Infectious Disease & Vaccine

Clinical Trial Excellence in Infectious Disease and Vaccine Development 

Searching for a CRO with expertise in infectious disease clinical development? Allucent helps small to mid-size biopharma companies advance infectious disease, vaccine, and monoclonal antibody programs through science-led strategy, operational execution, and regulatory support that mitigates risk, accelerates timelines, and delivers high-quality global clinical outcomes.

Our Allucent Center of Expertise (ACE): Infectious Diseases supports Phase I–III and post-approval infectious disease and vaccine clinical trials, including adaptive and platform trial designs, vaccine effectiveness studies, immunocompromised populations, and emerging pathogen and high-containment research, backed by proven global site activation, regulatory strategy, and flexible delivery models.

Top Challenges in Infectious Disease & Vaccine Drug Development

Dynamic Landscape

The dynamic and fast-paced world of vaccine development requires expert attention to potential risks, along with the implementation of proactive strategies to mitigate those risks.

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Dynamic Landscape

We combine scientific guidance with a patient-centric approach, ensuring that all patients are given a comprehensive understanding of trial procedures, and have the autonomy to make informed decisions about their participation.

Patient Recruitment & Ethics

Putting patients first is paramount in designing and implementing infectious disease and vaccine trials.

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Patient Recruitment & Ethics

We are fully equipped to implement various study types, including on-site, decentralized, and hybrid trials, to ensure that the diverse needs of all patients are being met. This is supported by our global network, spanning over 70 countries.

Real-World Evidence & Field Studies

Collecting valid Real-World Evidence (RWE) is complex, yet essential for researchers to demonstrate a vaccine’s effectiveness and safety to regulators. Implementing field studies to collect this crucial data allows patients to be monitored in natural environments that can accurately examine the immediate impact of the novel vaccine.

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Real-World Evidence & Field Studies

Allucent supports the compilation of RWE by establishing effective safety monitoring procedures. This includes on-site medical teams and real-time data reporting, where all adverse events are promptly addressed.

Regulatory Challenges

From accelerated approval pathways, to ever-evolving regulatory requirements, navigating the regulatory landscape necessitates comprehensive, global expertise.

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Regulatory Challenges

Allucent’s industry veterans include former regulators and long-time researchers with deep knowledge who have supported our clients in delivering vaccines during public health emergencies, like COVID-19.

Infectious Disease and Vaccine Development involves the specialized services and solutions of an experienced CRO to ensure effective patient recruitment and retention, risk assessment, and regulatory strategy.

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VACCINE DEVELOPMENT & SPECIALIZATION

MONITORING STRATEGIES

FEDERAL RESEARCH SOLUTIONS

REGULATORY STRATEGIES & SUBMISSIONS

COVID-19 RESEARCH & OPERATION WARP SPEED

ANTIMICROBIALS & MONOCLONAL ANTIBODIES

VACCINE DEVELOPMENT & SPECIALIZATION

Our vaccines development experts have extensive experience designing,
implementing, and executing clinical trials involving live attenuated, inactivated, subunit, toxoid, mRNA, and viral vector vaccines for infectious diseases, allergies, immunotherapies, and oncology indications.

MONITORING STRATEGIES

Data-driven, risk-based monitoring solutions, including centralized monitoring, are designed specifically to manage large data volumes upon enrollment of vaccine trials, while ensuring data integrity in remote settings.

FEDERAL RESEARCH SOLUTIONS

We have supported federally funded vaccine and infectious disease clinical research programs for more than 20 years. Our proven track record has allowed us to collaborate with multiple government agencies including NIH, DOD, BARDA, and CDC.

REGULATORY STRATEGIES & SUBMISSIONS

Whether your new product is a drug, vaccine, biologic, GMO, cell and gene therapy, device, or a combination product, we understand the nuances of regulatory requirements and have the resources and proven expertise to address your specific needs.

COVID-19 RESEARCH & OPERATION WARP SPEED

We are committed to advancing the fight against COVID-19 by assisting pharmaceutical and biotech companies with the swift deployment of clinical trials for vaccines and therapies. Our efforts include ongoing studies and participation as a prime CRO contractor for Operation Warp Speed, and its successor, the Countermeasures Acceleration Group (CAG).

ANTIMICROBIALS & MONOCLONAL ANTIBODIES

Our comprehensive antimicrobial and monoclonal antibody expertise includes innovative preclinical studies to complex clinical trials, with a strong focus on pharmacokinetics, safety, and efficacy. With a proven track record in regulatory navigation and cutting-edge analytical techniques, we ensure accelerated development timelines and successful outcomes.

Comprehensive CRO Support for Infectious Disease Trials

Allucent offers end-to-end capabilities tailored for the scientific and logistical demands of infectious disease programs, including: 

• Protocol design and epidemiological modeling 
• Site selection leveraging outbreak data and disease prevalence 
• Engagement with global health authorities (FDA, EMA, WHO, CDC, NIH) 
• Cold chain and biosafety logistics for high-containment agents 
• Central lab coordination, biomarker strategy, and diagnostics
• ePRO/eDiary and real-time surveillance integration 
• Adaptive trial design and statistical modeling
• Medical monitoring, pharmacovigilance, and global safety reporting
• Full medical writing, CSR development, and regulatory submissions 

Our Focus Areas in Infectious Disease Research

Viral and Parasitic Infections

• SARS-CoV-2 (COVID-19)
• Influenza
• RSV
• HIV
• Hepatitis B and C
• CMV, EBV, HPV, HSV
• Zika, Dengue, Chikungunya
• Ebola
• Malaria, Leishmaniasis 

 

Bacterial and Fungal Infections

• C. difficile
• MRSA and drug-resistant pathogens
• Tuberculosis
• Sepsis
• Pneumonia (CAP, HAP, VAP)
• Skin Infections
• Urinary Tract Infections

Vaccines

• Prophylactic/therapeutic
• Platform technologies (mRNA, viral vector, etc.)
• Adjuvants and immunogenicity
• Pediatric/geriatric
• Combination/multivalent

 

We take great pride in developing a thorough understanding of our customers’ challenges. Our expertise and dedication to innovation have consistently driven exceptional results and expedited breakthroughs for our clients.

Bruce McClenathan, MD

Executive Medical Director, Government and Public Health Services

Related Content

Patient Recruitment & Retention

Clinical Development

Regulatory Strategy

Government & Public Health Services

Additional Resources

Blogs

The Strategic Role of the CRO Principal Investigator: Improving Biotech Sponsors Through Protocol Design and Study Execution

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Blogs

Impact of COVID-19 on Rare Disease Research

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Blogs

Exploring the Complexities of Healthcare-Associated Infections: Challenges and Insights

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