Indications
Our investigators, clinical operations and project management teams have participated in dozens of allergy and immunology trials across the indications below, in both healthy volunteers and patient populations. For multicenter patient trials, we draw on a network of strategic partner sites.
Allergy
- Atopic dermatitis
- Allergic rhinitis
- Food allergies
- Urticaria/angioedema
- Immunologic Disorders
- Inflammatory bowel disease (Crohn’s, ulcerative colitis)
- Autoimmune disorders
- Psoriasis
- Immunodeficiency disorders
- Autoinflammatory disorders
Allergy & immunology assessments
Many of these early phase studies from Ib/2a rely on procedures and assessments specific to allergy and immunology research.
Our capabilities include:
- Spirometry to measure airflow and lung function.
- Skin and serum allergy testing to characterize allergic sensitization.
- Atopic dermatitis assessments to grade disease severity and treatment response.
- Ability to train subjects with use of specialized dosing devices (e.g. nasal inhalers, dry-powder or metered-dose inhalers)
- Ability to conduct subjective data collection (e.g. questionnaires or diaries)
Allergy & immunology infrastructure and partnerships
Clinical pharmacology unit
Our physician-led clinical pharmacology unit supports allergy & immunology 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 healthy normal and patient 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 allergy & immunology leadership
Our Allergy and Immunology team brings together experienced clinical research, operational and study management professionals dedicated to the successful execution of allergy and immunology trials. Having conducted dozens of allergy and immunology studies across all phases, the team is led by board-certified allergist and immunologist William Lavery, MD, PhD, whose expertise helps guide study strategy and execution.
Related resources
Considering DVCR for your allergy & immunology trial?
Talk to a team that has run allergy and immunology trials across all phases of research.
We can discuss your protocol and timeline and how our on-site assessments and experienced investigators support a predictable execution path. We work through operational considerations early,
so execution begins with a clear plan.
