life science experience

overview		Our staff has a wealth of experience in the life sciences industry. We have performed projects in: drug safety and surveillance, clinical data operations, information technology (IT), sales and marketing, finance, and manufacturing. Our employees are current in industry trends, key technologies, and regulations through a combination of on-the-job experience, formal training offered by such organizations as ISPE (International Society for Pharmaceutical Engineering), PERI (Pharmaceutical Education and Research Institute), and through membership and active participation in industry-specific organizations such as DIA and IIR. We have chaired several Special Interest Area Communities (SIACs) for the DIA on topics such as XML. We have performed numerous projects in the life science industry, especially in strategic technologies and business processes that support drug safety and clinical trials. The following is a sampling of such projects.
adverse events submission		Regulatory agencies worldwide require immediate analysis of reported adverse events that were potentially caused by a drug. Pharmaceutical companies are required to determine causality and, in some cases, report findings and warnings to the appropriate governing agencies.
		TCA consultants developed a world-wide, web-based application and supporting business processes to directly capture adverse events electronically from suppliers.
quality assurance and compliance		Upon the completion of the analysis of an adverse event, pharmaceutical manufacturers conduct a comprehensive quality assurance check to insure the completed analysis meets the corporate standard for thoroughness, correctness, and completeness.
		TCA consultants developed a computer system with business processes to statistically sample completed adverse event cases. These cases are automatically routed to analysts along with specific questions to be answered.
standard operating procedure management		Regulatory agencies require that pharmaceutical companies follow standard operating procedures (SOPs) for many business processes. These SOPs must be written and current. Creating, updating, approving, publishing and distributing these SOPs and the associated documentation have cost the industry significant amounts of money.
		TCA consultants developed a web-based SOP management system with supporting business processes that enables paperless document creation, distribution, control and management.
regulatory reporting		Pharmaceutical companies are required to submit reports to regulatory agencies. The assembly and generation of these reports are labor intensive.
		TCA consultants developed a paperless system and supporting business processes to manage, collect, assemble, review and distribute these reports.
clinical imaging		A significant number of activities performed within pharmaceutical business processes are “paper-based” and expensive to maintain and control. The FDA and other entities such as business partners and suppliers are demanding the use of digital media, electronic exchange, and electronic reporting. To achieve these goals, pharmaceutical companies are transitioning their traditional processes to those supported by paperless technologies.
		TCA consultants have performed analyses to determine the best approach to pursue in migration from or consolidation of multiple financial systems. These analyses addressed the organizational, business, process, and technology dimensions of consolidation. The result is well-defined implementation plans for consolidation based on costs, functionalities, and risk mitigation.
drug labeling		The management of drug labels is a complex and labor intensive activity. Coupled with an increasing emphasis on world-wide sales and distribution of products, the manual creation and management of labels in numerous languages have become a laborious, error prone, and expensive process.
		TCA developed a paperless solution for organizing, distributing, archiving and managing the drug label creation process.
case studies		Quality Assurance Adverse Events Processing Adverse Events Tracking for Enhanced Compliance Electronic Adverse Events Management Data Center Restructuring Regulatory Reporting Casebook Report Forms Electronic Clinical Imaging Processing System Implementation eSafety Distribution Center Drug Safety Quality Assurance Process Enterprise Project and Resource Management