Chiltern
Technology-enabled Clinical Trial

The clinical data management (CDM) arena has adapted several trends in the modern era; risk-based monitoring, being the promising one, is being seamlessly integrated into the drug development today. Injecting latest trends in its offerings, Clintern has designed and developed solutions that drive the improvement of human health and well-being. “We are committed to building strong collaborative partnerships, striving for clinical excellence,” asserts Jim Esinhart, CEO of Chiltern. Led by Esinhart, an expert at managing global biometrics, medical and regulatory affairs, and information technology, Chiltern is a contract research organization that specializes in clinical development, oncology, device and diagnostics, data, analytics and evaluation, and strategic service provision. “We deliver customized clinical development solutions based on our client requirements,” says Esinhart.

Chiltern, with its expert-led clinical development services, is actively involved in the development of Clinical Data Interchange Standards Consortium (CDISC) and Study Data Tabulation Model (SDTM) standards ever since its inception. “We are continuously working to achieve a goal to increase the flow of information through system interoperability and improve the clinical research process,” extols Esinhart.

Chiltern combines with visual analytics for a more comprehensive and proactive approach. “We collaborate 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,” explains Esinhart. Doing so, Chiltern paves the path for healthcare organizations to gain clarity across all clinical trials through its Collaborative Technologies (CT) client-centric platform. Functioning on MS SharePoint, Chiltern has integrated the CT platform that with its patient-centric visual analytics tools using Spotfire and SAS, enabling the customers with fast decision making capabilities.

We are continuously working to achieve a goal to increase the flow of information through system interoperability and improve the clinical research process

“Our tools and techniques help clients identify hidden opportunities and risks to quickly make heads-up decisions,” notes 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.

Chiltern emphasizes best-in-class communication and technologies to customize their services and serve clients briskly. In an instance, if a statistician shares best-practices on adaptive design and randomization technologies within the Chiltern’s Statistical Analysis Research Center, the Clintern experts work closely with Chiltern’s data management teams to provide customers the best technologies and processes within all regulatory environments. “Collaboratively working across vendors to present the best solution to customers, we put in a tremendous amount of effort to gain our clients’ trust and confidence across the clinical data management landscape,” remarks Esinhart.

‘Continuous innovation’ is a key aspect to Chiltern’s culture. “We are all set to soon announce a new offering focused on an investigator-centric suite of products to speed study startup, recruitment and closeout,” highlights Esinhart. 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.” Clintern’s future plans revolve around expanding innovations in technology, leveraging strategic and software partnerships and overall strengthening the global project management strategies to deliver customized clinical development solutions.