2. 2
● 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
3. 3
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
5. 5
● 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
6. 6
● 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
7. 7
● 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
8. 8
● 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
9. 9
● 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
10. 10
● 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
12. 12
● 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
13. 13
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
14. 14
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
15. 15
The Avoca Model for Establishing Best practices for
Working Effectively in Strategic Partnerships
Analysis
Assessment
A ApproachAction
The Art and Science of Partnering™
16. 16
● 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
17. Contact Avoca at:
(609) 252-9020
www.theavocagroup.com
info@theavocagroup.com
179 Nassau Street
Suite 3A
Princeton, NJ 08542
Thank you