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.
Looking at the CNN article at: http://www.cnn.com/2013/10/30/politics/obamacare-website-warning-memo/
It is very eye-opening and gives some good insight into the problems with the Obamacare website. If you scroll through it you will find a link to the memo they are referring to. The memo to Marilyn Tavenner has the subject, "Federally Facilitated Marketplace-DECISION" and indicates that the issue of not completing all of the security testing is a high risk. The memo also indicates that the risk must be accepted and mitigated. That means they are going to fix the problem(s) later (they hope within 6 months), but the product will still roll out. So they do have a plan to mitigate the risk. They will put together a team and monitor the site and/or servers.
This sounds like at least they have done some sort of risk assessment and came up with a plan. The question is have they implemented it? How are things going? The memo says that the mitigation plan does NOT reduce the risk to the system, but just the overall marketplace.
I don't know about you, but high risk sounds bad to me. How much worse does it have to get before you don't launch a website with a high risk? What is the scale here? Is critical higher than high? It would seem that their mitigation plan should reduce the risk, but it does not reduce the risk for the system, just the marketplace. Another problem is that open enrollment ends by March of 2014. Guess when they hope to be done testing the software? It looks like the end of March. So it would seem that there will be ongoing security testing till the end of Open Enrollment. That means that the general public is actually testing the software for the government.
The article says, "She compared the early roll out to a sort of early beta test and said the system was secure because data is stored in the same systems used by the Internal Revenue Service and Department of Homeland Security."
To me, the idea of comparing it to a beta test is really annoying. I also wonder if this is just political spin? Maybe it is actually an alpha release? We never ship alpha or beta software. We have some clients that have asked for patches to our Clinical Trials Management System (CTMS) software or have wanted to work with beta versions of our system. You can be assured though that we would never force any of our users to use beta software. The client always makes that decision. Most of our clients chose to wait until we have validated the new release of one of our products. Too bad the Obamacare website is not required to have a version number or at least a build number that is visible to the public.
When we roll out a new product you can tell by the new version number how much of change there is to the system. The version number always displays in the system. Our version numbers are formatted as follows: X.X.X(SR-X), where the X's are numbers. The X's constitute in order a major, moderate, minor or service release. For example, the previously available version of ClinPlus Data Management (CPDM) was v3.30(SR-2). That was a service release. The new version of CPDM is 3.4 and is a moderate release. Our clients can expect a moderate number of changes to the application and fixes to defects in previous versions of the system.
Each of one our clients makes their own assessment as to whether they plan to upgrade. We often see that these decisions are coupled with a decision to upgrade from a 32 bit to 64 bit operating systems or a new version of SAS (if applicable). In any case, DZS Software personnel are ready to help clients understand and reduce any risks to using our software.
I don't know the details of how the Afordable Care Act (Obamacare) website rollout was supposed to work, but in the software industry there is such a thing as alpha and beta testing. I did not hear about that at all. In fact all I heard was that the deadline was looming and the software was not working. Maybe they should have rolled it out to a large city first and then a state. Work the kinks out and then go into production.
With the ClinPlus line of software we take testing seriously. We don't just test to the requirements or just the enhancements added or defects fixed. We regression test to make sure changes in one place don't affect another place. We boundary test to make sure the system can handle regular and irregular data. We do security testing with a keen eye at 21 CFR Part 11 and other regulations since that plays a big part in the life sciences industries. This article shows just the first layers of the onion. It will be interesting to watch and see how quickly the government can resolve this issue. Hopefully sooner than you or someone you know has to use it.
Nearly 20 million Americans have now experienced the broken Obamacare website first hand. But Ben Simo, a past president of the Association for Software Testing, found something more than a cumbersome login or a blank screen—clear evidence of subpar...
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.
ClinPlus CTMS Version 2.2 programming has been completed and the project has moved to the validation phase of development, on target for a Q4/2013 release.
Version 2.2 builds on a reliable and robust system first release in 2009 that has gained enormous popularity primarily for its combination of features, usability and cost-effectiveness.
At DZS Software Solutions, our development philosophy has always centered on the customer, evidenced by the 50+ specific enhancements added in ClinPlus CTMS Version 2.2 as a direct result of client feedback. Of these enhancements, some of the more significant ones are:
| New Domain Features
- Limit access to Contacts, Institutions, and Projects by Domain Type (Production, Training, Testing)
New Country Features
- New Country Tab enables Project Management at the Country level
New Custom Tables
- Design new tables and fields
- Include Custom Table Data on Site Visit Reports
New Document Sharing
- Inherit Project and Country Regulatory Documents down to Site Documents
New One-Click Reports
New Informed Consent Tracking
- Track Multiple Consents per Subject
- Link to Regulatory Approval Docs
- Include on Site Visit Reports
New Statistics Variables
- Select Statistics for Overview Tabs
- Override Statistics with Manual Values
- Current and Monthly Statistics
New Reduced-Data Projects
- Summary data at Site, Country, or Project level
Enhanced Project Events
- Rollup Events from Site/Country
- Create Dependencies between Target Dates
- Override Calculated or Imported Dates with Manual Entry
Enhanced Project Security
- Assign Site/Country specific access and permissions
- Configure Notification Emails at the Site/Country level
Enhanced Calendar Features
- Display Holidays, Events, Vacations
- Show Cross-Project Staff Visits and Events
- Additional Colors
Enhanced Global Contact Details
- Link specific Address, Phone, Fax, and Email records to a Project
Enhanced Selection Tools
- Previous and Next buttons enable rapid navigation when reviewing Projects, Countries, Sites, and Subjects
Enhanced Data Import Tools
- Global Contacts and Institutions
- Project, Country, and Site Events
- Protocol Deviations
Representatives from DZS software will be attending this year’s WHO Drug User Group meeting in Princeton, NJ on the 19th and 20th of September.
As ClinPlus Coding has recently earned software certification from the Uppsala Monitoring Centre, DZS will be provided space for a table-top exhibit where coding experts from DZS will be available to answer questions about the ClinPlus software and discuss coding issues, techniques and procedures.
To register for this meeting, please visit http://www.umc-products.com/DynPage.aspx?id=75618&newsid=10893.
Multiple dictionary setups connected to a single dictionary build database?
This is how you would setup a new thesaurus for that clinical study. You would create a new dictionary setup which points at the same dictionary build. This setup will essentially have an empty thesaurus to which you can now add new thesaurus entries to. Note that the thesaurus entries for this dictionary setup are stored in the SAME TABLE in the database as the thesaurus records for the other dictionary setup.
Dictionary Build MedDRA 14
• The build definition connects to a database
• In the database, one thesaurus table is created to store all thesaurus entries
• The one thesaurus table stores all thesaurus entries for all dictionary setups linked to the build
Oftentimes, during a site visit, a Clinical Research Associate will update information and data in the system if they observe important issues or adverse events. Unfortunately, with many CTMS systems available today, not all of those changes will wind up in the final site visit report, creating silos of information or even worse, loss of information and data that might prove critical to the trial results.
DZS Software has addressed this issue and built an all new Site Visit Report Tool feature that enables CRAs and Project Managers to author and review trip reports, while managing the workflow from first draft through final approval. This new feature will enable clients to configure report templates based on visit type and country, and to integrate CTMS data directly into the trip report. Unlike many other trip report authoring tools, the data entered by the CRA while creating the report is deeply integrated with the main features of the CTMS to reduce data redundancy. Updates to system data elements commonly found in the trip report sections such as regulatory documents, issues, enrollment, SAEs and deviations are done while creating the report and do not need to be re-entered into other areas of the system.
"Price is the most specific piece of information customers use to understand the nature of an offering and not providing it makes people feel lost and reduces their understanding of a product line. We have miles of videotape of users asking "Where's the price?" while tearing their hair out." - Dr. Jakob Nielson, Web Usability Expert
Are you a Pharmaceutical, Biotech or Medical Device executive charged with finding ways to improve your clinical trial process by leveraging the latest technology? Are you frustrated that you are unable to adequately compare the various vendor’s offerings, particularly when it comes to defining the total cost of ownership? Are you adverse to talking to a salesman or being put into a lead nurturing program before you know if you can really afford their product? “Budgetary Information is the #1 item of interest prospects are looking for, but can't find, when they are researching new software solutions. If you don't provide it, someone else will. “ - Stefan Tornquist, MarketingSherpa
Well, now DZS Software Solutions’, manufacturers of the ClinPlus® brand of clinical trial software, is now offering self-service budgetary pricing on their website for each of their entire suite of products. The pricing utility is completely self-service and does not involve any DZS salesperson intervention or follow-up email marketing. The system provides pricing for both lease and purchase options, various numbers of users as well as implementation, training and validation script fees. How’s that for convenience when budgeting for upcoming business process optimization?
The technology DZS employs to accomplish this is called Echoquote http://echoquote.com. With EchoQuote™, when an interested prospect is on your website, they will be able to easily request budgetary information in seconds, even for complex solutions. They choose your items, enter their information and click "Get Budget Info". If approved, the end user gets their "budgetary quote" and you immediately begin to build trust. The entire process can happen in seconds, while the prospect is still thinking about your company. Want to check it out for yourself?
Simply go to the website at www.clinplus.com and search on any of their products and look for the button below:
ClinPlus Report is the industry's most widely-proven, SAS®-based, statistical table and listing authoring tool for creating the highest quality statistical tables and listings from any type of clinical data.
ClinPlus Report allows you to easily produce a variety of complex FDA-ready tables and listings in New Drug Application (NDA) quality. It also produces effective statistical tables, and utilizes over 70 different statistical values across numerous SAS/STAT procedures. You can choose precision, group and class variables, sub-setting, or subtotals, and you always have the final word in controlling the appearance of the table. ClinPlus Report's extensive format control features are a tremendous asset when preparing any summary you require and producing tables and listings in any format you need.
Reports generated with ClinPlus Report promise to be consistent, of superior quality and based on your standards, even across disparate programming groups. And you will benefit from the peace-of-mind that comes in knowing the reports you deliver are produced using a validated product and are totally CDISC-compliant when included in your eventual NDA, eCTD, NeeS marketing authorization applications.