Clinical Trials at Risk

Suddenly the risk-reward balance has shifted dramatically. Anyone with basic cold symptoms is being advised to stay home. And many people can no longer travel with COVID-19 in their community.

What if you can no longer visit your sites? Are you ready to use the tools at your disposal as contingency or risk-mitigation strategies to keep your studies going and ensure your patients can access their study medication and remain safely monitored?

During this virtual discussion forum were putting our minds together to combat the impact of the Coronavirus outbreak on clinical trials, and be better prepared in the future.

The MINDS-ON Think Tank

- Craig Lipset, Former Head of Clinical innovation at Pfizer
- Derk Arts, Founder & CEO Castor EDC
- Nancy Meyerson-Hess, Chief Compliance & Regulatory Officer at eMQT, Expert Partner at admedicum
- Andy Lawton, Consultant at Risk Based Approach Ltd
- Dr Johann Proeve, CSO Cyntegrity
- Artem Andrianov, PhD, CEO Cyntegrity

Some of the Dilemmas to Address

What do we need to do in order to guarantee safety and data integrity?
What are the various COVID-19 scenarios that impact clinical trial operations?
Coronavirus will be on the minds of the patients you are engaging as participants in clinical trials. How are you preparing for patients concerns?
What do the sites have to say? They are on the front line with patient interactions and engagement.
Are clinical trial planners today considering technologies (remote monitoring, telemedicine) as contingencies to ensure their patients can continue safely on investigational medicines?
In what way will COVID-19 reshape how clinical trials will be done?
Are we going to see a larger shift to decentralized trials, and at a faster rate than sponsors have planned?

Join us on March 30! Do you have any questions for the think tank, submit them to: post@cyntegrity.com
This webinar will take place on 30th Mar 2020 at 06:00 pm.
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To address current regulatory challenges and capitalize on these growth and improvement opportunities, clinical research organizations must be willing to evolve and change behaviors. The key to effective, productive change within a research institution lies at the nexus of people, process and technology.

People, process and technology are fundamental to any successful operational change. Attention to all three is required to implement significant and lasting improvements to research operations.

In Part II of "Dealing with Resistance - Facilitate Successful RBQM" Linda Bunschoten, CMO Cyntegrity, will address the Agile Change Management concept.

How to fight your biggest enemy, time, by agile change management. Use agile change management principles to effectively "start small; dont plan everything; address challenges as you go".
This webinar will take place on 2nd Apr 2020 at 05:00 pm.
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