Infectious Disease & Vaccine

Clinical Trial Excellence in Infectious Disease and Vaccine Development 

Searching for a CRO with the expertise to navigate infectious disease trials? At Allucent, we empower small to mid-size biopharma to accelerate infectious disease, vaccine, and monoclonal antibodies development. Our integrated, science-led approach simplifies the operational and regulatory complexity of infectious disease research, helping you mitigate risk, shorten timelines, and achieve high-quality outcomes that meet global standards. 

Your 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 Infections

Viral Infections

• SARS-CoV-2 (COVID-19)
• Influenza
• RSV
• HIV
• Hepatitis B and C
• CMV, EBV, HPV, HSV

 

Bacterial and Fungal Infections

Bacterial and Fungal Infections

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

 

Vaccines

Vaccines

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

 

Neglected & Emerging Diseases

Neglected & Emerging Diseases

• Zika, Dengue, Chikungunya
• Ebola
• Malaria, Leishmaniasis 

 

Expertise Across All Phases

We support infectious disease and vaccine programs from first-in-human through post-approval: 

• Phase I–IIa safety/dose finding 
• Phase IIb–III efficacy/registration 
• Adaptive/seamless/platform trials 
• Special populations including immunocompromised population  
• Real-world evidence and Phase IV  
• Monoclonal Antibodies  
• Vaccine effectiveness and long-term follow-up 

Why Partner With Allucent

• Therapeutic focus on infectious diseases and vaccines and monoclonal antibodies  
• Expertise in emerging pathogens/high-containment 
• Proven global site activation 
• Regulatory alignment across agencies 
• Integrated and flexible delivery models 

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.

Mila Grieg, MD

Executive Medical Director and Therapeutic Area Medical Lead

Advancing Global Health Together

At Allucent, we’re committed to advancing therapies that protect lives and control disease spread. Our team is built for small to mid-size biopharma, with flexible, full-service CRO support tailored to help you succeed in infectious disease and vaccine development

Meet Some of Our Infectious Disease & Vaccine Experts

Donna Campbell, AS

Global Operations Head,
Government

• 25 years in clinical research
• Strong background clinical operations, project management, and client engagement
• Extensive experience in infectious disease and vaccine studies
• Led several US Government contracts, including BARDA Clinical Studies Network and NIAID/DMID Early Phase Clinical Trial Unit

Mila Grieg, MD

Executive Medical Director,
Therapeutic Area Medical Lead

• Over 20 years of professional experience in the medical field
• Expertise in infectious diseases/vaccines, allergy, and immunology
• Oversees an international team of medical monitors and safety officers to ensure the medical/clinical integrity and quality of studies conducted by Allucent

Bruce McClenathan, MD

Executive Medical Director,
Government and Public Health Services

• More than 25 years experience
• Lead medical affairs physician and scientific advisor for Allucent’s Government and Public Health Services portfolio
• Previously served 20+ years as clinician and researcher with the DoD
• Task Order or Site Principal Investigator on multiple clinical trials (Phase 1-4) and research studies

Connect with our infectious disease and vaccine clinical development team to discuss how we can support your next study.

Related Content

Patient Recruitment & Retention

Clinical Development

Regulatory Strategy

Government & Public Health Services

Additional Resources

Blog

Running Large-Scale Infectious Disease and Vaccine Trials: Best Practices for Managing Complexity and Ensuring Success

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Blog

Important Milestones in Infectious Diseases Clinical Trials: A Timeline of Infectious Disease Research

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Blog

Leveraging Autoimmune Therapies in Infectious Disease and Vaccine Research

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