Pre-Clinical and Clinical Development

SAIC is focused on enhancing the cycle times and success rates in Clinical Development. Our core competencies include: Program Management; PM Assessment; Data and Systems Integration; Application/System Development and Integration; Mergers & Acquisitions; IT Strategic Planning for Enterprise Pre-Clinical and Clinical Data Systems, Computational Pharmaceutics, LIMS Integration, and Data Mining, Warehousing & Analysis; Integrated Document Management; Information Security and Identity Management; Clinical Data Standards; and Clinical Study Information Exchange.

See Merck Capital Venture and SAIC's three-to-five year vision of Improving Clinical Trials by Implementing Information Technology (382k PDF file*).

SAIC supports the development and global adoption of the Clinical Data Interchange Standards Consortium (CDISC) standards. The mission of CDISC is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. Please visit CDISC for more information.

Key Commercial Projects

• Top 3 Global Pharmaceutical Company - Consolidated records, data, and applications to support development of 44 compounds (over 800 protocols) across 8 therapeutic areas. Facilitated change to common responsibilities and terminologies. Accomplished major culture change without development business disruption; Synchronized transition with rapid and dynamic post-acquisition efforts; Identified opportunities for IT cost savings via archiving structured and unstructured data.
  
  
• Top 5 Global Pharmaceutical Company - Evaluated technology advancements that enable significant performance improvement across the clinical trials process. Provided a framework for customer stakeholders to prioritize technology choices based on benefits to the clinical trials process.
  
  
• Top 3 Global Pharmaceutical Company - Consolidated and migrated pre-clinical systems for pathology and toxicology operations. Enabled the consolidation of business process, infrastructure and information technology across the enterprise.
  
  
• Leading Contract Research Organization - Developed a secure, web-based system, providing client viewing of pre-clinical data. Provides a single-point access to numerous and distributed systems. CDISC - SAIC provides board leadership and membership to support CDISC standards development and implementation. Advances the industry's ability to access and transfer data and documents with sponsors, sites, regulators, and other 3rd parties.

Key Government Projects

• National Institute of Environmental Health Sciences - Implemented an integrated LIMS, which included protein analysis tools and laboratory workflow automation. Facilitate exchange and analysis of gene expression data generated during experiments directed toward understanding effects of chemicals on biological systems.
  
  
• National Cancer Institute, Frederick - Implemented integrated databases, applications and infrastructure technologies to enhance clinical trials. Provide cost-effective delivery of services, optimal resource allocation, and technological currency to clinical trials process.
  
  
• The United States Medical Research and Materiel Command (USAMRMC) - SAIC provides clinical research associate services to support Good Clinical Practice (GCP) compliance and regulatory affairs activities on site at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). This support includes activities such as monitoring study procedures to verify that conduct of clinical studies is in accordance with written procedures and GCP guidelines; auditing clinical studies and regulatory files; participating in protocol planning meetings; reviewing clinical protocols, preparing and reviewing SOPs, and preparing and reviewing study specific procedures.
  
  
• The United States Medical Research and Materiel Command (USAMRMC) - SAIC conducts literature searches, abstracts scientific data, and conducts technical analyses that culminate in the drafting and preparation of IND submissions, which include clinical protocols; investigator's brochures; chemistry, manufacturing, and control sections; and preclinical sections, primarily for biologics for biowarfare agents and infectious disease agents for submission to the FDA. The products under investigation include vaccines for biological defense, treatments for battlefield injuries, and laboratory diagnostics for warfare agents. We also support regulatory-compliant implementation of the Clinical Database Management System and the Electronic Document Management System.

*Note: PDF documents are viewed using Acrobat® Reader®.