Leidos Health

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:

• Request for Proposal development and publication
  
• pre-proposals/proposals receipt management
  
• scientific and programmatic reviewer recruitment and training
  
• peer and programmatic review meeting coordination and summaries
  
• post-award management and scientific review of annual/progress reports
  
• research site visit coordination and support
  
• human use, animal use, and environmental compliance audits
  
• grant close-out support
  
• Our proprietary Online Review Information Network (ORION), a secure, web-based tool for online proposal reviews and other virtual meetings, is a value-added feature to our approach.
  

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

• research gap analysis
  
• program design and development
  
• evaluation of research project and product development portfolios
  
• planning and conduct of program reviews
  
• technology life-cycle cost analysis
  
• program marketing and communications
  
• policy analysis and development.
  

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

• biopharmaceutical concept prototyping
  
• regulatory strategy
  
• product development
  
• successfully managing diverse science and technology platforms.
  

Advantages of Leidos Health:

• Leidos Health's Life Sciences team has established itself as a corporate leader by filling a market niche that unites sponsor mission and operational necessities with regulatory requirements and technical expertise.
  
• Our solid experience has led to tremendous proficiency in the identification, qualification, and oversight/coordination of current Good Manufacturing Practices (GMP)/Good Laboratory Practices (GLP) operations for the development and manufacture of pharmaceutical products, including multiple novel biopharmaceuticals (primarily monoclonal antibodies).
  
• Helping to ensure continuity across a distributed network of lifecycle contributors is an attribute that distinguishes our Life Sciences team from CMOs and CROs throughout the industry. As we have learned from 13 years of networked and collaborative biopharmaceutical development, there is a definite and critical need to unite the procedural and quality practices of contract entities that perform each step in the overall process.
  
• There are also gaps in the general service offerings of the CMO/CRO community that we seek to bridge in our effort to cover the full spectrum of lifecycle requirements.
  

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:

• We have extensive experience in the regulatory submission strategy, authoring and review of regulatory documents, and submission of regulatory applications, including Investigational New Drug Applications, Investigational Device Exemptions and Master Files, to the FDA in traditional paper, paper Common Technical Document (CTD), and electronic CTD (eCTD) formats.
  
• We are well versed in the transition from paper to eCTD submissions, including the configuration and implementation of electronic submission software, along with the development of, and training of staff on, eCTD submission-related processes.
  
• Our word processors have extensive experience formatting many types of regulatory documents, for both paper and e-submissions
  
• Our technical writers and editors have strong backgrounds in scientific and technical terminology to help ensure quality products.
  

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:

• We develop, implement, and manage compliance strategies for pharmaceutical, biologic, and medical device manufacturers.
  
• Leidos Health advises and trains customers on current:
  
  • Good Manufacturing Practices (GMP)
    
  • Good Laboratory Practices (GLP)
    
  • Good Clinical Practices (GCP)
    
  • Good Clinical Laboratory Practices (GCLP)
    
• We write and review vendor qualifications and process equipment validation protocols for completeness to help ensure these are in compliance with regulatory guidelines
  
• We also perform mock inspections and assess facility qualifications worldwide to facilitate manufacturing and product quality.
  

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:

• We have extensive experience in the regulatory submission strategy, authoring and review of regulatory documents, and submission of regulatory applications, including Investigational New Drug Applications, Investigational Device Exemptions, and Master Files, to the FDA in traditional paper, paper Common Technical Document (CTD), and electronic CTD (eCTD) formats.
  
• We are well versed in the transition from paper to eCTD submissions, including the configuration and implementation of electronic submission software, along with the development of, and training of staff on, eCTD submission-related processes.
  
• Our word processors have extensive experience formatting many types of regulatory documents, for both paper and e-submissions
  
• Our technical writers and editors have strong backgrounds in scientific and technical terminology to help ensure quality products.
  

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:

• To help ensure the proper procedures are in place, we develop, implement, and manage compliance strategies for pharmaceutical, biologic, and medical device manufacturers.
  
• Leidos Health advises and trains customers on current:
  
  • Good Manufacturing Practices (GMP)
    
  • Good Laboratory Practices (GLP)
    
  • Good Clinical Practices (GCP)
    
  • Good Clinical Laboratory Practices (GCLP)
    
• We write and review vendor qualifications and process equipment validation protocols for completeness to help ensure these are in compliance with regulatory guidelines
  
• We also perform mock inspections and assess facility qualifications worldwide to facilitate manufacturing and product quality.
  

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:

• research gap analysis
  
• program design and development
  
• evaluation of research project and product development portfolios
  
• planning and conduct of program reviews
  
• technology life-cycle cost analysis
  
• product development plans
  
• program marketing and communications
  
• policy analysis and development.
  

Advantages of Leidos Health:

• 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.
  
• In addition, Leidos Health has in-depth knowledge of the entire Grants Management process, and we can support a program from initial development through implementation and sustainability.
  

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:

• We offer a unique blend of grants domain and technical expertise that accelerates the research, development, and evaluation process, improves collaboration, and reduces management timelines to help ensure that research dollars are allocated more effectively.
  
• Leidos Health also provides subject matter experts to assess infrastructure, processes, and policies, and to conduct/support program evaluation initiatives.
  
• Our team of experts assists with program analyses and develops tools for evaluation and strategic planning—in support of organizations with or without an in-house evaluation infrastructure.
  
• Over the past two decades, our doctoral- and master’s-level scientists have been supporting biomedical research programs in the areas of military health and injury, cancer, diabetes, multiple sclerosis, autism, Alzheimer’s, and many other diseases.
  

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:

• research gap analysis
  
• program design and development
  
• evaluation of research project and product development portfolios
  
• planning and conduct of program reviews
  
• technology life-cycle cost analysis
  
• product development plans
  
• program marketing and communications
  
• policy analysis and development.
  

Advantages of Leidos Health:

• 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.
  
• For more than 20 years, Leidos Health has been supporting the full spectrum of biomedical research programs for government and non-government clients and our experience designing and developing new programs, performing landscape analyses, exploring partnerships, and providing support during the drug discovery process is matched by few.
  
• In addition, Leidos Health has in-depth knowledge of the entire Grants Management process, and we can support a program from initial development through implementation and sustainability.
  

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:

• interviewing
  
• scriptwriting
  
• researching footage and music beds
  
• video editing
  
• 3-D video graphics and animation
  
• exporting final video files for multiple venues.
  

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:

• New Drug, Investigational New Drug, and Biologics License Applications (NDAs/INDs/BLAs)
  
• final integrated clinical and statistical reports
  
• informed consent forms
  
• clinical study protocols
  
• nonclinical study protocols
  
• protocol amendments
  
• information amendments
  
• investigator brochures (IBs)
  
• annual reports
  
• case report forms
  
• patient narratives
  
• preclinical study summaries
  
• integrated summaries of safety and efficacy
  
• safety submissions
  
• chemistry, manufacturing, and controls sections
  
• annotated labeling; and package inserts.
  

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:

• scientific symposium posters
  
• biomedical illustrations
  
• flow diagrams and data charts
  
• 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. 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:

• biomedical illustrations
  
• flow diagrams and data charts
  
• posters
  
• animations
  
• small displays, and large trade show exhibits for many different publications and venues.
  

Advantages of Leidos Health:

• We have the capability to produce both free-hand and computer-illustration graphics, and we frequently combine both skillsets.
  
• 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.
  
• When needed, our designers work with customers to develop a consistent design identity, or “branding,” to communicate ideas and products effectively so the audience can quickly identify various types of materials connected with an organization.
  
• Leidos Health has an extensive photo library of licensed or public-use photo images, and a subscription to a stock photo website that provides access to more than 19 million photos.
  

Leidos Health’s regulatory scientists have in-depth experience with the preparation of clinical research and regulatory documents for pharmaceutical and biologics approval including:

• New Drug, Investigational New Drug, and Biologics License Applications (NDAs/INDs/BLAs)
  
• final integrated clinical and statistical reports
  
• informed consent forms
  
• clinical study protocols
  
• nonclinical study protocols; protocol amendments
  
• information amendments
  
• investigator brochures (IBs)
  
• annual reports
  
• case report forms
  
• patient narratives
  
• preclinical study summaries
  
• integrated summaries of safety and efficacy
  
• safety submissions
  
• chemistry, manufacturing, and controls sections
  
• annotated labeling; and package inserts.
  

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.