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.
Ah, the dreaded site assessment and feasibility: pages upon pages of requests for information. From equipment specifications to investigator experience to patient population, the amount of data needed to execute a clinical trial feasibility is onerous. You may have most of this information on hand—across a variety of spreadsheets, emails, documents—and in your head. But … Read more
Clinical researchers are looking for ways to reduce the operational challenges of clinical trials which can often occur by working with multiple sponsors. Some of these challenges include working with individual sponsor portals, using disparate processes and numerous platforms — each with a unique login credential – which can all lead to increased probability for error and placing patient safety in jeopardy.
As a result, a Shared Investigator Platform (SIP) integration, which can streamline the interaction with multiple sponsors, has become a high priority for many sites.
Scale with RealTime Get the flexibility you need without worrying about hidden costs. With RealTime, there are no hidden fees for user privileges—just clear, transparent pricing. Contact us today to learn more about our commitment to honest, straightforward pricing that scales with your needs. Contact Us Clinical Research Sites, Site Networks, AMCs & Health Network … Read more
As our industry shifts to paperless systems, virtual visits, and remote-monitoring, Sites, Sponsors, and CROs must pivot to what is now considered the new norm or business-as-usual. This transition has encouraged a complete re-thinking of processes and procedures to ensure compliance, efficiency, budgeting and profitability. RealTime’s vision highlights our continued commitment to reshape the global … Read more
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 second of this three-part series, we take a look at the implementation phase of the adoption of an eRegulatory solution.
RealTime eClinical Solutions is a leading, enterprise-grade technology provider facilitating global clinical trials with a comprehensive eClinical platform. Purpose-built for clinical research sites, site networks, academic medical centers, sponsors, and CROs, the platform goes beyond traditional CTMS to empower research and business workflows for modern-day clinical trials.
