chiltern
A Sole CDM Platform to Monitor All Clinical Trials

With the increase in the num¬ber of protocols for clinical trials, healthcare is burdened with complex scenarios. Patients and investigators are impacted to a larger extent, and the complexity has also triggered the need for more multi-vendor data sources and specialty laboratories. “The numbers of both unique and total procedures performed in a typical clinical trial have risen more than 50 percent in the past decade,” says Jim Esinhart, CEO, Chiltern.

Uncomplicating these scenarios is Chiltern, a contract research organization that is actively involved in the development of Clinical Data Interchange Standards Consortium (CDISC) and Study Data Tabulation Model (SDTM) standards as well as client-specific initiatives. “Our goal is to increase the flow of information through system interoperability and improve the clinical research process,” he adds.

One of the most promising trends in clinical data management has been the adoption of risk-based monitoring, which Chiltern combines with visual analytics for a more comprehensive and proactive approach. Chiltern uses central monitoring with expert data review, and targeted or adaptive on-site monitoring, to help investigators comply with study procedures and processes, oversee patient safety and continually assess near real-time data quality.

Headquartered in Wilmington, NC, Chiltern paves the path for healthcare organizations to gain clarity across all clinical trials through its Collaborative Technologies (CT) client-centric platform. Chiltern is integrating this platform, which functions on MS SharePoint, with its patient-centric visual analytics tools using Spotfire and SAS.

“Our CT platform enables fast decision making through adaptive trials and visual analytics tools. Our tools and techniques help clients identify hidden opportunities and risks to quickly make heads-up decisions,” states Esinhart.

CT also encompasses Clinical Trial Management System (CTMS) for real-time tracking of site status and monitoring activities; and Chiltern’s Site Agreement Management System (SAMS) to provide transparency across all clinical trial sites.

Additionally, Chiltern has indicated it will soon announce a new offering focused on an investigator-centric suite of products to speed study startup, recruitment and closeout.

Over the years, Chiltern’s people, processes and technology suites have benefited Chiltern customers in several ways. “We implement data standards libraries for EDC systems and dynamic reporting systems as well as other processes to reach the full potential of global sourcing,” shares Esinhart.

Additionally, because continuous innovation is part of the company’s culture, Chiltern emphasizes best-in-class communication and technologies to customize services and serve clients briskly. For instance, statisticians share best practices on adaptive design and randomization technologies in Chiltern’s Statistical Analysis Research Center. Then, these experts work closely with Chiltern’s data management teams to provide customers the best technologies and processes used today within all regulatory environments. “We put in a tremendous amount of effort to gain our clients’ trust and confidence across the clinical data management landscape,” remarks Esinhart.

Our CT platform enables fast decision making in the clinical trial process through adaptive trials and visual analytics tools

Furthermore, Chiltern concentrates on a best-of-breed approach toward systems, collaboratively working across vendors to present the best solution to customers. “Every sponsor and project requires a different set of processes and tools,” says Esinhart. “We customize our approach to ensure we create a competitive advantage for clients, while leveraging the strength of research from our vendors.”

For the future, Chiltern has major plans to enlarge its workforce by attracting well-qualified personnel, supporting them globally with abundant tools and training. “Additionally, we are building on our dedicated therapeutic alignment across our Biopharma, Medical Device & Diagnostics and Oncology specialties, and we are expanding our innovations in technology, leveraging our strategic and software partnerships and overall strengthening our global project management strategies to deliver customized clinical development solutions,” concludes Esinhart.