Clinical Trial Design Services
Datatrak’s team of experienced clinical trial design specialists are experts at working with you to implement your study protocol’s requirements into the digital platform and database to manage your study. Our team is also experienced at participating in meetings with study sponsors to help our CRO customers make the best impressions with sponsors and all study stakeholders. Our team can also help with custom requests and change orders should your study protocol change at any point during the process.We are committed to providing an unparalleled customer experience, working to ensure every client is impressed with our trial design software, services, and partnership.
Talk to a Trial Designer
Training Modules
Datatrak University offers options for either instructor-led, web-based, or onsite training sessions.
Solutions Consulting
Our team is here to understand your needs and guide the development of your clinical study design and implementation strategies.
Protocol Change Management
Our team can help with custom requests and change orders should your study protocol change at any point during the process.
Training to Build Your Own Studies
Datatrak’s clinical trial design team has trained thousands of users to build their own studies on our platform. Our friendly and helpful team will train you how to do the trial designs on the platform. Many of our customers have been trained by our team and have successfully designed hundreds of trials on their own.
Start Your Training
Expert team participates in sponsor meetings and stakeholder reviews
Instructor-led, web-based, or onsite training options available
Hundreds of trials successfully designed by trained customers
Custom change orders supported without disrupting your study timeline
Integrated Solutions
View All SolutionsElectronic Data Capture (EDC)
A powerful, cost-effective EDC system that enhances data capture and cleaning with a Rapid Startup option — easy to set up and built for any study.
Clinical Trial Management (CTMS)
Manage your clinical trials from startup to close with a fully integrated CTMS giving your team real-time visibility across all studies.
Electronic Trial Master File (eTMF)
Keep every trial document compliant and inspection ready with an eTMF system that cuts costs by 62% and integrates directly with EDC.
eConsent
Simplify patient enrollment and informed consent with digital eConsent software built for decentralized and remote clinical trials.
Post Market Surveillance
Conduct post-market surveillance and Phase IV studies with acloud-based pharmacovigilance software platform built for compliance.
EMR/EHR
Link electronic medical records to your clinical trial EDC with an EHR system and EMR software built for seamless data management.
Trial Design
Work with our expert clinical trial design team to implement your study protocol and train your users to build studies independently.
Data Management
Our clinical data management team supports your data cleaning, workflows for clinical trials, and study-specific needs from startup to close.
Frequently Asked Questions
What is clinical trial design?
Clinical trial design is the process of translating a study protocol into the structure, forms, workflows, and data collection logic needed to run the trial. Datatrak’s team of experienced clinical trial design specialists works with you to implement your study protocol’s requirements into the digital platform and database that will manage your study.
Can Datatrak’s team design our study, or can we build it ourselves?
Both options are available. Many of our customers have been trained by our team and have successfully designed hundreds of trials on their own through Datatrak University, which offers instructor-led, web-based, and onsite training sessions. For teams that prefer a hands-on partner, our Solutions Consulting group designs the study with you and participates in sponsor meetings and stakeholder reviews to help CRO customers make the best impression.
What happens if our study protocol changes during the trial?
Protocol changes are a normal part of clinical research. Our team can help with custom requests and change orders should your study protocol change at any point during the process, and our one-of-a-kind change management process allows teams to implement updates without required study downtime or data migration.
News & Insights
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Increase Diversity in Clinical Trials
Discussions around improving diversity in clinical trials have been ongoing for quite some time, with relatively gradual change to actual practice.
Finally Fountayn
In early 2022, we made the concrete decision to transition away from the Datatrak name and brand and rebrand to a fresh and modern look.
The Ultimate Clinical Trial Suite, Delivered.
The Clinical Trials Industry uses eClinical solutions to reduce costs and improve efficiency.
4 Ways to Scale eClinical Customer Education
Fountayn's training approach doesn't follow a "one size fits all" approach.
Into the Future with Fountayn Software
Scalability in software refers to its ability to adjust capacity and functionalities based on user demand while remaining stable.
ChatGPT, What Do You Think About the Future of AI in Healthcare?
The future of AI in the healthcare industry looks very promising. AI has already begun to make significant impacts in healthcare, including aiding in the diagnosis and treatment of diseases, drug development, and medical research.
Patient-Centric Trials
Patient-centric trials, also known as patient-centered trials, are a relatively new approach to clinical trials that aim to put the needs and experiences of patients at the center of the trial process.
5 Questions for Your EDC Provider
Does a Mid-Study Change Require System Downtime? Can Edit Checks, Dependencies, and Questions Reference Cross-Form Data?
7 Tips to go Live on Time
Shifting the Center of Decentralized Trials
The onset of COVID-19 fostered a rapid change in the practice of clinical trials.
Real-World Evidence
Real-world evidence (RWE) is data collected outside of traditional clinical trials, such as electronic health records (EHRs), claims data, patient-generated data, and social media data.
3 Questions to Ask When Choosing a CTMS Provider
Choosing a Clinical Trial Management System provider is a critical decision for a clinical trial Sponsor or Organization.
Ensuring Data Quality with Fountayn
Data quality in clinical research is one of the most important aspects of a successful trial.
Passing the Stress Test: Clinical Trials Day 2023
In honor of Clinical Trials, day we’d like to take a moment to reflect on not only one of the most outstanding moments in the history of clinical trials, but in the broader field of science.
Today's Clinical Trials Need More Than Just an EDC
As the Clinical Trial process has continued to improve over the last several years, the benefits of using an EDC system has become widely known throughout the industry.
Technology for Decentralized Trials: Agility Allows You to Pivot
This post is part of a blog series on what we believe the responsibilities of eClinical technologies to be in a time of increasing demand for trial decentralization.
Technology for Decentralized Trials: Providing Control and the Freedom to Innovate
This post is part of a blog series on what we believe the responsibilities of eClinical technologies to be in a time of increasing demand for trial decentralization.
Study Design in Fountayn: Build your Own Adventure
The Fountayn Solution Services department within Fountayn was established in 2010 and has operated on the key premise of offering customizable solutions that best fit the needs of each of our clients.
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Future Forward with Scalable Software
Scalability in a software offering is a system’s ability to adjust its capacity and functionalities based on its users’ demand.
Fountayn CTMS expanded with Business Intelligence
Clinical trials contain hundreds of millions of data points that can be used to help identify trial issues or trends.
Five Best Practices for Building a Robust EDC System
Electronic data capture (EDC) systems are essential and ubiquitous tools used in the Life Sciences industry by academic, medical device, biotech and pharmaceutical companies.
EDC Design With the End User in Mind
User experience is important within any software as it focuses on ensuring the product is doing its job correctly and in the most helpful way.
Do you know what SOC Compliance is and why it is important that your eClinical vendors have one?
When evaluating a vendor, especially a technology vendor, certain items are expected like security and compliance. One of the ways to ensure a vendor is secure and compliant is being SOC 2® Type II certified.
Customer Experience Questions to Ask Your eClinical Vendor
When choosing an eClinical vendor, it is important to understand the customer service/experience they will provide.
Clinical Trial Site Communications – A Must Have
In today’s world, this mantra means a lot more than it used to. Keeping lines of communication open is the path to staying afloat in difficult times. Clinical trial sites are no exception. The question is how do all of your research sites stay connected, especially these days.
3 Ways CTMS by Fountayn can Maintain Better Communication Within Your Organization
The Importance of Mid-Study Changes
What are mid-study changes and why are they so important to the lifecycle of a clinical trial?
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How Support Services Propel eClinical Technology Efficacy
eClinical technologies have become pervasive across clinical trials, whether the study is more traditional or implements decentralized elements.
How Partnering with Fountayn Can Make a Difference in Your Clinical Trials
Fountayn strives to be a valuable partner to our customers by providing the highest level of service as well as the most innovative technology. Our client’s satisfaction and success will always be our main priority.
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Four Ways to Make eClinical Customer Education Scalable
Central Monitoring: First Steps to a Risk-Based Approach
Adoption of risk-based monitoring practices has grown in the industry of clinical trials at a slow but steady pace over the last decade. For many looking to make this transition, however, the question of where to begin poses a challenging question.
Regulatory Support for eSource
eSource, broadly, is the idea that data entered into an electronic platform, like an EDC or an EHR, can be considered the source data for the purposes of reconstructing and evaluating the safety and efficacy of a clinical trial.
Why eSource: The Advantages of Abandoning Paper Records
The justification for designing eSource trials is in the advantages they provide in reliability across most human tasks that interface with a clinical trial database. In short, eSource as a strategy eliminates a broad spectrum of potential transcription errors in addition to fully leveraging the supporting eClinical technology to provide reliable consistent exchange of information.
The Challenges with eSource
Our previous post illustrated some of the most significant benefits to operational effectiveness and efficiency in clinical trials by implementing eSource practices. These advantages speak for themselves.
Industry Trend: Patient-Centered Medicine
GPT on FHIR
All About the Acronyms
The clinical trials industry is known for it’s extensive use of acronyms, which can often be confusing for those not familiar with the field. With numerous regulatory bodies, organizations, and medical terms, it’s no wonder that the industry has a vast array of acronyms. These are used to describe everything from medical conditions to regulatory documents to save time and simplify communication.
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