EHR (Electronic Health Record) based EDC for Clinical Trials and Quality Outcome in Eye Care The new World of Clinical Research in Eye Care 1
The new World of Clinical Research in Eye Care The electronic era in health care sets new dimensions Electronic Health Records (EHR) become the standards worldwide. Physicians are no more willing to enter clinical data 2 or even 3 times into digital systems or paper forms. Data from ophthalmic equipment (test devices, image and laser systems) have to be imported into EHR systems using seamless interfaces. More than 450 different systems and types can be connected. EHR systems in combination with digital equipment pools become the primary sources for Electronic Data Capturing (EDC) for all kind of clinical trials and studies. 2
The new Era of EDC with EHR in Clinical Research 80% of data entries can be saved by using innovative Health IT Traditional Clinical Studies History EDC / EHR based Clinical Studies Future 5% 5% Images Demographics Manual 5% 10% 10% 30% Images Instruments EHR Demographics Manual 90% 45% 3
What are the advantages for the physicians? The physicians save qualified clinical capacity (5% manual data entry versus 90% in the traditional paper world. The physicians can participate in more research projects and can re-use data as these are all compatible The physicians can use the data also for their own internal reporting and improvement of quality and efficiency. 4
What are the advantages for the industry? The sponsor can select qualified sites easily by screening digital patient profiles (anonymous). The sponsor can have access to the data anytime to evaluate the quality of the information and the compliance with time benchmarks. The sponsor can receive the results more timely (all information are already evaluated within the data collection process: clean data) 5
What are the advantages for the industry? (2) The sponsor can reuse data for follow up research and future trials The sponsor can realize 50-100% more clinical studies with the same budget The sponsor is always compliant with legal and regulatory requirements The sponsor can demonstrate its own innovation potential and leadership on the market (digital competence is an important USP) 6
Which criteria have to be considered (choosing the partner) The Qualified Research Partner (QRS) for EDC based Clinical trials should have access to EHR solutions (Health IT provider) The QRS should have approved and certified solutions (e.g. ARRA in the USA, ISO 900X for quality management etc.) The QRS has to provide solutions based on international standards (such as SNOMED, HL7, DICOM, CDA and IHE etc.) and connectivity to the complete ophthalmic instruments and devices! 7
International IT Platform The ifa Group is the exclusive provider of the Information Technology (IT) of EUREQUO EUREQUO is the largest Health IT project in ophthalmology. EUREQUO, hosted by ifa, is a web based platform for clinical outcome in eye care. So far more than 1,2 M surgery cases performed by approx. 1,400+ surgeons are stored in the system. The existing infrastructure is approved and offers a wide range of reporting functionality. Industry partners benefit from the ESCRS and ifa investments and save up to 25% of tradional costs for clinical research. Vendors (IOL, medical devices, pharmaceutical products etc.) can realize dedicated pre- and post maket studies by using the EUREQUO platform with separate data sets and dedicated data bases and offer the ophthalmologists compatible solutions. 8
Complimentary partners for Clinical Trials The qualified partners are dedicated only to eye care Ifa Group of Companies Leading Health IT in Eye Care worldwide More information on request www.ifa4emr.com www.eurequo.org EUREQUO Platform Established and approved IT environment 9