The Situation: A large client had been conducting infectious disease studies worldwide for several years and had collected patient data on hundreds of patients and thousands of paper CRFs.
The Problem: Unfortunately, because the patient data was collected at a variety of sites and in different ways, the CRF data wasn’t documented or presented consistently, making efficient double key data entry difficult. The data entry forms for the studies did not follow best practices for insuring rapid data input, often requiring the staff to reference ancillary data, jump from one place on the form to another or switch from straight text entry to mouse/click check boxes. While this may seem trivial, when data entry people have to change focus or switch from one method of entry to another, or look elsewhere for information, the resulting time loss can be significant especially across data entry groups who are on a strict timeline! The client understandably asked DZS Clinical Services to provide some expertise and assistance in order to complete this project on-time and within budget.
Solution: DZS Clinical Services, with over 25 years of experience in data management and a professional team of skilled employees, assigned a Project Manager. a data managers and data entry people, who were quickly briefed on the requirements of the project and the expected timeline. Over the course of three weeks, data was entered remotely into the Clients’ system continuously from several thousand CRF pages. As the data managers became familiar with the project and some of the complexities of the data entry task emerged, improvements to the screen design were suggested for future screen design. Because of the speed with which the first phase of the project was done, the client decided to give DZS thousands more pages, more than quadrupling the original task .These additional pages were completed ahead of schedule, within budget and excellent quality.
The Future: Because the project was performed by skilled and experienced data management and data entry professionals, common bottlenecks were avoided and the project went much smoother and was completed earlier than if the client enlisted the aid of inexperienced data management and data entry staff. As a result of completing the project earlier than expected, clean data was available earlier in the process for analysis and some immediate findings as to what medications and dosages were more effective for treatment of the disease were realized. Additionally, with suggestions from DZS as to how to more efficiently prepare screens and organize fields for input, data entry in future studies will be more rapid and efficient, cost less and allow research personnel to gain earlier visibility to future data, gain competitive advantage and realize greater return on their clinical research investment.
DZS Clinical (www.dzs.com
) is a full-service data management and biostatistics-focused CRO located in Bound Brook, NJ. We utilize our state-of-the-art clinical software to optimize data and information flow and report presentation. With very low employee turnover, we maintain a highly experienced and dedicated team of data managers, statistical programmers, medical writers and other clinical and biostatistics professionals who operate as a team and are familiar with client needs.
Who in my company will benefit from a Report system?
Reason for asking:DZS Answer:
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.
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 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.
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.
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.
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: