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.