Prelude Dynamics Publishes Client Case Study Featuring Great Ape Heart Project

AUSTIN, TX – March 23, 2015 – Prelude Dynamics, a global provider of web-based software systems for data collection, analysis and management, announced today the publication of a new case study featuring the Great Ape Heart Project (GAHP) based at Zoo Atlanta. The case study details the challenges GAHP faced in their quest to understand the underlying causes of heart disease in great apes and identify disease patterns across a global population of apes.

GAHP addresses a critical need within the zoo community to investigate and understand cardiovascular disease in great apes. A main GAHP goal is a centralized database that aids in the analysis of cardiac data and coordination of cardiac-related research, while improving communication among institutions where apes are cared for and housed around the globe.

Prelude Dynamics was selected to build the GAHP cardiac health registry to meet the challenge of collecting and coordinating world-wide data and to fulfill the need for a viable technology-based solution. Already known for an established EDC system, VISION™, and exceptional service and support in the animal health industry, Prelude was the obvious best candidate.

“Prelude had a deeper understanding of our needs than other companies that have not dealt with zoos or the veterinary community,” said Dr. Marietta Dindo Danforth, GAHP’s Project & Database Manager. Danforth went on to share, “The most immediate and valuable solution that VISION™ provides us is the ability to […] access our complete cardiac medical records from any place at any time…”

For more information about the Great Ape Heart Project based at Zoo Atlanta and their decision to use Prelude Dynamics; VISION™ as their online registry, read the case study today: Great Ape Heart Project Case Study

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

VISION Enables World-Wide Research With Multi-Language Capacity

 

Background

Conducting world-wide clinical research requires CRFs to be available in the participating clinic’s native language. This makes data entry post-data collection a complex process. Currently the majority of studies have two main options for this: collect data on paper-based forms or use an electronic format to collect the data. Paper-based Multilanguage data collection usually requires a local data entry person to enter the data into a useable electronic format. Then the multiple language electronic databases or spreadsheets have to be merged together which is a complex process for the data manager. Alternately, the electronic database can be used but is limited to displaying the information in one language, mainly in English.

When multiple databases are merged, there is potential for errors. For example, if the fields are translated in addition to their text labels or the value options are in multiple languages, complex matching dictionaries are needed in order to normalize the data into one language.  Not to mention if there is data entry that occurs from paper source documents, the possibility that there will be compromised data is much larger.

Challenge

The challenge is to provide an interface in multiple languages that can be used with or as a part of an EDC so that the data can be captured in real-time making the electronic version the original source document and allowing all the data, not matter what language it was entered in, to seamlessly be collected into one database. In order to ensure the highest quality of data was captured, the system would contain edit checks and messages ensuring all key and complementary data are captured. When data should fall within a given range, alerts should flag outlying values so they can be checked in real-time and measured again if necessary to confirm validity.

Since some of data being captured will be in free text form, the proposed solution would need to have a way for the translations into the final language to be captured directly into the EDC.

Proposal

Prelude Dynamics’ electronic data capture system, VISION™, already allowed researchers to capture information in real-time, provided standardized scales in a just-in-time manner, and adapted well to the natural work flow of complex study processes. It was proposed that Prelude add multi-language capability and a solution to capture translations directly into the database.

Solution

Prelude added a multi-language function to VISION. Basically, the user is now able to select between multiple languages as required by the study. Currently, the languages that are available are Chinese, Dutch, English, French, German, Hungarian, and Spanish. Additional languages will be added as studies require them. Once the end user selects a language, the text on the CRFs are automatically presented in the chosen language. The language settings are saved for future login and can be changed at any time without compromising data collection. All field names remained in English.

To facilitate translation of text entry fields, additional fields were included that were only visible to the roles involved in translating. The translator could then enter the translation into the available field. The translations were available in the CRF in which the data was collected. Upon export, both the translation and the original text would be exported.

Results & Benefits

Data is being collected internationally in the country’s native language. This facilitated the training of participating sites, increased their confidence in collecting data, and ultimately improved data collection and protocol compliance.

As real-time data is entered into VISION™, edit checks and warnings provide feedback in the appropriate language reminding researchers to collect missed data, check data that is outside of a normal range, and helping clean the data as it is collected. Monitors who are located remotely can log into the system on a daily basis and quickly identify any possible action items and tend to them quickly. Translators can log into the system on a regular basis, quickly identify items to be translated and enter the translations right next to the field they are translating.

Data managers no longer have to figure out how to combine multiple databases and no longer have the need to create complex matching dictionaries. They report the data is cleaner and easier to analyze. The time they spend on cleaning the data and normalizing it has practically been eliminated. The time to locking and archiving the database post-data collection has also been reduced from 9 or more months down to a couple of months.

VISION’s multi-language capability met and exceeded the expectations of the sponsor. They report they have greater confidence in the global data they collect and their study has run more effectively and efficiently.

VISION™ Reduces Clinical Timelines for Pivotal Aratana Study

AUSTIN, TX – February 9, 2015 – Aratana Therapeutics, Inc. (PETX) announced on December 18th the positive, statistically-significant (p < 0.05) results from its pivotal field study of AT-001 (Grapiprant), the company’s innovative drug for treating pain in dogs with osteoarthritis. This was just the latest pivotal clinical trial to use the VISION™ electronic data capture system, developed by Austin-based Prelude Dynamics and it was key to the conduct of the study.

“Using VISION™ to monitor the data in real-time, search data and create reports within the system to monitor progress was definitely instrumental in making the study run smoothly and efficiently,”

said Dr. Johnny Jacobsen, Chief Operating Officer at AlcheraBio LLC, the clinical research organization that managed the study. Study sites and AlcheraBio personnel find VISION™ intuitive and easy to navigate.

“VISION’s strength is its ability to automate the intricacies of the study for complex protocols beyond what sponsors typically expect,”

said Prelude Dynamics CTO, Dr. Alicia Browner. VISION™ has a library of customizable features that allow for these expedited timelines. For Aratana’s AT-003 study, assessments could be selectively hidden from view of the assessor when complete; integrated inventory-tracking streamlines the drug reconciliation process; Con Meds and AEs are cross-referenced; complex cross-form constraints and calculations are easily configured. All information is easily accessible directly on the page that holds the data, such as queries, notes-to-file, errors, and audit trail. Real-time remote access to data enables Monitors to query specific data, automatically notifying the site to review and respond. This built-in exchange allows data reviews to occur much closer to the actual data collection time.

“The fact that Aratana was able to lock the database and release their results simultaneously shows the quality of the data they collected and analyzed using VISION,”

said Richard Tieken, Prelude Dynamics CEO. This allows for studies to consistently close out months ahead of schedule. Where it may have taken months to clean and lock the entire data set, with VISION™ it takes days. Prelude’s services have benefited sponsors in hundreds of human, companion animal, and food animal clinical trials in all Phases, across 25 countries, in multiple languages with hundreds of sites and thousands of patients.

Prelude Dynamics Named in New GIA Report on E-Clinical Trial Technology Driven by Emphasis on Operational Excellence

SAN JOSE, CA (PRWEB) – February 4, 2015 – Demand for e-Clinical trial technologies is on the rise, spurred by the mounting pressure on biotech and pharmaceutical companies, medical device manufacturers, and contract research organizations (CROs) to accelerate the processes for clinical studies, regulatory approval, and commercialization of drugs. Stringent regulations mandating standardization of clinical study data and the acceptance of electronic submissions of clinical data by regulatory authorities are driving the need for advanced, user-friendly on-site data collection tools and eClinical systems. The growing trend towards globalization and outsourcing of the drug development process, coupled with the increasing complexity of Phase IV or post-marketing studies, are providing opportunities for clinical trial management solutions. Cloud computing is rapidly growing in popularity as a preferred model for delivery of e-clinical trial solutions. Cost advantages, flexibility, and functionality are key benefits driving customer acceptance of cloud solutions. Open source technologies are emerging into a preferred platform, given their cost advantages and interoperability benefits over proprietary platforms.

As stated by the new market research report on E-Clinical Trial Technologies, North America remains the most prominent market worldwide, supported by the strict legislative and regulatory atmosphere, and escalating clinical trial expenditure. Asia-Pacific ranks as the fastest growing market with a CAGR of 13.6% over the analysis period. Developing economies with large heterogeneous patient pools and high diseases prevalence are attractive locations for conducting clinical trials. Electronic Data Capture represents the largest technology sector, supported by the rapid replacement of the traditional paper based systems. Despite numerous time-saving and cost advantages, EDC adoption remains relatively low in Phase I clinical trials due to high purchase and implementation costs. Phase III clinical trials provide the bulk of sales revenue of EDC solutions. Tablet-based EDCs are gaining in popularity due to the portability benefits offered.

The research report titled “E-Clinical Trial Technologies: A Global Strategic Business Report” announced by Global Industry Analysts Inc., provides a comprehensive review of market trends, issues, growth drivers, recent mergers and acquisitions, strategic industry activities, and profiles of major and niche companies worldwide. The research report provides market estimates and projections in US$ Million for major geographic markets including the United States, Canada, Europe, Asia-Pacific (including Japan), and Rest of World. The global market is analyzed by major E-Clinical Trial Technologies, namely Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Electronic Patient Reported Outcome (ePRO), and Randomization and Trial Supply Management (RTSM) Systems. The EDC segment is further analyzed by Clinical Trial Phase (Phase I to Phase IV), and CTMS segment by Delivery Mode (Web-based CTMS, Cloud-based CTMS, and On-Premise CTMS).

Case Study: Great Ape Heart Project Database

Background

Since the early 1990s, CVD has been a growing concern for caregivers of great apes and, given the limitations described above, inspired the Great Ape Heart Project (GAHP) with a goal to improve the health and welfare of captive great apes and reduce mortality by facilitating collaboration, communication and connection between institutions housing great apes, zoo vets and SMEs.

The Great Ape Heart Project aimed to coordinate dedicated SMEs to provide a network of clinical, pathologic, and research strategies to understand and treat CVD in all the ape species. Animal records are kept locally at zoos and data is not collected in a standardized fashion to monitor for CVD-relevant trends. To remedy this, GAHP disseminated a standardized submission form to serve as a guide for more focused examinations and postmortem evaluation. This served to streamline the process of getting this CVD-relevant data from its local institution to the GAHP. However, the existing cardiac exam database consisted of manual maintenance, sharing and data aggregation of digital and hard-copy spreadsheets, shipped to and stored locally at Zoo Atlanta, and did not employ any software solution to manage data collection, storage, or secure sharing across numerous institutions and SMEs.

Challenge

Heart disease or cardiovascular disease (CVD) is a major cause of mortality in all four great ape genera managed in captivity (Bonobos, Chimpanzees, Gorillas, & Orangutans.) The Great Ape Heart Project, on a quest to understand the underlying causes of CVD, required a platform for identifying disease patterns across a global population of apes. GAHP Project and Database Manager Dr. Marietta Dindo Danforth captured the difficulty of the task, “One of the biggest challenges we have faced has not been the willingness to collaborate among zoos – but actually defining what cardiac disease is and its causes.”

With no efficient method to associate clinical data with postmortem findings, it is difficult to identify and report comparable or divergent CVD trends in the multiple ape taxa populations. Development of an effective approach to diagnose, treat and monitor heart disease in apes is limited by the lack of a centralized system that organizes data coordination, inter-institutional sharing and ensures data security. This further curbs critical retrospective and prospective CVD investigations and impedes ape management groups from forming alliances with Subject Matter Experts (SMEs).

Proposal

Prelude Dynamics was approached to develop a user-friendly, integrated, and cohesive web-based database solution that would adhere to GAHP’s values and mission. As stated by Danforth, “Prelude Dynamics was recommended to us by colleagues at Texas A&M who had a similar project to ours and who were extremely satisfied with the level of service and support from Prelude over the past decade. Knowing about their experiences and outcomes was not only reassuring for us, but it also meant that Prelude had a deeper understanding of our needs than other companies that have not dealt with zoos or the veterinary community.”

The Great Ape Heart Project required a database that could securely capture heart health data, medical reports, labs, digital ECG imagery, and necropsy reports, including file uploads, in a unified electronic patient record that would travel virtually with apes from zoo to zoo; provide mechanisms to standardize collected data to generate reliable reports, identify trends and make comparisons; allow establishment of familial relationships between apes; and allow continuous entry of new apes to the registry. While species-specific users would encounter a registry filled only with those apes applicable to their expertise, the managers at GAHP would have access to a cumulative registry of all great apes in all taxa or filter by species. The initial database would be prepopulated with historical data from multiple existing sources both digital and hard-copy. Additionally, the database would allow cross-taxa CVD data input and analysis that could be maintained by Dr. Danforth for years to come.

Solution

Prelude Dynamics’ established robust clinical trial management and electronic data capture (EDC) system, VISION, was selected as the platform for the Great Ape Cardiac Registry for its customization-ready, secure foundation that would ably meet the centralization and standardization needs of the Great Ape Heart Project.

Danforth emphasized, “What set Prelude apart from the competitors was the level of customer service we experienced from the very beginning.” Prelude’s Project Managers worked directly with Dr. Danforth and the GAHP team to customize a database that allows SMEs, cardiologists, pathologists, advisors and researchers to access species, institution, and ape-specific exam and pathology data in a single registry.  The customized database allows users to create and maintain cardiac exam and pathology data, upload massive ECG and other medical test files, which are stored and accessible in the system, summarize health data, transfer apes and their data between institutions, record and automatically link familial relationships, and generate search and ad-hoc reporting functions, all while facilitating clean and standardized data in real-time.

The database was initialized with existing cardiac exams and pathology data through a custom-built studbook and historical data uploader. When the GAHP Cardiac Registry launched, it had records from 69 institutions covering 446 individual apes and representing all four relevant species, including over three decades of global cardiac exam data for living and deceased apes – from a newborn orangutan to a 60-year old bonobo.

“The most immediate and valuable solution that VISION provides us is the ability to log in and access our complete cardiac medical records from any place at any time by multiple users,” Danforth said.

Medical exams can be created on-demand with a single click, and encompasses echocardiogram, electrocardiogram, blood work and anesthesia records. Authorized users have the opportunity to upload images, videos, and other files, and record detailed heart health information directly in VISION, at the time of exam or after. Uploaded material can be viewed or downloaded with the click of a link. Lab results from each exam are compared to preset lab normal ranges and out-of-range values are flagged, allowing the veterinarian to determine clinical significance. “When an ape is sick and a zoo is looking for immediate interpretation and advice on a cardiac case, we are able to use VISION to collect and coordinate exam data and expedite the review and feedback process,” states Danforth.

The necropsy data collection section includes multiple forms that collect data consistent with a typical workflow, and populates a report with basic demographic information, familial history of the disease, other possible causative zoonotic diseases, summarizes information from the last three exams, and allows the veterinarian to provide additional information, including the upload of files, and address the pathologist directly.  Additionally, the necropsy report lists archived or frozen tissues or slides and their storage location for future analysis.

Interactive graphs allow examination of different factors influencing the health of an individual ape in comparison to a particular species or to all apes in the system. VISION’s summaries allow at-a-glance monitoring of each site or the entire registry; and the search and filter capabilities display summaries for only the apes fitting the search criteria. Additionally, designated users can create ad-hoc reports to further examine the data, which is available globally, 24 hours a day.

Results & Benefits

Prelude staff trained GAHP personnel to utilize VISION to globally collect data on Great Ape heart health, which is accessible in real time for entry, review, analysis and export, including access to uploaded exams, images, and reports. Lab results are compared to set normals and outliers flagged for analysis. The Great Ape Heart Project Cardiac Registry launched in February 2015 and is poised for growth as data is expanded for the existing registered population and new institutions and apes are added. The system enables users to distinguish and examine data trends to report on emerging cardiac health patterns in localized and global populations, and anywhere in between.