This document summarizes the statistical services provided by Innovative Analytics (IA). It discusses how IA uses statistical analysis to design clinical trials and understand complex data from protocol design through clinical study reports. It also highlights IA's experienced team of statistical professionals who have worked in the clinical research industry since 2003. Finally, it provides examples of case studies and the therapeutic areas and global reach of IA's statistical expertise.

1. Statistical Services
From protocol design and statistical analysis plan to clinical study report, a properly-designed clinical trial uses the
analytical power of statistics to understand complex data and assure the validity and quality of the clinical results.
Experienced, dedicated, accessible professionals
Since 2003, Innovative Analytics (IA) has provided comprehensive, high quality statistical
services and support to emerging, mid-size, or large pharmaceutical, biotechnology, and
medical device companies.
Professional experience, organizational stability
create confidence “Companies come to us for
our expertise. After our first
In 2003, Patty Ruppel, PhD, and James Dancy had a vision to build the highest quality sta- meetings, they know their
interests are protected by
tistical services organization in the clinical research industry. They leveraged large-scale our genuine enthusiasm and
pharma reorganizations to create a core of expertise by adding three director-level, PhD knowledge about what we
statisticians with significant pharmaceutical regulatory submission experience. The do.”
addition of Directors of Medical Writing and Clinical Data Management created the full Thomas Oliphant, MS, PhD
complement of services that now define Innovative Analytics. Executive Director
Clinical Statistics
Comprehensive statistical services
Study Design / Protocol Input Study Analysis & Statistical Reports Clinical Program Support
Innovative/adaptive designs Traditional primary safety / efficacy Participate in regulatory guidance
 Continual reassessment method analyses; Preclinical, Ph I-II (III-IV) meetings
 Group sequential
 Seamless Phase II/III
 Sample size re-estimation
 Stopping rules (futility and
superiority)
Develop Statistical Analysis Plan (SAP) Exploratory analyses – data mining, CART Assist in product registration and
defense activities
Biomarker / novel endpoint development Participate on Data Safety Monitoring Provide statistical analyses for and
& validation Committees interpretation of publications
Device / Diagnostic / Drug development ROC analyses for diagnostics Analysis of integrated study results
2009—2010—2011
Innovative Analytics, Inc. www.ianalytics.biz 269.488.3200

2. Case studies
Efficient study design: Listen to the data, collaborate with clinicians, save money
A collaboration between clinicians and attentive IA statisticians on a TQT study led to elimination of one full cohort
from the study design. By working with the clinicians, IA saved the Sponsor and investors time and money.
Regulatory credibility
Innovative Analytics’ experts were called in to help a major pharmaceutical company respond to a “Refuse to File”
notice from the FDA. Within 120 days of the initial contact and after Herculean efforts by the Sponsor and IA,
IA restructured and reanalyzed key safety and efficacy data. The application was updated with re-documented data
set structures and the final application was subsequently accepted by the FDA.
Top line results
A client with a promising product was attempting to woo Japanese investors. Innovative Analytics’ professionals under-
stood their need and their limited window of opportunity. The IA team worked round-the-clock to complete and validate
top line results that were then presented to a potential buyer. The effort succeeded, the client’s company was purchased.
Innovative staffing solutions create efficiencies
Unlike many CROs, IA is willing to offer novel solutions, including resource augmentation, fixed project bids, and
consulting. For example, since 2006, four of our statisticians have been specifically dedicated to four sponsors as each
organization moves their products forward.
Robust therapeutic expertise
 Oncology  Infectious disease  Cardiovascular  Women’s health
 CNS  Immunology  Endocrinology  Acute care
 Orphan drugs  Rare diseases  Inflammation  Medical devices/ Diagnostics
Global reach
As clinical research extends its global presence, so does Innovative Analytics.
We provide services in the Americas, Western, Central, and Eastern Europe, and
the Asia/Pacific region. Recent projects involved Russia, the Czech Republic,
Georgia, Moldova, Armenia, Iceland, Cyprus and Israel.
For new business opportunities, please contact:
Cynthia R. Rutgers @IAnalytics_CRR
Executive Director, Business Opportunities
Mobile: 714.474.1250 Email: cindy.rutgers@ianalytics.biz linkedin.com/in/cynthiarutgers
2009—2010—2011
Innovative Analytics, Inc. www.ianalytics.biz 269.488.3200