Are you taking advantage of VISION’s CTMS?

Traditional Clinical Trial Management Systems (CTMS) are separately purchased tools that include a variety of features to help keep track of, plan and manage a study from beginning to end. They are sold to help manage multiple studies and typically do not include automated patient eCRF information. What information exists is redundantly, manually entered.

Prelude Dynamics’ VISION Premium includes integrated CTMS features that track the VISION patient database so there is no extra work to keep up with the events and tasks of organizing and conducting a trial, before – during – after.  Even the end of study archives for prior completed projects can be retrieved and viewed.

VISION CTMS includes features like these, and more, with all the normal VISION role permissions and audit trails:

  • Track and share protocols versions with text change controls and sign off.
  • Track IRB submission documents from draft form to final approval through FDA concurrence.
  • Document communications and visits with investigators, partners and vendors
  • Track inventory and supply shipping information
  • Facilitate budgeting and site payments allowing the generation and tracking of invoices
  • Provide a searchable master list of sites to identify and evaluate potential sites for the most current study from sites that have participated in previous studies as well as assess (even self assess) potential new sites
  • Generate metrics and reports for individual studies as well as aggregate across study information such as queries per site, time to query response, and current enrollment
  • Provide a calendar scheduling function and task list tracking in order to help keep ongoing studies on track.

Prelude can provide a CTMS platform where one can access information on all studies done with VISION, or other EDC vendor files, and track new study development. You are probably using some of the features but may not yet be taking advantage of all of them. For example, have you ever accessed the Summaries for the patient and site level list pages? What do you have on the pages at the study level?  Here’s more details:

Certainly searching, reporting, statistics and graphing are the most common features you probably use to track the progress of the study and analyze patient study data. The patient status summary provides a by patient listing of all key study visit dates. The form and query status shows the number of forms per form state (in-work -> final) as well as the number of queries per case and the query age/status.

The site level query summary shows the total queries per site versus the unresolved queries making it evident which sites have the most queries, which opens the door to risk-based monitoring review of a site. The site form graph quickly provides a view of all form states at a given site. The site level enrollment graph provides an at a glance graph of current enrollment versus planned enrollment on a study and site level to help you quickly track study enrollment success. Ad hoc reports, statistics and graphs put customization and immediate access to information about the study at your fingertips on demand. These summaries are included with VISION for no extra cost.

Some clients might also be taking advantage of VISION’s invoicing feature, which automatically generates invoices for activities completed once the monitor reviews and signs off on each pertinent form. But did you know there is a study budget management section where you can keep track of the study’s complete budget, and payments to sites based on patient activity is automatically incorporated? Here you can access a listing of all invoices paid/unpaid, a form where you can track the study budget, view per site payments or per vendor payments. While not an accounting system, it does manage the budget at macro-levels where you can include information about each study and billing as the patients progressed..

Others are using VISION’s inventory management feature which tracks current and dispensed inventory as well as reconciles it. Some take advantage of the automatic re-ordering and notification feature. There is also a shipment tracking feature. Together these provide a full inventory management solution typical of any CTMS system.

VISION contains an extremely powerful document management tool. This allows specification of required documents to be uploaded at the patient, site or user level. It provides a summary of whether the documents have been uploaded as well as aggregates an easy to use summary of all documents tracking which have been collected or not collected. The summary provides hyperlinks to the actual documents (pdf, doc, xls, etc.) for quick access and the audit trail collects an audit trail on any document downloaded. This makes it easy to track who has downloaded the document for review. The document management module can be used to track and share things like protocol and amendments, CRF development, SOPs, documents that are shared with sites, communication with sites, patient documents and much more with the intent to eliminate paper-based site binders and provide a wealth of information in one easy to access portal for communicating vital information with sites.

The document management module can also be used to track document evolution and approval through different management levels and external groups such as FDA and IRB committees. Any unloaded version of the document can be accessed at any time.

Use the document management module at the user level to track credentials, curriculum vitae, and other site staff qualifications including expiration dates. Add notifications 30 days in advance of expiration in order to automatically be alerted about any certifications that are about to expire.

VISION also has the ability to help in qualifying and managing sites. Custom site pre-qualification forms can be integrated at the site level. A site inventory and assessment form can also be added as well as an on demand mid study monitoring visit form and close out form. Basically any information that is currently being collected on paper can be turned into an electronic form and included in VISION.

To enable full study planning, VISION offers a task list where tasks can be assigned to an individual user, scheduled to a calendar, and placed on their user level task list, individual or site calendar. Tasks can be marked as completed and time for task completion tracked. The task list can be used to track monitoring efforts and time by the monitors so metrics such as time to monitor per site can be analyzed and average queries per patient by study can be aggregated in the multi-study CTMS.  The study manager can track all study tasks in one location and review their completion by assigned staff at any time making study management more efficient.

With VISION 9, Prelude introduced the next patient event and expected date on the list page. Now you can view it on a site calendar or study level color coded by site calendar making it easy to quickly review upcoming patient visits. This helps monitors know when and how to monitor sites allowing them to better plan their daily activities.

These are just some of the many ways in which your current study contains see CTMS functions. By using all of VISION’s robust functionality you can manage your study more efficiently.

For those of you wanting the multi study CTMS functionality, Prelude can it set up. It would list all studies, contain a master site list which could be searched for inclusion in future studies and invited directly from within VISION. Once they accept the site demographics can be pushed to your new study. This master list can also be used to track new sites that might be included in future studies. A site level rating sheet contains information about previous studies and metrics such a total recruitment, total enrollment, total queries, average time to query resolution and queries per patient as well as a section for notes and rating of the overall site.

The multi study CTMS contains a task list with assignment and tracking capability as well as a calendaring function so important tasks and milestones can be tracked in order to ensure smooth study setup and operation. As with any VISION study custom forms can be added at the site, project, and user level to help manage your studies better. For example if there is a desire to track site personnel credentials and expirations within this system, we can set up that form and functionality. We can even import the users from prior studies. No other CTMS provides this level of flexible customization. Additionally, search, reporting, statistics and graphing of data allow complete control over analysis of all CTMS data fields. This is just another way Prelude helps you accelerate and streamline your clinical study operations.

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

Prelude Dynamics Announces Its New Patient Event Feature

AUSTIN, TX – December 15, 2016 – Prelude Dynamics announces VISION’s latest enhancement

Prelude Dynamic announces the addition of a new feature to its Premier Clinical Trial Optimization Platform, VISION™. The new feature allows users to view the next event for all patients on the patient dashboard. The patient list can be sorted by date so both sites and monitors can quickly see which patients have upcoming events by date or by event visit number to see how patients have progressed through the visits. Once patients have completed the study or been removed, their next event shows up as “finished’ with a date of n/a. This makes it easy for everyone to know what patients and events to expect next. This enhancement is a result of Prelude’s culture or constantly listening to client’s needs and providing features that streamline every day tasks to make them more efficient saving the client both time and money.

Prelude who originally set out to create a world class clinical studies electronic data capture system (EDC) more than a decade ago, is now transforming the efficiency of studies. Prelude is going beyond EDC with its Clinical Trial Optimization Platform (CTOP) integrating useful features such as inventory management, automatic reordering, invoicing, integrated dictionaries, computer to computer lab data transfer, document management and much more. Prelude Dynamics is also the only provided of a full-custom solution and a do-it-yourself version. Prelude is dedicated to helping you optimize your study logistics and operations.

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 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

VISION Supported Xeris Pharmaceuticals in Diabetes Drug Research

Austin, Texas – Xeris Pharmaceuticals recently announced the completion of its Series B stock offering which will allow the commercialization of their newest Diabetes Injectable Drug offerings. The funding will be used to promote their G-Pen (a glucagon injectable).

VISION™, a clinical electronic data capture system, was used as the platform to collect and monitor the data necessary to conduct the research for G-Pen. VISION is also currently being used to collect data on its other products including: G-Pen Mini™ and G-Pump™ both providing different means for quickly administering glucagon.

“We are excited about the success that Xeris has had with its products. We are proud to be a partner in helping them capture solid clinical data. These medications are going to have a tremendous impact on the lives of many millions of people living with diabetes.” Said Richard Tieken, CEO of Prelude Dynamics.

About Prelude Dynamics

Prelude Dynamics leverages innovative software-as-a-service technologies, best practices and study experience into a simple-to-use, customizable and robust Clinical Trials & Patient Management Solution referred to as VISION™. They offer unique and innovative research and clinical solutions to all areas of data capture and information awareness for the pharmaceutical industry, in all corners of the globe. Prelude Dynamics provides the tools and technology to easily build, maintain, observe, and perform successful clinical trials.

Trademarks

VISION is a registered trademark of Prelude Dynamics, LLC. Other names may be trademarks of their respective owners.

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