Cloud-based systems are reducing clinical trial costs by maximising data entry and workflow efficiencies. Zaher el-Assi, president of the eClinical division of Merge, an IBM Company, takes Clinical Trials Insight through the company's leading-edge eClinicalOS (eCOS) platform.
The costs of clinical trials have risen dramatically as studies become more global and complex. It has been reported that the use of lower-cost facilities and in-home testing, combined with increased use of mobile technologies and electronic data capture (EDC), could rapidly reduce trial costs.
In fact, advanced EDC solutions are already helping clinical trial studies run more effectively by providing convenient mechanisms for communication, enhanced efficiency and accuracy of data entry, monitoring and optimisation of workflows, and better organisation and team interactions.
EDC tools can also be used to rapidly design and launch trials because full studies can be laid out generally, with details added later, making it possible to establish timelines, determine the required number of sites and define responsibilities.
EDC systems help ensure that demanding regulatory data capture and reporting requirements are met with confidence, so it's no surprise that the US FDA encourages their use for clinical trials.
Cloud-based systems such as eClinicalOS (eCOS), from the eClinical division of Merge, an IBM Company, eliminate the need to maintain and manage IT equipment. All of the data collected during clinical trials is stored in a central EDC system that is managed by a third-party service provider and accessed through web-based software using any type of web-based device.
Easy access to real-time data, which is automatically updated and collated from anywhere, makes even more rapid and efficient data monitoring and reporting possible, all without the need for large investment upfront.
For the global and complex trials of today, cloud-based EDC systems such as eCOS are ideal. Study managers can track the drug supply, manage images, coordinate reporting and even provide assistance with translation, while also improving communication and collaboration between sponsors, clinical research organisations, investigators, regulators and patients.
This results in more efficient end-point coordination and adjudication processes, shorter clinical trial timelines, lower study costs and a reduced time to market. More accurate resource forecasting with eCOS also improves the budget development and review process.
A modular and scalable EDC platform, eCOS offers core electronic data capture, management and monitoring capabilities with optional add-on functionality, from randomisation and safety reporting to translation and end-point adjudication. Importantly, eCOS can be configured to use specific tools that are needed for each study, which means the requirements of all trials can be met, regardless of size or complexity.
When combined with transparent pricing and payment based solely on what is used and for how long, the savings with eCOS are further maximised, even for small pharmaceutical, biotechnology and medical device companies. In addition, the modular eCOS platform has been designed for use at any given point in a customer's clinical trial management process, allowing flexibility and transparency.
A high percentage of clinical studies experience delays, costing drug manufacturers tens of millions of dollars. Effective cloud-based EDC systems facilitate the commercialisation of new drug development, but not in a vacuum.
The maximum value of EDC systems can only be achieved if clinical trial managers are willing to make suitable process changes and continuously work to improve operations. That's where strategic IT partners such as eClinicalOS add value.
The company recognises that the development of more effective and efficient tools, including cloud-based EDC platforms, is necessary to help reduce trial timelines and study costs, with the ultimate goal being the efficient development of advanced treatments for patients. ?
References are available upon request.