It's all About the Data and MetaData

safety tables & listings - 5 Questions to ask when buying software

Who in my company will benefit from a Report system?

Reason for asking:
If a wide variety of people like programmers, data managers, data coordinators, statisticians, QA and managers can see a benefit then the system will be more valuable and easily cost justifiable.

DZS Answer: 
Statistical programmers and statisticians use ClinPlus Report to create professional looking, submission quality tables and listings in less time and with more consistent results.

Data managers are easily able to produce high quality data listings as required during an ongoing study.  Patient profiles can also be created and used to facility the database QC process by selecting a random percentage of subject data to be printed.  A QC summary report will provide record and data point counts along with error acceptability calculations.

Medical writers benefit from the high quality RTF tables that may be included in the NDA submission document without any reformatting at all.  This will greatly reduce human error risks in the final steps of the process.

Stakeholders will also benefit by the time saved in preparing a superior submission document that will help bring the product to market sooner.

Will this system produce 100% of my reports?

Reason for asking:
To better understand the systems range and capabilities.

Inevitably you will come across a unique report requirement that can not be fulfilled by ClinPlus Report.  However, our clients report that virtually 100% of safety tables and about 80-100% of efficacy tables are easily produced along with 100% of listings and patient profiles.   DZS developers continually strive to improve system functionality and to meet ever-changing requirements and standards.

Is your software fully validated?

Reason for asking:
Software validation is a key requirement of clinical data systems used for FDA submissions.

DZS Answer:
DZS follows strict SOPs written to satisfy FDA and industry regulations and guidelines. No ClinPlus software is released until it has been fully validated.

Are validation documents available to me?

Reason for asking:
If a client or regulatory agency audits you, your software vendor should be able to produce a well organized complete validation report with supporting documentation and assist you with the audit.

DZS Answer:
Yes. A copy of the validation summary may be requested and all supporting documentation will be made available to you for an audit. DZS personnel are also available to assist in an audit.  We also recommend that you conduct a vendor audit before investing in any clinical trials software.

Do you provide a test plan?

Reason for asking:
This is important if your SOPs require that you validate the software in your environment. A comprehensive test plan may take many weeks, even months to write from scratch.

DZS Answer:
The test plan used in the validation process is provided along with any required data and programs. Test plans are extremely comprehensive and written in a cookbook style allowing persons not familiar with the software to conduct the tests.

Need to produce "SAS-based" Tables and Listings in a hurry?

Avoiding that huge mess when your lead SAS programmer gives notice...

Statistical Programmers are varied in their approach on how they execute their craft.  Each programmer is unique in how they get to their end result.  This varied approach can be challenging when you want to replicate what was done or pass on the knowledge to other programmers.  Worst case scenario, your lead programmer gives notice and you are left with deciphering their code. 

The impending disaster that could result when your lead programmer gives notice and leaves, with the intimate knowledge of the work in progress can be avoided if your team uses ClinPlus Report^® for generating reports.  Although ClinPlus Report is not a library of reports, it does produce reports in an extremely standardized, template-based manner. 

The system is not only capable of developing standardized and one-off reports, but it is also excellent for organizing reports for a workgroup. Corporate-level, standard template libraries are able to be created and maintained so that project and study-level templates can be easily derived by statistical programmers.  All of the templates are written using a common logical approach, thereby eliminating confusion amongst programmers and providing a clear path to understanding how templates are created for new programmers. 

Additionally the system includes additional features such as a title and footnote library layered in levels for easy maintenance, RTF output generation in format designed to please the pickiest of medical writers and the ability to extend to a listing, patient profile and data base QC tool for Data Managers.

The tables and listings generated out of ClinPlus Report are produced using an automatically generated SAS data null program that  provides the flexibility the Life Sciences  industry demands, without compromise.

So, when left in a lurch by key programmers who are moving on and your deadline is staying put, you can rest easy that new programmers or experienced DZS programmers can pick up the ball and run without delay using ClinPlus Report.  At this late stage in the game, can you afford any less?

For more information on ClinPlus Report and a FREE download of tables and listings examples please go to:

http://www.clinplus.com/report-landing-clinplus-report-tables-listings/?utm_campaign=Report%20&utm_source=DZS%20Blog