Case Study 1
For a major pharmaceutical company

Manage eight projects as part of a three year, multi-million dollar program spanning the discovery through clinical trial and regulatory phases of the drug development lifecycle. Integrate various systems to comply with FDA and ICH regulatory guidelines, improve the generation of reports in electronic and submission-ready formats for inclusion in filings such as INDs and NDAs, and provide system interfaces to eliminate manual transcription and improve data quality.

  • Manage all aspects of the program including:
    • Liaison with scientific community to define technical solutions to comply with various FDA and ICH regulations such as the Bioanalytical Method Validation, Specification for Annotated Electrocardiographic Waveform Data in Electronic Format, eCTD (Common Technical Document), 21 CFR Part 11, and GxP.
    • Staff and manage teams comprised of VECS consultants and full time staff including project managers, business / systems analysts, developers, database administrators, and quality assurance analysts.
    • Implement information technology solutions including systems integration of commercial off-the-shelf (COTS) products as well as internally developed applications. These include laboratory information management systems (LIMS), laboratory instrumentation and external clinical sites’ data collection and archival, study and specimen tracking, pharmacokinetic / pharmacodynamic (PK/PD) / statistical analysis, protocol and final study report and statistical report generation, and direct data capture (DDC) systems. The applications utilize Health Level Seven (HL7) and Clinical Data Interchange Standards Consortium (CDISC) industry standards.
    • Manage the request for information / proposal (RFI/RFP) process including identifying potential vendors, evaluating products and solutions, making recommendations for selection, and working with purchasing to negotiate vendor contracts.
  • Author the client’s response to the FDA’s request for response to draft guidance.
  • Oversee budgeting and financial tracking process for the projects including all staff, outsourcing, contracts, and solutions / software.

The organization now complies with current and new FDA and ICH regulatory requirements, realized a decrease in the average time to market by fifteen months, and reduced resources by approximately ten full time resources annually.

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