Have you Heard About Prelude Dynamics’ Newest eClinical EDC Solution, VISION™ Composer

AUSTIN, TX – May 10, 2017 – With the arrival of VISION™ Composer, Prelude Dynamics is proud to be the first software company to offer both a do-it-yourself solution (VISION™ Composer) as well as full-service, custom builds (VISION™ Premium). The fusing of these two solutions is what defines Prelude’s Clinical Trial Optimization Platform (CTOP), VISION™, and allows Prelude to continue to be the eClinical software pioneer for animal and human health trials.

WHAT?

Composer is a do-it-yourself eCRF build tool. Composer is accessed via a web browser and has the same end-user capabilities as VISION™.

WHY?

This puts the study build in your hands! Whether a small or large study, Composer gives your team the ability to build and manage your own eCRFs.

HOW?

Composer allows you to build eCRFs with drag-and-drop modules, add custom edit checks and assemble them into a visit schedule. eCRFs can be added to a Form Library and re-used as many times as needed.


Composer’s drag-and-drop interface and robust set of features is based on the globally recognized and 21 CFR 11 compliant VISION™ platform, and provides unsurpassed functionality out-of-the-box.

Need to upgrade to VISION™ Premium? No problem, you can take your Composer eCRFs with you!

Speedy Development, Integrated Hosting

With Composer, users are able to develop quality EDC solutions quickly and with minimal training. Since hosting is provided for Composer licensees, hardware and web connectivity issues are a thing of the past, and distributed data collection across the country and around the world is facilitated.

Submission-ready Datasets

Composer’s ability to provide data-cleaning functionality at data entry time, along with embedded utilities such as Search, Reports, Statistics and Queries, reduces the time required to prepare datasets for submission. The integrated XML Export capability generates files that may be seamlessly imported into SAS and similar tools – saving even more time.

About Prelude Dynamics

Prelude Dynamics is an industry leader at providing innovative software-as-a-service technology solutions for clinical trials across the globe. The company’s flagship product, VISION™, offers secure and configurable data capture and information awareness tools for the advancement of human and animal health, compliant with FDA/CVM and EMEA regulations. VISION™ facilitates real-time data collection, querying, cleaning, reporting, and analysis all based on the needs of the researchers. The company was established in 2003 with a goal to speed the study process, improve data quality, and facilitate easy data entry through automation.

Contact

Jim Pedzinski – VP of Business Development
jpedzinski[at]preludedynamics.com – 512-476-5100 ext. 210

Inventory Management & Automatic Reordering

 

Challenge

 

It is challenging for working clinics to ensure sufficient inventory of treatment and control medications or supplies are available throughout a clinical study. Prelude Dynamics was challenged to identify an inventory management system that was smart enough to know when medications and supplies were used at the patient level, keep track of current inventory, and reorder supplies as they became low. One challenge to accomplish this is the varied sizes of clinics and expected enrollment for each site, which required something more sophisticated than a one-size-fits-all solution. Rather, inventory thresholds would have to be able to be customized per site, and at least some portions of the inventory management system needed to be blinded from other site personnel.

 

Proposal

 

Prelude Dynamics proposed the client use VISION™, an electronic data capture system, which already has an Inventory Management Module to manage inventory. As the Treatment Dispenser recorded when a patient had received medication or supplies and the amount dispensed, the inventory module would update the inventory on-hand. Prelude proposed to add to VISION™ a feature that would trigger an automatic order when supplies reached a certain threshold, which could be set separately for each site. In addition to VISION™ automatically placing an order, the Treatment Dispenser, study Project Manager and Monitor would be automatically notified via email that the order had been placed.

 

Background

 

It is often difficult for busy clinics participating in clinical research studies often to manage the inventory required to be available for the study. Successful inventory management requires a designated person to keep track of how much is on-hand and order additional inventory as necessary. This person usually has other day-to-day responsibilities that make keeping up with this task difficult. If the designated person were to forget or put off the task the enrollment and treatment of subjects could be jeopardized because medication or supplies are not available. Automating this process would greatly reduce the effort involved in participating in the study and would ensure a better outcome.

 

Solution

 

Prelude staff trained the study staff to utilize VISION™’s existing Inventory Management Module to keep track of inventory as it is dispensed to the patient and logged in the dosing eCRF. The solution included setting the module up to handle the following scenarios:

 

  • Allow study management to initial inventory sent and site shipping information.
  • Allow initial inventory and future inventory received to be logged and tracked.
  • Aggregate the dispensing information into a summary table.
  • Reconcile the on-hand inventory in real-time.
  • Allow minimum and maximum inventory threshold levels to be set at the site level.
  • Automatically order additional medication and/or supplies when the inventory meets or falls below the minimum threshold, for the difference between the actual amount on-hand and the maximum inventory threshold.
  • Notify the study management personnel at site treatment dispenser that an order has been placed.
  • Manage final reconciliation at the end of the study, allowing the site to enter return shipment information for remaining inventory and study management to reconcile the shipment when received.
  • Provide tracking method for deviations or comments/notes to file when medication is not returned by subject or when medication is missing or lost.
  • Provide ability to track if empty bottles are collected and shipped back or disposed of as required by the sponsor and protocol.
  • Allow site personnel access to certain information, such as inventory received, but not any information that might disclose the treatment group provided to each subject in order to protect study masking during the study, but allow access to all the information upon study completion.

 

Results & Benefits

 

As a result of using VISION™, the burden on site personnel to keep track of inventory has been greatly reduced. The sites report that they appreciate the automatic reordering and email notifications of placed orders, adding that it is “such as stress relief to have VISION™ order for them.”

 

The study Project Manager was able to enter initial inventory ordered and shipped to the site, along with site shipping information, simplifying tracking all inventory information in a central location. She received email notification when the Treatment Dispenser entered the initial receipt of the inventory into the system, confirming its arrival. She was very pleased with the entire module, noting that, “It is wonderful to know that I can relax about whether the sites are keeping up with the inventory and reordering meds and supplies when they are getting low because it happens automatically. There are so many other things I have to keep track of. It is helpful not to have to be burdened by the inventory management.”

 

The Treatment Dispenser finds it useful view a single table for a full history dispensed medication and/or supplies. He appreciates instant viewing of aggregate dispensed and automatic reconciliation of inventory, and is able to add notes directly on the dispensing form if there is a discrepancy in the amount of medication returned or if there are missing medications or supplies. All these notes are aggregated automatically in a note to file with details about the form and field, who entered the note and when it was entered. This makes it much easier than having to enter all these details manually. He indicated that he was extremely satisfied with the inventory management. He said that keeping up with the inventory and reordering was so much less burdensome and stressful that it had been previously. In fact, the Treatment Dispense indicated he wished all studies used VISION™’s Inventory Management module and thinks everyone should consider using VISION™ for future studies. He said it was intuitive, easy to use, and followed the work flow well. Other treatment dispensers at other sites had similar positive experiences.

 

Throughout the study, sufficient inventory levels were maintained to be able to enroll all patients eligible for the study who were willing to participate. This gave all study personnel more confidence in their ability to successfully enroll a new subject every time.

 

Using Ad-Hoc Reports For Mid-Study Monitoring

Challenge and Background

Monitoring study progress and safety of subjects are critical factors to a study’s success. The most effective way to stay informed of the current status of these factors is to utilize a constant mid-study monitoring process. Even with the use of electronic data capture, mid-study monitoring has generally been limited to preset summaries or reports, or exporting data external programs to be analyzed. Alternately, for an additional cost, most EDC providers will add a report, but historically, mid-study monitoring has been very limited. Ideally, since data is collected electronically, the system should allow for the development of custom reports that fit the study’s needs as it progresses.

One challenge with setting up report parameters at the beginning of a study is that it is difficult to determine in advance every detail a report may need to output. As study data is collected and analyzed mid-study, the information that is most valuable to include in the reports for regular monitoring becomes more apparent.

Proposal

Prelude proposed the study use VISION™, an electronic data collection system, which already provides users with the ability to create an unlimited number of customizable searches and reports to fit study needs. Additionally, VISION™ already provides standard summaries and the data is available for continuous customizable export by designated users.

Solution

Prelude staff trained study staff to use VISION™ as the electronic data collection system and to utilize the system’s reporting functionality. Specifically, study staff was trained to perform searches to filter data, create ad-hoc reports, and share reports and searches with each other. They were also trained to copy reports into a spreadsheet and print as a PDF in order to share it with users outside the system.

Results & Benefits

Once trained, study staff was impressed with the system’s functionality and ease of use for creating and sharing searches and reports. During one of the trainings, as the trainer demonstrated how to put a report into a spreadsheet, one of the trainees asked the trainer to please do it again, then commented, “I had to see you do that again. It just could not possibly be that easy!” The report in VISION™ was formatted in such a way that the data could be highlighted, then copied and pasted directly into a spreadsheet, where it was automatically formatted to appear identical to the VISION™ report. All that remained to be done to it was to save and send it.

While ease-of-use is a great quality for VISION™’s ad-hoc reporting features, users were most impressed by how useful the actual reports were. For example, in one study, there were multiple time points at which a particular scale was assessed. It was possible to monitor the trend in changes by developing a report that showed the results of these scales across time. In another study, the monitor developed a report showing weight change across time. Yet another showed the progress of enrolled subjects through the study visits all the way to termination and indicated whether the cases were evaluable or not. Another monitor found it useful to create a report that not only indicated particular results, but who entered them and when they were entered.

Using the search criteria also allowed the project manager to view stratified reports by gender and age range. This allowed them to report specific critical information to the sponsor, and because the sponsor also had access to VISION™, the search criteria and report could also be shared, allowing for better communication about the study’s progress.

In one study, the ad-hoc reports were used to quickly monitor the change produced by different treatment groups. This information was used to identify whether additional mid-study analysis was required on the efficacy of a particular treatment. This lead to the eventual removal of a treatment arm from the study; future enrollees were stratified to the remaining treatment groups. The result was improved safety of future enrollees and reduced costs.

Overall, the study personnel who used the reporting function found it to be a tremendous asset to their role in the study. The project managers, sponsors and monitors found it extremely helpful to know real-time details and study progress.

About Prelude Dynamics & VISION™

Prelude Dynamics is a global provider of customized web-based software systems for data collection, analysis and management of clinical trials, studies and registries. We streamline eClinical operations through our unique and innovative VISION™ software system, which allows us to rapidly configure data collection solutions for pharmaceutical, CRO, medical device, animal health, and university organizations.

Prelude Dynamics Give Users the Ability to Create End of Study Archives

AUSTIN, TX – February 1, 2017 – Prelude Dynamics give users the ability to create end of study archives.

Prelude Dynamics announces that the new VISION™ 9 Clinical Trial Optimization Platform will give users the ability to create their own end of study archives. In addition to being able to create XML files with full audit trail, users can create their own HTML archives. An HTML archive allows users to navigate via a browser their study files as they did when the study was live. The HTML archives are read-only.

No other EDC system puts this much power into their Client’s hands. Whether client’s use VISION™ 9 as a custom built solution or they choose Composer, VISION™’s do-it-yourself form builder and study set up, clients will be able to generate both archive formats. This means that Clients can now create their archives in minutes.

“We know our client’s time is important, so we wanted to reduce the time it takes to archive a study and put that power in our client’s hands.” -Dr. Alicia Browner, CTO, Prelude Dynamics

Prelude Dynamics is an industry leader at providing innovative software-as-a-service technology solutions for clinical trials across the globe. The company’s flagship product, VISION™, offers secure and configurable data capture and information awareness tools for the advancement of human and animal health, compliant with FDA/CVM and EMEA regulations. VISION™ facilitates real-time data collection, querying, cleaning, reporting, and analysis all based on the needs of the researchers. The company was established in 2003 with a goal to speed the study process, improve data quality, and facilitate easy data entry through automation.

Contact

Jim Pedzinski – VP of Business Development
jpedzinski[at]preludedynamics.com – 512-476-5100 ext. 210

Introducing VISION™ 9

AUSTIN, TX – December 15, 2016 – Prelude Dynamics announces its release of VISION™ 9.

VISION™ is Prelude’s Clinical Trial Optimization Platform that goes beyond EDC. The launch of VISION™ 9 has generated much excitement. It’s new features promise to continue to optimize clinical trial management and data collection.

Integrated into VISION™ 9 as standard features are the ability to:

  • see on the form which roles have permission to view and edit each field (a toggle on/off feature)
  • create universal filters
  • view archived forms
  • conduct batch edit checks
  • review individual user activity logs
  • to create combo field boxes which learn entries and include them in a drop down list for future selection
  • perform statistical analysis on any eCRF field
  • generate end of study XML and HTML archives

VISION™ 9 also offers new training solutions including a training checklist with access to training videos, an eSignature form, and an electronic certificate. These can be completed in the training study as part of the training process and moved to the live study for archiving purposes.

Prelude Dynamics is an industry leader at providing innovative software-as-a-service technology solutions for clinical trials across the globe. The company’s flagship product, VISION, offers secure and configurable data capture and information awareness tools for the advancement of human and animal health, compliant with FDA/CVM and EMEA regulations. VISION™ facilitates real-time data collection, querying, cleaning, reporting, and analysis all based on the needs of the researchers. The company was established in 2003 with a goal to speed the study process, improve data quality, and facilitate easy data entry through automation.

Contact

Jim Pedzinski – VP of Business Development
jpedzinski[at]preludedynamics.com – 512-476-5100 ext. 210

Prelude Dynamics Now Has Integrated Statistics And Graphing Functionality

AUSTIN, TX – November 5, 2016 – Prelude Dynamics now has integrated statistics and graphing functionality.

Prelude announces its new, integrated statistics and graphing functionality in VISION™. With the statistics and graphing module, any field combination can be selected to generate statistics and graphs as long as the user has permission to view those fields. Statistics include: mean, median, maximum, minimum, 95% confidence interval and standard deviation. Once set up, statistics are generated in real-time and can be shared; there is no need to worry if a user is masked as VISION™ automatically will ensure the user that was shared with will only see what they have permission to see. This is just another way in which Prelude is providing customers with a simple, standardized and streamlined Clinical Trial Optimization Platform (CTOP).

Prelude Dynamics is an industry leader at providing innovative software-as-a-service technology solutions for clinical trials across the globe. The company’s flagship product, VISION™, offers secure and configurable data capture and information awareness tools for the advancement of human and animal health, compliant with FDA/CVM and EMEA regulations. VISION™ facilitates real-time data collection, querying, cleaning, reporting, and analysis all based on the needs of the researchers. The company was established in 2003 with a goal to speed the study process, improve data quality, and facilitate easy data entry through automation.

Contact

Jim Pedzinski – VP of Business Development
jpedzinski[at]preludedynamics.com – 512-476-5100 ext. 210