Statistical Associates, LLC Clinical research industry experts in statistics & statistical consulting; programming / validation / QC Services Joshua Baker, PhD

1. Statistical Associates, LLC
Statistics and Statistical Consulting
Programming / Validation / QC Services

2. Why Choose Statistical Associates?
 Expertise: Statistics is our core competency. Choose us and
your project will be managed by the most experienced and
senior team in the business.
 Accountability: Your project will be assigned to a Partner of
the Firm who serves as your point-of-contact.
 Transparency: From Consulting to Table and Listing
Production you will have complete access to our evaluation
and planning processes.
 Speed and Quality in Production: Cycle times for your
project will be the best in the industry.
Copyright 2012 Statistical Associates, LLC

3. Our Promise to Clients
 Select Statistical Associates and receive:
 Full understanding of the statistical issues that may
influence your development plan, trial designs and
results
 High speed and exceptional quality at low cost
 Fast responsive Project Management
 Realistic, accurate project production timelines
Copyright 2012 Statistical Associates, LLC

4. Overview
 Statistical Associates is a Partnership created by
Joshua S. Baker, Ph.D., an experienced clinical
research industry veteran
 Core competencies:
 Statistics & Statistical Consulting
 Programming / Validation / QC Services
Copyright 2012 Statistical Associates, LLC

5. Consultancy Services: Clinical Trial Design
 Expertly-designed clinical trials avoid errors that
produce inaccurate or incomplete results
 Clinical trial design considerations
 Define “Population”
 Set Objectives
 Select Primary End-Point
 Calculate Sample Size and Power
 Write statistical methodology section of the protocol
Copyright 2012 Statistical Associates, LLC

6. Consultancy Services: Clinical Trial Design
 Phase I, II, III and IIIb, IV expertise
 Parallel, Crossover, Interim Analyses, Adaptive Designs
 First-in-man, Proof-of-concept designs
 Therapeutic expertise
 Oncology
 CNS
 Anti-infective / Viral / Vector-borne
 Metab0lic
 Cardiovascular
 All major therapeutic areas
Copyright 2012 Statistical Associates, LLC

7. Consultancy Services: Regulatory
 Expertly-designed trials anticipate regulatory
demands
 Avoid delays
 Regulatory expertise
 Strategies for regulatory submissions and meetings
 Statistician of Record
 Full participation in regulatory meetings
 FDA (EMEA) Statistical Correspondent
Copyright 2012 Statistical Associates, LLC

8. Consultancy Services: Regulatory
 Small molecule development
 Pre-clinical testing
 IND to NDA
 sNDA, Extended formulation
 Biologics
 Pre-clinical testing
 IND to BLA
Copyright 2012 Statistical Associates, LLC

9. Consultancy Services: Regulatory
 Diagnostics/Device Development
 510 K Applications, CLIA Certification
 Clinical Trial Submissions, comparisons to GOLD
standards
Copyright 2012 Statistical Associates, LLC

10. Consultancy Services: DSMBs
 The configuration and management of a Data
Safety (Efficacy) Monitoring Board (DSMB)
directly influences the safety of clinical trial
subjects.
 DSMB Participation
 Statistical Member of DSMB
 Un-blinded Statistician
Copyright 2012 Statistical Associates, LLC

11. Consultancy Services: DSMBs
 DSMB Services Expertise
 Assessing the need for a DSMB for your trial
 Empaneling Members
 DSMB Charter Development
 Project Management of Meetings
 Membership (Statistical)
 Un-blinded Statistician
 Data Repository
Copyright 2012 Statistical Associates, LLC

12. Statistical Production Services
 On-time production of high quality statistical
tables, listings and figures is central to our core
competencies
 Statistical Production Services
 SAP + Protocol Development
 CRF Design
 Randomization
 TableListingFigure Production & Validation
 CSR Authorship
 CSR QC and QA
 ISS/ISE
 Teach Statistics
Copyright 2012 Statistical Associates, LLC

13. Statistical Production Services: Programming
 Statistical Programming Services
 Accurate, timely and consistent Statistical
Programming is a commitment that Statistical
Associates makes to each client
 Oversight and communication are the keys to
providing the highest quality table, listing and figure
programming
Copyright 2012 Statistical Associates, LLC

14. Statistical Production Services: Programming
 Statistical Programming Services
 SAS™ Production Platform
 Dual Programming Validation Methodology
 Full Code Review
 Scheduled Early Release of Production Materials for
round-table reviews.
Copyright 2012 Statistical Associates, LLC

15. Statistical Production Services: Infrastructure
 Full complement of SOPs
 21 CRF part 11 compliant production
environment
 Validated Server
 SAS Production Environment
 Independent QC/QA
Copyright 2012 Statistical Associates, LLC

16. Working Practices
 Every project executed and managed by a Partner in the
Firm
 Veteran clinical research experts provide depth of talent
and experience to assist with the most complex
statistical issues
 Team approach to analysis planning and presentation of
results supports understanding of analysis plan and the
results.
 Full transparency on materials and methods
Copyright 2012 Statistical Associates, LLC

17. Choose Statistical Associates, LLC
 Expertise: Statistics is our core competency. Choose us and
your project will be managed by the most experienced and
senior team in the business.
 Accountability: Your project will be assigned to a Partner of
the Firm who serves as your point-of-contact.
 Transparency: From Consulting to Table and Listing
Production you will have complete access to our evaluation
and planning processes.
 Speed and Quality in Production: Cycle times for your
project will be the best in the industry.
Copyright 2012 Statistical Associates, LLC

18. How Can We Help You?
Joshua S. Baker Ph.D.
Managing Partner
joshbaker@statassociates.com
Jared Byer, MBA
Marketing / Sales
jaredbyer@statassociates.com
www.statassociates.com
Copyright 2012 Statistical Associates, LLC