Infectious Disease & Vaccine

Infectious Disease and Vaccine clinical trials require a therapeutically aligned team with global expertise. Allucent’s specialized staff excel in this domain, possessing a broad range of experience in infectious disease and vaccine clinical development. Through decades of proficiency, we apply a deep understanding of the regulatory framework in the U.S., EU, Asia-Pacific, and Latin America.

In addition to sponsor-funded trials, we work in federally-funded trials which demonstrate our ability to conduct global large vaccine studies in acute settings.

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.

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 Lead,
Infectious Disease & Vaccine

Our team is well-equipped with diverse therapeutic expertise to help you navigate the complexities of infectious disease & vaccine trials.

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 Lead,
Infectious Diseases, Vaccine, and Allergy

• 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

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Patient Recruitment & Retention

Clinical Development

Regulatory Strategy

Government & Public Health Services

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