Clinical Ink, a US-based company that offers a tablet-based system for collecting electronic source data in clinical trials, has teamed up with ePharmaSolutions, a provider of technology-based clinical services, to address the particular difficulties of data-gathering in studies for central nervous system (CNS) diseases.
The aim of the partnership is to replace paper source documents generated at research sites in complex psychiatric and neurological trials with “intelligent” electronic forms. This includes integrating ePharmaSolutions’ proprietary remote video capture technology with Clinical Ink’s eSource platform to capture simultaneously scoring data and an audio/visual record of patient interactions.
Lance Converse, founder and chief executive officer of ePharmaSolutions, cited a “dramatic” increase in the number and types of site scoring errors on many of the psychometric scales used in clinical trials, due to “complex administration requirements and elaborate scoring algorithms”.
The relationship with Clinical Ink will set a new standard for completion of source forms by incorporating real-time data validation and scoring to eliminate the expense and burden of reconciling errors later in the study, Converse said.
According to Clinical Ink, the pharmaceutical industry has “largely ignored the most costly and time-consuming aspect of conducting a clinical trial – the need to manually review comprehensive patient information on paper documents at research sites around the world”.
Despite some “hopeful rhetoric”, claimed the company’s president Ed Seguine, neither electronic medical records nor existing electronic data capture tools “are viable alternatives” to paper documents in clinical research.
The partnership with ePharmaSolutions will leverage that company’s services expertise together with Clinical Ink’s SureSource electronic source record, which the latter says is “the first eSource application designed to look and feel like a familiar paper chart while running on the new-generation tablet PCs”.
Clinical Ink also announced that it has secured an additional US$2.7 million in debt and equity financing to build the market for eSource. The financing includes “substantial” new investment from the management team and existing investors, as well as several new private investors and a line of credit through Sun Trust Bank, Clinical Ink noted.
The funds will be used to establish a robust sales and service organisation for SureSource and to develop further the technology platform, so that it can capture other types of paper source documents as eSource data.
“Our ability to raise funds in such a difficult environment is an indication of our potential to dramatically change the business model of clinical research,” commented Doug Pierce, chief executive officer of Clinical Ink.