1. 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. “For IA, being competitive
means adding tangible
All of IA‟s lead data managers are CCDM-certified. Certification is important to Sponsors value to every study we
because it gives them the confidence that comes with knowing their clinical data is man- support.”
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 Karen Tindall, BS, CCDM
Director, Clinical Data
inspection. Management
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.
2009—2010—2011
Innovative Analytics, Inc. www.ianalytics.biz 269.488.3200

2. 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
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
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
 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:
@IAnalytics_CRR
Cynthia R. Rutgers
Executive Director, Business Opportunities linkedin.com/in/cynthiarutgers
Mobile: 714.474.1250 Email: cindy.rutgers@ianalytics.biz
2009—2010—2011
Innovative Analytics, Inc. www.ianalytics.biz 269.488.3200