SOURCE: Clinical Ink

Clinical Ink

October 28, 2015 10:30 ET

Clinical Ink Survey Confirms eSource Better Than Paper

Landmark Site User Study Reveals Clinical Ink's SureSource® Platform Faster and Easier Than Paper Source; eSource Reduces Site Workload More Than 50% and Improves Data Quality

WINSTON-SALEM, NC and PHILADELPHIA, PA--(Marketwired - October 28, 2015) - Clinical Ink, the pioneering provider of purpose-built eSource and patient engagement solutions for clinical trials, today announced key findings from its landmark "Site Impact" survey of 2,402 research coordinators and investigators to evaluate site impact of Clinical Ink's eSource platform (SureSource) versus traditional data capture methods, including paper source and electronic data capture (EDC). Clinical Ink's Site Impact survey is the first to provide conclusive evidence that SureSource is more effective than paper source for reducing site workload and improving data quality.

As life science companies look for new ways to optimize clinical trials, Clinical Ink's Site Impact survey highlights how SureSource can maximize study efficiency by eliminating inefficient, error-prone and expensive paper-based data capture forced onto research sites.

"This is the first evidence-based study that finds SureSource is faster and easier for sites to use than the traditional paper source / EDC approach," said Ed Seguine, CEO, Clinical Ink. "While anecdotal evidence has long supported this belief, we now have confirmation from 517 site users that SureSource reduces the burden on sites by eliminating data transcription, reducing queries, and improving data quality. In particular, this study debunks the myth that sites 'don't like technology' -- in fact they do if it's designed to actually make their lives easier -- and EDC doesn't make a site's life easier."

Clinical Ink's Site Impact survey was distributed in July 2015 to 2,402 research coordinators (71.4%) and investigators (28.6%) located in the United States (73.5%) and internationally (26.5%). All site respondents had experience using SureSource on at least one clinical trial. The survey included 12 questions that compared paper source to SureSource and evaluated the impact of various SureSource features for improving workload, efficiency and quality. A total of 517 responses were received (21.5% response rate) and chi-square models were used to analyze the statistical impact of numerous factors on improving workload, efficiency and quality.

Key findings are detailed in an October 2015 Clinical Ink white paper (eSource: Reducing Site Workload for Better, Faster, Safer Studies) that highlights relevant data to explain how SureSource reduces site workload better than paper source to improve study efficiency and data quality, including:

  • Simplifying Data Entry: More than 80% of coordinators and 75% of investigators found SureSource to be equal, easier or much easier to use than paper source. Ninety-three percent of respondents who have used SureSource in three or more studies found it easier to use than paper.
  • Reducing Data Queries: Site users who reported SureSource as effective for reducing data queries realized an average of nearly twice as many fewer queries (up to 44%) compared to paper source. Eighty-one percent of users who reported fewer queries with SureSource found its automatic edit checks to be helpful/very helpful in minimizing errors.
  • Eliminating Data Transcription: By capturing eSource data directly during the patient visit, SureSource eliminates data transcription and source data verification (SDV). Sixty-seven percent of users who reported receiving fewer queries with SureSource also felt the elimination of data transcription had a high impact on workload reduction.
  • Minimizing Errors, Improving Data Quality: An overwhelming majority of SureSource users -- more than 80% of coordinators and investigators -- felt that its automatic edit/validation check functionality was very helpful/somewhat helpful in minimizing data errors, including out of range values or missing/incomplete data.

"It's definitely a good feeling to not have to think about spending a portion of my day re-entering data into EDC," said Donna Straatmann, RN, BSN, CCRC, a research coordinator at Mercy Clinical Research and survey respondent. "SureSource saved at least 30% of my time, and that has allowed me to focus on doing more important things, such as spending more time with the patient during visits, recruitment efforts and seeing more patients."

Download Whitepaper eSource: Reducing Site Workload for Better, Faster, Safer Studies

About Clinical Ink

Founded in 2007, Clinical Ink is dedicated to transforming clinical development -- from Start to Submit™ -- by creating a completely paperless clinical trial platform for sites, sponsors, CROs and patients. Clinical Ink's SureSource platform is purpose-built to capture eSource data and documents electronically at the site, while the CentrosHealth patient engagement platform provides patients with a variety of configurable apps to keep them informed, involved and compliant throughout the duration of a clinical trial. Clinical Ink maintains offices in Winston-Salem, NC, Philadelphia, PA and Cambridge, MA. Additional information is available online at www.clinicalink.com or toll-free 1-800-301-5033.

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