Overview of Avoca Services Related to

Supplier Management with a Focus on Training

of Operational Teams

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●  Avoca provides consulting, training, and survey research services to pharmaceutical and biotech companies as well as CROs in the area of alliance and relationship management. This document is intended to outline a number of services that may be of interest to pharma companies. It includes Avoca’s approach to training and information about the company’s Art and Science of Partnering™ framework. This framework includes courseware, tools, and tailored exercises designed for Project and Alliance Managers within sponsor companies responsible for managing outsourced trials.

●  The initial information in this document focuses on Avoca’s services related to consulting and survey research. The information about the Art and Science of Partnering™ is included as a separate section following the survey research and consulting services overview.

Background

Overview of Avoca Services

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1)  Avoca Survey Research ╸  Needs Assessments: Gathering of actionable data to drive strategy implementation or to

determine communication needs

╸  Ongoing bi-directional measurement programs in which Avoca gathers data through a combination of web surveys and in-depth telephone interviews to assess the health of alliance relationships; creating a standard across alliance relationships enables our clients to use this data as a tool for managing relationships

2)  Avoca Consulting: Strategy Implementation and Change Management

╸  Assistance with engaging key stakeholders including senior staff, clinical operations, and strategic partners to ensure acceptance, understanding, and buy-in of the outsourcing and alliance models

╸  Development of (or review of) alliance management documentation, tools, and templates, e.g., Alliance Partner Management Guidelines, Governance Models, Issue Escalation Policies, and tools for alliance relationship management and oversight

╸  Development of Lessons Learned Programs

3)  Customized Training and Workshops

╸  Implementation of Avoca’s Art and Science of Partnering™ - Best Practices in Managing CROs and Alliance Partners

╸  “Just in Time” Training and Workshops

Overview: Three Main Areas for Avoca Support

Overview of Avoca Services

Avoca Survey Research and

Consulting

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●  To gather quantitative and qualitative data so that sponsors can better forecast issues and take action at critical time-points so as to avoid problems and failure later in the relationship

●  To collect data in a systematic and standard way across alliance partners; this allows our clients to compare the relative performance of CROs and this data can be used in managing the relationship, both at the project level and at the governance level (see sample data which is included as an addendum to this proposal)

Objectives of Measurement Programs

Avoca Survey Research

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●  Identification of performance and relationship metrics or review of established metrics based on Avoca’s unique vantage point of assisting pharmaceutical companies, biotech companies, and CROs with the development of measurement programs

●  Implementation of measurement programs

╸ Combination of gathering data through web-based surveys and in-depth telephone interviews

╸ Avoca survey specialists are subject matter experts that are able to probe to understand issues

╸ Focus on gathering actionable data

╸ Real-time reporting of data

╸ Red flag reporting of serious issues

╸ Access to information through AvocaView™, Avoca’s web portal for administration of surveys and reporting of information

Comprehensive Strategy for Measuring Strategic Relationships

Avoca Survey Research

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●  Data analysis and reporting is based on a deep understanding of the relationship dynamics between sponsors and CROs

╸ Reports include an industry perspective and recommendations based on experience with Relationship Management Programs

╸ Where applicable, data compared to blinded data in Avoca’s databases from relationship management programs and/or to data from our industry-wide reports

╸ Avoca senior consultants are often asked to present data at governance meetings, Lessons Learned meetings, or as part of Workshops that include the alliance partners

Analysis and Reporting

Avoca Survey Research

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●  Assistance with engaging key stakeholders including senior staff, clinical operations, and strategic partners to ensure understanding, acceptance, and buy-in of the outsourcing model

╸ This could include development and implementation of a comprehensive Communication Strategy and Training Plan to ensure that operational staff are fully aware of the outsourcing model and what it means for them; the plans would be based on data gathered as part of an initial Needs Assessment

Strategy Implementation, Alliance Management Infrastructure Development, and Change Management

Avoca Consulting

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●  Review of, or in cases where none exist, development of standards, documentation, and tools for managing strategic relationships

╸ We find that many companies are adept at developing standards for contracting with CROs, but gaps exist in terms of “operationalizing” the management of CROs within a strategic framework

╸ Avoca has developed a model for relationship management which includes tools for setting expectations and working with CROs under a strategic framework that is tailored for each client

╸ Avoca helps companies develop and implement comprehensive Lessons Learned Programs

o  Avoca consultants serve as a liaison between sponsors and CROs to bridge gaps

o  Lessons Learned meetings are anchored by objective data gathered by Avoca

o  Avoca helps companies develop systems for analyzing information across projects, therapeutic areas, and partners

Strategy Implementation, Alliance Management Infrastructure Development, and Change Management

Avoca Consulting

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●  Development of a Manual for Operations outlining expectations for managing strategic relationships

╸ Provides details on the “how” of the outsourcing model

╸ Functionally-specific and intended for clinical operations, includes guidelines for managing and working in collaboration with partners

╸ Developed with significant input from project team leadership (and could be developed with input from CRO partners)

╸ Intended to be used as a detailed reference for teams and to orient new employees

╸ Could be implemented as part of workshops and training focused on relationship management

╸ This would not replace existing SOPs, processes, and guidelines but would focus on the specific “behaviors” required for the partnering model to be successful

Strategy Implementation, Alliance Management Infrastructure Development, and Change Management

Avoca Consulting

Avoca Training: The Art and Science

of Partnering™

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●  The Art and Science of Partnering™ course entitled “Working with CROs: Effective Communication and Management to Ensure Project Success” challenges pharmaceutical company Project Managers to rethink their roles as they relate to managing CROs.

●  The course not only provides a sound theoretical foundation based on best practices in CRO Management; it also focuses on the specific critical thinking skills and communication skills necessary for pharma Project Managers to run successful outsourced projects and collaborate effectively with CROs and other suppliers.

Working with CROs: Effective Management to Ensure Project Success

Avoca Training

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Analysis Approach Assessment Action

Critical Thinking

Communication

The Art and Science of Partnering™

Avoca’s methodology and instruction focuses on the two parallel dimensions of Communication and Critical Thinking Skills

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The Foundational Principles help build the core competencies for not only managing the process side but also the people side of CRO management.

1)  Take personal responsibility for communication

2)  Be mindful of the CRO perspective

3)  Be meticulous in stating expectations

4)  One size does not fit all; implement a best practice process that works for your particular study

5)  Eliminate non-value adding work

6)  Pay attention to the “whitespace”; where the baton is being passed from your organization to the CRO

7)  Be an enabler rather than a micro-manager

8)  Energize the team

Foundational Principles

Avoca Training

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The Avoca Model for Establishing Best practices for Working Effectively in Strategic Partnerships

Analysis

Assessment

A Approach Action

The Art and Science of Partnering™

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●  Analysis: Knowing your project and preparing for project success

●  Approach: Creating a successful project (or partnership) with joint forecasting

●  Assessment: Managing and monitoring project success

●  Action: Taking corrective action to assure project success

Working with CROs: Effective Management to Ensure Project Success

Avoca Training

Contact Avoca at: (609) 252-9020

www.theavocagroup.com

info@theavocagroup.com

179 Nassau Street Suite 3A

Princeton, NJ 08542

Thank you