Statistical Associates, LLC Drug development and the Statistician

Statistical Associates, LLC The “Statistician’s” Role

in the

Drug Development Process

The Statistician’s Role in Sponsor / FDA Meetings

Sponsor/FDA Meetings

Study Design Input

Summary of Results

Responses to FDA questions from Clinical and Statistical Reviewers

Defense of Statistical Methods

Design, Primary Endpoints

Safety Measurements

Presentation to FDA

Dialog with FDA: Methods

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The Statistician’s Role in Pre-Clinical Studies

Pre-Clinical Studies

Review & Development of Study Designs

Sample Size Estimates (if needed)

Responses to FDA questions with regard to Statistical Issues with Pre-Clinical Package

Review of Presentation of Pre-clinical Materials in Regulatory Filings (IND, NDA, FDA Responses)


The Statistician’s Role in Phase I Clinical Studies

Phase I

Study Design

Statistical Section of Protocols

Statistical Analysis Plan

Randomization

CRF/eCRF Review

Table/Listing/Graph – Production and Validation

Study Report Review and Editing, QC

Interpretation of Results


The Statistician’s Role in Phase II Clinical Studies

Phase II Study Design

Primary Efficacy

Safety Measures



Randomization

CRF/eCRF Review




Recommendations for Phase III


The Statistician’s Role in Phase III Clinical Studies

Phase III Study Design

Sample Size Determination



Randomization

CRF/eCRF Review




Development of NDA Materials


The Statistician’s Role in NDA Preparation

NDA Preparation

Design of Integrated Summary of Safety (ISS)

Design of Integrated Summary of Efficacy (ISE)

Design of Integrated Database (ISS, ISE)

Preparation of ISS and ISE

Review of Database and ISS and ISE submissions to FDA

Review of full NDA


The Statistician’s Role in Special Regulatory Filings

Special Regulatory Filings

Presentation of Key Statistical Findings Motivating Filing

Review of Integrated Regulatory Package

Preparation and Justification of Future Study Designs

Presentation and Review of Population Disease Incidence and Integration with Filings


The Statistician’s Role in Advisory Committee Meetings

Advisory Committee Meeting Justification of NDA Statistical

Approach and Key Findings

Preparation of Key Sponsor Presenters for Statistical Questions from Advisory Committed

Review of FDA response to NDA filing and Development of Sponsor Rebuttal

Participation in Prep Meeting

Participation in actual Advisory Committee Meeting


Statistical Associates, LLC: Overview

Statistical Associates, LLC is a Partnership created by Joshua S. Baker, Ph.D., an experienced, senior clinical research industry veteran

Core competencies:

Statistics & Statistical Consulting

Programming / Validation / QC Services


Why 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.


How Can We Help You?

Joshua S. Baker Ph.D. Managing Partner [email protected]

Jared Byer, MBA Marketing / Sales [email protected]

www.statassociates.com


Business

Statistical Associates, LLC Drug development and the Statistician