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Statistical Associates, LLC  Statistics and Statistical ConsultingProgramming / Validation / QC Services
Why Choose Statistical Associates? Expertise: Statistics is our core competency. Choose us and  your project will be mana...
Our Promise to Clients Select Statistical Associates and receive:   Full understanding of the statistical issues that ma...
Overview Statistical Associates is a Partnership created by  Joshua S. Baker, Ph.D., an experienced clinical  research in...
Consultancy Services: Clinical Trial Design Expertly-designed clinical trials avoid errors that  produce inaccurate or in...
Consultancy Services: Clinical Trial Design Phase I, II, III and IIIb, IV expertise      Parallel, Crossover, Interim An...
Consultancy Services: Regulatory  Expertly-designed trials anticipate regulatory   demands       Avoid delays  Regulato...
Consultancy Services: Regulatory Small molecule development    Pre-clinical testing    IND to NDA    sNDA, Extended fo...
Consultancy Services: Regulatory Diagnostics/Device Development   510 K Applications, CLIA Certification   Clinical Tri...
Consultancy Services: DSMBs The configuration and management of a Data  Safety (Efficacy) Monitoring Board (DSMB)  direct...
Consultancy Services: DSMBs DSMB Services Expertise   Assessing the need for a DSMB for your trial   Empaneling Members...
Statistical Production Services On-time production of high quality statistical  tables, listings and figures is central t...
Statistical Production Services: Programming Statistical Programming Services   Accurate, timely and consistent Statisti...
Statistical Production Services: Programming Statistical Programming Services   SAS™ Production Platform   Dual Program...
Statistical Production Services: Infrastructure Full complement of SOPs 21 CRF part 11 compliant production  environment...
Working Practices Every project executed and managed by a Partner in the  Firm Veteran clinical research experts provide...
Choose Statistical Associates, LLC Expertise: Statistics is our core competency. Choose us and  your project will be mana...
How Can We Help You?Joshua S. Baker Ph.D.Managing Partnerjoshbaker@statassociates.com Jared Byer, MBAMarketing / Salesjare...
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Statistical Associates,LLC

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

Published in: Business, Technology
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Statistical Associates,LLC

  1. 1. Statistical Associates, LLC Statistics and Statistical ConsultingProgramming / Validation / QC Services
  2. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 18. How Can We Help You?Joshua S. Baker Ph.D.Managing Partnerjoshbaker@statassociates.com Jared Byer, MBAMarketing / Salesjaredbyer@statassociates.com www.statassociates.com Copyright 2012 Statistical Associates, LLC

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