Full Service Details For Clinical Trial Data Management
We work with you to transition the process you currently use to one that is Internet-enabled, allowing your team to focus on the clinical aspects of the trial. Our role begins with your IRB approved protocol, ends with a locked data set ready for your statistical analysis, and includes support along the way.
Prelude Dynamics will take your protocol, generate system requirements, and “build” the electronic case report forms, site forms, edit checks, and summary reports. Because of our state-of-the-art architecture, we are able to build studies very rapidly! With our short timelines, and comprehensive software, we can have your study up and running much faster than using more traditional software approaches, including Phase I studies. Typical build times are on the order of weeks.
The study development activities include:
- Requirements and Design – Producing a Study Requirements Document.
- Implementation – Producing electronic pages, charts and edit checks.
- Testing – Producing test results and change requests.
- Documentation – Producing a User’s Manual.
- Hosting Service Setup – Producing a server with the study loaded ready for the data center.
At Prelude Dynamics, we are ready to train the users involved in your study. Because of the intuitive user interface, training typically takes on the order of only 2-3 hours! There are two main methods of training that we suggest:
- Train the Trainer(s) – We can provide training to your Monitors, Data Managers, or trainers, who are then equipped to train the other participants in your study. This can be done at site initiation, to reduced travel and training costs.
- Train the User(s) – We are also happy to train your participants directly.
Either way, we can help you ensure your staff are all able to use the system. Feedback from other users is that our system is “the easiest EDC software I’ve ever used!”
Because the success of your trial is our number one priority, we offer technical support services during your study execution:
- Help Desk – Personnel are available to answer product questions and assist with administrative tasks. (The software is so intuitive that the majority of our help desk calls are for forgotten passwords.)
- Consulting – In order to ensure that the study is implemented the way you want, we provide consulting services to perform unique tailoring of the software, unique data imports, and system administration.
- Mid-Study Updates – It is virtually impossible to anticipate in advance every nuance of a study. In addition, because our system allows you to see data trends as the data is collected, you may decide additional or different information needs to be collected, edit checks changed, or new summary information obtained. Our elegant architecture allows us to modify data elements and edit checks, add summary or CRF forms, and change layouts so easily that the cost of change is minimal.
- Technology Enhancements – As we enhance our technology to take advantage of the most up-to-date advances, we provide the option for you to incorporate these advances into your study.
- Technology Transfer – For companies who desire complete control over their trial management software, we can provide our technology and train your technologists to use and modify the software.
At Prelude Dynamics, we know there’s nothing more important than protecting your data.
Some companies with extensive Information Technology support prefer to host their study data in their own facilities. For most, however, having the study data and software reside in a dedicated data center is more convenient and ensures the ultimate in protection for your study!
Therefore, we at Prelude Dynamics can support your hosting needs with a Tier 1 data center with UPS systems that provide redundant power sources along with generator and battery backups. The data center has multiple, redundant Internet connections to ensure continuous connectivity. In addition, its raised floor, high-capacity air conditioning, fire protection, and physical security all ensure that your data is as safe as possible.
Along with hosting, Prelude Dynamics will provide administrative support to your data collection, including backups and archives. At the end of the study, we’ll provide a final study data archive, decommission users, and remove the study from the server.
For more information or to schedule a trial run of the software, please contact us either via email at firstname.lastname@example.org or phone us at 512-476-5100.
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