Pre-Clinical and Clinical Development

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.