No, I have not gone off the deep end! Bear with me a minute. The FDA may, in the near future, declare that trans fat is an additive and therefore requires premarket approval to be included in food. See the following article for more details:
The article mentions that, "Trans fat has been linked to an increased risk of coronary heart disease, in which plaque builds up inside the arteries and may cause a heart attack." So you might wonder why we even include such things. Trans fat prolongs the shelf life of the product. The interesting thing to note is how many products that use partially hydrogenated oils that have trans fat.
It seems that as time rolls along we learn more and hopefully live better and longer lives. The problem in this case is that the problem did not come out untill long after the products had been on the market. It is the same with software. No company can possibly hope to test every possible way that their software will be used, unless the software is incredibly simple. In the pharmaceautical industry nothing is ever simple. So software companies strive to eliminate all possible defects from any version of their products.
This is one of the reasons the FDA decided to go with a risk based approach. When it comes to software you always need to look at what the ramifications are of the software not working properly? There is a world of difference to a report cutting off text on a report versus a machine that delivers a life threatening dose of electricity or radiation.
With the ClinPlus product line we evaluate each new version of the product. For example, ClinPlus Data Management creates and modifies clinical data that will ultimately be submitted to the FDA. That system runs a higher risk for what it can do to the data than say our ClinPlus Report product that just runs reports and does not modify data. Now there is risk presented by our Report product if the statistics it produces are not accurate. That is one of the reasons that product has its own built QC function that allows you to run just the base SAS code to check the calculations against.
So what in the software realm really compares to the whole trans fat issue? Maybe you remember the Y2K problem. Everyone thought that the economy might come to a crashing halt due to legacy systems that stored the date as a two digit number as opposed to a four digit number. Fortunately for us and our clients our dates were stored in numeric fields that allowed for four digit years already.
This whole plan to remove trans fat at its heart (all pun intended) is one to improve our health. At DZS, we strive to improve our processes so that we can be more effecient with existing resources. One way that we do that is to incorporate exploratory testing into the test phase for any new product. As we create our scripted test plans\test cases, we have to see how the existing system currently works and how the new system will work. This process helps the developers from the unit test phase to integration and system testing.
However, you cannot test your way into a quality product. You can try, but it will rarely be successful. It is far better to improve the entire software development life cycle (SDLC). This in the end makes testing the product easier, since you know how things work and what to expect. It makes the product easier to maintain since the design of the product is not an after thought.
We always work with our clients to help them understand the magnitude of change in any new version, so that they can better determine what level of revalidation they choose to take with the product.
ClinPlus Data Management 3.4 with over 30 functional enhancements is being readied for a Q4/2013 release. This release represents DZS’s commitment to the continued development of their Clinical Data Management that has supported thousands of clinical trials worldwide for more than 20 years.
The DZS Software development team has been working hard to design, develop and validate the many enhancements that were requested by our user community to simplify, streamline and add flexibility to the clinical data management tasks.
One of the key enhancements to the system is the addition of a Dashboard module that displays CRF Tracking, Clinical Data and Queries of all patients in a study. A tree view displays all casebooks with visual cues for page status, record existence, and query status. A list of key metrics is also displayed and used to drill into study information. Links to records, queries, audit trails, etc. within a click or two.
Some additional enhancements include:
- Query management module facelift to:
- Relocate query selection functions to a single button
- Allow resolving multiple queries at once with a comment only
- Display long text fields in a word-wrapped text pad (question, prompt, resolution)
- Alter the contents and order of data being displayed
- Add a link to Browse associated clinical records
- Show the Re-query parent link
- Enhanced sorting of displayed queries
- Improved workflow control via the addition of Restrictions and Reversion control in query Levels
- Overall performance of all query tasks has been significantly improved
- The addition of a Quick Query Viewer available on data entry screens allowing users with or without Query Management access to view queries
- Option to De-dup queries by Question Code in COVER processing
- Ability to inactivate display orders
- Search feature in the User Editor
- Export to CSV(Excel compatible) added top data listings
In addition to the functional enhancements, many support issues have been addressed to ensure the continued reliability of the ClinPlus Data Management system. Our support team strives to answer every question and resolve each issue quickly. This expert level of support coupled with the reliability of the system ensures productivity and fast data base locks.
Contact us for information about upgrading to ClinPlus Data Management Version 3.4.
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.
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.