At Syneos Health, our priorities in 2021 continue to be protecting health and safety, while partnering with our customers, sponsors and investigators to deliver life-saving medicines to patients worldwide. As part of our commitment to continuous communication, following our initial Business Continuity Planning (BCP) update and weekly editions throughout the majority of 2020, we’re now issuing a monthly BCP PULSE to keep you aware of our efforts.
RECOVERY ACCELERATION THROUGH COVID-19 VOLUNTEER PORTAL
As of early April, more than 655 million doses of COVID-19 vaccines have been administered worldwide. While we always have a front seat to the marvels of biopharmaceutical development, watching the industry come together during this pandemic has been incredible and inspiring.
In addition to working on more than 80 projects related to COVID-19, to accelerate the global response to this unprecedented pandemic, we have recently launched the Syneos Health COVID-19 Volunteer Portal. This Portal identifies and enrolls the right individuals in clinical trials to help identify new vaccines and help eradicate the virus.
While the pandemic isn’t over, we remain hopeful that that recovery is on the horizon. We continue to monitor regional and local regulations, and our own office reactivation planning is moving forward. We are optimistic we will see colleagues and partners offline in 2021, and look forward to that in-person collaboration.
BUSINESS CONTINUITY PLANNING REACTIVATION SUMMARY
Our Business Continuity Planning Transition Management Office (TMO), in alignment with FDA, CDC, WHO and other local and international health authority guidance, includes multiple workstreams. In each BCP PULSE, we’re including select workstream updates to keep you aware of our learnings and efforts.
- Regulatory Guidance: Aggregating and synthesizing EMA and FDA guidance, and updating regulations and restrictions in order to provide direction to our employees and customers on when – or when not – to pivot and/or reactivate.
- Change Management: Working internally and with customers on change management activities to ensure preparedness as dynamics shift.
- Field Team Connections: Monitoring field challenges and team resilience, compiling best practices for remote activities and HCP preferences, and benchmarking remote versus in-person detailing metrics.
- Sponsor Connections: Working collaboratively with sponsors in the “now normal” to press forward with studies underway while initiating new trials.
- Continued Preparedness Planning: Tracking evolving trends in COVID-19 cases and emerging variants, as well as vaccination rollout progress, to develop scenario plans and share best-practice learnings.
BEST PRACTICES – BEING AGILE TO ADAPT TO OUR EVOLVED ENVIRONMENT
Working hand in hand with hundreds of companies – and our 25,000 employees worldwide – we’re designing integrated lab to life solutions every day. Each challenge presents the opportunity to apply key learnings to build better approaches and resiliency.
- Leading the Way in COVID-19 Post-Marketing Drug Safety Reporting: With millions of patients receiving COVID-19 vaccines and therapies, developers are experiencing a significant increase in the volume of post-marketing drug safety reporting, and regulatory bodies have been challenged to keep pace with the speed, urgency, and volume of submission activity. With unprecedented development timelines and increased emergency use authorizations, regulators have raised the bar with respect to compliance scrutiny and reporting requirements to help ensure the safety of patients. Leaning on over 20 years of experience in pharmacovigilance and dedicated solutions through FSP360, our Syneos Health teams are working closely with customers to proactively develop comprehensive strategies to identify, manage and mitigate risks according to the regulatory standards of the regions and countries in which they are seeking marketing approval. If you’d like to speak with one of our pharmacovigilance experts, please contact us.
We’re regularly updating our COVID-19 Resource Center with capabilities and perspectives to navigate, deliver and learn together. We are looking to exchange your learnings and experiences, too. Should you have ideas, comments or concerns, please contact us.
Thank you for your partnership.