Clinical Ink--electronic source record software for clinical trials
While Clinical Ink just commercially released its first product, SureSource, in January, the firm holds lots of promise to replace a lot of the paper source documents filled out at clinical trials sites with electronic documents that cost less to manage and verify.
Most clinical trials now use electronic data capture (EDC) to manage and store data from the studies, but the truth remains that those systems still require trial sites to fill out paper forms with patient information--and then someone typically has to transcribe the data from the paper documents into the EDC system. Winston-Salem, NC-based Clinical Ink wants to change this practice with software that runs on tablet PCs and enables doctors to create electronic source records for clinical studies while seeing a patient.
To hear company president Ed Seguine tell it, Clinical Ink's technology tackles an even larger cost burden--site monitoring--than the data management issue that EDC and other clinical trials software address. Site monitoring, which involves tasks such as checking the accuracy and reviewing paper-based and electronic data in clinical trials, accounts for up to 40 percent of a trial's budget, while data management accounts for a mere 10 to 15 percent, Seguine said in an e-mail. Unlike the paper-based approach used with EDC systems, he adds, there's never any discrepancy between data collected directly from patients and what gets stored in the database using his firm's technology.
It's still early days for Clinical Ink, yet Seguine says the firm has landed its first major enterprise customer since the release of its software. He did not disclose the name of the customer. Clinical Ink, which has raised $5 million from private investors, is planning to expand its operations to the Philadelphia area, closer to the heart of U.S. pharma territory than its headquarters in North Carolina. Expect to see the four-year-old firm's sales grow as it gets in front of more health products makers and shows them how its system can save them time and money.