Ergomed’s goal is to find the best electronic data capture (EDC) solution for the specific needs of each project.
We use three different approaches to EDC, depending on the needs of your clinical program.
1. In-house EDC
OPVERDI has been developed by an interdisciplinary group of experts with many years of experience in international clinical research. It enables us to offer an individual solution at a competitive price with an extremely broad range of features:
Our in-house electronic data capture system using OPVERDI offers:
• Full compliance with FDA and European Commission requirements
• The ability to manage diverse study designs across phase I-IV and device studies
• A single database to manage various sources of importable data from central labs
• Full integration of a randomization and decoding module
• Email alerts upon dedicated user actions (for example, randomization, SAE data entry).
• Fast and flexible implementation of the electronic case report form (eCRF)
• User-friendly systems with intuitive navigation, study-specific guidelines and help functions
• Customized data listings/exports.
2. IBM CD EDC build
Where additional functionality is required – for example, electronic clinical outcome assessments, (eCOA) or integrated investigational product (IP) management and dispensing – we offer to build an EDC system using the IBM clinical development (IBM CD) system.
Our team of certified IBM CD designers are fully integrated into the wider data management team, enabling streamlined communication and reduced build times. IBM CD is a modular system, so costs are based on modules used and data stored, offering competitive pricing.
IBM CD has all the functionality of market-leading EDC systems plus two additional advantages:
- IMP Management: The ability to maintain a complete inventory of intellectual property, automatically trigger re-supply, track orders and dispense of individual items per patient.
- eCOA (ePRO, eDiary, eConsent): A wide range of data captured directly in real-time via patients, clinicians and caregivers, and any web-enabled device or phone app. Patients using electronic patient-reported outcome (ePRO) demonstrate significantly higher protocol compliance and real-time availability of data offers faster clinical development.
3. External EDC build
We are able to support clients who prefer to use a different system by building an EDC alongside our qualified vendors (for example, Medidata Rave, Oracle Inform and VIEDOC).