August 2015Company Overview

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

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.

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

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

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.

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

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

It’s All in the PlanningWe 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)

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.

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

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

processUnrealistic or push to meet the timelines

Define critical path and integration with

resourcesDecision-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/ex

perience/transition planning as part of the

PM/RISK and Communication Plans

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.

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

EngageCommunica

teTrain

Deliver

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

Contact Us at:(240) 385-9416 www.neotrials.cominfo@neotrials.com

NeoTrials, LLC6904 Southridge PlaceMiddletown, MD 21769

Let us help you get there!