30+ YEARS OF VACCINE DEVELOPMENT EXPERIENCE
As a global team of therapeutic specialists, we are fully immersed in the latest advances in the field of vaccine development with expertise in trial design, data analytics, manufacturing, project management, logistics, laboratory testing, pharmacovigilance and regulatory requirements. We combine our extensive therapeutic and laboratory expertise with our global resources to offer a distinctive caliber of vaccine development services.
Our services can be tailored across trial phases, for localized or global studies, for biotech and large pharmaceutical companies and not-for-profit and governmental programs. Our footprint extends across six continents—with local expertise in all regions—to apply needed insights for trial approvals, site identification and close oversight during study conduct. Our technologies enable rapid and transparent risk assessments and data access for subject safety on a real-time basis. This expertise, coupled with advanced technologies, enables us to provide an unparalleled partnership for your vaccine development needs.
Pandemic preparedness and rapid response
The unprecedented disruptions caused by the COVID-19 pandemic have been felt across the drug development industry, triggering renewed interest from government, biotech and biopharma entities alike to invest in pandemic preparedness initiatives. In response, we spearheaded the generation of a pandemic preparedness and rapid response delivery model. This program represents an executable action plan to deliver high-quality clinical data in the face of rapidly changing regulatory landscapes, compressed timelines and resourcing challenges.
Explore a partnership on your next vaccine development program.
“Once everyone has a moment to pause and reflect, we’ll learn many lessons from this pandemic—whether it was learning to have clinical monitors in closer geographic proximity or developing the ability to do remote monitoring. There are multiple changes across the industry, and we’re not going to go backward. We’ll continue to move forward.”
END-TO-END SOLUTIONS TO EXPEDITE COVID-19 VACCINE DEVELOPMENT
PPD’s experience across more than 63 COVID vaccines studies and end-to-end services allow us to provide customized and integrated solutions that accelerate COVID-19 vaccine development timelines. Our agile and flexible model can include risk-based monitoring, near real-time access to safety assessments via interactive dashboards and digitally enabled technologies to conduct low- or no-contact trials. Our commitment to urgency includes:
- Global operational teams with pandemic vaccine expertise enabling us to deploy knowledgeable resources in expedited timeframes
- Use of the Weekly Assessment of COVID Epidemiology (WAVE) prediction model to aid trial planning, site selection processes and alignment of demography of study population with epidemiology
- Global network of more than 160 AES sites for vaccine clinical trials with surge capability of up to 3,000 patients per week, experienced in emerging disease vaccines
- Digital solutions to speed recruitment and support remote/virtual patient follow-up post-vaccination
- Deep experience navigating government contract requirements and close collaboration with health authorities to avoid unnecessary delays
- Global clinical supplies capabilities with direct-to-patient options
- Digital and decentralized solutions to increase clinical trial access for patients, improve their overall experience, produce efficiencies and enhance data quality
- Integrated laboratory services including serology, neutralizing antibody and functional assays designed specifically for COVID-19 trials, as well as PBMC capabilities
Targeted High-Quality Monitoring Strategies Tailored to Vaccine Studies
We leverage the Preclarus platform as part of our approach to risk-based monitoring to create a customized profile of subjects across a wide range of clinical laboratory findings and to review safety trends for vaccine reactogenicity, labs and toxicity gradings. We share this data with you to inform early phase research and dose escalation meetings.
We create study-specific, risk-based monitoring plans based on key site performance indicators. This proprietary method allows CRAs to maximize their time on-site and focus holistically on site performance. This approach provides cost savings in conjunction with quality data.
PPD Laboratories’ vaccine sciences lab offers custom assay development, clinical testing and submission support services for new, modified and existing vaccines. Our capabilities and more than 25 years of specialized vaccine laboratory experience ensure development of innovative analytical methods and accurate, high-quality test results.
We have an experienced biostatistics group that is fully integrated into our lab operations from scheduling through data archiving. Our proprietary, fully electronic system supports the development, qualification, validation and routine maintenance of vaccine assays with tools specifically created to support complex biofunctional assays and molecular genomics studies.
- Streamlined the documentation process
- Complete electronic audit trail
- Improved data integrity and quality
- Reduced full-time equivalent (FTE) time and cost