In our blog, “What is eRegulatory in Clinical Trials,” we explored four key trends fueling the adoption of eReg/eISF across Academic Medical Centers (AMCs), sites, site networks, and sponsors. In this follow-up, we dive deeper, expanding on four additional trends driving eReg/eISF in clinical trials. The transition from paper-based systems or disconnected platforms to integrated … Read more
Academic Medical Centers (AMCs), sites, and health networks are constantly striving to streamline processes, reduce timelines, and improve outcomes. Central to achieving these goals is the ability to manage trials effectively, ensuring all key players have the data they need to make informed decisions. If you are looking to view, manage, and optimize site performance from … Read more
Clinical trials play a pivotal role in advancing medical research and bringing new treatments to patients. Traditionally, trials have been conducted using paper-based methods for startup activities and beyond, such as negotiating Confidentiality Disclosure Agreements (CDAs) and managing regulatory processes, but the landscape is rapidly evolving. In recent years, there has been a growing momentum … Read more
Technological advancements and adoption in clinical trials continue to reshape the way data is collected, managed, and analyzed by clinical research sites, sponsors and CROs. Over the last decade, Electronic Source (eSource) has gained prominence for enabling direct data entry by investigators, reducing transcription errors and enhancing data quality. However, eSource in clinical trials is … Read more
Are your clinical trials ready for an audit, inspection and/or site monitoring visit now? If your organization is running clinical trials, you know that being audit ready is essential to meet Good Clinical Practice (GCP) guidelines, avoid trial delays and disruptions and, most importantly, to protect the rights and safety of human subjects. It’s also … Read more
There has been a sharp increase in the demand for n of 1 trials. Many institutions are vying to become the dominant leader in this space because of the numerous benefits. However, significant challenges are preventing scaling these trial types, primarily regulatory compliance. Leading research institutions rely on Complion eRegulatory to help overcome these barriers. … Read more
Institutional review boards (IRBs) are ethics review committees that ensure human research subjects’ rights are protected, as well as the rights of the patients who ultimately benefit from the research. Operating under US federal regulations, state laws, and institutional policies, the IRB has the authority to approve, require modification to, and disapprove research. IRBs are an important part of regulatory efforts and their approval is required for all human research. Here’s a quick overview of IRBs and the expectations for working with them.
We explore Coastal Pediatric Research’s journey to adopting Complion’s eRegulatory solution which has enabled the site to increase efficiency, greatly improve time management, and eliminate duplication of work while conducting their clinical research studies. In the first of this three-part series, we take a look at the selection phase of the adoption of an eRegulatory solution.
As a technology provider that connects central trial operations teams with decentralized site staff and clinicians, our goal at Devana Solutions is to help research organizations speed new therapies to patients by automating clinical trial processes and capturing site metrics for analysis and execution. You may be familiar with PROPEL, our enterprise-level platform for managing … Read more
eRegulatory binders help clinical sites organize and digitize the regulatory process, but each binder is different depending on the specific clinical trial site protocol. Here, we provide an overview of the specific sections and documents that must be included for an FDA-regulated study.
