Confidently solving the world’s most critical public health challenges
We drive discovery in cancer research, drug development, and other scientific domains through basic, translational, and clinical science and strategic management services.
We combine world-class talent in imaging, drug development, data science, research technology, virology and other scientific specialties with expertise in regulatory review, inspections and compliance, and grant lifecycle management to provide interdisciplinary experience.
Biomedical Product Development
We execute a diverse portfolio of medical science, biopharmaceutical, and grant/program review contracts and have the ability to support all phases of manufacture, evaluation, and regulatory affairs for biologics, drugs, and medical devices. Our virtual pharma approach involves production and testing of vaccines and biotherapeutics for use in human clinical trials and utilizes a proven operating model that leverages the technical expertise of multiple CMOs, CROs, biotech firms, and academia.
Clinical Research Services
Leidos provides a broad range of clinical services and solutions to researchers, product sponsors, U.S. Government agencies, and other biomedical enterprises, hospitals, and health systems. We conduct efficient, innovative clinical research from initial planning to closeout and remain vendor-neutral while fostering and managing collaborations with the right clinical research partner(s) for your study. We can also advance your existing clinical research capabilities by incorporating real-world data such as electronic health records.
Quality & Regulatory Compliance
We develop, implement, and manage compliance strategies for pharmaceutical, biologic, and medical device manufacturers to help assure that their production facilities apply industry best practices and are in compliance with stringent FDA and international regulatory requirements. We offer document preparation and control; quality program development and systems auditing; regulatory affairs consulting, compliance support, and gap and risk analysis; and training.
Regulatory Affairs Support
Our Life Sciences team provides critical regulatory guidance to help accelerate product development at every step. We help clients navigate the complex regulatory pathway from R&D to clinical trials and licensure, including assistance with document preparation and eCTD services.
Biomedical R&D Program Management
Leidos executes a diverse range of program management services for biomedical R&D organizations to help them plan, manage, and defend their research programs. We offer scientific, technical, and business analyses for federal biomedical R&D organizations as well as portfolio management expertise and comprehensive capabilities in all phases of grant and contract management to provide practical strategies and solutions that help our clients meet their goals.
Additional life sciences support
Our diverse team of scientific, technical, and communication experts provide a broad range of additional capabilities including:
- Leidos-Enabled Antibody Production Platform (LEAP2) enables a one-stop monoclonal antibody development solution from bench-to-clinic.
- Online Review Information Network (ORION) platform provides multifunction database support and interactive, customizable solutions to streamline meeting processes.
- A full-service publications and video/multimedia team with extensive experience producing high quality products ranging from regulatory submissions to effective communication tools in support of medical research programs and other federal customers.