Innovative Analytics, Inc. www.ianalytics.biz 269.488.3200

Data Management Data integrity is the heart of clinical research. For Innovative Analytics (IA), our commitment to integrity begins with a

comprehensive data management plan and continues until final database lock.

Pharmaceutical , biotechnology, and medical device companies also understand data‟s central role in Phase I-IV clinical

trials. They know that choosing the right team, one staffed by experienced data management professionals, is a critical

first step in keeping a clinical trial on course.

Imagine having all of your studies managed by a CCDM-certified professional

Since 2010, IA has been recognized by the Society of Clinical Data Management (SCDM)

as a Certified Clinical Data Manager® (CCDM) Industry Partner. Globally, fewer than 20

data management companies or clinical research organizations (CROs) are designated by

SCDM as Industry Partners.

All of IA‟s lead data managers are CCDM-certified. Certification is important to Sponsors

because it gives them the confidence that comes with knowing their clinical data is man-

aged by experts trained in global best practices and processes. Sponsors are also assured

that their data management resource is documented as qualified for any regulatory

inspection.

Better query processes create better sponsor/clinical site relationships

Innovative Analytics understands that clinical sites have limited resources to manage site queries. To reduce site frustra-

tion and support strong Sponsor / site relationships, IA uses a site query process that minimizes queries to sites and

eliminates automated, cascading, logical failures.

The site query process combines electronic SAS-based edits, manual reviews, and targeted listings to generate queries to

sites. In addition, Innovative Analytics ensures that no query leaves IA without critical review by a Clinical Data

Manager.

Our process ensures that queries are easily understood by clinical site staff. Innovative Analytics‟ data managers alert

sponsors when QC check specifications need review or modification, before the queries leave IA. This proactive

approach is valuable for managing ex-US sites, where English is not the first language of site personnel.

System flexibility enables adaptive clinical study designs and quick response to unexpected protocol amendments

In today‟s clinical research environment, IA recognizes that the „research‟ aspect of „clinical research‟ needs to accom-

modate adaptive and flexible clinical trial designs as well as unexpected protocol amendments. Our clinical data

management experts understand the need to quickly and accurately respond to the dynamic environment of a clinical

study.

“For IA, being competitive

means adding tangible

value to every study we

support.”

Karen Tindall, BS, CCDM

Director, Clinical Data

Management

2009—2010—2011

Innovative Analytics, Inc. www.ianalytics.biz 269.488.3200

Case study: Flexible solutions make it possible To ensure compliance and patient safety, diary information needed to be queried within 24 hours of receipt and new

insulin targets calculated prior to the patients clinic visit. Innovative Analytics custom-designed a rapid query process

that was both affordable and efficient, making the impossible, possible.

“The team at Innovative Analytics understood the importance of and were committed to ensuring high-quality,

rapid data collection and query response which was critical to the successful conduct of our trial.”

- Eran Bashan, CEO, Hygieia, Inc.

Dynamic timeline management

Comprehensive data management services From expert, pre-study guidance on clinical data management models to the on-time, on-budget delivery of a clean,

locked database, IA provides the full spectrum of data management services to emerging, mid-size, and global

pharmaceutical, biotechnology, and medical device companies.

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.

Key Milestone Timelines IA Standard Timelines IA Accelerated Timelines

Final protocol to live DB 3 weeks 1 week

Protocol amendment to eCRF and database update 1 week 48 hours

Last patient visit data to final queries 48 hours 8 hours

@IAnalytics_CRR

linkedin.com/in/cynthiarutgers

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

Oncology Infectious disease Cardiovascular Women’s health

CNS Immunology Endocrinology Acute care

Orphan drugs Rare diseases Inflammation Medical devices/ Diagnostics