James M. Corrigan, President & CEOFrom manual data collection to electronic data capture to eClinical software suites, pharmaceutical companies have seen significant shifts on the road to attaining efficiencies in the development of new medical products. Today, pharma companies typically use three to five data capture systems, often from multiple vendors who have created high value solutions for specific uses within clinical development. While these systems deliver significant advantages in the more efficient collection of data, they have also created new challenges for CIOs, data managers and study management teams. Data that are confined to these respective collection systems create silos of information, making it difficult to gain a holistic view into clinical trial progress. To help CIOs overcome these recurring data fragmentation challenges, eClinical solutions provider ERT delivers a combination of technology, consulting and cloud-based services that improve the efficiency of clinical trials.
ERT’s cloud-based technology platform, Insights Cloud, leverages a flexible centralized data integration strategy that enables real-time operational intelligence throughout clinical development. Fully automated and compatible with any eClinical software used by trial sponsors, “Insights Cloud is a next-generation solution that enables seamless data integration,” states James M. Corrigan, CEO of ERT. Instead of replacing current data capture technologies by purchasing another eClinical suite, a sponsor can layer Insights Cloud’s technology on top of their existing systems and link them together through a single and easy-to-use operational interface. “ERT’s Insights Cloud acquires data and converts it into actionable insights, no matter what the data source,” Corrigan further elaborates. It provides built-in dashboards with metrics, KPIs and analytics along with reporting tools to equip study teams with the operational information they need to make real-time decisions about an ongoing clinical trial or program and flexible workflow solutions to document actions. “As the industry continues to evolve toward risk-based trial management modalities, effective data surveillance is critical for ensuring safe and cost-effective clinical trials,” cites Corrigan. To this end, Insights Cloud delivers centralized data surveillance to enable risk-based monitoring strategies.
An example case study is a mid-sized pharmaceutical company who was carrying out a complex phase III study, leveraged ERT’s Insights Cloud to integrate data from their existing data collection systems.
ERT’s Insights Cloud assembles data no matter what the data source and converts it into actionable insights and analytics used in more effective operational management and risk-based monitoring for clinical research
The solution gave the global study teams real-time updates on the status of subject recruitment, clinical data, study metadata, and investigative site performance. The eClinical platform enabled team members to track data, rapidly identify missing data and access detailed work lists and performance metrics that incorporated specific protocol and regional complexities for missing, discrepant and uncollected data. With Insights Cloud, the sponsor was able to make timely decisions and proactively manage large vendor teams by mitigating potential issues before they occurred. As an end result, the sponsor and its service providers were quickly able to resolve bottlenecks, maintain timelines, hit targets and successfully bring a first-in-class drug to the market.
In its next big step of advancing new concepts in eClinical research and to increase efficiencies while reducing risk for pharmaceutical research, ERT will officially open an Innovation Lab facility in the first quarter of 2016 in its Boston office. Dedicated to “expanding the art of the possible,” the ERT Innovation Lab facilitates the development of technological concepts to enhance data collected from patients. “Measuring ERT’s success through our customers’ eyes,” Corrigan ensures that, “ERT will continue its journey of innovating better health by investing in technology solutions such as Insights Cloud that offer great promise for the simplification of the ever-increasing complexity of clinical trials and increasing efficiency for its customers.”