Clinical Ink''s eSouce Platform Selected to Power Global Central Nervous System Study
Clinical Ink's SureSource(R) Platform Will Provide Real-Time Data Capture and Remote Monitoring for Phase II Alzheimer's Clinical Trial
(firmenpresse) - WINSTON-SALEM, NC and PHILADELPHIA, PA -- (Marketwired) -- 09/22/14 -- , an innovation-driven eSource solutions company, today announced that its SureSource® platform was selected to capture the critical efficacy data for a global Phase II central nervous system (CNS) study. Clinical Ink''s SureSource will replace paper scales with fully electronic questionnaires incorporating built-in logic, automated scoring, and integrated audio recordings to improve the assessment of critical efficacy endpoints.
"The ability to capture and assess validated data in real-time is particularly critical for complex CNS studies," said Ed Seguine, CEO of Clinical Ink. "With SureSource, the vision of a ''paperless'' clinical trial is realized and the impact on costly, time intensive, cumbersome monitoring and data management activities yields dramatic and immediate cost savings. These benefits are particularly significant for CNS studies where outcomes are highly dependent on effective execution and subtle data quality factors."
Scheduled to begin in October 2014, Clinical Ink has built nine customized electronic scales in 14 languages for 75 participating clinical research sites located throughout North America and Europe. Sites will capture patient visit details electronically -- including audio recordings -- during the subject visit. Using SureSource, clinicians can focus on the subject -- not the scoring rules. Sponsors can monitor source documents remotely and in real-time. For CNS studies in particular, SureSource simplifies the complexities of scale administration by incorporating "smart" form design to identify errors and simplify data entry.
Scheduled to enroll more than 600 subjects over an 18-month period, this Phase II study will test the safety and efficacy of an investigational medication for the treatment of Alzheimer''s disease. According to a 2014 Alzheimer''s Association report, the number of Americans age 65 and older with Alzheimer''s disease may nearly triple by 2050 (13+ million) -- barring the development of medical breakthroughs to prevent, slow or stop the disease.
Developers of SureSource® -- the industry''s most widely used eSource platform -- Clinical Ink is an innovation-driven eSource solutions company. Our vision is to transform clinical trials -- from Start to Submit ™ -- by creating a completely ''paperless'' clinical trial platform. Clinical Ink maintains offices in Winston-Salem, NC and Philadelphia, PA. Additional information is available at or toll-free 1-800-301-5033.
:
Alicia Maguire
Clinical Ink
t: 336.464.0696 ext 812
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Datum: 22.09.2014 - 08:36 Uhr
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