Blog - Complion

Overcoming regulatory issues to expedite site activation

Complion 01/21/2021 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.

Developing a Technology Budget During COVID-19

Complion 11/02/2020 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 10/26/2020 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.

Complion Makes #NoGoingBack Pledge

Complion 10/19/2020 Clinical Research Trends, COVID-19, Research Trials

Complion, Inc. has joined #NoGoingBack, an industry-wide social movement which focuses on keeping in place the clinical research advancements gained during the COVID-19 pandemic.

The Case for Standards in Site Regulatory

Complion 10/12/2020 eRegulatory, Site regulatory standardization

The development of standards is a proven methodology for efficiency and quality. By implementing an eRegulatory solution, research institutions have the opportunity to standardize clinical trial documentation and processes.

Developing a Disaster Preparedness Strategy for Your Site

Complion 10/05/2020 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.