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

VISION™ Feedback Tool Has Been Enhanced to Support Client Approval and Testing Documentation

AUSTIN, TX – March 10, 2016 – Prelude announced today that it has enhanced its feedback tool. Clients use VISION’s feedback tool during the study build process to communicate changes and needs to their Prelude Project Manager. Feedback is integrated into the study and allows users to leave feedback directly on the pertinent field.

When feedback is left, as with all data entered into VISION, there is a full audit trail of who left the feedback and when. The feedback tool tracks the communication between the Sponsor and Prelude related to study design needs.

As expressed by one of our clients, “We appreciate the iterative development study process and relationship we have with Prelude. The feedback tool allows us to quickly note any changes. It keeps track of the changes we have requested, and allows us to have a team of people testing and interacting with the study during the development phase. As the PM in charge of this process, this enhancement allows me to approve the suggested changes before Prelude implements them. And the audit trail allows me to see which of our staff entered the change so I can follow up with them if I have questions prior to approving the change.”

The enhancements include addition of a change approval column and a reviewed column. The change approval column is intended to be used by the project lead to indicate whether the suggested change should or should not be made. This is important because many clients engage teams to collaborate in and test the study build. Each of these team members comes from a different perspective and might make different suggestions based on their experience. Some of the changes suggested might not be needed or might be in conflict with other changes, so this allows the project lead to review and designate each change as desire prior to Prelude’s implementation.

The reviewed column allows clients to better track and review the requested changes. Once the change is made, the Client needs to ensure the change is made as desired. Many clients were tracking this offline on excel sheets because it was an important quality assurance process. Now, they can quickly indicate their review directly in VISION™ which gives them a full audit trail of their approval.

Additionally, the testing documentation provided to clients as a suggested starting point for testing their study has been enhanced. It is now available as a pop-up window rather than a download. This makes it easy to have the testing document beside the study to ensure thorough testing.

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

Vaccines – Tracking Multiple Doses

Challenge

Vaccine dosing studies usually require information to be entered with high accuracy in a short amount of time. Blood draws often occur every 10 to 15 minutes during an initial time period and then hourly or every several hours for a second time period. When collecting information on paper for several cases at the same time, this can become challenging since the data requires the phlebotomist’s signature, and the date and time the information was recorded. Additional observations, such as the case’s physical reactions (injection site reactions, mood, level of energy or lethargy, etc.) are often required in addition to lab data.  Depending on study objectives, the extent of data collection can vary and collecting large amounts of data in a short time on paper can be stressful and prone to errors. Further, when labs results are returned and analyzed, the results must be integrated with existing patient data. Each data entry process on paper introduces the change for human entry errors. The challenge was to develop an electronic system that would streamline the data collection process, reduce errors, and stress.

Proposal

Prelude Dynamics proposed the study use VISION™, an electronic data collection system, to allow researchers to capture information in real-time, follow the natural work flow of the study process, and ease data collection. The proposed system would automatically integrate lab results into patient files, compare them to established lab normals and flag outliers, and allow the researcher to determine if the flagged outliers were clinically significant.

Background

Vaccine trials usually consist of understanding real-time antibody development occurring post-introduction of the vaccine. Generally, different dose amounts are compared to determine the optimal dose to produce an effective vaccine. This requires the researcher to collect multiple blood samples after initial dosing. The intervals of the blood collection are typically every 10 to 15 minutes for an initial time period and then hourly or every several hours for secondary time period.

During each blood collection event, additional data on various physical responses to the vaccine is also collected (blood pressure, heart rate, etc.). Depending on the method of vaccine administration, other observations are recorded, such as injection site redness, heat, and pain if administered via injection, or coughing rate and breaths per minute if administered via breathing. These observations demand close attention from the researcher and increase the stress level the researcher experiences during data collection.

Historically, vaccine studies are costly because the researchers-to-subjects ratio of at each data collection event is low to allow enough time to collect the data. Development of an electronic data capture system that streamlines the process can increase the accuracy of data collection, and allow for more subjects to undergo the vaccine therapy simultaneously, ultimately lowering costs, decreasing data collection time, and reducing time to market.

Solution

Prelude Dynamics proposed to utilize VISION™ to develop an electronic data system for vaccine trials that:

  • Includes an integrated time management system that prompts the researcher to administer the doses or collect specific data within designated timeframes.
  • Expedites data entry of dosing or blood draw by collecting researcher information, data and time stamp for each data collection event with one button click.
  • Standardizes data collection by allowing researchers to select designated options rather than writing out observations.
  • Allows researchers to augment the clickable answers with additional details when pertinent.
  • Alerts researchers immediately of missing required data to ensure the data is collected prior to the data collection event.
  • Integrates lab analysis into patient files, including notifying researchers of the receipt of lab results and flagging outlying results based on designated lab normal values.
  • Allows monitors and sponsors to view data collection in real-time even when they are located remotely so that if data needs to be queried, it can occur quickly.
  • Allows sponsors and researchers to examine demographic results of the data collected to date to allow mid-study monitoring.

VISION™ contains administrative panels that allow the sponsor to determine the frequency of vaccine dosing and challenge dosing and blood draws. Acceptable timeframe deviation ranges can be entered into this panel. When site personnel or researchers initiate the time clock for the case by clicking the “now” time button, VISION™ automatically starts the countdown to the next event and displays any data that must be collected in the interim. When the “now” button is clicked, the user’s ID, date, and time stamp are recorded in the system, eliminating time to write the dame and time, reducing future data entry costs, and increasing the accuracy of data collection. Once the researcher clicks “save,” the data entered is hidden. When it is time for the next event (blood draw, dosing, etc.), the system alerts the researcher on the screen and displays the data to be collected for that event. Because VISION™ is an online data collection system, field researchers are able to access the study and enter data on any mobile device.

These features allow for dosing and blood draws to occur for multiple cases in a tiered fashion, which maximizes the researchers’ time without compromising data integrity. When multiple cases are being entered simultaneously, switching between patients can be done either through the list page or by entering the case ID and hitting the search button. The system is constantly communicating with the researcher what needs to occur next and what data needs to be collected.

The additional data to be collected between doses or draws is standardized in order to allow entry through selection from a drop down menu of choices, radio buttons or checkboxes. When additional information needs to be added, comments or notes can be added directly to the pertinent field. Additionally, if needed, free text fields can be provided for entry of comments or in response to certain questions. Edit checks that fire when the form is saved alert the researcher to missing or out-of-range information. VISION™ collects a full audit trail of all data recorded in the system, and each data point is stamped with who entered the data when (date/time).

While lab analyses do take time, VISION™ allows the labs to enter data directly into the system, and the researcher receives an email notification of the lab data arrival. The lab results are automatically compared with the designated lab normal ranges and out-of-range data is flagged to allow the researcher to determine if it is clinically significant.

Remotely located sponsors or other researchers can access data in real-time, which allows queries to appear in the system at the site during data collection. Site or field personnel respond within the system to the queries, and can collect additional data immediately.

For vaccines using injections as the administration route, digital photos can be captured and uploaded into the system. An additional module allows measurements to be collected.

VISION™ also contains pre-existing summaries which assist in monitoring the data 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 for only cases fitting the search criteria. Additionally, designated users can create ad-hoc reports to monitor additional criteria and 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

During the initial testing of the system, researchers collected data both on paper as well as within VISION™. Within minutes, it was obvious that the VISION™ solution was far superior, reduced time and data entry errors, and was well liked by the researchers. In fact, the users were so impressed with VISION™ that they called upper level management to come observe the difference at the last minute. Upper management was also very impressed at the capacity of VISION™ to streamline the process, and agreed there were cost savings and efficiency benefits to their studies.

Real-time data is entered into VISION™ and has eliminated the need for paper CRF collection. Researchers spend less time entering data and the data entered is standardized as they select from designated options. In cases where text entry fields are available, as items are entered, they become available for future selection in a drop down menu adding real-time standardization to data entry.

Additionally, data is accessible in real time for review, analysis, export, or additional data entry. Users have access to all digital photographs, and labs are compared to designated lab normals and outliers flagged for analysis. Users report the streamlining of the process has helped reduce errors and improved efficiency.

They are currently working on standardizing additional data collection forms so that they can be used as templates for future studies further standardizing their studies. Meanwhile, Prelude is working on developing a way to provide them with the ability to pick the forms they want to use from their existing library of forms via an administrative panel so they can design future studies faster and at a lower cost. Additionally, within each form, they will have the ability to select what modules of information they desire to use on the form for that particular study.

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.

Randomization

Challenge

Ensuring that patients are appropriately randomized to the correct treatment group is a critical factor for all clinical studies. Additionally, it is imperative that designated study personnel are masked to the assigned treatment group unless there is a medical necessity to disclose. Ideally, at the end of the study, there is a proportional number of cases in each treatment group as planned in the study design.

However, a variety of issues can occur that compromise the desired treatment group mix.  For example, a case might be accidentally given the wrong treatment or a case that was randomized might be terminated early from the study. In some cases, in order to enroll enough patients, there is a need to allow certain sites to add additional patients. When a randomization table is used, even though there might be a few additional randomization lines available, more often than not, it is necessary to generate additional randomized treatment groups to support the site case enrollment expansion.

Furthermore, when either electronic or paper-based randomization tables are used, study personnel designated to be masked may accidentally become unblended due to simple human error, such as the randomization table mistakenly being left out on a table.

Additionally, sometimes the randomization strategy needs to be applied across the whole study rather than just at the site level. A study-wide randomization makes it more difficult for site-based personnel to try to pre-empt what treatment group the case might be assigned to and to start to notice trends that might allow them to start guessing what treatment each case is receiving. This is important as it is a natural behavior to try to guess and this inadvertently introduces unnecessary researcher bias.

In some cases, it may be ideal to apply multiple stratification criteria to assign cases to particular groups (for example, gender or age). When using paper-based or spreadsheet tables, adding stratification criteria is a complex proposition.

Prelude Dynamics was challenged to develop a smart electronic interface that will more easily perform randomization processes and allow for complex stratification criteria, mitigating these challenges.

Proposal

Prelude Dynamics proposed to develop an integrated dynamic randomization module to meet the challenge and to respond to given specifications for future studies. The module will allow researchers to select whether the randomization is site- or study-based, input treatment group ratios and block size, and apply multiple stratification criteria. Further, the module will reassign the treatment group for a case that does not complete the study to new enrollees, ensuring treatment group minimums and ratios are met. The module would also be automated such that randomization would only be available when inclusion/exclusion criteria have been met.

Background

The success of a clinical trial study relies on consistent randomization of patients into treatment groups and dependable masking of certain roles in order ensure biases is not introduced into the study. Generally, this means that at least one person at the site level, the treatment dispenser or coordinator, is knowledgeable about the treatment group to which each subject is assigned. Historically, this role had maintained a written table that indicated to which group the subject is assigned dependent on the enrollment order into the study.

Written randomization tables pose several challenges for the study overall. The unmasked role must ensure the randomization table is kept confidential and that information that could indicate the assigned treatment group is not accidentally verbally disclosed. Additionally, if there is inventory that needs to be kept up with, the inventory must be kept in such a manner that it does not inevitably disclose and relationship between subjects and treatment group.

When an individual is relied on to determine randomization of treatment groups, problems can occur due to human error. A subject being inadvertently given the wrong treatment is one of the biggest such problems. This would require making a decision about how to handle the next enrollee. The decision maker would have to evaluate if the next enrollee should be provided with the treatment this subject should have received, thereby skewing the order of randomization. Further, if the mistake is not discovered immediately, other subjects may have since been enrolled and the randomization ratios become harder to control and manage.

Subjects also sometimes withdraw from studies, which can cause a difference in the number of subjects per treatment group. Historically, it has been difficult or nearly impossible to guard the integrity of the study randomization and reassign the treatment group to another study. Unfortunately, subjects dropping out of the study for various reasons is a frequent and costly event.

Another problem that can be a consequence of study dropouts or inaccurate enrollment predictions is that more subjects need to be enrolled to satisfy the study design. When this occurs, there might be sites that have had more success enrolling the desired patient demographics than others, and these sites may be asked to expand the number of subjects enrolled. This presents a problem when the randomization table is exhausted, and makes it necessary for the study biostatistician to develop an appended randomization table.

Historically, it has been nearly impossible for studies to use complex stratification criteria to enroll subjects and assign treatment groups. These studies have to choose between either developing multiple randomization tables for each set of stratification criteria or simplifying the stratification criteria altogether. Additionally, if multiple randomization tables are used, the study incurs cost to train the treatment dispenser or unmasked role to use the more complicated tables. It has also historically been problematic to randomize across the study when it is conducted in different clinics.

Solution

Prelude Dynamics proposed to train users to utilize VISION™’s randomization module, which allows for dynamic randomization and was set up to handle:

  • Study-wide randomization across clinics
  • Reassignment of dropouts
  • Reassignment of accidental treatment assignment errors
  • Just-in-Time randomization
  • Dropping of treatment groups if deemed ineffective due to mid-study monitoring and statistical analysis

Results & Benefits

As a result of using VISION™, treatment masking and assignment is completely secure and occurs in real-time. VISION™ eliminated the paper tables that could be left lying around or inadvertently unmask the wrong role. Additionally, since the treatment dispenser only sees one treatment group upon randomization, the subject is more likely to receive the correct treatment. If a subject is accidentally given the incorrect treatment, VISION™ mitigates the error by assigning the treatment again according to the randomization set up. When dropouts occur, VISION™ automatically knows what treatment group has been reduced and can automatically reassign it to new enrollees to maintain treatment group ratios.

As mid-study monitoring and data analysis occurs, if a treatment is deemed to be ineffective, VISION™’s randomization module settings can quickly be changed to assign future subjects into the remaining treatment groups. This can save thousands of dollars on the study.

VISION™ makes it possible to handle study-wide randomization across multiple sites. Whenever a new subject is enrolled, regardless of the clinic where the subject is enrolled, VISION™ automatically uses the same formula that would have generated the paper randomization in order to designate the appropriate treatment group. Utilizing study-wide randomization makes it more difficult for any masked personnel to be able to predict treatment assignment.

Additionally, because VISION™ integrates with information located in other eCRFs, its randomization module settings can be used to enter stratification criteria. For example, a study could require each treatment group to be assigned to at least 30 subjects of each gender over 50 years old with diabetes and high blood pressure, 30 subjects of each gender under 50 years old with diabetes and high blood pressure, 30 subjects of each gender and age group with only diabetes, 30 subjects of each gender with only high blood pressure, and 30 subjects of each gender and age group that do not have either condition. VISION™ has the ability to handle these criteria by checking all the stratification criteria and then employing the formula to generate the correct treatment group. Only the treatment group assigned is displayed and all the dosing calculations are automatically done for that treatment. This reduces dosing errors and any other errors that might occur due to treatment group assignment.

Sponsors indicate they are excited about using VISION™’s randomization functionality, and appreciate the cost savings and benefits that it can provide. The principal investigators have always found it a challenge to design studies without or with minimal stratification, and recognize that VISION™ allows them to stratify all the desired criteria. Statisticians recognize that they now have more control over the stratification criteria, which allows for more accurate comparisons between treatment groups. Statistically speaking, when stratification criteria is not applied correctly during randomization, one treatment group could contain insufficient subjects to meet the stratification criteria at the end of the study and could interfere will proper analysis, and therefore, study integrity.

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 Announces New Initiative to Build a “Composer” Build-it-Yourself Study Definition Feature Within VISION

AUSTIN, TX – August 06, 2015 – Prelude is constantly listening to its client’s needs and desired because we are dedicated to improving the clinical trial workflow, experience, and accuracy. Our clients love VISION™ and want to be able to use it for smaller trials and earlier trial phases. After considering the logistics, the Prelude Change Control Board announced a new initiative – a build-it-yourself product called “Composer.”

“We are excited to announce the development of Composer, a build-it-yourself tool that will allow our clients to leverage the power of EDC for pre-clinical and phase I studies that have a smaller number of subjects. We expect it to be available next summer.” stated Prelude Dynamics’ CEO, Richard Tieken

Composer will have a user-friendly intuitive interface that will allow current VISION™ users to learn to quickly build studies within a few days. Composer will leverage Prelude’s flagship product, VISION, as its behind the scenes core. Prelude is certain Composer will soon be the premier build-it-yourself solution in the market place.

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