Leidos Health is an experienced provider of biopharmaceutical product development services from bench-top to bedside. Our services span the full spectrum of the biomedical product life-cycle, from discovery through post-marketing surveillance. We deliver program management support, including planning and portfolio review and process development, and apply our in-depth knowledge of the FDA regulatory process to help prepare products for FDA evaluation. We also work with manufacturers to assure quality and compliance with current Good Manufacturing Practices (cGMP). We also work with hospitals and research centers to conduct clinical trials in accordance with good clinical practice, Code of Federal Regulations, and FDA guidance. Our scientists boast deep domain knowledge in a variety of disciplines such as molecular biology, immunology, biochemistry, toxicology, pharmacology, program management, clinical research, regulatory affairs, and more. Our publications and multimedia team has over 10 years of experience preparing documents for FDA submission and over 15 years of experience preparing brochures, annual reports, displays, and videos that demonstrate medical research efforts and accomplishments. Simply put, Leidos Health helps clients get the results they need.
Leidos Health Life Science’s team provides multi-platform training programs and mentorship for patients, family members, caregivers, and other stakeholders to facilitate their engagement as integral members of the entire research enterprise. Through collaboration with our clients we empower patients with knowledge to:
• Engage fully as research team members,
• Participate on decision-making committees within research organizations,
• Assume leadership roles in the research enterprise,
• Participate as equal members in peer review of research applications and
• Disseminate opportunities for patient engagement and results from funded studies.
Prices on request
Leidos Health has in-depth knowledge of the entire grants and contract management process. Our team includes highly skilled scientific writers and editors, as well as full print and visual production capabilities and IT expertise. We have experience supporting congressional programs from initial development through implementation and sustainability. Our team can provide:
For more than 20 years, Leidos Health’s Life Sciences team has been supporting the full spectrum of the biomedical product life-cycle, from discovery through post-marketing surveillance. Leidos Health supports biomedical research and development organizations with comprehensive scientific and business analytical expertise, including the development of Product Development Plans (PDPs). The PDP provides a comprehensive analysis of the product development pathway through clinical development by clear and concise delineation of objectives, crucial milestones, and realistic timelines.
Other areas of expertise include
Our flexible business model allows us to take on projects of all sizes and complexities. From improving program processes to optimizing business operations, we design and deliver customized solutions that help you perform more efficiently—all to the benefit of your patients, your employees, and your organization. Our experience in designing and developing new programs, performing landscape analyses, exploring partnerships, and providing support during the drug discovery process is matched by few.
Leidos Health's Life Sciences team executes a diverse portfolio of medical science, biopharmaceutical, and grant/program review contracts that encompasses a spectrum of infectious diseases, cancers, and neurological disorders. 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 Contract Manufacturing Organizations (CMOs), Contract Research Organizations (CROs), biotech firms, and academia. Our specific expertise is in
Advantages of Leidos Health:
Our Leidos Health's Life Sciences team provides critical regulatory guidance at every step of the product development process. Our regulatory scientists collaborate with client integrated product teams to help navigate the complex regulatory pathway from research and development to clinical trials and licensure. Leidos Health provides comprehensive regulatory affairs consulting services to foster the submission and approval of accurate, scientifically sound regulatory documents:
Leidos Health's Life Sciences quality and regulatory compliance experts assist customers to help ensure their production facilities apply industry best practices and are in compliance with stringent FDA and international regulatory requirements. Supporting customers globally, Leidos Health performs comprehensive pharmaceutical manufacturing and testing facility audits and assessments to help identify potential process deficiencies and take corrective action prior to regulatory agency inspections. To help ensure the proper procedures are in place:
Prices starting at $150
Our Leidos Health's Life Sciences team provides critical regulatory guidance at every step of the product development process. Our regulatory scientists collaborate with client integrated product teams to help navigate the complex regulatory pathway from research and development to clinical trials and licensure. Leidos Health provides comprehensive regulatory affairs consulting services to foster the submission and approval of accurate, scientifically sound regulatory documents.
Advantages of Leidos health:
Prices starting at $60
Leidos Health's Life Sciences quality and regulatory compliance experts assist customers to help ensure their production facilities apply industry best practices and are in compliance with stringent FDA and international regulatory requirements. Supporting customers globally, Leidos Health performs comprehensive pharmaceutical manufacturing and testing facility audits and assessments to help identify potential process deficiencies and take corrective action prior to regulatory agency inspections:
For more than 20 years, Leidos Health’s Life Sciences team has been supporting the full spectrum of biomedical research programs for government and non-government clients. Leidos Health supports biomedical research and development organizations with comprehensive scientific and business analytical expertise, including:
Advantages of Leidos Health:
Prices on request, starting at $51.57
Project Evaluation
Leidos Health provides project evaluation support for federal and private (non-profit, commercial) research funding organizations, individual research programs, and other research-focused initiatives. For more than 20 years, Leidos Health’s Life Sciences team has supported the full spectrum of biomedical research programs for government and non-government clients through program/portfolio performance evaluation, comprehensive grants management, and financial auditing.
The primary goals of project evaluation are to review project outcomes to determine the extent to which an organization has contributed to advances in areas such as science, engineering, disease prevention, diagnosis and treatment, health care quality, and patient quality of life, and to assess whether the organization is advancing science management, thereby making an impact on the broader scientific community.
Advantages of Leidos Health:
Prices on request, starting at $50.
Leidos Health’s Life Sciences team supports biomedical research and development organizations with comprehensive scientific and business analytical expertise, including:
Advantages of Leidos Health:
Leidos Health’s video production team has produced over 150 scientific/research-related videos since 2007, many of which were originally shot in academic research laboratories all over the country. Our producers have extensive experience with:
Leidos Health is outfitted with state-of-the-art equipment, including a high-definition Sony Camcorder, audio equipment (wired and wireless), light kits, and monitors. Our team also has experience in developing interactive products to place on the web or on tablets to demonstrate customer accomplishments.
Leidos Health’s graphic designers create biomedical illustrations and animations for both PowerPoint presentations and video. We have the capability to create both free-hand and computer-illustration graphics, and we frequently combine both skillsets when developing a design.
Leidos Health’s regulatory scientists have in-depth experience with the preparation of clinical research and regulatory documents for pharmaceutical and biologics approval including:
Our word processors have extensive experience formatting many types of regulatory documents, for both paper and e-submissions. Leidos Health’s technical editors have strong backgrounds in scientific and technical terminology; a variety of style guides, including AMA, AP, and Chicago; proofing for formatting and acronyms; and ensuring quality products that meet the requirements needed for the journal or end user.
Leidos Health’s videographic designers are skilled in the art of adding animation to scientific processes to provide both clarity and interest to the final presentation. We create animated biomedical illustrations and animations for both PowerPoint presentations and video. We have the capability to create free-hand and computer-illustration graphics, and we frequently combine both skillsets. Our team also has experience in developing interactive products to place on the web or on tablets to demonstrate customer accomplishments.
Prices: $75, $100 and on request.
Leidos Health’s graphic designers have more than 15 years of experience creating:
We have the capability to create both free-hand and computer-illustration graphics, and we frequently combine both skillsets. Our scientific writers and editors are experienced in streamlining text for poster presentations and can analyze content to help provide layout recommendations, when needed.
Leidos Health’s graphic designers create:
Advantages of Leidos Health:
Leidos Health’s regulatory scientists have in-depth experience with the preparation of clinical research and regulatory documents for pharmaceutical and biologics approval including:
We employ technical editors with strong backgrounds in scientific and technical terminology to help ensure quality products.
Prices on request, starting at $50
Leidos Health’s technical editors have strong backgrounds in scientific and technical terminology; utilizing a variety of style guides, including AMA, AP, and Chicago; proofreading for correct formatting and acronym usage; and ensuring quality products that meet the requirements needed for the end user.
Prices: .02-.04/word, $126/hr, and on request
Leidos Health’s graphic designers create biomedical illustrations, flow diagrams and data charts, posters, animations, small displays, and large trade show exhibits for many different publications and venues. We have the capability to create both free-hand and computer-illustration graphics, and we frequently combine both skillsets.
Prices starting at $100
Leidos Health has an experienced publications staff that provides high-quality products for our biomedical and regulatory customers. Our word processors have extensive experience formatting many types of documents, including regulatory reports, presentations, correspondence, and meeting read-ahead packages and proceedings. Staff members skilled in desktop publishing create color schemes and layouts for all types of print publications, such as annual reports, books, brochures, program booklets, and newsletters. Technical editors with strong backgrounds in scientific and technical terminology ensure quality products.
Leidos Health employs experienced technical and scientific personnel that can provide expert review of literature in the public domain. Our subject matter experts conduct literature reviews for a variety of client requirements, including landscape analyses, gap analyses, and benchmarking studies. Literature review products are often used for strategic planning, research outcomes management, program evaluation, and product development planning.
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