NeoTrials, LLC is a consulting firm focused on providing outstanding service for your clinical research program.

1. August 2015
Company Overview

2. Overview of NeoTrials
• NeoTrials Difference and What we do makes us unique
• NeoTrials Experience and Benefits of Working With Us
• Services
• Program Management (all in the Planning)
• Clinical Operations Aligned with Outsourcing Management
• Idea to Execution = Operationalizing Change
• Custom Solutions
• Reasons to choose NeoTrials
• Recommendations and Client Feedback

3. The NeoTrials Difference
• Our business is based on a deep understanding of clinical research and the
various challenges faced by industry stakeholders.
• Our industry experts have a proven track record of success that allows us to
create solutions to meet your needs.
• We understand the various reasons to seek consultants and strive to
exceed your expectations whether it is to: provide expertise, fill gaps, serve
as catalysts, supplement staff, identify problems, and provide creative
solutions that influence positive change.
• NeoTrials brings experts from project management, clinical operations,
quality assurance, and related backgrounds to meet the rigors of an FDA-
regulated environments.

4. What We Do Makes Us Unique
• Demonstrated leadership and influence
• Advanced knowledge of clinical research challenges
• Clinical business best practices
• Strategic Outsourcing
• Integration of stakeholders
• Operationalize strategy
• Patient engagement
• Demonstrated ability to drive change within the organization
• Broad industry experience that integrates multidisciplinary best practices
• Agile and pragmatic approaches to results driven solutions
• Customized Programs: Education/Training workshops and lessons learned
meetings

5. NeoTrials Experience
• 20 + years leading trials across multiple therapeutic areas
• Pharmaceutical, biologic and medical device clients
Therapeutic
Area
Years
Experience
Web Based
Client
Solutions
Studies Phases
Oncology 4 yrs 20+ Preclinical-phase 3
Infectious Disease 9 yrs 9 yrs. 20+ Phase 1-4/peri
Cardiology 7 yrs 2 yrs. 6 Phase 3
Neurology 2 yrs 2 yrs. 3 Phase 3
Nephrology 2 yrs 2 yrs. 4 Phase 3
Pulmonology 2 yrs. - 1 Phase 4/peri
Biologics/vaccines 3 yrs 3yrs. 10 + Phase 1-4
Medical devices 6yrs - 4 Phase 2-3

6. Benefits of Working with NeoTrials
• An extension of your team: Work with a team of experts that understands
your systems, your processes, and your expectations.
• Industry leaders: Benefit from the knowledge and experience of our
industry leading experts in Project Management, Clinical Operations, and
Quality standards.
• Flexibility: Our business model provides an easy and flexible way to add the
best experts at the right time and avoid the expense of underutilized
resources.
• Transparency: Open communication creates better long-term planning and
availability resulting in faster turnaround times.
• Cultural fit: We seek to partner with Sponsor companies that are a good
“fit.” Strong relationships are critical to making collaboration programs
work.

7. Services
•Program Management
•Global Clinical Operations
•Strategic Initiatives
•Outsourcing Alignment
•Change Management
•Compliance and Quality
•Education and Training
•Patient Engagement
Custom solutions are what our services focus on. We take the time to learn
about your organizational needs, gaps, and goals to define an optimal
approach

8. Program Management
NeoTrials will ensure cross functional success with proven
methodology whether you are a small start-up or a large
biopharma organization.

9. It’s All in the Planning
We can help you ensure all seven core PM processes are part of the four phases
(plan-execute-control-close) for each of your clinical trials.
• Define Scope, Time, Cost, Quality, Communication, Risk and Performance
Management of programs and projects
• Develop plans for all aspects of the program (i.e. PM, Risk, Subcontractor)
• Build teams, resources and infrastructure
• Integrate program control of cost, quality, and schedule across stakeholders
• Ensure program and project governance
• Risk control and performance reporting
• Fiscal planning and control (Earned Value Management (EVM) tied to Risk
Mitigation strategies)

10. Clinical Operations Aligned with
Outsourcing Management
• Overseeing work at the strategic level rather than tactical level avoiding
unwanted micromanagement.
• Our consultants define an approach to qualify, select and manage any
clinical research service provider supporting your outsourcing strategy.
• Leading through collaboration to build the right mix of talents and
expertise to ensure your stakeholders balance the ecosystem.

11. Clinical Operations with Outsourcing Alignment
• Develop, implement, monitor, and support Standard Operating Procedures (SOPs) and
work processes to ensure the efficient operations = audit ready
• Develop trial design and author study protocols
• Oversee global operations, planning, execution, and closure of trials
• Advise on trial feasibility, site selection, enrollment strategy and audit assessments
• Establish appropriate oversight, project management and operational performance
reporting
• Management of vendors (e.g. CROs, labs, IRBs, imaging) and partners
(NIH/BARDA/Sponsor)
• Optimize vendor services, technology and in-house capabilities
• Integrate all stakeholders to ensure alignment of expectations, process, and RR
• Maintain and further develop the quality management system for clinical operations
• Manages all aspects of process improvement strategies and document lessons learned

12. Root Cause Issues in Outsourced Trials
Sponsor CRO Solution
Inexperienced PMs with poor
communication, clarity or
proactivity
Lack of planning or
specifications
Define specifications and
agreed acceptance criteria
Timelines slow or don’t allow
for concurrent process
Unrealistic or push to meet
the timelines
Define critical path and
integration with resources
Decision-Making impacts
quality (without CRO input)
Utilize a partnership
approach in decision making
Lack of resources; lack of
training; poor quality;
turnover
Define
resources/RR/training/experi
ence/transition planning as
part of the PM/RISK and
Communication Plans

13. Idea to Execution
• Our consultants look at new ways to
approach your organizational
challenges.
• We assess current processes,
procedures, roles and responsibilities
of stakeholders, communication,
planning, tools, and more to ensure
your evolving idea is put into place to
solve core clinical research
problems.

14. Operationalizing Change
• Leadership is key to providing guidance, conditions,
organizational values, in order to define goals and plans
• Companies need to be very clear about what they do, how
they do it, and who they do it for
• Assess Gaps and Success Factors
• Creating a sense of urgency/overcoming resistance
• Aligning the change initiative with the business strategy
• Identifying passionate champions
• Gaining endorsement of a focused vision
• Developing a variety of visible, broad-based actions
designed to impact the business and employees
• Data-driven decision making
• Ensuring continuous communication to all
stakeholders
• Emphasizing personal and organizational adaptability
• Establishing clear measures/metrics tied to business
performance.
• Effective communication is a way to engage every employee
NEW
?
Define
and
Plan
Assess
Gaps
Engage
Communicate
Train
Deliver

15. Reasons to choose NeoTrials
• Worldwide experience
• Flexible and Responsive
• Deep knowledge of service offerings
• Breadth of therapeutic area knowledge and experience Phase 1-4 trials
• Expertise of consultants average 20 +years within specialty
• Proven methodology to support small start-ups to large biopharma
• Highly developed PM, Clinical, QA and Outsourcing tools
• Customized approaches and tools

16. Contact Us at:
(240) 385-9416
www.neotrials.com
info@neotrials.com
NeoTrials, LLC
6904 Southridge Place
Middletown, MD 21769
Let us help you get there!