accelerating clinical trials

Accelerating Clinical Trials

Laurence P. Birch, CEO

Forward Looking StatementsThis presentation contains "forward-looking statements" within the meaning of the “safe-harbor” provisions of the Private Securities Litigation Reform Act of 1995. Such statements involve known and unknown risks, uncertainties and other factors that could cause the actual results of the Company to differ materially from the results expressed or implied by such statements, including the limited operating history on which the Company’s performance can be evaluated; the ability of the Company to continue to enhance its software products to meet customer and market needs, and other factors. Accordingly, there can be no assurance that such expectations will prove to be correct. The Company has no obligation to update or revise any forward-looking information contained in this presentation.

DATATRAK www.datatrak.netfrom Concept to Cure™

Mission Statement

DATATRAK’s mission is to be the clinical enterprise solution to safely

accelerate every drug, every biologic and every device

from Concept to Cure™

DATATRAK from Concept to Cure™ www.datatrak.net

Why is a unified solution important?


Life science organizations are always looking for solutions to help move their

research forward swiftly and safely.

Market Overview


$131.7B Global R&D Spend

$53B Clinical Development Spend

$2B Clinical Technology Spend

Concept Cure

Drug Development ProcessCost = $1.2B Time = 10-15 yrs 20-year patent

4,100 organizations

2008 2009 2010 20113,600

3,800

4,000

4,200

4,400

4,600

4,800

5,000

4,0804,173

4,523

4,791

2008 2009 2010 20114,000

4,200

4,400

4,600

4,800

5,000

5,200

5,400

4,524

4,9154,820

5,254

# of R&D Projects in Development

# of R&D Projects in Clinical Trials

DATATRAK www.datatrak.net

Market Challenges Create Opportunities

from Concept to Cure™

The need to speed successful drugs and

devices to the market safely is more

critical than ever.

• Increasing number of drug failures҉ENumber of NDA submissions trending down over last three years√ US approvals of new drugs hit a seven-year high last year (30)

• Stagnant product lines҉EM&A, big pharma and healthcare reform√ More investment in non-blockbuster drugs and small Biotechs

• Patent expirations for blockbuster drugs҉EDevelopment of cheaper generic drugs√ Increased number of clinical trials for generics

• Heightened regulatory oversight҉ETighter controls in approval processes√ eSource draft guidance favors unified systems

• Global challenges҉EGrowth of emerging markets√ NTT and other global initiatives

How does technology affect Clinical Trial Development timelines?


eClinical Landscape Problems• Built on Decades of Independently Evolving Systems• Laden with Silos• Redundant Processes• Inhibits Decision Making• Lost Time

It’s complex!DATATRAK from Concept to Cure™ www.datatrak.net

Plan Setup Conduct Close Out Analyze & Report Submission

File Storage

The Integrated Solution

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Plan Setup Conduct Close Out Analyze & Report Submission

File Storage

The Unified Solution

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uCDRDATATRAK ONE™ unified Software SuiteDATATRAK Exchange™DATATRAK Exchange™

SASSAS LABSLABSCDISC and

Other Standards

CDISC and Other

Standards

OtherModules

OtherModules

Executive Management

Biostats Clin-Ops Clinical Data Mgmt Finance Regulatory

Unified (Single) Database

Sites

Labs

CROs

Unified Database is pure integration – Single point of access for all data in real-time

Clinical Research with a Single Source of Truth


FDA eSource DRAFT Guidance


DATATRAK ONE™


Unified Software Suite

• One Database• One Process• One Platform• One Unified Suite• One Common Interface• Import / Export Tools

Unified Clinical Data Repository:

Benefits of a Unified System• Make informed decisions faster

– Track overall progress of studies and pipeline in real-time

• Create new efficiencies– Eliminate manual interactions between systems– Streamline processes – Consolidate data to a single source of truth

• Provides a low total cost of ownership– Easy to maintain: secure, accessible, global and sustainable– Easy to use


Safely Accelerating Regulatory Approvals Eliminate the 8 - 12% of clinical trial costs associated

with moving data around Lower technology costs by 10% - 20% Reduce study cycle times by six months or more Focus resources on more promising products Speed best candidates to market safely


When you have a $1 Billion drug and you close a trial six months early, you pull forward

$500 Million in new product revenue.

DATATRAK InternationalCleveland, Ohio Bryan, Texas Cary, North Carolina

888.677.DATA (3282) Toll Freewww.datatrak.net

Safely accelerating drug development timelines

from Concept to Cure™with DATATRAK ONE™

accelerating clinical trials

Business