Prelude Returns to Speak & Exhibit at 2019 SQA Annual Conference

Prelude Dynamics is thrilled to be returning as the premiere EDC exhibitor at this year’s 2019 Annual Society of Quality Assurance Conference in Atlanta. We are excited to exhibit and engage with SQA members on the increasing demands of electronic data capture in conducting human and animal clinical trials.

Make sure to drop by our booth #’s: 319 & 320 on 4/30-5/01, Tuesday through Wednesday, to get a first-hand sneak-peek of our most exciting software upgrade yet, VISION 10.0™! We will have Prelude members on-hand to give demos and answer any questions you may have.

We are also pleased to announce three of our executive members, Dr. Alicia Browner, Ph.D. (CTO); Richard Tieken (President); and Dr. Karina Loyo, Ph.D. (Director of Clinical Research Services), will be featured on panels and roundtable discussions over the course of the conference.

They will be speaking on the following topics:

  • Audit Trails: “Over the River and Through the Woods: Following the Audit Trail” with Alicia Browner
  • EDC Challenges and Opportunities: Challenges and Opportunities Using Electronic Data Capture Systems in Animal Health Studies” with Richard Tieken
  • Best Practices to Build a Study: “The Secrets of a Good Study Build: What You Wish You Knew” roundtable discussion with Karina Loyo
  • IT Compliance: 90-minute Session “Open Microphone with CVIC” with Richard Tieken

[Note: Make sure to check the SQA program schedule for their exact speaking sessions and times]

As the only attending EDC provider at SQA, we are honored to be given the opportunity to contribute to meaningful conversations on compliance and data quality as more clinical trials are integrating with EDC platforms. So, make sure to visit us at our booth, or attend one of our speaking sessions during the conference and see the #1 EDC platform for human and animal health in action!

We hope to see you in Atlanta!!

How a Clinical Trial Data Management System Can Support Your Work

When you are running a clinical trial, you would like your systems to operate smoothly and your data to be secure and reliable. With a powerful data management system, you can put more of your focus on the clinical aspects of your trial while your system keeps all the details in place and running properly. The key is to find the clinical trial data management system that will afford you the freedom to work and the knowledge that all your data, financials, and regulatory controls are properly addressed.

Powerful Data Management

Your clinical trial hinges on data. With the right data management system from Prelude Dynamics, you can be sure the data will be secure and accessible at any time. You also get the flexibility of working with your data, accessing the reports you need, and sharing them with stakeholders.

Increased Efficiency

A major benefit of a powerful clinical trial data management system is the increased efficiency it affords your study team. By providing simple access and intuitive controls, all of your team members can stay on the same page, avoid redundancy, and eliminate errors to make your overall efforts more efficient and effective.

Greater Collaboration

An online data management system offers ease of access to trial participants in far-flung locations. Participants can enter data, and trial managers can run reports and update information seamlessly so each trial partner can instantly see updated information.

Scalability

Along with access across varied locations, an online data management system allows for greater scalability. Trials can expand in scope, larger follow up trials can utilize the same design, and new trials can be designed using existing templates for greater efficiency and reliability.

Streamlined Financial Controls

Keep track of all financial transactions, record financial information, and track billing seamlessly to ensure that every penny is accounted for and all regulations are followed.

Reliable Regulatory Processes

Input regulatory data and maintain ease of access and sharing with an online data management system. The system also provides simple updates to regulatory information that will keep all participants informed.

Contact Prelude Dynamics to learn more about VISION and how we can transform your clinical trial data management, no matter the size or design of your trial.

What is Electronic Data Capture?

When conducting a clinical trial, you know the importance of your data. Not only do you need to design your study well, but you also need to ensure that it is entered correctly and stored securely and that it remains accessible to each member of your study team. Electronic data capture (EDC) has come a long way in the field and now offers more seamless features to reduce human error, save time, and make data more readily accessible.

Electronic Data Capture Ends Transcribing Errors

One of the main issues that arise during a clinical trial is the cumbersome process of entering data correctly. In the past, this meant recording data on paper and eventually entering that information into a database. The process involved a lot of moving parts that could lead to errors during data input or transcribing. It also meant significant delays in accessing data.

Electronic data capture puts those issues in the past and significantly streamlines the process of recording and accessing data. Using an online platform, data is entered and securely stored. This eliminates the added steps associated with transcription, thereby reducing the probability of human error. It also saves your team time, affording you greater focus on the clinical aspects of your study.

The Future of Electronic Data Capture

Prelude Dynamics takes electronic data capture a step further by simplifying and streamlining the process. Using simple online forms that require very little training, all members of your study team can input data into a secure database. Each entry is visible and updated in real time, so you have instant access to your data in its latest form.

Our team stands ready to assist you with the transition to our system. Training and data transfer are simple, and support is always available.

Make your clinical trial data management work for you. You get powerful data management in its simplest form, so your data is reliable and your processes streamlined. Contact us today.

Prelude Dynamics Releases Latest VISION Software Upgrade

Prelude Dynamics Releases New Software Version: VISION 10.0 – Exceptional User Experience and Industry-Driven Enhancements 

Prelude Dynamics, LLC, has recently announced the release of its latest software upgrade, VISION 10.0. The new version includes many new features in Composer, VISION’s do-it-yourself study builder, including enhanced usability, additional form logic and bulk editing capabilities for a more efficient study build experience. Monitors will enjoy the new risk-based-monitoring tools and streamlined report creation. As the #1 Electronic Data Capture (EDC) software in animal health, Prelude Dynamics offers a premium EDC solution for both human and animal clinical trials at affordable pricing. VISION 10.0 simplifies data monitoring practices, streamlines study cycles and accelerates approved submissions to the FDA and the Center of Veterinary Medicine (CVM). As quoted from Richard Tieken, the President of Prelude Dynamics,

Prelude has been advancing the conduct of clinical trials internationally with automation for 15 years. VISION 10.0 continues the excellence and has included significant improvements to fulfill the needs of our Full-service and DIY clients.  We know what Data Managers find useful, because we also do that job!  Our clients see results that ease building, managing, and submitting clinical data to FDA/CVM and EMA, and our clients should see even more successful submissions with VISION 10.0.

With this release, users can expect significant functionality enhancements to data capture, data analytics, and data exportation within an improved and friendlier user interface that is also more optimized for mobile-device and offline data capture. Some note-worthy enhancements include:

  • Form libraries to save and re-use forms from past studies
  • Automated invoicing functionality by site
  • A new two-way lab interface with Marshfield Labs that enables automatic submission directly to the lab without manual intervention from the sites
  • Improved AE and ConMed dictionary coding capabilities
  • Enhanced export capabilities including CDISC export format and greater data format configurations
  • A built-in risk-based monitoring tool that highlights the most critical fields in the study as it progresses (AI driven)

Tommy Jackson, COO at Prelude Dynamics, is excited for the release,

Efficiency and compliance are top of mind to every sponsor and CRO with whom we’ve interacted. The enhancements to VISION Composer were specifically designed to address these demands. We are excited for clinicians and data managers to be introduced to an affordable EDC alternative with the same or greater level of functionality and compliance than they are used to.

Focusing on a seamless user experience, Composer offers a fresh new look and reboot to its graphical user interface (GUI), now enabling form building and study schedule assembly all in one central place. Building, copying, and organizing study forms is now easier than ever with a form library that collects previously-built forms and stores them for use in future, per-client Composer studies. Site invoicing, a feature previously only available in the full-service version of VISION, is now configurable within the tool and a new standout feature that tracks site payments and study milestones within the DIY tool. This is just one of the multiple customizable features and functions to be expected in this year’s product release. Prelude Dynamics is focused on the future of animal and human health clinical trial advancement, leveraging industry-driven software updates to its EDC platform and enabling clients to build and configure faster, more complex study protocols in one encompassing product platform with greater data accuracy.

Best Practices for Conducting Clinical Trial EDC User Acceptance Testing

User Acceptance Testing (UAT) is a critical component of clinical trial development using Electronic Data Capture (EDC). It’s the responsibility of the Sponsor/CRO to perform UAT prior to using the EDC to collect data in accordance with a protocol.

Early and thorough UAT can result in studies that are easy to use and monitor, and have short submission preparation timelines. We’ve found this to be especially true when our best practices for conducting UAT are followed. Our VISION EDC provides tools and features that facilitate UAT every step of the way, making it a faster and more effective process. Prelude Dynamics’ seven best practices are described in more detail below. Perhaps you have some of your own you can share with us!

  1. Thoroughly test every e-CRF
  2. Verify masking and role-dependent access
  3. Involve a site
  4. Test the electronic lab interface
  5. Consider risk factors
  6. Involve the statistician early
  7. Conduct Pre-UAT

Thoroughly test every e-CRF

This may seem obvious, but it’s surprising how often this is not done. Sometimes test personnel become complacent when most e-CRFs work as expected, and abandon test efforts early. But then during study conduct it turns out that the Investigator Signoff form – which is the typically the last subject form to be filled out – isn’t working correctly.

It’s especially important to verify that the Inclusion/Exclusion e-CRF is working correctly. Imagine the consequences to the clinical trial if subjects that should be excluded are not. Similarly, dosing calculations should be rigorously vetted.

This is a good time to check the upper and lower limits on data entry fields and to make sure all calculations are operating as intended. VISION’s embedded Field Specification displays this information for every form in the study, which facilitates this process.

Verify Masking and Role-dependent Access

There’s almost nothing worse than unmasking a study, so don’t risk it! Identify every e-CRF where the treatment group (or other masked field) is present and verify that masked roles cannot see the value in either the e-CRF or the audit trail. VISION’s Field Specification is also useful for performing this task.

Inversely, imagine that the treatment dispenser has no access to the Dosing form. Avoiding mid-study changes to permissions reduces the probability of non-contemporaneous entry of critical study data. VISION’s Study Requirements Document (SRD) Configuration can be used to verify that permissions to view, edit, review and finalize each study form have been configured correctly.

Involve a Site

Sites are ultimately one of the most critical components of any successful clinical trial. If e-CRF layouts are clumsy or non-intuitive, sites will have trouble completing them correctly. When this is the case, site enrollment may suffer due to user frustration with the EDC.

Involving one or more trusted sites early in the UAT process can provide early insight into usability issues and allow them to be corrected before the study goes live. VISION’s Feedback function can be useful in capturing site input on usability issues. Happy sites require less monitor intervention and produce cleaner data.

Test the Electronic Lab Interface

Studies that benefit from the use of electronic lab interfaces, such as those supported by IDEXX and Marshfield, enjoy more accurate and timely lab results data in their study. It’s important to coordinate with lab company personnel to assure that data required by their LIMS is included in electronic lab requests, and in the e-CRFs if necessary. It’s typical to configure study-specific parameters used for tracking and billing in the EDC, and to test the interface in a training study (or training site) prior to going live. VISION supports fully validated electronic interfaces for both IDEXX and Marshfield Labs.

Consider Risk Factors

Every study has risks, but for every risk there is a way for the EDC to assist in detecting when a risk is becoming a reality. Many EDCs support ad-hoc query functions that generate reports based on user-entered criteria.  These can be configured to generate reports pertaining to potential risks such as a high number of reactions at a drug injection site, or abnormally high blood glucose level after dosing.

Losing subjects due to lack of adequate follow up poses both a financial and a schedule risk. Tools such as the VISION Event Calendar provide ways to quickly and easily detect missed visits before a protocol deviation occurs. EDC statistics functions can also be used to view data in graphical format, which is more intuitive than rows of numbers and can be used to identify outliers.

Custom reports can be developed in the EDC that are tailored to look for specific potentially risky outcomes. These can be developed at study build time, or added later when unanticipated risks begin to arise during study conduct.

Involve the Statistician Early

Configuring the study database so that the data is organized in a way that makes it easy for the statistician to prepare the data for submission is something that is sometimes overlooked when studies are being developed. This can result in both time delays in submission and difficulty with data analysis.

We recommend entering test data into either a training study or training site, and exporting the data for analysis as part of UAT. This approach allows the statistician to take an early look at the exported data, and test it with their statistical analysis software. If changes are needed to the database to facilitate analysis, these can be made and testing prior to going live.

Conduct Pre-UAT

Pre-UAT? It’s not unusual to identify multiple study changes while testing, especially when unfamiliar with the power and flexibility of EDC. Conducting a Pre-UAT ahead of the UAT schedule can help identify and address most of these changes ahead of time. When this is done, UAT consists of verifying that all requested changes have been implemented, tested and work together in an intuitive way.

Starting study test early is generally recommended to avoid cramming test efforts into the last week prior to going live. When testing is deferred, sites have a more difficult time entering data and study conduct is more difficult and lengthy than it needs to be.

Conclusion

In our experience, following these best practices for performing UAT results in less risky, higher quality studies with excellent usability and data integrity. EDCs such as VISION provide many validated, integrated tools that facilitate both UAT and study conduct. Prelude Dynamics provides training in the use of these tools prior to the conduct of Pre-UAT and/or UAT. We are increasing receiving requests to deliver the data from training studies/sites as part of study closeout. This data serves to demonstrate that UAT has been conducted.

If you’d like more information about any of the tools and features discussed in this article, or would like to schedule a demo, please contact us.