January, 2018

Introduction to NeoTrials, LLC

www.neotrials.com

Introduction to NeoTrials, LLC

General Information

• Registered Company Name: NeoTrials, LLC

• Year Incorporated: 2015

• State of Incorporation: Maryland

• Corporation Type: Limited Liability Corporation

• D-U-N-S Number: 079825099

• CAGE Code: 7DDE4

• Federal Certification: SBA - EDWOSB

• NAICS: 541618, 541690, 541990

What We Do Makes Us

Unique

We take a holistic approach to organizational problem solving with

• Client analytics/assessments

• Strategic technical solutions

• Outsourcing and Insourcing Optimization

• Skill Gap analysis

• Integration of stakeholders

• Culture of performance

• Specialized staffing

= customized services and solutions

NeoTrials Value Proposition

• Unique Benefit: NeoTrials has a new way to help you see things clearly, figure where you want to be, how best to navigate there and leave you feeling confident about carrying it forward into implementation. We are unique because our methodology ensures risk is managed long before execution.

• Competitive distinction:

• focused on action items/insightful deliverables/quality data equating to operational change

• agile and purposeful methodology and tools

• limber team that is customer focused by specific service, we are not generalists

• experienced in common research pitfalls and optimal remediation strategies

• every engagement is 100% focused with no competing priorities

The NeoTrials Difference

DepthOur business is based on a deep understanding of product development and the various challenges faced by multidisciplinary industry stakeholders.

Demonstrated LeadershipOur industry experts have a proven track record of success in all functional areas that allows us to coach, lead or mentor teams while building creative solutions to meet your needs.

BreadthWe 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 innovative solutions that influence positive change.

5

RigorousNeoTrials brings experts from project management, clinical operations, medical management, quality assurance, and related backgrounds to meet the rigors of an FDA-regulated environments.

Demonstrated InfluenceAbility to drive change within an organization with agile and purposeful methodology to develop customized best practices, while optimizing receptive participation for results driven solutions.

ResultsOur assessments, analysis, tools, models, plans, tips, debriefs, reports and work product allow organizations to administer data driven results crystallized into customized and effective.

Qualifications

• Consultants have Masters level or PhD/MD level education with 20+ years of experience

• Therapeutic Areas (biologics, pharmaceuticals and medical devices)

• Cardiology/Vascular

• Dermatology

• Endocrinology

• Infectious Disease and Vaccines

• Neurology

• Oncology

• Pulmonology/Respiratory

• NeoTrials team members have over 20 years vaccine experience. Some examples include:

• Influenza

• Plague

• Botulinum

• Various immunotherapies

• HHS and DoD experience

7

An extension of

your teamIndustry leaders

Flexible and Transparent

Cultural Fit

Benefits of NeoTrials

Services

• Consulting

• Program Management

• Clinical Operations

• Outsourcing Alignment

• Quality and Compliance

• Regulatory Affairs

• Strategic Initiatives

• Specialized contract staff –Regulatory or Medical

ConsultingResearch advisers for various products/indications and strategic initiatives

Tactical

• Coordination of Multidisciplinary operations/activities

• Project management/Fiscal Planning and Control (define governance/scope/timelines/budget or EVM/risk/quality and develop reports/plans/reviews)

• Build Infrastructure

• Operationalize New Initiatives

• Optimization of functional service providers/stakeholders

• Operational Gap analysis

• Contractual performance/compliance

Strategic

• Strategic/Development Planning for foreign companies

• Clinical Research Expertise/SMEs

• Early Clinical Stage Government contracting and capability development

• Strategic Outsourcing/vendor procurement, quality assessments and performance management

• Change management (SOPs/tools/resource assessments/development)

Program Management

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)

Clinical Operations

• Oversee specific aspects of global operations (i.e. planning, feasibility/enrollment, vendor mgt., DSMB mgt.)

• 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

• Advise/conduct on trial feasibility, site/CRO selection, enrollment strategy and audit assessments

• Establish appropriate oversight, project management and operational performance reporting

• Create trial budgets (with industry intelligence), and CRO and PI contracts

• Create custom key operational performance indicators (KPIs)

• Create study procedures or align global team SOPs

• Execute on standard/custom tasks (GCP site visit vs customized site training for recruitment initiatives)

• Create custom tool kits/reports/assessments/quality assurance evaluations

Outsourcing Alignment

• Outsourcing services (procurement, bid evaluations, subcontractor management and audits)

• Perform vendor qualification audits and vendor management

• Request for Proposal (RFP) creation and Bid Evaluations

• Assess, manage and report on procurement processes

• Create alignment with Procurement and Operations functions

• Build a network of Preferred Providers or Strategic Partners

• Optimize vendor services with in-house capabilities

• Develop SOPS aligned with internal and external resources

Root Cause Issues in Outsourced Trials

Sponsor say CRO say 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

Decisions lack depthDecision-Making impacts

quality (without CRO input)

Utilize a partnership

approach in decision making

Lack of resources; lack of

training; poor quality;

turnover

Turnover of resources; bid

and execution resource

disconnect

Define

resources/RR/training/experi

ence/transition planning as

part of the PM/RISK and

Communication Plans

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.

14

Manage CollaborateQualify

Quality and Compliance

• Consultants with 20 + years across multiple therapeutic areas

• Pharmaceutical, biologic and medical device clients

• GxP team auditing experiences

• Preclinical thru Peri approval

• Over 400 audits performed (site, CRO/vendor, computer/system, due diligence)

• Consult on existing and developing new compliance and quality program

• Customized GxP tools (SOPs, Checklists, analysis [Corrective Action Preventive Action (CAPA) and Root Cause Analysis (RCA)], plans and reports)

• Mock inspections for readiness with bench-marking and gap analysis

• Remediating audit or inspection findings

• Training programs for compliance

Regulatory Affairs Services

• Strategy Development

• FDA Meetings

• Write all submission documents

• Regulatory support/Maintain files

• Electronic/paper submissions

• IND/NDA applications

• Briefing Documents/Annual Reports/Safety Reports/Post-marketing Reports

• Navigate Electronic Common Technical Document (eCTD) process

• Publishing

• Literature searches

New Strategic Initiatives

The NeoTrials process is easy

second

17

lastFirst

1. Before any initiative is implemented, we assesses SOPs, RR, communication, planning, tools, and

more to ensure your evolving idea is put into place to solve core problems.

2. Use tools to test the vision (reducing cost and failing less) in high uncertainty environments

= validated learning

3. Plans are adapted incrementally (with course pivots along the way)

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

Recent Project Examples

• Program management (including EVM), GxP auditing and monitoring of class III medical device for x-US device manufacturer

• Providing clinical research training to clinical imaging vendor

• Contract Research Organization (CRO) Procurement for global device company

• Regulatory Consulting Procurement for x-US pharmaceutical and supply company

• Gap Analysis of Clinical Research/Medical Affairs/Procurement practices for large US pharma company

• Conducted Quality Audits for Inspection Readiness for US biotech

• Wrote Clinical Operations SOPS and policies for a global pharma company

• Partnered with another consulting firm to conduct an IRB survey and SMO Initiative

Specialized Staffing

• Professional contract staffing - MD, PhD and Master Level

• Clinical/Strategic Advisors

• Program/Project Managers

• Clinical PMs

• Subject Matter Experts (SMEs)

• Regulatory strategists and Specialists

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

• Customized approaches and tools

• Specialized expert staff

Contact Us at:

(774) 987-9636

www.neotrials.com

info@neotrials.com

NeoTrials, LLC

6904 Southridge Place

Middletown, MD 21769

Let us help you get there!