Chiltern launches global EDC solutions

EPP News Bureau - Mumbai

Leading clinical research organisation Chiltern International, catering to the global demand for information, training and guidance on Electronic Data Capture, has launched a new service — EDC Solutions, according to a release issued by the company.

The company, which has offices in the USA, Europe and Asia, has created a global electronic support team to provide support to all stakeholders in EDC projects. According to current estimates, between 10 and 20 per cent of clinical trials worldwide incorporate the use of an EDC system and this figure is expected to rise to 50 per cent of trials in the near future.

Even so, there remain problems in the uptake of this technology due to differing perceptions of sponsors and investigators. Many pharmaceutical companies believe EDC offers faster time to database lock, reduced paper records and more accurate data, but adoption of proprietary systems is being held back in the industry due to worries about the cost, the range of features and applications systems currently exhibit, the lack of a clear leader amongst EDC suppliers, questionable scalability of any given solution, regulatory concerns and the fear that there may not be sufficient return on investment.

The idea of the Chiltern service is to provide on-hand experts and advice to allay these fears and issues. ‘‘By providing professional support for the EDC process, Chiltern will be able to reduce the focus of the research effort from the day to day detail to the study itself,’’ explained Karen Roy, Global Head of EDC Solutions, who will head up the new EDC solutions initiative.

‘‘We also want to make investigators feel that they are being fully trained and supported so that there are no barriers to the use of EDC. Thereby improving, sponsor support to investigators.’’

Chiltern’s initiative will involve a number of features. These will include site staff and client training, the setting-up of client staff and sites with subsequent support, the provision of necessary hardware, a helpdesk for everyone involved in the project and the processing of EDC software and process documentation throughout studies, the hosting of client or vendor systems. Additional services offered will include SOP rewrites to integrate EDC, general EDC training and general expert EDC advice.

Support can be given as a total package or in selected areas of the project. Chiltern will also provide a global EDC support team with company specialists in each of its global locations. ‘‘Our international network will allow the identification and understanding of key EDC players who have the knowledge and expertise to turn the use of EDC into a positive experience for both sponsors and investigators,’’ continued Karen Roy.