Our management and operational support for clinical and bioscience research programs and clinical trials expedites the availability of safe and effective therapeutics. DLH offers our customers, including the military medical community, full-service clinical research solutions, custom-designed for their specific research development program.
Clinical Development Planning, Protocol Design, and Project Management
We develop comprehensive project management plans and standard and tailored tracking tools. DLH implements rapid study startup with a focus on subject recruitment, accrual, and protection, conducting simulation modeling for recruitment design and study rollout. Our experts also emphasize strategic site selection.
Quality Management and Regulatory Affairs
DLH strives to attain the shortest path to product approval that ensures quality and regulatory compliance. Quality is managed by implementing and deploying continuous improvement processes, and tools such as Lean Six Sigma. Expertise in documentation management, supplier/vendor management, protocol compliance, and protocol submission management leads to an emphasis on quality control at every step. Training programs for study personnel, participants, and vendors, as well as frequent audits, allow for continual improvement.
We develop and write regulatory documents and offer cloud-based eTMF and eSubmission platforms. Protocol amendments, safety events and reports, FDA RFI responses, briefing documents, IND submissions, and 510K applications are among the many documents DLH researchers draft and submit to satisfy regulatory requirements.
Clinical Monitoring and Site Management
We offer comprehensive clinical monitoring plans, clinical site visits, reporting, and protocol-specific tool development.
Biostatistics and Data Management
DLH provides remote data capture and CRF design, offering real-time views of clinical trial forecasts, budgets, and data. Data standardization is accomplished using CDISC standards, and our statisticians hone in on analysis, modeling, and adaptive design. Priorities include protocol development for meta-analysis of data sets, data monitoring committee, and interim analyses.
Medical Monitoring and Safety Management
DLH develops comprehensive safety management plans, determines subject eligibility, and reviews medical coding, safety data, ECG, and lab data. We offer 24/7/365 SAE receipt, notification, reconciliation, and reporting.