EDC Market
http://edcmarket.eclinicalhealth.com
About EDCMarket
History
In 2009 eClinicalOpinion compiled a catalog of Electronic Data Capture systems, comparing EDC systems and vendors in an attempt to make it easier to understand the choices in this market.
The survey was useful but each company was listed as a separate page and it was difficult to compare EDC systems side-by-side. To address this eClinicalOpinion created the EDC Market Tool and announced it in a post on his blog.
To date, the Original EDC Market tool has been visited more than 3,000 times by people comparing EDC vendors and systems.
This new version of the EDC Market Tool has been expanded to include additional features of EDC systems including Site Payments, Randomization, Inventory Tracking, Offline capability and integration with Electronic Health Records (EHR).
In October 2013, eClinicalHealth took over the running and updates of the site on behalf of eClinicalOpinion. We aim to continue the excellent work of eClinicalOpinion, and over time expand the information with external reviews and widen the scope fully beyond EDC.
If you are a vendor, and you wish to submit a new eClinical solution that you have released, or, if you have updates, please complete the following Please fill out my form.. We will then check details, and apply the updates to the register on your behalf.
Methodology
EDCMarket is an attempt to bring together information on commercially available Electronic Data Capture systems in a way that makes it easier for potential EDC users and buyers to research the market.
Every EDC system is different and I have chosen a dozen features to try to make it possible to compare EDC systems in broad terms. The information for the survey comes from the vendors own websites and marketing materials. Capabilities may have been overlooked or given more weight that they deserve, this is a general guide only and a basis for your own research.
Trademarks, Service marks, Copyrights etc are all the property of their respective owners.
Accuracy & Corrections
If you feel that a system or company is being incorrectly classified please get in touch. You can do this privately at eclinicalopinion@gmail.com or use the Feedback tab on the side of every page. I welcome corrections and additional information about a company or product.
If you are the owner of a particular company or system and would like the image of your company or system to be updated please provide me with a 1024x768 JPEG file and I will update.
This section describes the meaning of the various features tracked by this website.
Document Management
The capability to store documents related to the trial. These might be archived reports, regulatory documents or CRF Completion guidelines. The system may offer simple document storage or may have more advanced portal and/or document management features such as document versioning and workflow.
ePRO (Electronic Patient Reported Outcomes)
Electronic Patient Reported Outcomes (ePRO) is a method that allows patients to complete questionnaires. This could be a handheld eDiary device or it could be web-based via IWR (Interactive Web Response) or telephone based with IVR (Interactive Voice Response). What type of ePRO best suits your study will depend on your patient population.
Randomization
It has been traditional to use an Interactive Voice Response System (IVRS) to randomize patients to trial supplies. Some EDC systems provide an integrated method to perform randomization (using various algorithms) which may be more convenient for users in some situations than a telephone (IVRS) and computer (EDC) combination.
Inventory Tracking
Managing inventory levels of trial supplies at site, re-orders, shipments and receipts is usually managed by IVR Systems. Some EDC systems now provide inventory management or offer out-of-the-box integrations with these management systems.
Ad-Hoc Reporting
EDC systems have reporting capabilities. Many boast of the number of pre-defined (canned) reports that are provided as standard with the system and most vendors will provide further customized reports for a fee. In recent years Ad-Hoc reporting has become a must-have feature, allowing users to create their own reports. The best of these systems will allow reports created for one study to be easily used in other studies so that companies can develop a set of standard reports that support their processes.
Safety
Increasingly Sponsors are looking to EDC to alert them to Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) as soon as they are entered into the system. Many EDC systems claim to be able to complete CIOMS or MedWatch forms. Others may have sophisticated systems that allow you to automatically integrate with a Pharmacovigilance system via E2B formatted messages and web services. Generally EDC systems are not a replacement for systems that track and manage the reporting of Serious Adverse Events, instead they provide early warning.
PDF Archiving
At the end of the trial it is necessary to provide the Investigator with an archive copy of the data collected during the trial in a readable form. PDF (Portable Document Format) is a popular way to manage this. PDFs with a format very similar to a paper CRF and including all queries and audit trail can be prepared and provided to the site. Other forms of PDF archive can be used for submission purposes.
On Demand Export
A data collection system is only as good as your ability to get that data out. EDC systems should provide the ability to schedule data dumps in your format of choice (SAS, Excel, ASCII etc) but also provide "data on demand" so that you are not forced to wait to get the data when you need it immediately.
Lab Management
When Lab tests are taken, whether processed at a Central or Local lab, it is useful to have the normal lab ranges integrated into the EDC system so that validation checks can be run on the analyte values entered and outliers flagged. Analyte values themselves might be entered by the site, by a central group or be fed in directly via a lab-feed integration. Out of range values should be flagged by automatic queries or warnings.
Multi Language
Is the EDC system Internationalized and into what languages has it been localized? Clinical trials are run all over the world and although many trials collect data entered in English there is often a need to collect data in the local language for late phase trials. A multi-language system may allow just CRF content to be translated and may or may not allow simultaneous use of multiple languages. More advanced systems will have the entire system translated into the local language (all screens, reports, help messages etc).
Site Payment
For a long time site payment capabilities have been a feature of Clinical Trial Management Systems (CTMS). Some EDC systems are now providing rules-based site payment capabilities which identify the conditions for payments to be made, track approvals and payments made.
Paper Trials
EDC is great until the power runs out, the network dies or the investigative site just plain won't use it. In those situations you'll want the hybrid capability that some EDC systems provide. The best of these systems will provide different types of double-key entry and reconciliation, a system to track the sheets of paper in and through verification and a method to create, send, receive and track Data Clarification Forms (DCF's). This capability should not be confused with Offline Capability which allows an EDC system to be used disconnected from the network, re-syncing when the network is restored.
Offline
Offline capability is useful when you want to use an EDC system in an area where network connectivity is poor (for instance, rural locations) or where you want users to be able to work disconnected from the network. EDC systems that support this store all data and queries until network connectivity is available and data can be synced.
Medical Coding
Does the system provide some method to perform medical coding activities with standard dictionaries such as MedDRA? The best of these systems will provide auto-coding facilities, allow custom dictionaries to be loaded and synonym lists to be managed.
Electronic Health Record (EHR) Integration
Medical records are rapidly migrating away from paper files to electronic records. Some EDC vendors have demonstrated capabilities to extract data direct from EHR systems, removing the burden of transcription from the site. EDC systems or vendors that have demonstrated the capability to integrate with EHR systems through the emerging standards such as the Continuity of Care Document (CCD), Continuity of Care Record (CCR) and Retrieve Form for Data Capture (RFD) or proprietary method are credited here.
Many vendors support the CDISC ODM standard. In this section we highlight vendors who have achieved official CDISC ODM Certification, what version and when certification was granted.
Planet EDC is an aggregator for a number of EDC and eClinical related blogs. If you have an appropriate blog and would like it included, email me at eclinicalopinion@gmail.com.
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