IMARC Research

Articles

Every successful clinical trial must protect patients while collecting complete, accurate data that supports evaluation of the safety and effectiveness of the drug or device. Here’s a closer look at why data and safety managers are so important to a clinical trial, what can go wrong when they aren’t aligned and how to improve collaboration between them.

How to Get Data and Safety Managers on the Same Team

ttp://www.appliedclinicaltrialsonline.com/act_w/normal

Throughout the global COVID-19 pandemic, clinical research activity has morphed and changed through the shut down and eventual reopening of research sites and studies. During this webcast, we will discuss how to prioritize in this “new normal”, whether that involves reopening sites, catching up on a backlog of work, or fully implementing remote capabilities. In addition, we plan to discuss some of the important aspects of clinical trial management from a Sponsor/CRO level and what mindset shifts may need to occur to proactively create study plans. A few areas of focus will include:

Resuming activity for ongoing studies, including strategies for increasing enrollment and adjusting study plans to account for new processes

Planning upcoming studies, including assessing potential sites, using electronic informed consent, determining when to use remote monitoring, and creating an electronic Trial Master File

Adjusting budgets for sites and CRO teams

Understanding what short-term solutions should be considered as long-term process changes for clinical trials

Ability to critically think through current projects and apply changes to continue clinical study progress

Determining how to plan for future studies when considering the long-term changes to industry processes


Brandy Chittester, MS, CCRA, President, IMARC Research, Inc.

Stephani D. Hulec, MS, CCRA, Associate Director, Monitoring Services, IMARC Research, Inc.

Wednesday, Sept. 16, 2020 at 2pm EDT | 1pm CDT | 11am PDT

	On demand available after airing until Sept. 16, 2021.

http://www.appliedclinicaltrialsonline.com/act_w/normal

Webcasts

Join us to discover how you can keep your clinical trials moving forward in the midst of the COVID-19 pandemic, using creative strategies such as remote enrollment, monitoring, and data management. Hear real-life examples and discover how to apply these strategies to ongoing studies, as well as how to incorporate them into future study plans. 

Live: Wednesday, Sept. 16, 2020 at 2pm EDT | 1pm CDT | 11am PDT

On demand available after airing until Sept. 16, 2021.

Prioritizing in the New Normal

With new technology and groundbreaking medical devices being introduced every week, there’s never been a more exciting time to be involved in clinical research. Even during the coronavirus pandemic, the pace of innovation has only accelerated. 

6 Emerging Medical Device Trends

While the FDA has issued guidance to help sponsors, investigators and IRBs decide on the best ways to protect patients while keeping their trial moving, the decision is ultimately up to each individual research team.

IMARC has assisted research teams with remote monitoring, auditing and other activities for years. More recently, our team helped one company transition to an entirely remote clinical trial.

We wanted to share this example to show it can be done, under certain circumstances and with careful consideration.

Remote Enrollment in a Non-Significant Risk Device Study