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 …

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.

The Real Site Regulatory Problem

Complion eRegulatory, Regulatory Compliance, Streamlined Processes

A lot of work is being invested to ensure research site audit readiness, oversight, and completeness of regulatory files or binders. Unfortunately, there is a lack of understanding if everything is being done to the level of completeness, accuracy and quality that is required. As a result, site regulatory can be a real challenge for Sponsors and CROs.