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 moving to a bi-weekly BCP PULSE to keep you aware of our efforts.
RESILIENT REACTIVATION: EMPLOYEE SAFETY AND PATIENT PRIORITY FOCUS
We’re actively building reactivation plans to address the entire lab-to-life continuum. Across the globe, trials are being reactivated and field teams are starting to prepare for in-office returns – with each company facing unique considerations and having varying degrees of risk tolerance. The co-creation of reactivation plans – with our customers – will lead to best-practice exchange, adaption and refinement as no two plans will look the same.
With a public health lens, we’re bringing innovation and creativity to the table to solve these challenges. From social distancing office designs to best practice clinical trial continuation, we’re leading with smart-start, people-focused solutions.
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.
- Assisting Catalyst Sites: Knowing sites can be different in operations and financial resources, our team has continued to work with our Catalyst sites – particularly for psychiatry, analgesia, and ophthalmology – to ensure site considerations are reflected in all that we do. These ongoing conversations ensure site continuity in the midst of COVID-19, including taking care of patients via telehealth visits, getting IP (Investigational Product) to patients through various courier services and collecting data to maintain study integrity.
- Standardizing Deviations: We’ve built site and project-specific risk assessments, including the handling of protocol deviations that will inevitably occur. We have altered standard monitoring and data cleaning processes to allow projects to continue to collect and use data, even to the ability to lock databases. Each project has a customized workflow to address such deviations, and has processes to be enacted once onsite visits resume. While no formal guidance has been issued, we believe regulatory agencies such as FDA or EMA will be accepting of such deviations in light of COVID-19 and we’ll continue to adapt as appropriate.
The rolling COVID-19 outbreak will result in a rolling recovery, meaning there are variations in restart timing around the world. Global companies are discovering that regional and cultural differences will impact reactivation in a variety of ways.
- Early Re-Openers: China is one of the most closely watched countries, as early reopening strategies have led to new restrictions to prevent full resurgence of COVID-19. We are tracking re-opening and renewed restrictions and regulations closely.
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.