Posted by Keith ward on Tue, Dec 06, 2011 @ 01:24 PM
Whatever your mode of entry, DZS Software Solutions has a solution!
As the industry slowly moves toward site-based entry, companies are finding it necessary to support multiple modes of clinical data management, oftentimes within the same study.
Electronic data capture has promised unsurpassed productivity gains for several years now, but reality is that there are still many life science organizations, particularly emerging to mid-sized Pharma, Biotech and Medical Device sponsors, conducting paper trials.
ClinPlus Data Management supports paper-based and site-based entry with features such as role-based menus, electronic signatures, and site-based security.
In addition, ClinPlus Data Management offers:
1. Shorter term return-on-investment
2. A self-sufficiency learning curve that is much shorter than getting your staff up to speed with EDC processes
3. Less complex integration with legacy systems, projects and external systems
4. Greater latitude to adapt to different size and different phase studies
5. No need to export SAS data from within the system
6. CRF imaging techniques that facilitate side-by-side data entry
7. Full CRF tracking and query management capabilities
8. An extensive array of reporting capabilities.
If you've shopped around, and followed the technology trends you know that full EDC systems carry a hefty price tag, and often the technology support and hidden fees to keep the system running smoothly can catch up with you, making you wonder where the promised productivity is.
If you'd like to compare the ClinPlus Data Management/EDC system with others, we encourage you to use this handy tool to see the details: http://edcmarket.appspot.com/
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).
EDC Market 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.
Posted by Keith ward on Wed, Jan 12, 2011 @ 05:43 PM
When your using a clinical data management system, screen design and flexibility are very important. Below are 6 screens from the ClinPlus DM system, a SAS-based solution that has been used since 1996 by over 60 biopharmaceutical organizations worldwide.
1. Data Entry Screens
Data entry screens are designed in our screen design module and can include input objects such as Text Entry, Text Pad Entry, Drop Downs, Radio boxes and Check Boxes. Labels can be added as needed. Fields can be placed in any order. Cursor control is by position unless set in NextField property or custom coded in the fields OnLostFocus() event.
2. Data Entry with Image Viewing
The data entry screens can be set to provide side by side image viewing. Images are linked to a data entry record by the page tracking information. Typically this setup is used with an OCR system which scans the forms in. The tracking data and image path information would be imported.
3. Audit Trail
The audit trail for a record may be viewed directly from data entry by clicking on the Audit Trail icon. Additionally, any of the System or Clinical audit logs can be viewed from the Listings module.
4. Screen Edit check based on field property ValidValues.
Several field level properties can be set to validate the use input. In this example the field will error if value entered is not in ValidValues list of D, M or Y. A default message is displayed in message line.
5. Screen Edit Check based on custom Code
For any field, custom SAS SCL code can be written to validate values entered into a field including cross referencing of fields on the screen or lookups of other data. A custom message can be set and displayed. A popup message can also be programmed if required.
6. SAS Transport files / exporting data
The system supports exporting data to flat SAS datasets or SAS Transport files. Both the XPORT and CPORT engines are supported. The export utility allows remapping / renaming of table and variable information upon export. For further manipulation, a post-process SAS Script can be used to create derived data or further manipulate the exported data.
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