Cloud-based systems are reducing clinical trial costs by maximising data entry and workflow efficiencies. Zaher el-Assi, president, Merge eClinical, takes Clinical Trials Insight through the company's leading-edge eClinicalOS (eCOS) platform.
Clinical trial costs 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, organisation, monitoring and optimisation of workflows as well as team interactions.
EDC tools can also be used to more rapidly design and launch trials because full studies can be laid out on a general level and then details added, making it possible to establish timelines, determine the required number of sites and define responsibilities. EDC systems also help to ensure that increasingly demanding regulatory data capture and reporting requirements can be met with confidence, so it's no surprise that the US FDA encourages their use for clinical trials.
Cloud-based systems like eClinicalOS (eCOS) from Merge eClinical 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 that is automatically updated and collated from anywhere makes possible even more rapid and efficient data monitoring and reporting, all without the need for large upfront investment.
For the global, complex trials of today, cloud-based EDC systems like eCOS are ideal. Study managers can track the drug supply, manage images, coordinate reporting or even provide assistance with translation, while also improving communication and collaboration between sponsors, clinical research organisations, investigators, regulators and patients. The result? More efficient end-point coordination and adjudication processes, shorter clinical trial times, lower study costs and a reduced time to market. More accurate resource forecasting with eCOS also improves the budget development and review process, which is a crucial issue for the clinical trial industry today.
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 custom configured to allow use of the specific tools that are needed for each unique study, which means the requirements of all clinical 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 can be 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 for true flexibility and transparency.
An alarmingly high percentage of clinical studies conducted today 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 their operations.
That's where strategic IT partners like Merge eClinical add real value. Merge eClinical recognises that the development of more effective and efficient tools, including cloud-based EDC platforms, is necessary to help reduce lengthening trial times and climbing study costs, with the ultimate goal of enabling the efficient development of advanced treatments for patients in need.
References are available upon request.