It's all About the Data and MetaData

A course in Data Management 101 from ClinPlus

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"We are a small emerging life sciences company, and we need to have a data management system that can handle paperCRF-based trials initially, with the ability to move to electronic data capture eventually, but we're not sure what's required in terms of additional staff, hardware and validation."

• Does ClinPlus software require specialized hardware?

Reason for asking:
Both minimum and recommended requirements should be obtained. The simpler the requirements the less costly the system.

DZS Answer:
The hardware requirements for the ClinPlus DM system are the same as SAS's. Generally, if you are able to run SAS then you will be able to support ClinPlus.

• Do we need to have programmers on staff to support your software?

Reason for asking:
Be sure to find out in what situations or phases of study setup where staff programmers are needed. Then inquire about what skill sets are required. The fewer the programmers and the less advanced they need to be, the more likely the software is better designed and easier to use and modify.

DZS Answer: 
Although programming is not required when designing data entry screens, ClinPlus does include "events" where custom code may be inserted.  This allows users to define data entry screens to work exactly as required for their unique application.  SAS SCL programming is used to support this feature (many examples can be found on our User Forum section under Support). 

 Also, Base SAS programming is required for writing edit check programs and any custom reports that are required. No DBAs are required to maintain system data.

• What kind of on-site support staff will we need with your software?

Reason for asking:
Onsite support includes IT support, DBAs, programmers, writers etc. You should also know what skill sets are required. The more support, the more demanding the skill sets requirements, the more expensive the system is to operate.

DZS Answer:
Typically the data managers administer the ClinPlus system. Because ClinPlus is purely SAS, there is little need for IT intervention other than hardware and data backup support. A SAS programmer or two may be needed primarily aiding in screen design and writing edit check programs.

• Will I receive upgrades and enhancements? How often? How much will they cost?

Reason for asking:
While you should expect to receive periodic upgrades and service releases, when those updates are too-frequent "patches", it may be an indication of software instability. Such instability can result in a validation nightmare. It is advisable that you inquire as to the release history of the system. The cost of upgrades should also be considered and added to the overall investment cost.

DZS Answer:
ClinPlus Data Management has been evolving for nearly 20 years with incremental updates including feature and performance enhancements and bug fixes. Incremental releases have averaged 1 per year. If serious problems are identified then a service release is provided immediately. This has occurred less than 10 times in the entire history of the software. DZS is dedicated to the continued development of the ClinPlus software to better serve our clients and to react to the ever-changing technologies and regulations.

• What aspects of the clinical trial process does ClinPlus software address?

Reason for asking:
Most clinical trials software programs are quite specific in their application. Be sure to determine exactly what applications are supplied as well as what other integrated modules are available. Although you many not recognize a current need for a specific capability, it is advisable that the software you choose be able to smoothly integrate with the full scope of clinical trials software requirements.

DZS Answer:
The ClinPlus Data Management product supports CRF tracking, data entry and data review with additional features that support EDC capabilities, import/export and a customizable report writer.   Also available are ClinPlus Coding that supports auto and manual coding of adverse events and drugs, ClinPlus CTMS for your clinical trial management needs and ClinPlus Report for the production of NDA quality tables and listings.
DZS Software Solutions provides the broadest suite of software available for clinical trial support.

• Is ClinPlus software fully validated?

Reason for asking:
If the software in not fully validated, neither is the data it will generate. Software validation is a key requirement of data submitted to the FDA.

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:
You are urged to conduct a vendor audit before investing in any clinical trials software. If you are audited by a client or regulatory agency, 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 during an audit. DZS personnel are also available to assist in an audit.

For more information regarding the implementation requirements of the ClinPlus Data Management System please go to: