Biostatistics Programming Sourcing Solutions

Capabilities and Experience:

Advanced Clinical has comprehensive Biostatistics competencies across all phases and several therapeutic areas, with experience in 110+ studies. The Biostatistics team combines our dedicated department, headed by Pat Wozniak, PhD alongside qualified statisticians, programmers and our expert ecosystem. Our capabilities support the end-to-end needs of a clinical trial, from planning and design to statistical consulting and medical writing. Advanced Clinical also has extensive Clinical Data Interchange Standards Consortium (CDISC) Capabilities.

Error Proofing Techniques:

Advanced Clinical has superior Error Proofing techniques to ensure delivery of the highest quality product 2-5 working days after database freeze.

Results:

Our Biostatistics engagements have produced significant results for clients.

Subsidiary of Large Japanese Pharmaceutical Company:

• Prepared TLFs for 4 Phase 2/3 Studies (1,800 patients)
• Prepared TLFs for submission to two regulatory authorities and prepared tables for IND annual report
• Provided reports for a DSMB and an endpoint adjudication committee – Phase 3 studies (3,000 patients)
• Provided ad hoc reports and analyses to sponsor and FDA using warehouse data from 12 legacy studies
• Results:
  • Delivered final TLFs within 2 days of database lock
  • Met or beat timelines for submission to FDA and Canada
  • Enabled sponsor to evaluate critical safety outcomes
  • Enabled sponsor to respond to regulatory agencies and business partners quickly and efficiently

Mid-Size European Pharmaceutical Company:

• Provided statistical support in Phase I-III studies
• Performed activities such as sample size calculations, eCRF review, protocol review, SAP production, derived datasets, interim analyses and final TLFs
• Results:
  
  • Provided central resource with knowledge and familiarity across studies
  • Delivered TLFs within 2-5 days of database lock

Small Pharmaceutical Company:

• Support for Phase II/III Adaptive design study
• Provide randomization schedules for IVRS, eCRF review, derived datasets, classification tables and final TLFs
• Results: Reduced time between end of Phase II and start of Phase III

Deliverables:

We also offer a range of Biostatistics deliverables:

• Tables, Listings and Figures for IND annuals reports, DSMBs, Adjudication Committees
• Interim Analyses
• FDA Safety Requests
• Integrated Summaries
• Publications
• Annotated eCRFs
• SDTM and ADAM Datasets
• Metadata

Differentiators:

We have significant differentiators within Biostatistics that ensure our clients’ clinical trial success:

• Our Team Expertise:
  
  • 100 percent employee retention over 2 years
  • Strong leadership with 27 years of statistical expertise, including academic experience and extensive management experience in a large pharmaceutical company
  • 100+ clinical trials completed across 23+ therapeutic areas
  • Ecosystem of experts to gain additional insight and allow us to flex up/down as trials need
  • All SAS programmers are SAS 9 certified; most have advanced certification

• Our Clinical Trial Accelerators:
  
  • Bayesian Adaptive trial experience
  • Standard templates for all deliverables
  • Templates and tools to streamline all work elements
  • Strong directory system to protect data and deliverables and to quickly locate historical data
  • CDISC (SDTM and ADAM) standards

• User-Friendly Deliverables:
  
  • Easy to read tables and listings with consistent and standard formatting
  • All programs, programming deliverables and documentation packaged and delivered at the end of the trial

• Commercial Models:
  
  • Performance/unit-based pricing with no hidden costs and less need for change orders
  • Asset Transfers – solutions for important retention and lower overheads
  • Dedicated Capacity – AC professionals who are fully dedicated to the client, even if there is volatility in the actual work required

• Results:
  
  • Efficiency: detailed Statistical Analysis Plan with mock tables and listings reduces programming errors and increases efficiency
  • Quality: validation programming and quality control checklist increase quality and reliability of deliverables
  • Metrics:
    
    • Top-line results delivered two working days after database lock
    • Final tables, listings and figures delivered five working days after database lock
    • On budget 100 percent of the time