At Syneos Health, our priorities continue to be protecting our employees’ health and safety, and 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 updates, we’re now issuing a bi-weekly BCP PULSE to keep you aware of our efforts.
RESILIENT REACTIVATION: EMPLOYEE SAFETY AND PATIENT PRIORITY FOCUS
Our Syneos Health office reactivation plans are focused on enabling a safe and productive environment – today and tomorrow – for employees, customers and patients. The rolling COVID-19 outbreak will result in a rolling recovery, meaning there are variations in reactivation timing around the world. Global companies are discovering that regional and cultural differences will impact reactivation in a variety of ways. Our Reactivation Playbook has been designed to provide flexibility to customize a reactivation plan for each office, based on local restrictions and government guidance.
As we bring together cross-disciplinary Office Activation Teams across the globe, all are guided by the following “Resilient Reactivation” Guiding Principles:
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, updating regulations and restrictions in order to provide direction to our employees and customers on when – or when not – to pivot and/or reactivate.
- Office Activation: Actively reviewing government guidance by region/country/state and outlining office reactivation phases – identifying Office Activation Teams worldwide.
- Field Team Connections: Monitoring company-by-company redeployment plans, hosting Field Team Town Halls and compiling lessons learned to reactivate personnel for in-person activities.
- Procurement and PPE: Securing PPE for CRAs, nurses, and field teams as first priority for early return, enabled by a COVID-19 vendor database for ongoing procurement.
- Human Resources: Surveying employees to understand concerns about office reactivation, current sentiment and leadership response indicators.
- Resurgence Preparedness Planning: Preparing for a potential fall COVID-19 resurgence, coupled with the annual influenza surge, by developing scenario plans and sharing best practice learnings to withstand another wave.
BEST PRACTICES – BEING AGILE TO ADAPT TO OUR EVOLVED ENVIRONMENT
Working hand in hand with hundreds of companies – and our 24,000 employees worldwide – we’re designing clinical and commercial solutions every day. Each challenge presents the opportunity to apply key learnings to build better approaches and resiliency.
- Helping Biopharma Re-establish Clinical Operations: The operating environment for clinical trials has been impacted in numerous ways by COVID-19, and the biopharmaceutical industry response has been variable. Each organization’s effectiveness in protecting patients, ensuring data integrity and re-establishing pipeline momentum will depend on their ability to assimilate and respond to new information. Syneos Health has hosted three Clinical Operations Forums, with Clinical Operations leads from 22 biopharmaceutical companies, to discuss their experiences including:
- The general impact of COVID-19;
- Recovery planning and lessons learned in patient engagement; and
- Site perspectives on clinical trial restart.
Insights harvested from these discussions have resulted in the development of rapid restart assessment plans focused on providing confidence in near-term initiatives, while enabling companies to progress thinking on “post-COVID-19” changes to operations.
We’re regularly updating our COVID-19 Resource Center with capabilities and perspectives to navigate, deliver and learn together. We’re looking to exchange your learnings and experiences too. Should you have ideas, comments or concerns, please contact us.
Thank you for your partnership.