Customization Enrollment Graphs And Tables

 

Challenge

 

Clients challenged Prelude Dynamics to develop customizable enrollment graphs and tables in order to quickly reflect current enrollment rates and/or adjusted projected enrollment at any point, per site or across the whole study.  In evaluating this challenge, Prelude anticipated the need for a highly customizable function for creating the enrollment graph to accommodate a variety of different studies and sponsors. Additionally, field names may vary from study to study and different studies have different criteria for actual enrollment. For example, some studies may determine enrollment by if a treatment group has been assigned while others may use screening results as enrollment criteria, and still others may not consider a subject fully enrolled until the first dose is administered.

 

Proposal

 

Prelude Dynamics proposed to add an enrollment graph module to VISION™, an electronic data capture system built explicitly to support clinical research.  In particular, Prelude proposed development of an administrative panel where enrollment graphing information could be set up. A separate form would be employed for graphical display of the specified information. Prelude Project Managers would determine initial settings with the study project manager. Then study project managers would be trained on how to change the criteria if necessary.

 

Background

 

Successful tracking of enrollment for a clinical study is imperative in order to maintain study schedule and budget. When multiple sites are involved, this can be complex, particularly because some studies have sites location across the globe. A single location within the EDC where enrollment could be monitored would be very helpful in tracking study progress.

 

Solution

 

Prelude developed an enrollment graph and table settings panel and a corresponding results display section. The enrollment settings allow the selection of the form and field to be used as an indication of successful enrollment. The expected and projected total and monthly enrollment can be put into the settings and changed at any time. The project manager can choose to view graphs, tables or both for each site, all sites or a combination.

 

Results & Benefits

 

The Prelude project manager worked with the study project manager to input initial enrollment settings. As data was collected, the enrollment graph and tables were used to quickly view the progress of the study. The project managers using this feature found it helpful to be able to track the study progress, and reported that the location of enrollment information in a single location better facilitated planning subject recruitment activities and working with the clinics experiencing difficulty meeting monthly enrollment goals.

 

The study project manager was able to modify projected enrollment settings mid-study to address realistic enrollment. The project managers were quickly able to identify which sites were successful at enrollment and which were struggling, which contributed to beneficial strategic planning sessions to improve enrollment at low-enrollment sites. Project managers used this information to communicate with the sponsor to decide if successful enrollment sites could enroll additional subjects to mitigate the reduced enrollment at other sites. This allowed them to stay on track and meet the study enrollment projections.

 

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.

Reducing Qualitative Data Analysis Through Autocomplete Text Fields

Background

One of the difficulties in doing research that occurs during the data analysis phase is how to analyze open text entries. Anytime data is collected into a text field, it becomes a qualitative data point when it comes to data analysis. Analyzing qualitative data tends to be more time consuming and is open to the analyst’s interpretation.

In some cases it is difficult to come up with all the options to include in a drop down choice field. So many times, other is offered as a selection and a text entry field is made available to capture the other descriptor. In many cases, a text field is offered simply because there might be a lot of other type options even when most people will enter the same response because the potential answers are not part of a validated scale. Whatever the reason, this makes for complex qualitative data analysis.

Challenge

The challenge was to develop a way to allow both free text entry and a choice of drop down items. Ideally where the drop down list grew as a result of prior entries into the field and where the choices would appear once someone began to type into the field. That way the person had a choice to select an option or continue typing.

Proposal

Prelude Dynamics proposed that it could add functionality to VISION™, an electronic data collection system, that would capture the information entered into the field and display it back as selectable options within a dropdown list.

Solution

Prelude added functionality to VISION called an autocomplete function. The autocomplete captures information that is entered into a text field and when the next person starts to enter information, offers the previously entered responses. In this fashion, the subsequent users have access to a growing list of options to choose from. With a little training, users would know to choose the best option that describes what they would enter or add a new option where none fit.

Results & Benefits

Autocomplete has allowed data entry of qualitative fields to become organically quantitative. As information is entered into the field, a drop down list populates with prior entries. Each subsequent person has access to a growing drop down list of options to select or can enter their own. This basically let’s the person doing the data entry select qualitatively the category that best fits their answer.

The statisticians have commented positively about how this has impacted their work. “It used to be that I would spend hours reading through a list of text entries and try to make sense of them by categorizing them into groups for analysis. Using VISION’s Autocomplete function has greatly reduced the time I spend on that. People select existing options categorizing their entries. All I have to do is look at the ones that weren’t selected frequently and decide whether to have an ‘other category’ or code them into existing categories. It is so much easier.”

As a result of using the new Autocomplete feature, data is more streamlined, data analysis time is shorter and more efficient, there are less errors and less is left up to the statistician’s subjective analysis. The people doing the data entry report they appreciate being able to select from existing options instead of entering the same text over and over again.

In the end, the data is cleaner and can be analyzed quicker. This improves confidence in the results of the study and reduces time to market for new drugs.

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.

Vision Enables Remote Monitoring

Background

One of the most critical roles in clinical studies is monitoring. Monitoring to ensure that the data is collected according to the protocol and standard operating procedures; the data is correct, accurate and clean according to good clinical practices and are well documented and verifiable; and subjects are kept safe in the process. This normally requires the monitor to visit the study site frequently to monitor the data collection and review the data that has been collected. Additionally, the monitor ensures that all medications being studied are kept under appropriate environmental conditions. Generally, after conducting initial site visits, monitors visit sites about every 2 months in order to review source documents and ensure data integrity.

Monitoring site visits are generally lengthy and arduous as lots of time is spent reviewing and comparing source documents to the data that is collected for the study to ensure it is correct. The most common findings during site monitoring are: failure to follow the protocol, failure to keep adequate and accurate records, a problem with the informed consent, failure to report adverse events, and failure to dispose of study drugs adequately.

By the time the monitor identifies that a participating site has either failed to follow the protocol or failed to keep adequate and accurate records, several cases may be lost. This is not only expensive, but also delays the study. As an industry, the number of subjects required for any given study is based on the ability to obtain a power of 80. Being able to collect better data and adhere to the protocol would increase the power and decrease the number of subjects needed to achieve that power.

Challenge

The challenge was to enable monitors to have access to real-time data. This would allow monitoring to occur very quickly after the data was entered.  Timely monitoring would quickly identify any protocol deviations, allow the clarification of any questionable data, and would allow quick response to adverse events.

Monitors log into VISION every morning and look at what happened yesterday.

Johny said they spend 30 min each day on this. ID problems. Then charges and spends time on corrective action.

At any point, they have realtime knowledge of what is happening within their projects. On paper they would handle 1-2 studies. On VISION, they can handle 5-6 studies.

Loses $ on the site visits, but he gains because he is charging more on an hr rate. For corrective actions.

Reduced cost of N.

Enables monitors to have visibility into study data in real-time.

A DATABASE is just random data. VISION allows us to turn data into knowledge and allows us to better monitor the study and immediately work on corrective actions which in turn drives compliance.  95% of the data entered into VISION is not modified. – Queries/field and through history of fields. Monitoring is reduced to 5% of data that is needing corrective action.  Cleaner data fast.

Reduces fraud.

Metrics out of VISION –

Want to get 95% of data entered once. How can we measure this?

Less data lost. u/k data.

Fewer deviations.  Deviations/subject

Completing their studies sooner.

Lowers cost.

Estimated amount of data being unevaluable (Study power). Impact study power. 80% power versus 85% in real $ is $800K – 1M in cost on the human side. (from literature)

Using VISION can help them to require fewer patients because that data is that much better. The impact is that it touches everything.

Caryn Thompson – can VISION save you on power.

Metric – cost/time savings with using the interface Inventory and shipment management interface – 3K.

Proposal

Prelude Dynamics proposed utilization of VISION™, an electronic data collection system, to allow researchers to capture information in real-time, provide the standardized scales in a just-in-time manner, follow the natural work flow of the study process, and ease the data collection process. In order to restrict the scales to the appropriate individuals, form level permissions would be assigned to specific roles. VISION™ would be programmed to use custom calculations to automatically start the clock from the surgical start time entered and provide the correct dosing amount of any medications administered.

Background

It is a common study objective to understand how animals respond to a certain surgical procedure, anesthesia, or post-surgery medications. Researchers examine an animal’s response at specific time intervals over a period of time to reach this understanding. When this time period extends over multiple days, it is necessary to utilize multiple observers to complete standardized scales.

When the data is collected on paper, it is difficult to blind current observers from information completed on forms by a previous observer. Access to previously entered information can bias the current observer, regardless of whether he or she collected the prior observation or it was collected by someone else. Reducing bias is important to obtaining reliable information.

Solution

Prelude staff trained the study staff to utilize VISION™ to show and provide access to only one scale at a time, restricting access to the individual with the appropriate permission at the designated time. VISION™ was programmed to start running the time clock off the entered surgical start time. Permissions were assigned to roles that corresponded with access to particular scale forms as indicated in the study protocol. Some scales could only be filled out by a certain role while others had multiple roles that could fill them out. Once a scale was filled in and signed off on, that scale became inaccessible or hidden and the next scale became accessible. Based on the initial entered surgical start time, each scale displayed the expected date and time that scale needed to be filled in.

As a standard, VISION collects full audit trail information on each data point entered into the system, including who entered the information and a date and time stamp. It also allows data entry fields to be augmented with comments or notes, which is an important feature if additional information needs to be added that might otherwise be limited to a selection of choices.

VISION™ also contains pre-existing summaries which assist in monitoring the data being collected at the patient level, at each site or for the study as a whole. Using VISION™’s search and filter capacity allows these summaries to display data of only the cases fitting the search criteria. Additionally, VISION™ provides users with certain permissions the ability to create ad-hoc reports which they can use for monitoring additional criteria or in order to answer important research questions. The data within the system is available for export 24/7/365 with the appropriate user permission. Export features the ability to export in multiple formats including SAS-ready format.

Results & Benefits

Real-time data is being entered into VISION™, and standardized scales are being filled in and signed off on, the completed form is no longer accessible to the individuals completing forms.  Using VISION™ eliminates observer bias since current observers cannot view or compare findings entered by a prior observer. There are certain roles designated by the Sponsor to maintain read-only access to view all the scales at any time.

Additionally, scale scores are immediately calculated and feedback automatically provided if scores indicate necessity for removal from the study or other treatment. This identifies potential problems quickly and reduces the risk to the participating animal.

VISION™ also identifies these animals quickly so they can be taken out of the study and prevent further costs associated with tracking an ineligible subject. Additionally, when an animal is removed from the study, VISION™’s Randomization module which is behind the scenes, and will reassign the withdrawn animal’s treatment to a new case to ensure that sufficient cases are enrolled for each treatment group.

The need for data collection on paper CRF has been eliminated. Researchers spend less time entering data after the fact because they are able to enter information directly into the system in real-time. There is also a cost savings and error reduction by eliminating data entry at a later date.

Additionally, the data is accessible in real time for query, review, analysis and export. Users report the streamlining of the process has helped reduce errors and improved efficiency.

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.

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Prelude Launches Composer, a DIY Solution That Puts The Study Build In Your Hands

AUSTIN, TX – June 20, 2016 – Prelude launches Composer, a DIY solution that puts the study build in your hands!

Prelude Dynamics announces a new solution that puts EDC development into the hands of the clinical trial community and raises the industry standard for DIY Clinical Trial Development. Composer’s drag-and-drop interface and robust set of features is based on the globally-recognized and 21 CFR compliant VISION™ platform, and provides unsurpassed functionality out-of-the-box.

“We wanted to make VISION’s capabilities available to users such as small pharma companies, the education community and sponsors who conduct pilot studies on a large scale .” said Dr. Alicia Browner, Chief Technology Officer, Prelude Dynamics. “Our Composer tool delivers big EDC functionality at a small price.”

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.

Robust Feature Set

In addition to the standard features supported by Prelude’s VISION™ platform (provide link), Composer provides:

  • Study visit configuration
  • Re-usable form library
  • Powerful edit checks
  • Calculations across forms
  • Conditional field display
  • XML and HTML Export
  • Role-based permissions
  • Randomization
  • Site Invoicing
  • Dictionary coding (e.g. VeDDRA)
  • Electronic lab interface (e.g. IDEXX)

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.

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

Handling a Surgical Study with Repeated Observation Times

 

Challenge

 

While collecting repeated observations of animals using a standardize scale is not in itself a challenge, allowing access to only one scale at a time during the appropriate time frame to the correct individual is a challenge. For this particular study, up to three individuals could conduct the observations around the clock at specific intervals over a minimum of a 72-hour time-frame and were restricted to conducting observations at specific times. The scale needed on-demand functionality as well in case additional observation times were necessary. The clock for the observation period started running off the surgical start time, which also had to be incorporated into the solution. Additionally, if the score was above a certain threshold, the researcher had to be alerted that an alternate procedure (medication or treatment protocol) had to be followed and/or the animal had to be removed from the study.

 

Proposal

 

Prelude Dynamics proposed utilization of VISION™, an electronic data collection system, to allow researchers to capture information in real-time, provide the standardized scales in a just-in-time manner, follow the natural work flow of the study process, and ease the data collection process. In order to restrict the scales to the appropriate individuals, form level permissions would be assigned to specific roles. VISION™ would be programmed to use custom calculations to automatically start the clock from the surgical start time entered and provide the correct dosing amount of any medications administered.

 

Background

 

It is a common study objective to understand how animals respond to a certain surgical procedure, anesthesia, or post-surgery medications. Researchers examine an animal’s response at specific time intervals over a period of time to reach this understanding. When this time period extends over multiple days, it is necessary to utilize multiple observers to complete standardized scales.

 

When the data is collected on paper, it is difficult to blind current observers from information completed on forms by a previous observer. Access to previously entered information can bias the current observer, regardless of whether he or she collected the prior observation or it was collected by someone else. Reducing bias is important to obtaining reliable information.

 

Solution

 

Prelude staff trained the study staff to utilize VISION™ to show and provide access to only one scale at a time, restricting access to the individual with the appropriate permission at the designated time. VISION™ was programmed to start running the time clock off the entered surgical start time. Permissions were assigned to roles that corresponded with access to particular scale forms as indicated in the study protocol. Some scales could only be filled out by a certain role while others had multiple roles that could fill them out. Once a scale was filled in, reviewed and approval given, that scale became inaccessible or hidden and the next scale became accessible. Based on the initial entered surgical start time, each scale displayed the expected date and time that scale needed to be filled in.

 

As a standard, VISION collects full audit trail information on each data point entered into the system, including who entered the information and a date and time stamp. It also allows data entry fields to be augmented with comments or notes, which is an important feature if additional information needs to be added that might otherwise be limited to a selection of choices.

 

VISION™ also contains pre-existing summaries which assist in monitoring the data being collected at the patient level, at each site or for the study as a whole. Using VISION™’s search and filter capacity allows these summaries to display data of only the cases fitting the search criteria. Additionally, VISION™ provides users with certain permissions the ability to create ad-hoc reports which they can use for monitoring additional criteria or in order to answer important research questions. The data within the system is available for export 24/7/365 with the appropriate user permission. Export features the ability to export in multiple formats including SAS-ready format.

 

Results & Benefits

 

Real-time data is being entered into VISION™, and standardized scales are being filled in and signed off on, the completed form is no longer accessible to the individuals completing forms.  Using VISION™ eliminates observer bias since current observers cannot view or compare findings entered by a prior observer. There are certain roles designated by the Sponsor to maintain read-only access to view all the scales at any time.

 

Scale scores are immediately calculated and feedback automatically provided if scores indicate necessity for removal from the study or other treatment. This identifies potential problems quickly and reduces the risk to the participating animal.

 

VISION™ also identifies these animals quickly so they can be taken out of the study and prevent further costs associated with tracking an ineligible subject. Additionally, when an animal is removed from the study, the VISION™ Randomization module, which is behind the scenes, will reassign the withdrawn animal’s treatment to a new case to ensure that sufficient cases are enrolled for each treatment group.

 

The need for data collection on paper CRF has been eliminated. Researchers spend less time entering data after the fact because they are able to enter information directly into the system in real-time. There is also a cost savings and error reduction by eliminating data entry at a later date.

 

Data is accessible in real time for query, review, analysis and export. Users report the streamlining of the process has helped reduce errors and improved efficiency

Prelude Enhances Automated IDEXX and Marshfield Lab Data Representations to Include Both Tabular and Non-Tabular Formats

AUSTIN, TX – April 14, 2016 – Prelude enhances automated IDEXX and Marshfield lab data representations to include both tabular and non-tabular formats.

Data managers and Biostatistitians now have a choice when exporting lab data in studies that use IDEXX and Marshfield labs as their lab of choice. The data can be exported in a tabular or non-tabular format, whichever suits their need for analysis.

This is an important enhancement as the automated computer-to-computer lab interface that allows both IDEXX and Marshfield to send lab data directly to VISION™ provides the data in a non-tabular format. Previously only the non-tabular export format was available.

This new enhancement translates the non-tabular format to a tabular format that often is preferred by data managers for use in their analysis. While data managers and biostatisticians can do this conversion themselves within their statistical software, it is a time consuming task that no longer needs to occur with the use of this enhanced automated lab interface.

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