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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.

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.

Disaster preparedness

Developing a Disaster Preparedness Strategy for Your Site

Complion Disaster preparedness, Paperless Research Sites

There are limitations to how much property can be protected after a disaster. In the case of clinical research sites, paper documents can burn, or they can be damaged or destroyed by smoke and water. An important consideration for sites is to develop a disaster preparedness strategy with a focus on transitioning to paperless documentation by moving critical study documents to a digital format.