University Hospital Southampton NHS Foundation Trust

University Hospital Southampton NHS Foundation Trust

EDGE was developed within the National Cancer Research Network in 2000 as an information system solution to help front line clinical research staff manage research data. Our aim is to embed the capture of research data and performance datasets into the clinical research process and support reporting thereon. EDGE enables clinical staff to concentrate solely on research by intelligently supporting core research staff and the research process, the activity of reporting becomes a natural by-product of the research itself rather than an administrative burden. With over 200 organisations using EDGE in the UK and overseas, the application continues to go from strength to strength helping more organisations manage their research in a simple, adaptive, robust and secure web-based system. How we have grown Since developing EDGE 14 years ago, our team have frequently been approached by other medical research organisations requesting access to EDGE. We have grown organically within the clinical community and have nurtured an online, collaborative environment to support the research path and best practice. 2014-2015 is an exciting year with Transition within the UK NIHR Clinical Research Networks underway. This institutional change is bringing about new opportunities for alignment and efficient management of research data. Having started with just two staff in 2000, the EDGE team at the University of Southampton now employs a team of 14. EDGE development has gathered momentum in the last three years with the launch of EDGE v2 building on the feedback from previous versions and expanding the EDGE system to provide tools for R&D departments. The EDGE team will be continuing to work closely and collaboratively with our Users and the NIHR to develop EDGE further to support the end Users. This collaborative and joined up working helps to uphold the National Research Agenda. We look forward to seeing England, Scotland, Wales and Northern Ireland continue their roll out during 2014 across many of the new research structures. 2

17,000+ Projects 87,000 Documents 8000+ Users 900,000 Patients 1 Solution ü LPMS SOC Compliant

ABOUT EDGE EDGE has been specifically designed to give a real-time view of clinical research activity whether it s within a single site, a hospital Trust or across a Clinical Research Network. By providing a single, innovative, centrally-hosted clinical management system, EDGE supports collaboration and information sharing between key stakeholders from project registration through to closure. EDGE has a simple interface with a logical approach to governance and data collection enabling organisations to easily and accurately create reports, thereby turning their data into information, thus providing staff with a clear insight into their research environment. OUR VISION Facilitate and promote a collaborative research environment for all stakeholders Provide a single economic solution for entire geographic regions Support, share and promote best practice within the clinical research process and across the NHS Maintain the application to an exceptionally high standard through development and support Improve the quality of research management Continuously strive to meet and exceed the needs and requirements of our community 4

HAVE IT YOUR WAY The EDGE team understands each organisation is different, therefore the key components of the EDGE system are flexible enough for you to tune the system to the exact requirements of your organisation. The application is designed to help you better understand your internal departmental and stakeholders processes. These are mapped into the system, enabling organisational clarity on processes and real-time tracking of the entire research path. We are committed to organisational change being an on-going and positive process which should be supported by your research systems and not dictated or hindered by them. EDGE enables organisations and Users to customise: Fields for Data Capture: EDGE provides unlimited bespoke data fields at Organisation, Hospital Site, Project, Project Site and Patient level to ensure you can use EDGE as your sole research management system. Document Management and Sharing: Users with appropriate permissions can upload, download and share documents across all levels either within single or across multiple organisations using EDGE s version controlling, folder templating and accessibility controls. Patient Data Collection and Management: The system allows Users to configure patient workflows against the project site, as well as bespoke patient data fields, to capture vital information for clinical staff, which can in turn be used in reporting. Finance recording and reporting: Users create templates for projects, sites or patients and manage these efficiently in real-time to create reports for invoicing and activity. Project KPI s: A dashboard for each project can be accessed by your organisation to provide a snapshot or overview of performance. Reports: The flexible reporting combinations available within the application bring all the parts of the system together to enable the mining of the exact information you require at any time. Reports include: Time and Target NIHR High Level Objectives (HLOs) Report Sharing Multiple format exporting Patient Monitoring Reports Research Governance Workflows: These respond to the changing demands and challenges of research governance. The workflows function can also be used to manage: Feasibility, Expressions of Interest, Amendments, Finance and more. 5

Subscriptions With Transition to the new NIHR reporting structures and the introduction of LPMS Systems of Choice, EDGE has introduced a new annual subscription structure to reflect and support these changes, including the move to a per capita charge. For just 3.5p per annum per head of population, a CRN gains not just a tool for reporting time to target and the other HLOs to the NIHR but one that provides functionality from project registration, through recruitment to closure. In addition, Trusts in a region can make use of the same functionality for their non-adopted studies enabling them to keep all their R&D data in a single system, providing a complete overview of research within their institution. The CRN subscription model also covers use by Primary Care and any other parties in the area who participate in clinical research. In order for the CRN and Trusts to be able to drive out maximum benefit from their EDGE subscription, we place no restriction on the numbers of Users who may be given access to the application. The EDGE Community As part of the EDGE community, our Users are at the forefront of collaboratively setting and improving data standards for research. Since launching EDGE version 2 in September 2010, we have strived to maintain a single national record for each research project. As such, the EDGE team have merged almost 1000 records of duplicated projects, helping organisations work closer together with better data. The National Cancer Research Network has also appointed three EDGE coordinators from existing staff to move forward the standardisation of Randomised Projects Arms, Participant types, Disease Classification, ICD-10 coding sets and Patient Follow-Up Monitoring. This on-going work will see improvements to both centrally-held EDGE records and the NIHR s Portfolio Dataset. As an EDGE User, we would welcome you to our yearly conference to discuss topics such as Information Governance, Local Portfolio Management System roll-out, the use of e-crf s, effective resource management and National Data Standards. 6

Helping and Supporting Research At EDGE we strongly believe in supporting and facilitating the process of system adoption. We don t just provide you with a system access and a user manual and leave you to work out your own approach. Our Knowledge and Delivery team are here to ensure that you are supported in getting EDGE up and running in your organisation quickly and efficiently. Our structure has three main service categories to help you achieve your strategy and ambitions. Knowledge Our Knowledge team works with a subscriber s appointed Local Administrators throughout the process of training and implementation. This close working relationship and interaction with our Users helps us understand your organisation better and develop ideas, methodologies and systems in order to tailor our implementation to your requirements. Our team has a full understanding of the research landscape and the practicalities of working within the NHS gained through assisting numerous and varied organisations. We are thus well-placed to support Users get the best out of EDGE. Our contacts in the research community - both in the UK and overseas - enable us to provide advice beyond EDGE on many research issues, together with providing a more formal, integrated consultancy service should it be required. Delivery Our Delivery team is here to ensure that we liaise closely with you about what s happening within the EDGE programme, as well as to engage in the oversight and management of our system, processes, projects and business functions. Delivery includes our dedicated technical support services and acts as another source of feedback to the Knowledge team in order to drive continual improvements in the development and implementation of EDGE and other services. Development Our Development team works closely with our Knowledge and Delivery teams to deliver the functionality in EDGE that our subscribers require. EDGE has been independently audited to ensure that we are taking the best approach to security, development, testing and our technical platform creation. Going forward, EDGE is committed to carrying out such an audit annually and sharing the feedback from it with the User community. Knowledge Technologies We focus our efforts on the challenges of informatics within clinical research with the aim of transforming our customers research environment through software, informatics and organisational change. The EDGE team has a detailed knowledge and experience of regulatory requirements so that, regardless of the size of your organisation, we can help with compliance in areas such as: GxP EMEA, European Clinical Trials Directive FDA, 21 CRF Part 11 Human Tissue Act Data Protection Freedom of Information Guidance on Standards e.g ODM, CDIC, HL& ISO 9001 Quality Management We operate our systems out of hosting facilities that are compliant to the highest levels of security and resilience (Tier 4) and that are accredited to both ISO 27001 and 9001 standards, as well as ITIL support process standards. Although not legally required to be audited by regulatory authorities in our current role, we have taken it upon ourselves to be audited regularly by an independent Auditor. This extra effort ensures that we are meeting highest possible standards of customer service, operational management requirements and development processes. Our team is formally PRINCE 2, Good Clinical Practice, ITIL, ISO 9001 Quality Management Systems Auditing and Data Protection trained. Our Development is driven by you EDGE has always been a system developed and driven by the end User s requirements. The most powerful assets we have at our disposal are YOU, the Users. Effective information flow has to be in both directions, therefore, EDGE has implemented IdeaScale to help us gather and crowd source on feedback and functionality requests so we can quickly evaluate and prioritise it into our development schedule. This means you get what you need, sooner. IdeaScale is a community feedback forum from the EDGE application which is accessed through the Support tab in EDGE. It is designed to help us be more effective by enabling our Users to discuss their ideas about EDGE and derive suggestions for application development and improvement. In February 2014 we had 26 User driven ideas in Development, all of which are due for release during the year. 7

The flexibility offered by EDGE means we have been able to successfully introduce it not just to the research staff but also to our service departments, such as Imaging, who traditionally have used standalone systems. This means we are benefitting as we can use the system as an intelligent data management tool to fully integrate information from all departments to produce meaningful, quality data for outcome analysis We wanted a system that was intuitive to use and that focused on the needs of both researchers and research managers. We knew that we also had to have information about how we are performing at our fingertips but wanted to reduce the reporting burden for our research teams. The EDGE system delivered all of our requirements. We needed a system that would reflect the organisational change we have invested in to improve our research performance and capability that we need to be a world class research environment. EDGE provides us with that. Advice We do not only deliver and develop the EDGE Application. If you require advice about data management or informatics in clinical research and you think we can help, please feel free to contact us. Join our community If you would like to join our community of research organisations that want to make a difference then we would be happy to discuss this with you in more detail. Please contact us for general enquiries or a demonstration. Come and talk to us EDGE Clinical Research, Clinical Informatics Research Unit, Somers Cancer Research Building MP824, Southampton General Hospital, Tremona Road, Southampton UK SO16 6YD +44 023 8120 6432 contact@edgeclinicalresearch.com www.edgeclinicalresearch.com