Last week, ARITHMOS hosted a symposium on eCRF needs and requirements for various sectors conducting clinical research. The purpose of the symposium was to discuss the importance of eCRF vs. paper trials and how Sponsors conducting trials on restricted budgets can still implement eCRF and EDC solutions. The symposium was hosted at the University of Milan-Bicocca, which is celebrating its tenth year of the Faculty of Statistics.
The symposium included presentations on eCRF requirements for the CRO environment and in academic research. Professor Giovanni Corrao of the University of Milan-Bicocca discussed requirements for academic clinical research.
One of the main points of the event was: why eCRF?
Conducting a study requires the collection of a large amount of data that can be entered, checked, confirmed and finally grouped together in a single database. These steps require significant logistical means in order to comply with GCP (Good Clinical Practice) and regulations on the protection of people’s safety and well-being.
The setting up of a central database and an electronic collection form via the Internet called eCRF (electronic Case Report Form) meets these needs by combining technology, simplicity, privacy and data security. The use of electronic case report forms to gather data in randomized clinical trials has grown to progressively replace paper-based forms.
Cost is, of course, an important factor to be considered when choosing an EDC system. Although the nature of licensing and support required to maintain an EDC system are the main predictors of cost, the purpose of data capture and workflow at the site of implementation also have a major influence. Commercial EDC systems are expensive in comparison to open source or proprietary EDC systems, the latter being more common in the non-profit, academic sector.
The symposium pointed out that smart open source and/or proprietary EDC systems offer enormous opportunities to expedite clinical trials. They can be tailored to the needs of all parties involved and still perform numerous trial functions. These systems can simplify study monitoring and reduce costs for on-site monitoring visits. Additionally, they can improve safety monitoring through real-time surveillance. These systems would empower and enable a wider variety of people to conduct trials since capturing, cleaning and extracting data would not be overly daunting or expensive. While a proprietary system can be beneficial and cut costs, it is also important that the system be cloud-based, as pointed out during the symposium, in order to manage studies anywhere, anytime with no hardware or software installation required.
ARITHMOS’ Stefano Piccoli, who leads IT Quality & Compliance, discussed the importance of data integrity and having a validated eCRF to be compliant with EU regulations and GCP standards.
ARITHMOS finished the symposium with a demo of its propriety, cloud-based EDC system, Symphony, which is an affordable EDC system that has essential features such as database build, integration with ePRO and customizable reporting tools. For more information, visit www.symphony-edc.com and check the ARITHMOS website for upcoming events and symposiums.