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THERAPEUTIC EXPERTISE

Immunology & Vaccine

As a result of developing vast and deep operational expertise in conducting immunology and vaccine trials, we understand the unique challenges associated with these studies and take your objectives to heart.

The Linical team works tirelessly as an extension of your team to optimize the timeline, conduct, budget, and quality of your trial as if your compound was our own product.

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THERAPEUTIC EXPERTISE

Global Immunology and Vaccine Experience

Linical has vast experience in managing full-service, Phase I-IV immunology studies across the globe. Because of our extensive operational experience in the immunology space, Linical is your trusted provider for success, speed, efficiency, flexibility, and quality in clinical research.

Our experience spans many indications including:

  • Prophylactic Vaccines
  • Therapeutic Vaccines
  • Outbreaks & Epidemics
  • Respiratory & Pulmonary Disorders
  • Allergic Disorders
  • Autoimmune Disorders

Award-Winning Vaccine and Immunology CRO

Linical's immunology and vaccine experience and success has been recognized and honored as Best Vaccine CRO across multiple years at the World Vaccine Congress. Put that expertise and experience to work for you by entrusting Linical to lead all aspects of your immunology trial through our highly-coordinated, accelerated, and cost-effective approach.

Why Linical for Immunology and Vaccine Clinical Trials?

Linical has nearly 20 years of experience managing clinical development for immunology and vaccine products. Our deep knowledge spans many types of products, patient populations, and regulatory requirements.

Proven Experience Across Many Therapeutic Areas

Proven Experience Across Many Therapeutic Areas

  • Acute Rhinitis
  • Allergy
  • Anthrax
  • Anti-infectives
  • Chikungunya
  • Chronic Granulomatous Disease
  • COVID-19
  • Cystic Fibrosis
  • Ebola
  • Encephalitis
  • Fever
  • Hepatitis
  • Influenza
  • Lupus
  • Malaria
  • MERS
  • Nerve Agents
  • Norovirus
  • Pharyngitis
  • Pneumonia
  • Respiratory Tract Infection
  • Sepsis
  • Shingles
  • Smallpox
  • TDAP
  • Travelers Diarrhea
  • VEEV
  • West Nile Virus

Familiarity with Varied Routes of Administration

Familiarity with Varied Routes of Administration

  • Oral (pill / liquid)
  • Patch
  • Electroporation
  • Intranasal
  • Intramuscular
  • Intradermal
  • Intravenous
  • Microneedle
  • Transdermal
  • Needle-free injection

Established Capability Across Diverse Patient Populations

Established Capability Across Diverse Patient Populations

  • Adult
  • Infant
  • Pediatric
  • Elderly
  • Niche
  • At-risk Therapeutic Populations (e.g. Oncology, Hepatitis)

Sustained Skill in Government Contracts

Sustained Skill in Government Contracts

Linical has successfully collaborated with clients around the globe to secure funding from Government agencies (e.g., BARDA, NIH, DoD, CDC, NIAID) for vaccine development.

Specialties

Immunology & Vaccine, Specialties

Linical’s legacy as a leading vaccine and immunology CRO means you get the “A Team” on your clinical trial. We match our project teams to your particular indication, and many of our team members have worked on vaccine and immunology research for their entire careers. We have team members located in all key clinical development regions across the globe, including North America, Europe, and Asia-Pacific, giving you the local area knowledge and strategies you need to find subjects/patients and position your trial for regulatory success.

Vaccine Clinical Development Expertise

Our vaccine clinical research experts have extensive experience with study design and execution for many types of vaccine trials.

Our knowledge includes live attenuated, inactivated, subunit, toxoid, mRNA, and viral vector vaccines for many therapeutic areas including infectious diseases, allergy, immunotherapy, and oncology indications.

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Optimizing Patient Recruitment

Geographic location, diversity of trial participants, and study timing are all important site-selection criteria for immunology clinical trials.
Our global reach, including top sites across North America, Europe, and Asia-Pacific, provides access to patient populations, site networks, and academic institutions. We are committed to meeting and exceeding your enrollment goals.
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Customized Monitoring Plans

Linical deploys strategic, data-driven approaches to monitoring immunology and vaccine trials.
Our project teams can recommend the best solution for your particular vaccine or immunology clinical trial, including risk-based monitoring or centralized monitoring, capable of managing large amounts of data upon enrollment, while ensuring the highest quality data in remote settings.
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Successful Regulatory Strategies

Our regulatory experts across the globe are well-versed in local regulatory requirements, offering key insights and strategies to get your product through clinical testing and on the way to approval.

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.

Our goal is to position your innovative drug, vaccine, biologic, device, or combination product for success, adding value every step of the way.

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“Dear Linical Team - Let me extend the gratitude of the entire project team for helping us achieve this key milestone for our trial. We could not have made these almost impossible timelines without your continued support and hard work. THANK YOU!”

Associate Global Trial Director

Mid-sized biotechnology company

Explore Linical’s Immunology & Vaccine CRO Services

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Drug Development Strategy

Drug Development Strategy

Linical provides comprehensive solutions for drug development strategy, including regulatory affairs, protocol development and study design, medical writing, and quality assurance.Through assessing scientific, regulatory, and commercial considerations, Linical works in collaboration with clients to optimize your trial’s drug development strategy.

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Clinical Trial Management

Clinical Trial Management

Linical’s comprehensive clinical trial management services are designed to help your program achieve high-quality data, on time and on budget. From study start up and feasibility, to project management, biometrics, and drug safety, Linical has the flexibility and experience you need.

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