Supporting the Development and Acquisition of Safe, Effective, and Innovative Medical Solutions
Medical and Public Health Preparedness
Patricio Enterprises is dedicated to assisting the Federal Government and its partners in developing improved health outcomes for infectious diseases, emerging infectious diseases, and potential chemical, biological, radiological, and nuclear events to protect our Nation, our people, and our allies.
We are fully engaged in national and international efforts to prevent and reduce the effects of naturally occurring and manufactured threats through ongoing research, science and technology activities, and acquisition support. We support preparedness initiatives in the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense medical countermeasure programs, the U.S. Army’s Development Command Science and Technology priorities, and the Department of Health and Human Services Assistant Secretary for Preparedness and Response (ASPR) efforts to prepare for, respond to, and recover from disasters and public health emergencies. Our goal is to provide technical expertise coupled with quality control processes ensuring smart decision-making and resource prioritization in a defensible and uniform manner.
PE is working diligently to assist our clients to deliver effective vaccines, diagnostics, therapeutics, and enablers across the entire spectrum of medical countermeasures. Our staff is serving on cutting edge acquisition teams working to develop and field medical countermeasures for viruses like COVID-19 and Ebola.
They conduct requirements planning and facilitate the development of specialized supply chain management procedures for medical products including test kits and autoinjectors. We expedite the procurement of drugs, biological products, and medical devices that are safe, effective, and widely accessible to all Americans. We also support CBRN/medical supply fulfillment and support capabilities to ensure that responders have the necessary equipment and supplies to combat multiple threats. We focus on building additional technical and workforce capacity to best support our customers. We are building capacity by partnering with industry, academic institutions, research facilities, and the complex Federal Government system of military and health affairs. By having a thorough knowledge of the challenges each agency faces, we can field the technical expertise needed to solve complex issues of strategic importance. The key is to engage early enough to assist our clients to prepare for and mitigate the effects of bioterrorism and public health emergencies thereby saving human life and reducing environmental impacts.
Statistical and Regulatory Oversight
• Tech Base Programs and Advanced Development
Programs Technical Assistance
• Statistical Analysis Plans
• Statistical Programming Validation Plans
• Position Papers
Submissions Support Publishing
• eCTD Publishing Services
• FDA Electronic Submission Gateway (ESG)
• LIQUENT SmartDesk
• InSight and LORENZ eValidator
Product Compliance
• Food and Drug Administration (FDA) Regulated Non-Clinical, Product Manufacturing and Testing Subject Matter Expertise
• Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) Subject Matter Expertise
• Clinical and Non-Clinical Studies Regulatory Compliance
• Research Protocol Development and Review
• Assay Development and Validation
• Contract Research Organization (CRO) Oversight
Clinical Data Management
• Protocol Review
• Data Management Essential Documentation
• Database Development, Testing, Validation, and Maintenance
• Statutory, Regulatory, Policy Compliance – FDA, Army Regulations, Clinical Data Acquisition Standards and Harmonization (CDASH), Good Clinical Data Management Practices (GCDMP), Good Clinical Practices (GCP)