Project Examples
See below for project examples related to Life Sciences.
Translational Research
SAIC develops data management tools and enterprise architecture frameworks to help move scientific discoveries into clinical practices. We help facilitate the management, integration and analysis of clinical and molecular data and images from clinical studies. We capture and analyze a variety of data types, including clinical, epidemiological, gene expression, protein expression, chromosome aberrations, and other genetic mutations and epigenetic changes. Through the integration and analysis of diverse study data, we assist in the discovery of novel disease biomarkers as well as in the classification of patient groups to determine optimal therapies, resulting in improved outcomes.
Clinical Guidelines Development
To support the development and enhancement of clinical practice guidelines, SAIC applies expertise in knowledge management. Through knowledge-mining techniques, we support guideline development activities and help to create an evidence base from the outcomes and results contained in relevant studies from published scientific literature. These services facilitate the movement of critical research into clinical practice for use by practitioners and patients in making decisions about their healthcare options.
Vaccine Development Support
SAIC supports a federal program to move vaccine concepts from basic laboratory research to products for testing in clinical trials. To accomplish this work, SAIC has engaged, managed, and integrated the services and products of more than 12 subcontractors. Responsibilities include process development, current Good Manufacturing Practice (GMP) pilot production and formulation, Good Laboratory Practice (GLP) preclinical safety and immunogenicity testing, analytics and repository services, and regulatory support for compiling Investigational New Drug applications. SAIC support has led to the discovery of potential vaccine candidates. Through cost-effective and efficient program management, we have helped accelerate the research and development process.
National Biodefense Countermeasures Support
SAIC managed large U.S. government laboratory, nonprofit institute, and national laboratory performance teams conducting pathogen research and development projects requiring Biosafety Level 2 (BSL-2), BSL-3, and BSL-4 laboratories. This work involved planning and oversight of several projects that required production and analysis of live, high-risk viruses, including influenza, filoviruses, alphaviruses, and flaviviruses.
Mock Inspection Audits and Remedial Action Planning
SAIC conducted a mock preapproval inspection (PAI) for a major pharmaceutical manufacturer in the People's Republic of China to determine whether the client's facility was in compliance with Food and Drug Administration (FDA) current Good Manufacturing Practice (GMP) requirements and to assess their readiness for an FDA PAI. This audit assessed the aseptic production of sterile injectable drugs and evaluated the manufacturing process, including the client's quality system, quality control operations, facilities and equipment, manufacturing processes, materials system, packaging and labeling, standard operating procedures, and training. The audit team identified potential deficiencies and recommended remedial actions to prevent delays in the approval process. Through our proactive involvement, we helped reduce regulatory risk and improve time-to-market.
Auditing, Validations, and Qualifications Support
SAIC provided global regulatory compliance support for a government medical research laboratory that produces biologics, drugs, and medical devices in facilities located in the United States, United Kingdom, France, Singapore, North Africa, and Central and South America. We assessed equipment qualifications, clinical laboratory readiness, contract manufacturing organization qualifications, and early- and late-phase clinical site and laboratory readiness. We conducted Good Laboratory Practice (GLP) audits and provided current Good Manufacturing Practice (GMP) person-in-the-plant support. We also validated assays, provided cold-chain management for multiple products, and designed and managed stability programs. Our support assured that quality systems were in compliance with regulatory requirements and facilitated the timely completion of development activities.
Document Preparation and Control for Regulatory Submissions
SAIC provides hands-on technical and administrative assistance for an infectious disease research institute. We support the preparation, review, assembly, archiving, distribution, and tracking of all pre-Investigational New Drug (IND) briefing documents, INDs, investigational device exemptions, master files or equivalent submissions, and subsequent supplemental submissions to regulatory authorities. In addition, we maintain the database that archives and tracks all protocol registration documentation and enables orders for clinical trial materials. Our expertise enables documentation to meet stringent Food and Drug Administration (FDA) and regulatory requirements and helps assure document control.
Regulatory Affairs Consulting for Product Acquisition
SAIC provides critical guidance on product development, from preclinical research to Food and Drug Administration (FDA) market approval, for a government biomedical research organization that is responsible for the acquisition of drugs, vaccines, therapies, and diagnostic tools for public health emergencies. We apply our deep understanding of FDA regulations and practices to provide our customer with a realistic picture of manufacturers' regulatory strategies and timelines for FDA licensure and approval. SAIC also provides extensive reviews of essential IND documents and evaluates and interprets FDA correspondence to the manufacturer. This support helps to assure that, should a health emergency arise, public health organizations have an adequate supply of countermeasures to combat the threat.
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Cancer Biomedical Informatics Grid and caBIG are registered trademarks of the U.S. Department of Health and Human Services Agency of the United States Government in the United States and/or other countries used in connection with the National Cancer Institute's caBIG® program.