275 Grove St., Suite 101C, Newton, MA 02466
+1 617 454 9300
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+1 919 544 3170
© 2000-2022. Parexel International Corporation.
275 Grove St., Suite 101C, Newton, MA 02466
+1 617 454 9300
2520 Meridian Parkway, Research Triangle Park, Suite 200, Durham, NC 27713
+1 919 544 3170
© 2000-2022. Parexel International Corporation.
BY Anna Zourabian-Scalese, Vice President, Quality Assurance - 5.4.20 -
Business Continuity Plans (BCP) is not a novel concept, but COVID-19, with its global impact, unceremoniously put many companies’ BCPs to the test, steadily pushing the limits of BCP adaptability to our continuously changing landscape. With the uncertainty surrounding this pandemic, many companies are dusting off their BCPs to ensure they can weather this storm, no matter the duration.
In Clinical Trials, business and clinical trial continuity needs to focus on several key element, keeping subject safety, data integrity and GCP Compliance at the core of it all:
And finally, when putting a BCP in motion – it kicks off with a bang but cannot be sustained at the same intensity indefinitely. Be aware and closely monitor and manage battle fatigue; communicate regularly and timely with all your stakeholders (internal and external).
How can Parexel help?
Parexel can conduct GCP investigator site audits remotely in this global restricted access period. We provide an independent evaluation of trial conduct and compliance as well as independent feedback of the continued standards of quality of clinical trials at sites that can no longer accommodate physical visits. The audit scope supports maintaining an oversight of the clinical trial whilst ensuring the rights, safety and wellbeing of the participants.
Additional information on how Parexel can assist with COVID-19 risk mitigation for your business operations, as well as, remote audit capabilities can be found here:
For more information please contact us.
"Do you have a Business Continuity Plan? Do you have criteria and a process to determine critical needs and prioritize their business continuity roll out?"
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We are always available for a conversation.