Innovative Analytics, Inc. www.ianalytics.biz 269.488.3200

Study Design / Protocol Input Study Analysis & Statistical Reports Clinical Program Support

Innovative/adaptive designs

Continual reassessment method

Group sequential

Seamless Phase II/III

Sample size re-estimation

Stopping rules (futility and superiority)

Traditional primary safety / efficacy analyses; Preclinical, Ph I-II (III-IV)

Participate in regulatory guidance meetings

Develop Statistical Analysis Plan (SAP) Exploratory analyses – data mining, CART Assist in product registration and defense activities

Biomarker / novel endpoint development & validation

Participate on Data Safety Monitoring Committees

Provide statistical analyses for and interpretation of publications

Device / Diagnostic / Drug development ROC analyses for diagnostics Analysis of integrated study results

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

In 2003, Patty Ruppel, PhD, and James Dancy had a vision to build the highest quality sta-

tistical services organization in the clinical research industry. They leveraged large-scale

pharma reorganizations to create a core of expertise by adding three director-level, PhD

statisticians with significant pharmaceutical regulatory submission experience. The

addition of Directors of Medical Writing and Clinical Data Management created the full

complement of services that now define Innovative Analytics.

Comprehensive statistical services

“Companies come to us for

our expertise. After our first

meetings, they know their

interests are protected by

our genuine enthusiasm and

knowledge about what we

do.”

Thomas Oliphant, MS, PhD

Executive Director

Clinical Statistics

2009—2010—2011

Innovative Analytics, Inc. www.ianalytics.biz 269.488.3200

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

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

Executive Director, Business Opportunities

Mobile: 714.474.1250 Email: cindy.rutgers@ianalytics.biz

2009—2010—2011

@IAnalytics_CRR

linkedin.com/in/cynthiarutgers

Oncology Infectious disease Cardiovascular Women’s health

CNS Immunology Endocrinology Acute care

Orphan drugs Rare diseases Inflammation Medical devices/ Diagnostics