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