fda-inspections-need-not-be-stressful

Overcoming regulatory issues to expedite site activation

Complion CROs, Document Management, Research Trials, Sponsors, Uncategorized

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.

Clinical research

The Future of Clinical Research Technology: Single Dose Studies

Complion Clinical Research Trends, Sponsors

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.