Government & Public Health Services

HOME  /  SOLUTIONS  /  GOVERNMENT & PUBLIC HEALTH SERVICES GOVERNMENT & PUBLIC HEALTH SERVICES The know-how, experience, and relationships to successfully execute clinical trials on time HOW CAN WE HELP? SCROLL Why Allucent? It’s simple, really. We have the track record and expertise to lead you through the requirements of government-funded and public health research. We collaborate with and support leading public health agencies worldwide including: Biomedical Advanced Research and Development Authority (BARDA) Centers for Disease Control and Prevention (CDC) National Institutes of Health (NIH) U.S. Department of Defense (DoD) While also successfully supporting clinical trials for non-government (NGOs) and nonprofit organizations, we’re well-informed in Federal Acquisition Regulations (FAR), Defense Federal Acquisition Regulation (DFAR), Health and Human Services Acquisition Regulation (HHSAR), and International Traffic in Arms Regulations (ITAR). We identify the regulations applicable to your study or research program and support compliance. PRE-AWARD CONSULTING Allucent provides flexible, global solutions that streamline clinical safety operations at the study or portfolio level in a pharmacovigilance partnership model. Leveraging the latest technology advancements in combination with deep expertise, enhances pharmacovigilance efficiency, providing high quality, complete safety oversight. Risk management Patient recruitment Budgeting Regulatory strategy Feasibility assessment THERAPEUTIC EXPERTISE Our scientists, through their collective expertise working for big pharma, government and regulatory agencies, and academia have demonstrated proficiency in most therapeutic areas. They come well-prepared: Efficient trial design Regulatory insight Unparalleled understanding of disease and treatment landscape High success rates LEARN MORE INFRASTRUCTURE AND RESOURCES Allucent is built to support small and mid-size biopharma. This approach begins and ends with the scientists we recruit and retain who have vast experience and demonstrated therapeutic expertise at all levels of clinical trial management: from our project managers to CRAs, from biostatisticians to medical writers; and regulatory affairs specialist to the principal investigator. Government Contracts Overview BARDA CLINICAL STUDIES NETWORK Allucent assists BARDA by conducting phase 1-4 clinical trials to advance research and development, manufacturing, and procurement of medical countermeasures (MCMs) that protect against health security threats such as chemical, biological, radiological, and nuclear (CBRN) incidents, pandemic influenza, COVID-19, and emerging and re-emerging infectious diseases. Allucent has supported the following BARDA trials: Project NextGen – Phase IIb COVID-19 Clinical Trial Project NextGen – Home Focus Decentralized Observational Trial SABER – Phase I Trial Specimen Collection Observational Trial for COVID-19 BARDA DECENTRALIZED CLINICAL OPERATIONS AND HEALTHCARE RESEARCH Allucent was recently selected by BARDA for its new Decentralized Clinical Operations for Healthcare and Research (D-COHRe) initiative. DEPARTMENT OF DEFENSE/JOINT PROGRAM EXECUTIVE OFFICE Allucent supports multiple programs at the Department of Defense to advance the development of medical countermeasures (MCM) and protect soldiers from existing and emerging infectious diseases. Our support includes providing full service COVID-19 clinical trial services at various military sites in the United States, and biometric services to support the clinical evaluation of Orthopoxvirus countermeasure(s). Noise-Induced Hearing Loss Trials Operation Warp Speed – Phase III COVID-19 Trials Operation Warp Speed – VIRAMP Trial Office of Regulatory Affairs – TPOXX Trial NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE We support NINDS mission to advance the treatment of neurological disorders and stroke. We recently completed consulting services to support the NINDS’ HEAL Program and other NIH neuroscience-focused drug discovery and development programs to improve non-addictive therapies to treat pain. NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) Allucent supports NIAID on multiple long-term programs which includes preclinical and clinical trial support for the development and evaluation of vaccines and therapeutic candidates. Our services include regulatory consulting for non-clinical activities and clinical trial support for Phase I-IV trials of bacterial, viral, parasitic, and fungal countermeasures to prevent and treat infectious diseases and toxins in people of all ages and risk categories. NIAID Early Phase Clinical Trials Unit (EPCTU) Program NIAID Preclinical Services for Biopharmaceutical Product Development Program "[The Project Award to Allucent] contributes to the goals set in the BARDA 2022-2026 Strategic Plan, which highlights the importance of ensuring the nation’s response posture accounts for the needs of all segments of the population, and that participants are included from an appropriate balance of diverse backgrounds into clinical studies and/or trials that BARDA funds." BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY “We recently hired Allucent as our global CRO on an extremely complex cell therapy program in oncology. In the bid process they went above and beyond any CRO I’ve worked with to respond to questions, collaborate and even advise us to a degree that it seemed like they had thought about the program as much as we had.” GLOBAL BIOTECH COMPANY Meet Your A-Team At Allucent, we’re your trusted partner for navigating the complexities of drug development. With unparalleled expertise and a global perspective, our diverse team of US Government experts is here to guide your study to success. Bruce McClenathan, MD Executive Medical Director, Government and Public Health Services More than 25 years experience Lead medical affairs physician and scientific advisor for Allucent’s Government and Public Health Services portfolio Previously served 20+ years as clinician and researcher with the DoD Task Order or Site Principal Investigator on multiple clinical trials (Phase 1-4) and research studies Elissa Thomas, LPN, CCRC, PMP Project Director Clinical Project Management 32 years experience in oversight of FDA regulated clinical trials 15 years operated federally funded grants and contracts at military installations Associate Director Research Management at The Geneva Foundation Oversight of all research activities for central and western regions DoD Innovation Award and Joint Meritorious Unit Award Donna Campbell, AS Global Operations Head, Government 25 years in clinical research Strong background clinical operations, project management, and client engagement Extensive experience in infectious disease and vaccine studies Led several US Government contracts, including BARDA Clinical Studies Network and NIAID/DMID Early Phase Clinical Trial Unit Related Topics CLINICAL DEVELOPMENT DRUG SAFETY & PHARMACOVIGILANCE REGULATORY STRATEGY CLINICAL PHARMACOLOGY Additional Resources BLOG THE STRATEGIC ROLE OF THE CRO PRINCIPAL INVESTIGATOR: IMPROVING BIOTECH SPONSORS THROUGH PROTOCOL DESIGN AND STUDY EXECUTION LEARN MORE BLOG RUNNING LARGE-SCALE INFECTIOUS DISEASE AND VACCINE TRIALS: BEST PRACTICES FOR MANAGING COMPLEXITY AND ENSURING SUCCESS LEARN MORE BLOG FDA’S COMMISSIONER’S NATIONAL PRIORITY VOUCHER PROGRAM: STRATEGIC CONSIDERATIONS FOR A NEW ERA OF ULTRA-RAPID DRUG REVIEW LEARN MORE