EDC Design With the End User in Mind

Discussions around improving diversity in clinical trials have been ongoing for quite some time, with relatively gradual change to actual practice.

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 Clinical Trials Industry uses eClinical solutions to reduce costs and improve efficiency.

Fountayn's training approach doesn't follow a "one size fits all" approach.

Scalability in software refers to its ability to adjust capacity and functionalities based on user demand while remaining stable.

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, 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.

Does a Mid-Study Change Require System Downtime? Can Edit Checks, Dependencies, and Questions Reference Cross-Form Data?

The onset of COVID-19 fostered a rapid change in the practice of clinical trials.

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.

Choosing a Clinical Trial Management System provider is a critical decision for a clinical trial Sponsor or Organization.

Data quality in clinical research is one of the most important aspects of a successful trial.

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.

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.

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.

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.

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.

Scalability in a software offering is a system’s ability to adjust its capacity and functionalities based on its users’ demand.

Clinical trials contain hundreds of millions of data points that can be used to help identify trial issues or trends.

Electronic data capture (EDC) systems are essential and ubiquitous tools used in the Life Sciences industry by academic, medical device, biotech and pharmaceutical companies.

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.

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.

When choosing an eClinical vendor, it is important to understand the customer service/experience they will provide.

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.

What are mid-study changes and why are they so important to the lifecycle of a clinical trial?

eClinical technologies have become pervasive across clinical trials, whether the study is more traditional or implements decentralized elements.

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.

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.

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.

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.

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.

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.