Service Offerings

SAIC brings innovative scientific and technical solutions to address performance problems and enable improvements spanning from drug development to public care.

Data and information are the life's blood of most modern life sciences organization. For biopharmaceutical R&D, it can be argued that the major activity of the R&D organization revolves around the creation, management, distribution, publication and ultimate disposition of its information assets. Given the importance of information to life sciences organizations, SAIC offers comprehensive services and solutions that improve the management and value of information across an organization and its extended network.

To solve the most demanding technical programs, SAIC is establishing new relationships among government sectors and private sector entities. For example, with our active participation in life science and healthcare data standards consortia, SAIC is helping the integration of healthcare processes and technologies with clinical trials. With Centers for Disease Control and Prevention (CDC), SAIC created the ability to share critical health information among national, state and local systems through systems integration and by facilitating the adoption of national standards and specifications. We are also designing and building the IT infrastructure to establish electronic transfer between drug developers and the FDA and highlights are successes in establishing relationships between public and private sectors.

List of Offerings

• Program Management Assessment
• Program and Project Management
• R&D Data Analysis and Management
• Data and Systems Integration for Mergers and Acquisitions
• IT Strategic Planning and Governance
• Application/Systems Development and Integration
• IT Outsourcing
• Integrated Document Management
• Knowledge Management
• Clinical Data Standards
• Clinical Study Information Exchange
• Information Security and Identity Management
• Regulatory Affairs and Quality Compliance
• Pharmacovigilance & Risk Management

Program Management Assessment

• Independent identification of shortcomings in project cost control, resource management, and scheduling.
• Understanding of comparative project management performance against competitors across bio pharmaceutical industry.
• Assessment of the appropriateness of existing project management performance indicators.
• Roadmap for implementing cost effective improvements to your project management capabilities.
• Elimination of project management re-work and inefficiencies through focused improvements.
• Strengthened alignment between top down R&D business goals and bottom up clinical study operations.
• Project managers who are better able to provide credible information and gain' stakeholder buy in to actionable recommendations.

Program Management Assessment (80k PDF file*)

Program and Project Management

• Increased consistency in successfully meeting project and business objectives.
• Improved allocation of internal PM resources to focus on activities that are strategically important to core business needs, while augmented PM staff are assigned to less business critical projects.
• Enhanced capacity to acquire specialized skills for short term project management needs, improving the ability to rapidly respond to new demands.
• Reduced risk because of proven mitigation, change control, and quality assurance procedures.
• Accelerated project start-ups and scale-ups that improve project efficiency and cost effectiveness.
• Improved customer satisfaction among project stakeholders.
• Increased insight into the status and health of projects

Program and Project Management (132k PDF file*)

R&D Data Analysis and Management

• Increased capability to make proactive, informed decisions in less time, with less associated costs, through automated prediction of future trends, behaviors, and patterns.
• Transformation of volumes of data from multiple sources and formats into consistently usable information that appears as a single, coherent data source.
• Increased capability to collaborate and manage knowledge, in a timely manner, across the bioscience community.
• Early identification of new technologies and lower cost of delivery of leading technologies by leveraging SAIC's leadership in federal and commercial business

R&D Data Analysis and Management (175k PDF file*)

Data and Systems Integration for Mergers and Acquisitions

• Timely, cost effective business mergers ensured by a streamlined migration and integration approach.
• Minimal disruption to day to day business operations resulting from rigorous strategic planning and tactical process/ system deployment.
• Accelerated IT program start up and quick response to changing needs via proven management "best practices."
• Lower total cost of ownership and reduced production environment complexity, resulting from application rationalization and consolidation.
• Controlled IT costs and reduced risks resulting from common M&A process/ system life cycle methodology procedures, applications, data, and systems (i.e., harmonization of IT environment).

Data and Systems Integration for Mergers and Acquisitions (77k PDF file*)

IT Strategic Planning and Governance

• Well integrated IT leadership and management structure that improves market responsiveness.
• IT strategic plans and projects aligned with business objectives.
• Streamlined business operations that reduce timelines and improve use of IT resources.
• Cost effective services based on innovative outsourcing partnership arrangements.
• Capacity to optimize IT investments while keeping technology up to date.
• Effective enterprise IT evaluation methodologies to reduce IT investment risk.
• Pragmatic practices combined with cutting-edge discovery technology for a balanced approach to drug discovery.
• Comprehensive migration plans that effect smooth transitions of mergers and acquisitions with minimum disruption to business operations.

IT Strategic Planning and Governance (67k PDF file*)

Application/Systems Development and Integration

• Enhanced research productivity enabled by technically advanced software systems.
• Reduced time in clinical trials by focused automation of drug research and development processes.
• Better informed clinical trial decisions facilitated by expanded data management and analysis capabilities.
• Decreased time and resources spent in system validation by applying system life cycle processes that ensure compliance.
• Globalization and consolidation of application architectures, reducing cost and increasing business interoperability.
• More timely start up information, allowing manufacturing to begin production more quickly.
• Rapid deployment of advanced tools facilitated by expert staff, with surge capacity for peak project workloads.
• Improved IT reliability and availability to maximize business productivity.

Application/Systems Development and Integration (72k PDF file*)

IT Outsourcing

• Increased freedom to focus on core business competencies while implementing best of breed solutions.
• Greater access to specialized skills for short term needs and flexible resourcing to respond to market changes, surge requirements, and niche expertise.
• Enhanced ability to leverage IT asset procurement, via SAIC's strategic alliances that provide potential volume discounts.
• Increased availability of customer's internal IT staff to focus on new system development opportunities.
• Minimized total cost of ownership and improved levels of user support and satisfaction.
• Potential reduction of service delivery costs by 25-50% and increase operating efficiency by 35-40% with use of SAIC's existing NAISMC or an ISMC set up near the client's location.

IT Outsourcing (73k PDF file*)

Integrated Document Management

• Improved productivity by providing researchers with local access to distributed documents.
• Increased ability to efficiently share secured information across organizations.
• Secure environment for on line document processing (e.g., creation, revision, storage, retrieval, disposition).
• Streamlined R&D operations due to fewer labor intensive manual processing activities and ability to process documents more rapidly.
• Significant reductions in paper usage, handling, and storage.
• Ability to leverage collective intellect to solve problems and foster innovation.

Integrated Document Management (67k PDF file*)

Knowledge Management

• Productivity enhancements accelerated by the transfer and use of existing know how.
• Ability to learn, decide, and adapt faster than the competition.
• Capability to quickly access and build on experience and ideas to fuel innovation.
• Improved visualization of information patterns enabled by viewing data in ordered relationships.
• Enhanced decision making through access to complete knowledge and analysis.
• Increased cooperation and collaboration among stakeholders created by effective knowledge sharing.
• Ability to leverage collective intellect to solve problems and foster innovation.
• Continuous workforce performance improvement facilitated by an efficient knowledge management system.

Knowledge Management web site

Clinical Data Standards

• Minimize the costs of data transformation between data collection and submission.
• Improve the ease of data exchange between sponsors, partners, and regulators.
• Facilitate the development of reusable technology for the generation of standard safety tables and listings for clinical study reports.
• Design a well defined roadmap for galvanizing and guiding the organization.
• Provide tailored solutions that bridge your existing technical infrastructure with emerging software offerings and trends, and accommodate your organization's cultural and budgetary concerns.
• Minimize disruption to ongoing studies due to well planned transitions to new standards.

Clinical Data Standards (82k PDF file*)

Clinical Study Information Exchange

• Protection of the study/portfolio value by ensuring exchange is complete.
• Assurance that originator and recipient companies' standard operating procedures are followed,
• Cost effective fulfillment of regulatory responsibilities.
• Minimal disruption (or impact) on study timelines.
• Protection of intellectual property through a comprehensive transfer.
• Retained focus of management on important tasks with confidence that the details are being well-managed using tried and proven approaches,
• Early identification of risks and timely mitigation.
• Established focal point for enhancing transparency, communication, and cooperation between originating and receiving organizations.

Clinical Study Information Exchange (57k PDF file*)

Information Security & Identity Management

• Secure, cost effective information exchange via a multi provider network.
• Flexible archiving solutions that ensure secure access, traceability, and the efficient retrieval of documents.
• A common legal structure for improved internal enforceability and lower cost of information security.
• Optimization of people, processes, and technology to enhance security performance and manage risk affordably.
• Multiple best of breed products for all levels of the security spectrum.
• Ability to maintain orderly control and integrity of core IT resources without business disruption.

Information Security & Identity Management (59k PDF file*)

Regulatory Affairs and Quality Compliance

• Strategically aligned regulatory documentation with product development and manufacturing to successfully meet business objectives and market launch.
• Compliance at Day 1 by skillful planning and coordination of validation execution, completion, and facility start-up.
• Compliant promotional labeling and advertising literature.
• Efficient laboratory, clinical, and manufacturing processes that adhere to good management practices and regulatory guidelines.
• Improved and enhanced records and document management processes to meet enterprise information needs and facilitate compliance with regulations.
• Strengthened intellectual property processes to protect brand name products.
• Globalized validation processes and methodologies that reduce life cycle costs of validated systems.

Regulatory Affairs and Quality Compliance (65k PDF file*)

Pharmacovigilance and Risk Management

• Improved patient safety and reduced product liability for sponsors and regulatory authorities through proactive risk management,
• Real time access to global product safety data.
• Improved signal detection and predictive modeling through the integration of data collected throughout the drug's life cycle (pre clinical, toxicology, clinical, etc.) and through external data sources.
• Ability to proactively manage risk in a compliant manner, increasing overall speed to market and reducing total cost or product development.
• Early detection of potential drug issues, enabling more timely corrective action.

Pharmacovigilance and Risk Management (116k PDF file*)

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