Infectious Disease and Vaccines

Tackle even the most complex trials with integrated expertise

We develop comprehensive strategies for treating and preventing life-threatening illnesses, no matter how complex. How? By integrating our deep scientific, epidemiological, medical, public health, and regulatory expertise with solutions that cover everything from medical feasibility assessment to trial management, pathogen surveillance, and market access.


 

Lean on our holistic, cross-functional team

Our infectious disease team is built upon the global experience and public health knowledge your project needs. Our expertise includes regulatory affairs, real-world evidence, epidemiology, genomics, pulmonology, cardiology, and all other relevant therapeutic areas across age groups. With this expertise, we optimize protocols and implement innovative trial designs to drive your research forward.

Read the transcript

What sets Parexel's Infectious Disease therapeutic area apart from others, and then really it's the people. The group consists of over a dozen ID specialists and solutions consultants that basically span the globe. Our mission is to assist sponsor companies in developing both treatments and vaccines for communicable diseases. The ID therapeutic areas is targeting -- so both established treatment, recalcitrants, communicable diseases such as antibiotic resistant bacteria and chronic viral infections such as Hepatitis B.

We also recognize that the challenges that we face include emerging diseases such as COVID 19. In Hepatitis B, we ran the largest Hepatitis B vaccine trial that's ever been run, and we did it ahead of schedule. That's certainly one accomplishment that I'm quite proud of. Hepatitis B is is a disease that afflicts almost a third of a billion people worldwide.

During the COVID pandemic, we were asked by a sponsor to help them with developing their COVID therapeutic. The timelines were tight. They wanted to bring their product to market as soon as possible, with the intent of helping intervene with the pandemic in a meaningful way. Parexel met and exceeded their timelines and were able to test their product, beating all previously defined timelines for testing.

The trends that we're seeing, we're seeing novel approaches to both therapeutics as well as vaccines. So with the latter, with vaccines, we're seeing really exciting new platforms such as the MRNA and self amplifying RNA vaccines. We're also seeing exciting developments with novel treatments such as microbiome based therapies. These microbiome based therapies are being used to address both infectious diseases as well as a variety of other diseases, such as inflammatory bowel disease.

We're creating drugs that help with people's lives and help maintain their health. That's really why it's important. And for the infectious disease group and for every other therapeutic area within Parexel.

Experience in the past 5 years with infectious disease & vaccines

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clinical projects
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enrolled patients
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sites

Viral indications

Our team has extensive global experience with viral indications that include COVID-19, SARS, H1N1, MERS, and Ebola, as well as influenza, RSV, HIV/AIDS, HSV, HPV, and hepatitis B and C.

Roger Inouye, M.D.

Senior Medical Director

Marlena Diallo, M.D.

Senior Medical Director

Rohan J. Vilms, M.D., MPH

Medical Director

Bacterial indications

We have specialized expertise in multi-drug-resistant infections, including cIA, cUTI, HAP/VAP, ABSSI, joint infections, and osteomyelitis.

Akhtar Wani, M.D.

Medical Director

Beth Marshall, M.D.

Medical Director

Vaccines, preventative, and treatment

We’ve done extensive work in preventing and treating COVID-19, influenza, RSV, pneumococcal and meningococcal infections, and dengue, including development experience with pandemic vaccines and with combination vaccines for pediatrics.

Zoltan Koroknai

Senior Medical Director

Roger Inouye, M.D.

Senior Medical Director

Marlena Diallo, M.D.

Senior Medical Director

Akhtar Wani, M.D.

Medical Director

Critical care

We offer access to a global network of critical care specialty centers, with particular expertise in sepsis indications, nosocomial infections, and hospital-based critical care studies.

Zoltan Koroknai

Senior Medical Director

Bettina Klein

Senior Director, Project Management

Long COVID syndrome

We’ve developed a Long COVID Syndrome Program to address the continuing impact on these patients — working with sites, registries, and patients across therapeutic areas to streamline research. For these patients and their little-understood conditions, it’s more crucial than ever to listen to their voices, seating them at the head of the table to guide us toward meaningful outcomes. We also bring strong experience working on COVID-19 treatments, with recognition as a top-ranked CRO for COVID-19 clinical development services, according to the Life Science Strategy Group.

Zoltan Koroknai

Senior Medical Director

Ariel Hernandez, M.D.

Medical Director

Advantages

Strong focus on vaccines

Our extensive vaccine experiences and capabilities help your trials thrive throughout the life of your program. We’ve developed regional pathogen surveillance programs, conducted global epidemiology research, and are involved in ongoing regional incidence tracking. We also use patient mapping, chart reviews, community outreach, and lab results to target future volunteers at their first point of medical contact. 


Better access to diverse patient segments

We’ve developed methods for recruiting study participants ranging from neonates to geriatrics, with a global network of research sites that include vaccine centers, decentralized community outreach, outpatient clinics, hospitals, and critical-care specialty centers. This ensures you have access to the patients you need.


End-to-end support, whatever you need

Our cross-functional expertise is integrated across all stages of development, from Phase I to Phase IV. Our deep understanding of the nuances of delivering trials for infectious disease is reflected in our operational excellence, which includes a specific focus on microbiological and clinical endpoints, as well as long-term surveillance and case event capture.


Deep experience with academic and government research

In addition to lab-based work that incorporates genomics, prognostic biomarkers, and state-of-the-art diagnostics, we bring extensive expertise in hospital-based and global trials for academic research, as well as research funded by third-party organizations like governments (BARDA, NIH, EMA) and grant providers.

Highlights


Awards & Recognition

2024 ViE Best Contract Research Organization

Parexel was selected by a distinguished industry advisory board for its range of services in niche and core therapeutic areas, methods of performance improvement, attention to and quality of relationships with clients, reaching milestones and final outcomes, and building and maintaining existing and long-term partnerships. The annual ViE Awards, organized by Terrapin, celebrate the industry’s most outstanding achievements and showcase excellence in the global vaccine industry.

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