INSIGHTS: eRegulatory

Important Clinical Research Insights

Coastal Pediatric Implements Complion eRegulatory
eRegulatory

Part 1: How Coastal Pediatric Selected an eRegulatory Solution

We explore Coastal Pediatric Research’s journey to adopting Complion’s eRegulatory solution which has enabled the site to increase efficiency, greatly improve time management, and eliminate duplication of work while conducting their clinical research studies. In the first of this three-part series, we take a look at the selection phase of the adoption of an eRegulatory solution.

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Clinical Research Trends

CenterWatch Study: Sponsors Place More Burden on Sites

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.

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eReg Binder
eRegulatory

eRegulatory Binder Checklist: What Does the FDA Require?

eRegulatory binders help clinical sites organize and digitize the regulatory process, but each binder is different depending on the specific clinical trial site protocol. Here, we provide an overview of the specific sections and documents that must be included for an FDA-regulated study.

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Investigator file checklist
eRegulatory

What Goes Into An Investigator Site File?

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.

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CROs

Overcoming regulatory issues to expedite site activation

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.

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Negotiating clinical research budgets
Contracts/Budgets

Developing a Technology Budget During COVID-19

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.

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eReg Binder
eRegulatory

The Real Site Regulatory Problem

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.

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