Vaccine Development


Vaccines are among the greatest advancements in public health, and developing new vaccines remains one of the most difficult challenges we face. As vaccine development researchers achieve important success to control one devastating disease, another pathogen emerges. Your vaccine strategy represents an important blueprint for tackling some of the world’s most deadly and disabling diseases and ensuring science and society work together to protect public health.

At PPD, we apply the expansive global footprint, development capabilities and expertise we’ve built in vaccine development to help customers attend to the unique needs of vaccine trials and accelerate development with proven solutions and dedicated resources.


Experts discuss advanced-planning strategies for effectively managing clinical research during the next public health emergency.

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Staff with vaccines experience

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Studies in the past five years

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Vaccine experienced priority network sites

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Mega trials successfully completed

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Patients in each mega trial

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COVID-19 vaccine trials supported


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.

Learn more about pandemic preparedness

Explore a partnership on your next vaccine development program.

Contact Us

PPD has conducted vaccine studies in more than 90 countries

Les Enterline
Les Enterline

“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.”


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


We work with clients of all sizes across a wide spectrum of vaccine programs from legacy vaccines to emerging pathogens. Our vast global footprint enables rapid deployment of teams to support the staffing needs of vaccine studies, including separate unblinded teams. We offer:

  • PPD priority vaccine sites and networks to support rapid startup and timely enrollment with performance guarantees
  • Expertise with seasonal studies and northern/southern Hemisphere execution strategies
  • Innovative real-time data technology to support safety trends analysis and decision-making during trial conduct
  • Operational expertise to deliver pivotal, field-efficacy studies globally and across a range of targeted populations
  • Rapid site identification and capacity to support large vaccine efficacy trials
  • Broad experience with cold-chain management and sample logistics
  • Distinct quality control for serology specimens, including storage facilities with centralized alarm systems to protect serum integrity
  • Expertise in immune assay development and laboratory testing

Dengue, malaria, West Nile,
Zika, Chikungunya, Japanese
Encephalitis, rabies, yellow fever

RSV, SARS/MERS, pandemic SARS-CoV-2, pandemic flu, seasonal flu, meningococcal, pneumococcal, tuberculosis, pertussis, strep A/B, diphtheria

Rotavirus, norovirus,
E. coli, Shigella, typhoid,
cholera, C. difficile

Sexually transmitted
HIV, HPV, CMV, herpes,
chlamydia, hepatitis B

Hepatitis, rubella, measles,
mumps, MMR, varicella, tetanus,
polio, HIB, Staph. aureus

Real-Time Access to Clinical Trial Data

Preclarus®, our comprehensive data solution, provides real-time access to the tremendous quantity of clinical trial operations and subject data produced in vaccine studies. Our Preclarus solution enables:

Collection of subject-level data, which facilitates real-time feedback on safety and immunogenicity measures and direct communication of key study assessments
An integrated technology platform that links data across sites and laboratories

Less frequent on-site monitoring visits and a remote monitoring approach with a customizable plan drive by continuous site-level risk assessment
Development of eSource solutions for sites, allowing for more immediate access to source documentation and facilitating remote source verification

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.

Laboratory Services for Vaccine Studies

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sq. ft. vaccine lab

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years of experience

PPD Laboratories has supported 13 vaccine programs approved by the U.S. Food and Drug Administration and 3 COVID-19 vaccine programs that have emergency use authorization or international approval.

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

Access to Special Subject Populations

Our priority vaccine sites network includes more than 670 high-quality vaccine-experienced sites across all geographic regions that have experience with special populations for bridging studies such as pediatric, adolescent, elderly, pregnant women and immunocompromised.