel architecture deployed in the Duke University Cancer Clinics. More rapid and efficient than the current method of paper transcription plu s dictation, but still conforming to current physician workflow preferences, this technology solution can serve to streamline the collection of patient data for clinical trials while enabling more automatic sharing of important patient care information, le ading to improved patient health outcomes via both research and care. This innovative combination will allow clinicians to simultaneously collect patient data for clinical trial electronic Case Report Forms (eCRFs) and document patient progress notes via b oth pen and speech dictation. This system will provide busy clinicians with a familiar, easy to use system that will enable the automatic transcription of patient data from care records into case report forms and later transcription of dictated progress no tes. The solution will also allow for the automated communication of CRF data and progress notes to existing systems for quicker availability to clinical trials sponsors and other members of the clinical care team, ensuring better communication and coordin ation for more efficient clinical trials and improved patient care. PUBLIC HEALTH RELEVANCE: The offerors propose to develop and test a novel hardware and software combination solution composed of the Livescribe Pulse Smartpen with Mi-Forms data col lection software, for use in clinical data collection during patient care documentation at the bedside. This system will utilize a new hardware device that captures both handwriting and speech dictation, and create a user- friendly clinical trials data ent ry system that reaches the patient bedside and automatically populates back-end systems for clinical research and patient care. New systems that improve efficiency and also increase clinician satisfaction in collection of clinical trials data are beneficia l to public health through more streamlined creation and testing of new medicines.

* information listed above is at the time of submission.

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