Investigator file checklist

What Goes Into An Investigator Site File?

newDevEnv eRegulatory, IRB, Site Files

The investigator site file (ISF) plays a critical role in a study’s success. But only if the people in charge of it – clinical trial investigators – keep its contents accurate and up to date. In this post, we provide an overview of all essential documentation in an effective, compliant ISF.

Impact of Covid on Clinical Trials

The Impact Covid Had on the Execution of Clinical Trials

Joe Wochna COVID-19, eRegulatory, Tradeshows and Events

Complion’s VP of Customer Experience, Keith Martinek talks of the impact Covid had on the execution of clinical trials. Recently, at DPAHRM 2021 (Disruptive Innovations to Advance Clinical Research), Complions’ VP of Customer Experience, Keith Martinek spoke of the impact Covid had on the execution of clinical trials. Even though inspection and audit-readiness has always been important in the work we …

Complion Tradeshows and Events

Complion Hits the Road

Joe Wochna Tradeshows and Events

Join us in person, or virtually, as we showcase our solutions at Clinical Quality Oversight Forum, DPHARM, and Global Site Solution Summit Clinical Quality Oversight Forum September 27-29 | Philadelphia PA Be sure to watch Rick Arlow, CEO of Complion, and Aaron Grant, VP of Solution Consulting at Phlexglobal, as they present Tuesday (9/28) at 1pm: “eTMF and eISF Integration: …

SIP integration

SIP integration developed for KU Cancer Center

Complion Clinical Research Trends, Research Trials, Shared Investigator Platform (SIP), Sponsors, Streamlined Processes

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.

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.

Negotiating clinical research budgets

Developing a Technology Budget During COVID-19

Complion Contracts/Budgets, eRegulatory

The current pandemic has had a dramatic impact on our personal lives as well as our work lives. And no exception is the impact on clinical research contracts and budgets. In this blog post, we will take a look at how to achieve internal leadership approval – and even sponsor reimbursement – for technology systems, specifically eRegulatory platforms.