What We Do
Prelude Dynamics is a global provider of customized web-based Clinical Trial Management Systems and Services. We offer unique, innovative research and clinical solutions to all areas of the pharma industry, world wide.
For more information or to schedule a trial run of the software, please contact us either via email at email@example.com or phone us at 512-476-5100.
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- About Prelude DynamicsOpen or Close
Trial & Data Management: Prelude Dynamics is a global provider of customized web-based Clinical Trial Management Systems. We offer unique and innovative research and clinical solutions to all areas of the pharmaceutical industry, in all corners of the globe. From university research groups and single site animal health organizations, to multi-national CROs and pharmaceuticals: We provide the tools and technology to easily compose, orchestrate, and perform successful clinical studies.
The development of our UNIFIED "VISION" system has allowed us to streamline eClinical solutions into ONE powerful package. Conduct your own performance - Data, Site, and Trial Management, eDC, IWR and CTMS - you choose the instruments, and the level at which they play in a PERSONALIZED ORCHESTRA built from the ground up. There is simply nothing else like it!
Using VISION as a solid foundation, and a level of service that is unsurpassed, Prelude has successfully implemented advanced user intuitive solutions that support organizations just joining the eClinical environment. With the ability to continually develop features that out pace and out perform, we support the technological challenges, superior solutions, and dreams of those that are looking for a new, dynamic performance. From the basics to the highly developed, we grow and evolve with you.
Based in Austin, Texas - "The Live Music Capital of The World", our experience with forward thinking pharmaceutical, CROs, medical device, animal health, and university organizations is unsurpassed. We work to streamline, and make more efficient the clinical operations of groups world wide, and offer a system and services that allow you to set up your Team, your Study, and your Trial as easy as 1, 2, 3.
- Founder BiosOpen or Close
Prelude Dynamics' founders, Richard Tieken and Dr. Alicia Browner, have over 50 cumulative years of experience designing, building, and supporting sophisticated software systems that focus on collection of data and presentation of information aiding awareness and decisions by managers and executives. Below is a short biography of the leadership of Prelude Dynamics.
Richard Tieken - Co-founder
Mr. Tieken holds a B.S. in Computer Science, and has over 25 years of experience designing and deploying complex software systems. He began his career in software, working at NASA on the first Space Shuttle program, and spent many years developing rigorous software systems for military commanders, first as an engineer with Lockheed Martin and later as Director of Engineering and Branch Manager for the Northrup-Grumman INRI facility in Austin, TX. Mr. Tieken subsequently became the Director and VP of Development for an internet-based electronic medical patient records company. In 2003, he became a co-founder of Prelude Dynamics LLC, applying patient records software expertise to the trial management and electronic patient CRF domain.
Alicia Browner - Co-founder
Dr. Browner's primary expertise is implementing solutions to systems engineering, operations research, and computer science and mathematical problems. She has a Ph.D. in Mathematics and over 20 years of experience in high-level design and analysis, software development, and design of models, simulators, and optimization algorithms using Operations Research methods. In Dr. Browner's early career, she created automated systems for the US Government and NATO, culminating in the position of Consulting Scientist at Lockheed Martin. Following her DOD work, Dr. Browner entered the clinical applications domain as Chief Systems Engineer for a startup company developing practice management software. Dr. Browner became a cofounder of Prelude Dynamics, designing and developing software tools to automate data collection and processing for clinical trials.
- Our ProcessOpen or Close
Our process begins by understanding your unique needs and requirements. Using study protocol and discussions with your team of clinical experts, we write a Study Requirements Document (SRD) that describes the functionality, forms, data elements, summary charts, and edit checks that apply to your study. We use personal interaction to ensure that we have fully understood your requirements and are providing the most efficient and complete solutions.
With your approval of the Study Requirements Document, we build the electronic Case Report Forms; along with multiple edit checks and summary charts that give your study a streamlined and sturdy foundation. If you have designed paper CRFs, we will customize and implement forms that closely resemble your paper pages. Specialized tailoring of the system and visual adjustments will then be made to make the system and tools yours. The customized system is then thoroughly tested and validated.
User Acceptance Test
When the study build is completed and validated, we deploy the results for your test team to verify that the end product and functionality meets and exceeds your expectations. Any problems are quickly fixed and small adjustments are made before the system is redeployed and accepted.
The final working system and study build is loaded into a dedicated server. At this time, user accounts are established and your clinicians can begin the training for the trial using a duplicate training database. Training shifts to the real database when you are ready by a simple reassignment of the users. You immediately begin to see the benefits as your study progresses. Your data is stored in a Tier 1 facility that provides the ultimate in protection and security.
For the life of your study, we provide backups and archives of your study data to guarantee the ultimate in data traceability and site control. In addition, help desk personnel and our software architects are ready to assist you and answer any questions as you progress.
We can all safely agree it is virtually impossible to anticipate every data element and edit check in advance. Furthermore, as the study progresses, the trend charts may indicate additional information that would be advantageous to collect. Our elegant architecture facilitates addition to and change of data elements, edit checks, and summary charts with an ease unparalleled in traditional or competing software systems. In addition, Perceptive Connection offers a "revalidation" feature that allows data managers and other study personnel to change the edit checks and have the system automatically reprocess all forms for checking.
At the end of the study, we make a final archive and decommission the study, removing the study data and user accounts. The archived data is sent to the sites and the client.
- Full-ServiceOpen or Close
Services We Offer
Prelude Dynamics provides a complete set of services designed to off load all the CRF/data collection aspects of a trial. We work with you to transition the process you currently use to one that is Internet-enabled, allowing your team to focus on the clinical aspects of the trial. Our role begins with your IRB approved protocol, ends with a locked data set ready for your statistical analysis, and includes support along the way.
We will "build" the electronic CRF pages, edit checks, and summary charts for your protocol.
Prelude Dynamics will take your protocol, generate system requirements, and "build" the electronic case report forms, site forms, edit checks, and summary reports. Because of our state-of-the-art architecture, we are able to build studies very rapidly! With our short timelines, and comprehensive software, we can have your study up and running much faster than using more traditional software approaches, including Phase I studies. Typical build times are on the order of 2-3 weeks. The study development activities include:
- Requirements and Design -- producing a Study Requirements Document
- Implementation -- producing electronic pages, charts and edit checks
- Testing -- producing test results and change requests
- Documentation -- producing a User's Manual
- Hosting Service Setup -- producing a server with the study loaded ready for the data center
We will ensure that all users of your electronic study know how to use the system.
At Prelude Dynamics, we are ready to train the users involved in your study. Because of the intuitive user interface, training typically takes on the order of only 2-3 hours! There are two main methods of training that we suggest:
- Train the Trainer(s): We can provide training to your Monitors, Data Managers, or trainers, who are then equipped to train the other participants in your study. This can be done at site initiation, to reduced travel and training costs.
- Train the User(s): We are also happy to train your participants directly.
Either way, we can help you ensure your staff are all able to use the system. Feedback from other users is that our system is "the easiest EDC software I've ever used!"
We can host your study and its data in a secure facility to guarantee the safety of your data.
At Prelude Dynamics, we know there's nothing more important than protecting your data!
Some companies with extensive Information Technology support prefer to host their study data in their own facilities. For most, however, having the study data and software reside in a dedicated data center is more convenient and ensures the ultimate in protection for your study!
Therefore, we at Prelude Dynamics can support your hosting needs with a Tier 1 data center with UPS systems that provide redundant power sources along with generator and battery backups. The data center has multiple, redundant Internet connections to ensure continuous connectivity. In addition, its raised floor, high-capacity air conditioning, fire protection, and physical security all ensure that your data is as safe as possible.
Along with hosting, Prelude Dynamics will provide administrative support to your data collection, including backups and archives. At the end of the study, we'll provide a final study data archive, decommission users, and remove the study from the server.
We support you with help desk, consulting, mid-study updates, and technology enhancements, and, if desired, technology transfer.
Because the success of your trial is our number one priority, we offer technical support services during your study execution:
- Help Desk: Personnel are available to answer product questions and assist with administrative tasks. (The software is so intuitive that the majority of our help desk calls are for forgotten passwords.)
- Consulting: In order to ensure that the study is implemented the way you want, we provide consulting services to perform unique tailoring of the software, unique data imports, and system administration.
- Mid-Study Updates: It is virtually impossible to anticipate in advance every nuance of a study. In addition, because our system allows you to see data trends as the data is collected, you may decide additional or different information needs to be collected, edit checks changed, or new summary information obtained. Our elegant architecture allows us to modify data elements and edit checks, add summary or CRF forms, and change layouts so easily that the cost of change is minimal.
- Technology Enhancements: As we enhance our technology to take advantage of the most up-to-date advances, we provide the option for you to incorporate these advances into your study.
- Technology Transfer: For companies who desire complete control over their trial management software, we can provide our technology and train your technologists to use and modify the software.
With high quality standards, we are here to support you in any way we can. Your satisfaction and the success of your clinical trial is of paramount importance to us.
For more information or to schedule a trial run of the software, please contact us either via email at firstname.lastname@example.org or phone us at 512-476-5100.
Effective Date: March 30, 2015
Prelude Dynamics is a Software as a Service (SaaS) provider who develops VISION™, an electronic data capture (EDC) software system for the conduct of clinical trials. Our clients are pharmaceutical companies and Contract Research Organizations (CROs), hereinafter referred to as “Sponsors”, who contract with us to implement EDC systems that collect, store, report on, analyze and export clinical trial information for sponsor-specific projects. The information collected by VISION™ is digitally transferred to, and stored in, an SSAE-16 compliant data center located in Austin, TX, and can be accessed by our Sponsors and other authorized users via the Internet. The information gathered is used solely for the purpose of the Sponsor’s clinical trials and is ultimately transferred to our Sponsors, who hold rights and responsibilities with respect to that information. Per contract, Prelude Dynamics is explicitly prohibited from disclosing any trial-related information to third parties without explicit authorization or as required by law.
“Sponsor” means any individual, corporation, or other entity which contracts with Prelude Dynamics to perform services involving the transfer, processing, or reporting of clinical trial information on behalf of and under the instructions of said ”Sponsor”.
“Personal Information” or “Information” means information that (1) is transferred from the European Union (“EU”) to the United States; (2) is recorded in any form; (3) is about, or pertains to a specific individual; and (4) can be linked to that individual.
As a SaaS provider, it is the duty and responsibility of our Sponsors to notify individuals of how their information will be used and/or distributed to third parties. As a contracted agent of the Sponsor, we have no authority, and in fact are prohibited from, distributing data concerning an individual to anyone other than the Sponsor (or their agents as directed). Should the EDC be used in any way to document or provide notice, we will work with the Sponsor to ensure that the notification provided is complete and easily understood, and refrain from allowing the trial to register any individuals until we feel that the notification provided sufficiently complies with this principle.
Trial participants, by their participation, are volunteering to supply certain medical information to support the Sponsor’s study goals. Participants may or may not be compensated by the Sponsor for participation. The Sponsor determines the Study design, content, goals, and end usage of collected information.
Our contractual Sponsors are obligated to provide individuals with the ability to choose whether their Personal Information will to be disclosed to a third party or used for a purpose other than the purpose for which it was originally collected or subsequently authorized by the individual. Individuals will typically opt out by communicating directly with our Sponsors. When notified by a client that an individual has chosen not to give permission, or revoked their permission for our Sponsors to use their Personal information, we will remove (electronically delete) the individual’s information from the VISION system.
Should an individual contact us directly with an opt-out request, we will notify the Sponsor on the individual’s behalf.
It will not be possible to remove an individual’s data when a trial has already been completed (locked and archived).
The Sponsor retains all rights and responsibilities with respect to onward transfers. Our Sponsors transfer data to Prelude Dynamics for storage and processing, but we are contractually prohibited from releasing this information to anyone other than the Sponsor unless specifically authorized to do so, or are obligated to do so for legal reasons.
All requests for access to personal information should be directed to the appropriate Sponsor. When necessary, Prelude Dynamics will assist the Sponsor in compiling a read-only copy of the personal information requested.
Prelude Dynamics hosts its EDC systems in an SSAE-16 compliant data center hosted in Austin, TX. All communications with our servers are implemented via secure, encrypted https protocol and a dedicated firewall appliance. The data center itself is manned 24/7/365 and stringent authorization and entry procedures are in place. The VISION™ system itself requires a role-permission based user ID/password combination to be entered before access to the system is granted. Issuance of such user IDs and passwords is the responsibility of the Sponsor and sponsor representatives with strict need-to-know for a specific trial. While every effort has been made to reasonably safeguard Personal Information, we cannot absolutely guarantee the security of Information transmitted via the Internet. All participants using the VISION™ system, regardless of role, are expected to have and maintain anti-malware software on their local computers.
Our Sponsor organizations are responsible for assuring data integrity at the time of data entry or in a contemporaneous monitor review. Prelude Dynamics adds to this assurance by providing a comprehensive audit trail of data entered, and VISION utilizes comprehensive error and constraint checking to encourage correctness at data entry time. In addition, the data transmission protocol utilizes advanced technology to guarantee that the data transmitted to our secure server is identical to the data entered. If any participant believes information collected is in error, they should contact their Sponsor representative as soon as possible.
After communicating with the Sponsor, Prelude Dynamics encourages individuals to raise complaints directly with us prior to proceeding to an independent recourse mechanism for resolution. We agree to give prompt and courteous attention to complaints about an individual’s privacy, and to address them in a timely manner.
In addition to self-assessment, Prelude Dynamics commits to cooperate and comply with both European Data Protection Authorities (DPAs) and the Federal Data Protection and Information Commissioner of Switzerland in the investigation and resolution of complaints brought under Safe Harbor. We will comply with any advice given by these authorities where the authorities take the view that our organization needs to take specific action to comply with the Safe Harbor Principles, including remedial or compensatory measures for the benefit of individuals affected by any non-compliance with the Principles, and will provide these authorities with written confirmation that such action has been taken.
The contact information for the above-mentioned authorities can be found at:
EU DPAs: http://ec.europa.eu/justice/data-protection/article-29/structure/data-protection-authorities/index_en.htm
Swiss FDPIC: http://www.edoeb.admin.ch/kontakt/index.html?lang=en
Questions, comments or complaints regarding the Prelude Dynamics’ Safe Harbor Policy or data collection and processing practices can be communicated using one of the methods below.
Attn: VP Quality Assurance
3906 Manchaca Rd
Austin, TX 78704
- CareersOpen or Close
All positions are currently filled.
- Contact InfoOpen or Close
Prelude Dynamics, LLC.
3906 Manchaca Road
Austin, Texas 78704