Approximately 80 percent of clinical research sites polled in a recent Complion, Inc.-sponsored survey said the costs and burden associated with administrative tasks for a single study has increased over the past two years, continuing a five-year upward trend.
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.
If you’re a Sponsor or CRO, capturing and accessing the required regulatory information for an activation or ongoing study execution can be quite challenging. The sites need to manage and maintain from a regulatory or ISF perspective what’s necessary to be reviewed by the sponsor. This information can be stored in multiple places, emails and portals so often the information is getting lost, it’s hard to know if it’s the right version or even the right information. In the case of master trials, these issues are further compounded.
While electronic document management is becoming more mainstream, it’s still considered uncharted territory for some research sites. The transition is often approached with trepidation, fear, and questions. Complion has found sponsor pushback to be a common concern. To that end, Complion offers a few tips to ease the apprehension.
Because research study sponsors are continually seeking efficiencies, and all stakeholders in studies have an interest in minimizing the time required of, and the potential risk to, volunteers who participate in studies, there will be a decrease in the number of single drug studies in the future. That is the observation of John Neal, CEO of PCRS Network. In the final post of this four-part series, we explore the evolution of clinical research and the opportunity for collaboration among multiple sponsors based on Neal’s insights.
During this pandemic, a key aspect of remote monitoring that seems to be a source of struggle for the industry is SDR/SDV. This is an extremely extremely risky aspect as sensitive PHI is shared across virtual organizational walls. Fortunately, there is a very simple solution if the right eRegulatory solution is used. This blog post takes a look at the three primary requirements when looking for a remote SDR solution.
Competition in the clinical trials landscape is fierce. For sites looking for more studies, it can be difficult to capture the attention and trust of sponsors and CROs. In this post, we break down what sites should do to keep their study pipeline full.
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