Strategic Consulting

Three areas of PharmaStat’s core expertise include planning the Biometrics “run to submission,” planning the implementation of CDISC standards, and setting up the tools, processes and procedures for the Biometrics statistical computing environment. We frequently find that our customers need help in all three of these areas at once when they get ready to launch their pivotal study. At that point they have maybe 18 months to plan and execute a submission in which the source data will be in SDTM and the analyses will be generated from ADaM datasets. There is usually legacy data to convert and an integrated safety database to assemble. This can be very stressful to the customer’s management team. Because every member of the PharmaStat team has experience managing Biometrics departments and submission projects, we augment our customer’s management resources so the job gets done on time.

Examples of strategic consulting engagements:

• Planning high-level process and outsourcing strategies for regulatory submissions
• Oversight of vendors for production of regulatory submissions
• Implementation plans for CDISC data standards
• Development of requirements for statistical programming environments
• Evaluation, selection, and implementation of software tools for managing workflow
• Defining business rules for tracking analysis projects
• Defining methods for managing project metadata
• Integrating multiple software technologies into a coherent, reproducible, transparent process
• Development of Standard Operating Procedures for biostatistics and statistical programming