Ed Seguine, CEOTagging Electronic Data Record as a bit of a red herring can’t be way off the mark in clinical trials. A ypical EDC system is designed to streamline the work of statisticians rather than the clinicians. In fact, the focus on statisticians and emphasis on standardizing data entry are exactly the reasons why EDC has never been widely accepted as a tool that actually helps clinicians. To alleviate this issue, Clinical Ink took a different approach, and architected the SureSource platform—a purpose built source documentation tool that captures both structured and unstructured data, to meet the needs of clinicians first and statisticians second.
Clinical Ink’s SureSource aims to capture as much of the source data as possible. Be it instrumented results from a hemodynamic machine or laboratory data, SureSource takes the source information directly into the clinical trial database. Once the data is in Clinical Ink’s system, it can be reviewed electronically by monitors and physicians through a review portal. The platform also triggers other key milestone events like, assessing the quality of data and automatically paying research sites; and flagging of dependant or conditional values, making the on-site work much easier. Clinical Ink effectively voids on-site source data verification and monitoring—the most expensive and laborious activities in clinical trials. Since the source data is captured electronically, it is automatically populated and can be reviewed remotely and instantly. This saves a huge amount of time and money by eliminating the need to manually capture data on paper and rekey it into an EDC system, which has potential for errors. They have incorporated a number of features in their platform and made it as robust and reliable as possible because, unlike conventional EDC systems, SureSource has to deal with numerous unique real world limitations and vagaries.
With the FDA’s regulatory uncertainty regarding the validity of electronic source data in clinical trials diminished, Clinical Ink’s platform is significantly more appealing tocompanies.
Our platform enables a different and more efficient execution model
They strive to capture the maximum amount of source data and make its interaction with existing backend data management environments, as easy as possible. Not only are they automating the frontend processes, but also making substantial investments in streamlining the backend processes; their intuitive framework helps preserve accountability at a research site, while allowing integration with different EMR systems. Clinical Ink’s system has been deployed in academic research institutions and single site practices to dedicated research facilities in the UK as well as, remote locations in Africa—where it is being used in vaccine studies.
Novartis, a multinational pharmaceutical company, has opted to work with ClinicalInk to do one of the largest asthma studies that will span the next few years. Taking a different route, Novartis has selected Walgreens as a clinical trial site rather than hospitals. With Walgreens never having performed clinical trials before, Clinical Ink’s platform has a crucial role to play—helping to enforce the rigor of good clinical practices, while eliminating the need to visit hundreds of different Walgreens sites on a periodic basis to review data. “Our platform enables a different and more efficient execution model,” says Ed Seguine, CEO, Clinical Ink.
Looking to the future, Clinical Ink is building their scale to be able to do longer and bigger studies across a greater number of geographies. The company is also investing heavily in their core infrastructures and processes, and is focused on expanding their platform’s functionality. “Ultimately, we want to replace EDC and become the platform that EDC should’ve been all along,” asserts Seguine.