Indications and study types
Our investigators, clinical operations and project management teams support infectious disease and vaccine programs in healthy volunteers and patient populations. For multicenter trials, we draw on strategic partner sites access to study populations and operational readiness.
Vaccines/Antibodies
- Influenza (Seasonal/Pandemic)
- Respiratory Syncytial Virus (RSV)
- COVID-19 and emerging respiratory viruses
- Herpes Zoster (HZ)
- Peanut Allergy
- Hepatitis (HBV, HCV)
- Japanese Encephalitis (JE)
- Nipah Virus (NiV)
- Emerging viral diseases
Other Infectious Diseases
- Bacterial infections
- Fungal infections
- Emerging infectious diseases
Biologics & Immunotherapies
- Preventive vaccines
- Therapeutic vaccines
- Monoclonal antibodies
First-in-Human (FIH)
Vaccine Studies
- First-in-Human (FIH) vaccine studies
- Dose-ranging studies
- Immunogenicity studies
- Booster studies
NDA-Enabling Clinical Pharmacology Studies
Phase Ib/IIa Proof-of-Concept (PoC)
Phase I-III Multicenter Patient Trials
Infectious disease and vaccine assessments
Many early phase infectious disease and vaccine studies require intensive safety monitoring, immunogenicity evaluations and specialized laboratory procedures. Our capabilities include:
- Immunogenicity and antibody response assessments
- PK, PD and ADA sample collection and processing
- Vaccine reactogenicity evaluations
- Respiratory specimen collection and handling
- Serial laboratory sampling and safety monitoring
- Subject-reported symptom and outcome assessments
- ePRO and electronic diary training
- Intensive inpatient and outpatient observation periods
- Central laboratory coordination and specimen logistics
- Investigational product accountability and cold-chain management
Infectious disease and vaccine infrastructure and partnerships
Clinical pharmacology unit
Our physician-led clinical pharmacology unit supports infectious disease and vaccine studies requiring inpatient stays, intensive PK sampling, continuous safety monitoring and complex multi-period designs, so studies with demanding monitoring or dosing requirements can be executed in a controlled environment. The unit accommodates both healthy volunteer and patient cohorts.
Multicenter trials
For multicenter patient trials, we draw on an established network of strategic site partners with documented experience enrolling infectious disease and healthy normal vaccine populations. Site selection and ongoing oversight are managed by our Site Partnerships Team, with criteria aligned to investigator experience, enrollment performance and data quality standards, helping sponsors achieve consistent execution across participating sites.
Through our Lead Site Model, we can serve as both the CRO and the first enrolling clinical research unit, providing firsthand operational insight that helps strengthen protocol compliance, improve feasibility and identify potential challenges before they impact study conduct. This approach supports faster site readiness, streamlined communication between sponsors and sites and delivers consistent execution across the study lifecycle.
Central lab
Our Central Laboratory supports multicenter studies with laboratory manual development, kit production, site supply logistics and standardized specimen management. Centralized laboratory data and real-time access to results help improve data consistency across sites, supports safety oversight and streamlines study execution from startup through final reporting.
PK processing &
safety laboratory
Our CLIA-certified PK Processing & Safety Laboratory provides on-site safety testing, endpoint sample processing and real-time access to laboratory results. Integrated technology and barcode-enabled workflows support efficient study execution, data quality and timely study decisions.
Pharmacy services
Study drug is prepared and stored on-site in our 2,500 sq. ft. cGMP-compliant pharmacy, which is DEA-registered to handle and store Schedule I-V controlled substances. The pharmacy is equipped to prepare investigational products across multiple routes of administration, including injectable formulations, nasal insufflation, powder-in-capsule, powder-in-solution and over-encapsulation. Integration within our Phase I unit enables rapid delivery of prepared doses under controlled conditions, reducing the number of handoffs, maintaining chain of custody and delivering on-time dosing.
Technology and data visibility
Our fully integrated technology platform, including eSource, EDC, and CTMS, along with AI-driven tools help streamline data collection throughout the study. These secure, cloud-based systems provide real-time data visibility, validated audit trails, data integration and scalable access to reliable, high-quality data across the entire study lifecycle.
Our infectious disease and vaccine leadership
Our infectious disease and vaccines team brings together experienced medical, clinical research, operational and project management professionals. The team supports protocol planning, medical oversight, site strategy and study execution across early phase and multicenter programs.
Featured study
Challenge
A sponsor required rapid execution of a Phase 3, randomized, double-blind infectious disease/vaccine type study involving approximately 210 healthy adults. We served as both the CRO and clinical research site, requiring close integration of clinical operations, site conduct, medical oversight, data management, biometrics and external vendors. The study combined an exceptionally compressed enrollment and dosing period with eDiary platform challenges during active data collection and evolving sponsor priorities that later accelerated database-lock and downstream statistical deliverables.
Approach
We used an integrated CRO/site model to coordinate project management, clinical and medical oversight, site operations, data management, biostatistics, programming, PK/PD activities and external laboratory and ePRO vendors. Cross-functional teams worked in parallel to support rapid screening, randomization, dosing and follow-up while actively managing vendors. When eDiary access, diary availability, compliance-reporting and reconciliation issues emerged, we coordinated closely with the sponsor and vendor, escalated issues, supported ongoing reconciliation and maintained participant and site oversight. As sponsor priorities evolved, the team also reassessed database-lock and biometrics timelines and coordinated accelerated downstream deliverables while maintaining data quality
Outcome
Enrollment was completed within 5 business days, 216 randomized and 210 volunteers dosed. The team then maintained study momentum through follow-up while managing eDiary/vendor issues, multiple external data streams and reconciliations and changing statistical and database-lock priorities. This integrated approach demonstrated our ability to execute a high-volume Phase 3 study rapidly while adapting to complex operational, technology, data and biometrics demands throughout study conduct.
Related resources
Considering DVCR for your Infectious Disease or Vaccine Trial?
Talk to a team that understands the operational demands of infectious disease and
vaccine studies.
We can discuss your timeline, population strategy and key operational risks. We work through the operational considerations early so that execution begins with a clear and coordinated timeline and ends with a fully enrolled study delivered on time and on budget.
