Chiltern stresses benefits of new TMF management system
While global expansion of the clinical research sector promises to test new drugs in more patients and help drugmakers access new market, it also dramatically increases the complexity of managing the transfer of information between trial locations.
Chiltern’s new system, known as SAFE, is designed to address these issues and let sponsors to remotely monitor and track regulatory documents during clinical trials conducted at multiple sites.
The firm claims SAFE can also identify missing reports, the absence of which could otherwise hamper the regulatory submission process and delay market launch, potentially “costing” sponsors millions in lost revenue.
Sarah Hitching, Chiltern's director of records management, told Outsourcing-pharma that SAFE was developed as an in-house way of managing trial master files (TMF) for the firm’s increasingly complex full service projects.
“Projects were increasing in size, global coverage and size of study team and complexity, and Chiltern SAFE’s success in managing such studies led Chiltern to develop the system further.”
Hitching went on to contrast the Chiltern approach with that offered by the wider research service industry, explaining that: “Most CROs have only manually managed TMFs with their inherently labour intensive quality steps.
“Chiltern SAFE has a unique approach allowing documents to be tracked from the sender to the file, including documents that are not yet finalised though are known to be required in the TMF.”
These thoughts were echoed by Chiltern executive VP of trial monitoring Stuart Young who said the system would be offered as “a standalone service or as part of our full clinical trial service package and for future or historic studies.
“Another distinct advantage of Chiltern SAFE,” Young continued “ is our dedicated records management (RM) team on site at each of our three data repositories globally: Germany, UK and USA.”
