quality management system (qms) - transcelerate management system initiative: ... enabling element...

TransCelerate Quality Management System Initiative: Clinical Knowledge Management

Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. 2CKM Detailed Overview

Approved for Use August 2016

TOPICS

Knowledge Management (KM) as an

Enabling Element of a Clinical Quality

Management System (QMS)

Clinical Knowledge Management Basics

Designing, Implementing, and Sustaining a

Clinical Knowledge Management Program

Clinical Knowledge Management Tools

01

02

03

04

Knowledge

Management is an

Enabling Element of

a Clinical QMS

01

Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. 4

Elements of a Clinical QMS Conceptual Framework

Processes

Resources, Roles & Responsibilities

Risk Management

Issue Management

Knowledge Management

Partnering

Documentation Supporting Achievement of Quality

Ass

ess

ing

th

e C

QM

S

Ma

na

ge

me

nt

Re

vie

w

Foundational Aspects

CULTURE OF QUALITY

Understand the Context

Continual Improvement of the Framework

Leadership Commitment to Quality

Organizational Commitment to Quality

Why Is TransCelerate Addressing Clinical

Knowledge Management?

In a recent anonymous survey of 152 individuals across Clinical Development / Quality organizations in TransCelerate Member Companies:

➢ Only 10 % of participants believe their organizations have a high or comprehensive understanding of

Knowledge Management. Approximately 50% believe there is some understanding and almost 40% believe

their organization have little to no understanding.

➢ Over 75% of participants indicated that improvements in sharing and searching for knowledge within their

Clinical Development organization would have a high to very high positive impact in each of the following

ways: Saving time, avoiding “re-inventing the wheel”, and enabling timely and accurate decision making.

TransCelerate Member

Company interviews and

discussions with regulators on

the effective elements of a

Clinical QMS identified

Knowledge Management as

an area of interest and

potential improvement Knowledge Management


A Practical Definition and Value of Knowledge

Management for Clinical Development

“Strategies and processes designed to

identify, capture, structure, value,

leverage, and share an organization’s

intellectual assets to enhance the

clinical development organization’s

performance and the performance of

QMS elements, including issue

management and risk management,

based on two critical activities:

1. Capture, storage and accessibility of

institutional explicit and tacit

knowledge, and

2. Its assimilation, interpretation,

dissemination, application and

maintenance within an organization”

Adapted from The Business Dictionary: http://www.businessdictionary.com/definition/knowledge-management.html)

Clinical QMS Conceptual Framework Concept Paper

“Getting the right information to

the right people at the right time”

Value

Enhances decision making

Connects people with information and experts more rapidly

Retains and facilitates sharing of critical knowledge

Enables searching, finding and applying information faster

Reduces unnecessary or redundant re-work across teams/functions

http://www.businessdictionary.com/definition/knowledge-management.html


Examples of KM in Action- What “Good” Looks

Like

When KM is in practice, people across an organization will…

Know what knowledge

exists, where to look for

it and how to quickly

find it

Capture knowledge

in a consistent and

searchable manner

Share lessons learned

so new work always

starts using current best

practice

Know who the experts

are and how to

contact them for

advice

Connect readily across

boundaries of teams,

functions and

geographies


Insert Relevant Case Scenarios

A number of Clinical KM scenarios have been developed

and can be inserted here (or relevant scenarios from your

own company) to help demonstrate common challenges

and the value of implementing a Clinical KM Program.

http://www.transceleratebiopharmainc.com/assets/quality-management-system/

Clinical Knowledge

Management Basics

02


Transformation of Data into Knowledge

Knowledge…

Is know-how, understanding, experience, insight,

intuition, contextualized information

Information…

Is data that has been contextualized,

categorized, calculated and condensed

Data…

Facts and figures which relay

something specific, but which

are not organized

Source: http://www.knowledge-management-tools.net/knowledge-information-data.html


EXPLICIT KNOWLEDGECaptured and Documented

Examples:

• Protocols and Study Reports

• Submission Summary Documents

• Response to Agency Queries

• SOPs, Regulations, Guidances

TACIT KNOWLEDGEExperience and Insight

Hard to document and measure, in the minds of people and/or shared by personal connection.

Examples:

Experience and insights acquired through

lessons learned from

– Clinical program execution

– Internal audits and regulatory inspections

– Partnering engagements

– Application of SOPs in real-life situations

Difference between Explicit and Tacit

Knowledge


1 2 3 4

5

6


PeopleBusiness Process

Content Technology

• KM Specific roles

• Training, teaching, mentoring

• Change management roles

• Integration of KM in business processes

• Governance

• Measurement

• Change management

• Tacit & explicit knowledge

• Taxonomy & metadata

• Templates & tools

• Data Storage

• Document repositories

• Team sites

• Networking software

• Search capabilities

Continuous Improvement

Culture

• Flexibility

• Knowledge-driven learning and improvement

• Leadership commitment

• Promotes knowledge seeking and exchange

TransCelerate’s Knowledge Management

Framework

Adapted from O’Dell and Hubert, 2011.


Key Roles

Highlights

People

• Clinical KM

Champion

• Executive Sponsor

• Governance

body

• Change Agents

• Clinical KM

Group/Individual

• Subject Matter

Experts

Individuals embrace the KM behaviors

of seeking and sharing knowledge and

collaborating across functional areas

and geographical boundaries.

People engagement in and use of

Clinical KM is directly related to

company culture.

Depending on the size of the

organization, these roles may be served

by the same person, multiple people,

shared or outsourced.

1 2 3 4

5

6


PeopleBusiness Process Content Technology





• Governance

• Measurement





• Data Storage


• Team sites




Culture

• Flexibility• Knowledge-driven learning and improvement

• Leadership commitment• Promotes knowledge seeking and exchange


Key Roles

Highlights


• Governance

• Measurement

• Change Management

KM approaches should be integrated

into clinical development business

processes.

KM Business Processes enable oversight

of the Clinical KM Program and support

meeting its goals at different stages of

Clinical KM development and maturity:» Core KM Processes

» Governance

» Measurement Approach

» Change Management

A comprehensive communication plan

with targeted messaging for sponsors

and stakeholders during development,

implementation, and ongoing use of

the Clinical KM Program.

Business Process

1 2 3 4

5

6







• Governance

• Measurement





• Data Storage


• Team sites




Culture




Key Content

Approaches for Organizing

& Managing Content




Business rules for where to store and

how to categorize content for

successful search and retrieval.» Review of taxonomy categories for suitability for

changing needs and consistency across relevant business areas

Validation of the content on initial

capture and assurance that the

content remains current.

Archival of out-of-date content.

Content

1 2 3 4

5

6







• Governance

• Measurement





• Data Storage


• Team sites




Culture




Example Capabilities

Highlights

• Data storage


• Team sites



Technology should support the Clinical

KM program, strategy, and selected

approaches.

Technology can:

» Bridge geographies and people

» Enable real-time and rapid access

» Simplify complex multiple sources of information

» Be fit-for-purpose and fit within existing business processes

Technology

1 2 3 4

5

6







• Governance

• Measurement





• Data Storage


• Team sites




Culture




Key Points

Maturity Model

Initially, the Clinical KM program and strategy will be designed to meet current organizational needs. A roadmap will guide its evolution.

It should evolve to meet changing demands of the business in response to internal and external influences.


1 2 3 4

5

6







• Governance

• Measurement





• Data Storage


• Team sites




Culture



Level 1

INITIATEGrowing

Awareness

Level 2

DEVELOP

Localized and

repeatable

practices

Level 3

STANDARDIZE

Common

processes and

approaches

Level 4

OPTIMIIZEMeasure and

adaptive

Level 5

INNOVATE

Continuously

improving

practices

Ad hoc Knowledge

Applied Knowledge

Enable Knowledge

Scalable Knowledge

Source: APQC’s Level of Knowledge Management Maturity.

Reproduced with permission


Key Points

Enabling Behaviors

An organizational culture of seeking and sharing knowledge is critical to the success of a Clinical KM Program.

High dependency on the behavior of both individuals and the clinical development organization as a whole.

• Actively seeking and sharing knowledge

• Using existing knowledge in a proactive manner

• Openly communicating and collaborating across boundaries and

focusing on the collective goal rather than individual roles or functions

• Considering all questions valuable

• Considering both positive and negative outcomes as sources of valuable

knowledge

• Viewing time spent seeking, sharing, and capturing knowledge as a value-added activity that is a routine part of job roles

• Promoting continuous learning and collaboration

Culture

1 2 3 4

5

6







• Governance

• Measurement





• Data Storage


• Team sites




Culture



Designing,

Implementing, and

Sustaining a Clinical

KM Program

03


Considerations for Implementation of a Knowledge

Management Framework Tailored to a Clinical

Development Organization

Think big, start small. And most importantly – Start!

Understand the Knowledge Needs

Identify the critical knowledge

necessary to drive optimal

outcomes tailored to

organizational needs

Assess Opportunity

Understand where improvement

of knowledge flow may provide

opportunity for enhanced

execution to improve critical

business outcomes

Design and Implement Solutions

Define and deploy

mechanisms to enable

and improve knowledge

access and sharing

Improve and Sustain

Assess performance against

anticipated outcomes and

adjust as necessary. Assess

opportunities for continuous

improvement to sustain the

framework over time.

1

34

2


1. Identify most critical information

and knowledge needed by the

organization

2. Understand the challenges and

risks related to knowledge gaps

3. Assess KM behaviors of the

organization

Step 1: Understand the Knowledge Needs

1

3

4

2Understand the Knowledge Needs

Assess Opportunity


Improve and Sustain

Actions to Take:


1. Identify current gaps in the

availability of specific knowledge

needed to support key business

processes

2. Prioritize opportunities based on

business needs

3. Propose business case and pilot

projects to relevant governance

body for approval

Step 2: Assess Opportunities

1

3

4


Assess Opportunity


Improve and Sustain

Actions to Take:


1. Select relevant KM approach(es) to address the types of knowledge to be

managed

2. Design Clinical KM solutions/tools

3. Develop training plan and training materials

4. Communicate training and implementation plans to users

5. Deliver training to users

6. Deploy Clinical KM solutions/tools

7. Support users

8. Define measures for assessing use and effectiveness

Step 3: Design and Implement

1

3

4


Assess Opportunity


Improve and Sustain

Actions to Take:


1. Establish ongoing oversight and

business processes for Clinical KM

Program maintenance and

improvement

2. Update and/or expand Clinical

KM Strategy and Program based

on evolving business needs

3. Define and implement business-

related measures for assessment

of Clinical KM performance

4. Develop approaches for

reinforcement and recognition of

Clinical KM successes

Step 4: Improve and Sustain

1

3

4


Assess Opportunity


Improve and Sustain

Actions to Take:


Key Messages

Common approaches that enable sharing of and searching for knowledge across

organizational and geographic boundaries facilitate consistent quality of execution,

enhanced efficiency, and continual improvement of business processes.

A knowledge seeking and sharing culture coupled with supporting business processes

and people are critical for the successful integration of KM approaches into routine

work.

The development of a Clinical KM Program begins with obtaining Senior Leadership

sponsorship and engaging the clinical development organization on the potential

benefits of KM.

Start with prioritizing KM needs and a narrow focus on a pilot project with a vision to

expand based on demonstrated value.

As part of the ongoing support and continual improvement of the Clinical KM program,

the value of KM should be measured, realizing that success will mean different things at

different stages of Clinical KM development and maturity.

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