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.
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.
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.
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.