Infectious Disease and Vaccines CRO

Tackle even the most complex trials with integrated expertise

As an infectious disease and vaccines CRO, 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

Hepatitis B

Our team has extensive global experience with chronic hepatitis B (CHB), along with strong relationships with 150+ investigators and 46 alliance members to support hepatitis B studies.

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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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Show more


Frequently asked questions

When selecting a Contract Research Organization (CRO) for infectious disease and vaccine clinical trials, several critical factors should be considered. The CRO's expertise and experience in the specific disease area, along with their global reach and regulatory knowledge, are paramount. Look for a CRO with a strong track record of successful trials, established relationships with investigators and research sites, and a deep understanding of relevant regulatory requirements. The organization should also demonstrate robust scientific capabilities, operational excellence, and the use of innovative technologies in trial management.

Additionally, evaluate the CRO's safety monitoring systems, laboratory services, and patient-centric approaches. The ability to scale operations, provide cost-effective solutions, and deliver high-quality outputs are also crucial. Consider the CRO's reputation in the industry and seek references from previous clients. By carefully assessing these criteria, you can select a CRO that best aligns with your specific trial needs and increases the likelihood of a successful study in the complex field of infectious diseases and vaccines.

An infectious disease and vaccines CRO employs a multi-faceted approach to manage patient recruitment and retention for clinical trials. Initially, they develop a comprehensive recruitment strategy tailored to the specific disease and target population. This often involves leveraging existing relationships with healthcare providers, patient advocacy groups, and research sites. The CRO may use targeted digital marketing campaigns, social media outreach, and community engagement events to raise awareness about the trial. They also utilize advanced data analytics to identify potential participants who meet the trial criteria. For vaccine trials, especially during outbreaks or pandemics, CROs may collaborate with public health authorities to access larger populations quickly.

Retention strategies are equally crucial and begin from the moment a patient is enrolled. CROs implement patient-centric approaches, such as providing clear, easily understandable information about the trial process and its importance. They often use mobile apps or web portals to maintain regular communication with participants, send reminders for appointments, and collect real-time data on symptoms or side effects. To minimize dropout rates, CROs may offer transportation assistance, flexible scheduling for site visits, and even home visits where appropriate. They also train site staff in patient engagement techniques and may provide additional support like 24/7 helplines for participants. For long-term vaccine trials, CROs might implement strategies to keep participants engaged and informed about the trial's progress and its potential impact on public health.

An infectious disease and vaccines CRO requires extensive and diverse experience to effectively handle complex global trials. First and foremost, the CRO should have a proven track record of successfully managing multi-center, international studies across various infectious diseases and vaccine types. This includes experience in navigating the intricate regulatory landscapes of different countries and regions, such as dealing with the FDA, EMA, and other national health authorities. The CRO should demonstrate proficiency in coordinating with multiple sites across different time zones, cultures, and healthcare systems. Additionally, they need experience in managing the logistical challenges of global trials, including the transportation and storage of temperature-sensitive vaccines, handling of biological samples, and coordination of specialized laboratory services across borders.

Furthermore, the CRO should possess deep scientific expertise in infectious diseases and vaccinology to address the unique challenges these trials present. This includes experience in designing adaptive trial protocols that can respond quickly to emerging data or changing epidemic conditions. The CRO should be adept at implementing robust pharmacovigilance systems capable of rapidly detecting and responding to safety signals across diverse populations. Experience in managing trials during disease outbreaks or pandemics is particularly valuable, as it demonstrates the CRO's ability to operate under pressure and adapt to rapidly changing circumstances. Lastly, the CRO should have a strong background in data management and analysis, capable of handling large volumes of data from multiple sources and ensuring data integrity and comparability across different geographic regions and populations.

An experienced infectious disease and vaccines CRO can significantly accelerate the timeline for vaccine development and approval through several strategic approaches. Firstly, they can leverage their extensive network of investigators, research sites, and regulatory contacts to streamline the startup process. This includes rapid site selection and activation, efficient contract negotiations, and expedited regulatory submissions. The CRO can also employ adaptive trial designs that allow for more flexible and efficient studies, potentially combining multiple trial phases or adjusting the trial in real-time based on emerging data. Their expertise in protocol optimization can help design trials that gather the most critical data in the shortest time possible. Additionally, a seasoned CRO can implement advanced technologies for patient recruitment, data collection, and monitoring, which can significantly reduce timelines and improve data quality.

Moreover, a specialized CRO can accelerate development by providing crucial scientific and strategic input throughout the process. They can offer valuable insights on regulatory pathways, helping sponsors navigate accelerated approval processes or emergency use authorizations when applicable. The CRO's experience with similar trials can help anticipate and mitigate potential roadblocks, reducing delays. They can also employ risk-based monitoring approaches and centralized monitoring techniques to identify issues quickly and maintain high data quality without slowing the trial. Furthermore, a CRO with strong data management and biostatics capabilities can provide rapid, high-quality analysis of trial data, facilitating faster decision-making and regulatory submissions. By managing all these aspects efficiently and in parallel, a skilled CRO can significantly compress the overall timeline from initial development to regulatory approval, which is particularly crucial in addressing urgent public health needs such as during a pandemic.