DLH advances clinical research with speed, precision, and purpose. Our technology-enabled, scientifically grounded approach accelerates development while safeguarding quality, compliance, and outcomes.
Putting people first in every step of clinical research
At DLH, our unwavering commitment centers on the person—the patient, the warfighter, and the entire individual—at the heart of every study. We believe that clinical research is not just about data, protocols, or milestones; it is about people and the communities they serve.
With extensive experience across a broad spectrum of infectious and chronic diseases, we support research spanning oncology, metabolic disorders such as diabetes, influenza and other respiratory pathogens, HIV/AIDS, and emerging global health threats—among many others. Our interdisciplinary team of clinical research specialists, physicians, epidemiologists, biostatisticians, program leaders, data scientists, regulatory, and IT professionals integrates scientific expertise with advanced technology to deliver solutions that are precise, efficient, scalable, and held to the highest standards of quality and integrity.
DLH’s dedication to ethical conduct, transparent communication, and holistic care ensures that the entire person ecosystem—mind, body, and community—is respected and supported. By valuing the individual, we advance scientific discovery with purpose, trust, and respect.
Comprehensive clinical trial execution—from concept to closeout
DLH is a full-service clinical research organization delivering end-to-end trial management across the entire clinical development lifecycle. From protocol strategy and study startup through site activation, patient enrollment, data management, biostatistical analysis, and final reporting, we provide integrated oversight and operational leadership at every stage. Our services are available as standalone functional solutions or as a fully outsourced model, with DLH serving as a strategic partner accountable for performance, compliance, and results from first patient in to final database lock.
Project Management
DLH brings full-service delivery of programs at the local, regional, or national levels—from pilot studies to large, multi-site programs. Our Project Management Office (PMO) provides end-to-end clinical trials project management, supporting initiation, planning, execution, and monitoring across the full study lifecycle. We reduce client risk and oversight burden through our deep experience with clinical trial systems, comprehensive documentation and financial management, and multi-tiered project oversight and governance for faster, better-informed decisions, earlier risk visibility, and consistent execution.
Quality Management
DLH’s quality management organization delivers precise protocol execution, rigorous data integrity, and proactive risk management throughout every stage of your clinical trial. Our dedicated team ensures continuous staff training, comprehensive audits, vigilant document control, and thorough oversight of all suppliers and vendors, driving consistent operational excellence and ongoing improvement. Above all, we uphold participant safety and ethical standards, instilling confidence in both our clients and the broader clinical community.
Protocol Development
Highly experienced protocol navigators and writers offer direct and indirect support to PIs and other trial leaders throughout the life of the protocol. We offer comprehensive protocol services including feasibility assessments, literature reviews, endpoint selection, risk assessment, and integration of operational considerations to ensure protocols are both practical and aligned with best industry practices. From initial concept through submission and amendments, DLH’s team ensures seamless navigation of complex requirements, clear documentation, and expedited timelines to facilitate trial success.
Multi-site Management
DLH has deep experience maintaining financial, administrative, and technical activities across large, multi-site trials. Leveraging validated Clinical Trial Management Systems (CTMS), we ensure continuous performance monitoring for enrollment, budget, query response, data entry, and protocol deviations. By expertly coordinating activities across multiple sites, we drive programmatic consistency, realize significant cost efficiencies, and reduce protocol deviations—delivering high-quality outcomes while optimizing resources and accelerating study timelines. This centralized approach also enables faster patient recruitment, improved data quality, and real-time performance tracking, ensuring our clients achieve reliable results with greater speed and operational flexibility.
Site Monitoring
DLH leverages an extensive global site monitoring network to deliver comprehensive oversight throughout the trial life cycle, from site selection and initiation to interim monitoring and close-out visits. Our tailored monitoring plans are designed to ensure protocol adherence, data integrity, and regulatory compliance across all participating sites. With a flexible, site-oriented approach, DLH emphasizes capacity building, targeted training, and proactive risk mitigation, empowering site staff and fostering high performance to achieve consistently reliable trial outcomes.
Site Identification
DLH optimizes site identification, viability, and management through geospatially enhanced site identification and feasibility assessments to boost patient recruitment, retention, and study access. Our standardized, site-focused contract and budget templates reduce start-up timelines and accelerate negotiations. Dedicated site specialists cover all functional areas, including data management, investigational product, centralIRB, contracts, and performance monitoring to track enrollment, budget, query response, data entry, and protocol adherence. Our maintained master services list of turnkey sites enables faster study start-up and rapid First Patient Enrolled (FPE).
Data Management
DLH manages clinical data within fully validated systems that meet GCP guidelines and uphold strict data protection standards. Our secure platforms ensure data integrity, auditability, and transparency, while our FISMA-moderate compliant Secure Data Center (SDC) environment addresses all federal cybersecurity requirements. Our experts implement real-time data cleaning, standardization, mapping, and integration, uncovering linkages across a variety of sources including electronic health records. This comprehensive approach to data management assures clients that their data is protected, regulatory compliant, and managed with the utmost integrity throughout every stage of the clinical trial.
Recruitment and Retention
DLH engages with a diverse range of individuals and communities in our clinical recruitment. We support underrepresented populations, with expertise in designing studies for underserved, hard-to-reach, and priority populations. Our integrated participant support pathways improve retention and cooperation. We use a variety of methods, from social media to award-winning videos, to maximize recruitment and retention of diverse populations. Through clear messages and precise procedures, DLH works to minimize burden while maintaining interest.
Biostatistics
DLH biostatisticians and epidemiologists leverage their experience in designing adaptive platform trials, blinded trials, and randomized trials, cluster randomized trials, pseudo-randomized trials to forecast future probabilities of disease patterns, health behaviors, and other variables, using complex datasets from disparate sources – including population- and individual-level data. This expertise empowers our clients to make confident, data-driven decisions, minimize trial risks, and accelerate the path to meaningful clinical insights and regulatory success.
Regulatory Affairs
DLH’s Regulatory Affairs team ensures seamless compliance with FDA, GCP, ICH, and all relevant regulatory requirements, expertly guiding clients through every stage of the clinical trial process. We provide comprehensive inspection readiness, ongoing regulatory support, and precise management of all submissions to streamline approvals and maintain project momentum. Our proactive approach minimizes regulatory risk, supports successful outcomes, and instills confidence in sponsors, investigators, and stakeholders alike.
Leveraging a clinical research network with global reach
DLH has access to an extensive list of domestic and international clinical research sites collaborating for investigational therapeutic discoveries. Our worldwide, rapid-deployment network consists of over 730 sites in 48 countries, all field-tested for surge capacity. This broad reach enables accelerated patient recruitment—especially among diverse and hard-to-reach populations—scalable support for multicenter trials, and rapid access to strategic therapeutic areas. With a proven track record in executing complex global studies and navigating region-specific regulatory requirements, DLH’s established network ensures clients achieve fast, reliable, and high-quality trial results anywhere in the world.
Laboratory capabilities to support large-scale public health and epidemiologic studies
Our laboratory staff customize services to meet the specific needs of each client–from specimen collection, storage, analysis, and beyond. DLH’s Biosafety Level 2 (BSL-2) Central Processing Laboratory (CPL) in Durham, NC, has managed the efficient tracking of millions of specimens for more than 100 protocols. In addition to our in-house capabilities, we maintain collaborative partnerships with a trusted network of specialized laboratories, including a surge network of external labs and core facilities with access to BSL3 and BSL4 labs. We tailor testing strategies—including advanced molecular, immunological, genetic assays, or research and analysis that may require high-risk, high-containment handling (e.g. ABSL3-ABSL4)—to align precisely with your project’s unique scientific and regulatory requirements. This flexible, partnership-driven approach ensures rapid turnaround times, comprehensive testing solutions, and reliable, high-quality results for even the most complex large-scale studies.
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Advancing innovative approaches to clinical trial support
DLH supports non-traditional data collection operations and sampling approaches, with deep experience in web, phone, in-person, and biospecimen collection models that provide non-traditional clinical trial support. Our hybrid approaches blend probability and non-probability methods. Our mixed methods combine quantitative and qualitative approaches to enhance validity and insight. We complete 50,000+ complex de novo multi-mode surveys annually.
Over 30 years experience managing clinical trials
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