1. Clinical Knowledge Management: Executive Overview

2. Currently there are challenges that prevent organizations from realizing the full value of knowledge
Document repositories difficult to navigate/not user friendly
Information is siloed
Users don’t have access to the right information
Knowledge leaves when people leave
Most companies have an approach for storing documents and might believe that they have a Knowledge Management (KM) system in place. The reality is that a consistent and widely understood structure is needed to enable people to easily find documents that might be stored. In addition, KM is more than just housing documents. It includes consistent approaches for connecting people to knowledge and each other to leverage existing content and experience across an organization. Isolated approaches, such as a training program used in a single therapeutic area, while useful and a good starting point, limit opportunities for broad collaboration and sharing of knowledge.
The items listed on this slide are key challenges typically experience when a structured Knowledge Management system is not in place.
Experts are not well-identified/not easy to find them
Information not available at the click of a button
New knowledge is not effectively disseminated
Best practices not captured/ shared

3. Knowledge is “Information in Action” - using knowledge proactively to improve performance or decision making
Potential State
Results in:
Extracting optimal value from Knowledge
Opportunities for competitive advantage
Minimization of risk
Easy access to the right knowledge and the right people
Improved decision making
Improved organizational performance: Growth in productivity and profit margins1
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
This slide describes aspects that would exist in a structured KM system:
- People know where to look for the knowledge they need.
- Knowledge is effectively captured and shared.
- Lessons learned are gathered, documented, and shared to prevent repeat issues and continuously improve business processes
- Experts can be easily identified and freely share their experience and insights.
- People are able to collaborate and share across boundaries, functions and geographies (siloes are transcended).
The benefits that are gained from an effective KM system are listed on the right and can be discussed.
Know who the experts are and how to contact them for advice
Connect readily across boundaries of teams, functions and geographies
1 McKinsey Global Institute (MGI) research: the state of digitization in sectors across the U.S. economy

4. Capture knowledge in a consistent and searchable manner
Knowledge should be organized and accessible in formats that are easily searchable and correctly tagged
Challenges
Do not know where/how to find information
Inefficient search engine technology/poor results
Information distributed across multiple locations and systems
Illogical organization of content
Ineffective tagging (labeling) when contributing content
Content not easily usable
Consequences
45% of users surveyed found it difficult to search for and find the information they needed1
Inability to easily find information leads to 16% lost time on a weekly basis or $5M annually, based on industry studies2
Opportunities with KM
Know what knowledge exists, where to look for it and how to quickly find it
These next 3 slides explore in a little more detail the key aspects of an effective KM program.
One of the biggest issues that colleagues list as impeding their ability to work effectively, is that people struggle to find the information they need easily and quickly - and when they do find it - there may not be any assurance that it is accurate.
Search capabilities return thousands of results which are not all useful; the information is stored in other departmental systems and not easily accessible.
The content is not logically organized or tagged and can’t be easily located. Finally, the content itself might not be usable. Colleagues often spend hours re-packaging the information into useful formats.
In a survey of TransCelerate member companies in late 2015, 45% of respondents surveyed found it difficult to search for and find the information they needed. In an IDC survey of 2155 organizations, it was found that workers lost 16% of their time looking for information. This translates to over $5 million a year, assuming a 41.8-hour (average) work week and an annual salary of $80K.
The points displayed on the right hand side of the slide show that an organized KM approach would lead to easily locating relevant information.
Capture knowledge in a consistent and searchable manner
1 Source: KM Survey of TransCelerate member companies - Sept 2015
2 International Data Corporation (IDC’s) Unlocking the Hidden Value of Information Survey, Dec organizations surveyed

5. Proactively implement and use insights to minimize risk
Organizations can leverage KM solutions to learn from prior experiences and drive strategic decisions
Issues Caused by Lack of Knowledge Sharing or Resource Availability
Use of past lessons learned results in
Reduced risk of:
Repeat inspection / audit findings
Protocol amendments
Study delays
Less redundancy / not reinventing the wheel
Reduced loss of institutional knowledge
Shared insights and improved collaboration
Opportunities with KM
Wasted time due to re-work
Repeat issues
Poorly informed decisions
Ineffective KM with external parties
Delays in study/program timelines
Higher costs
Repeat audit/inspection findings
Over emphasis on training for CAPA remediation
100%
90%
80%
70% 0%
Percentage of respondents
Share lessons learned so new work always starts using current best practice
Proactively implement and use insights to minimize risk
This slide deals with the importance of capturing lessons already learned. Often times, this is tacit, or undocumented knowledge, which resides in the minds of people or study teams. If not captured, such information remains siloed in that team only. The result is that others do not benefit from this team’s prior experience!
The graph on the left reflects data from the TransCelerate survey. It shows the issues that employees experience due to knowledge not being shared or readily available. (Highlight a few items and the % of respondents that experienced the issue based on your audience).
In the middle column, the benefits of using lessons learned or insights are explained. Presenters could engage the executive as to which benefits he/she thinks would be relevant in his/her organization. Examples include exploring the benefits of:
Risk Mitigation and Compliance (ensuring people have the correct version of documentation with processes in place to store and retrieve it)
Insights from audits and inspection findings used to influence future protocol authoring, study site selection, etc.
Potential time savings of ~16% for knowledge workers.
Again, column 3 shows what an organized KM approach would deliver and provide for an organization.
Source: KM Survey of TransCelerate member companies - Sept 2015 (survey conducted on blinded basis)

6. In a globally distributed organization it is important to be able to find the right people or experts
Challenges and Impact
No systematic approach to easily identify experts
After Action Reviews (AAR) not held / not effective
People networks either don’t exist or knowledge is not shared through them
Costly lost opportunities:
Wasted time / milestones missed spent looking for the right people
Ineffective sharing of insights
Non-optimal decision making
Errors repeated due to not knowing about insights
Potential State
Knowledge experts are readily identifiable and easily accessible
Timely conduct of After Action Reviews: insights in the minds of individuals help others learn
People go to their networks when faced with complex / abstract challenges
Opportunities with KM
Know who the experts are and how to contact them for advice
Imagine having the ability to instantly access all available knowledge relevant to a question you have or decision you need to make.
Typically, people with the right expertise are not easily located, especially in a globally dispersed firm.
Items highlighted in the left hand column portray the challenges that many companies have enabling employees to locate and access the specific expertise they need. The second column indicates the lost opportunities. (Again, the presenter could engage the executive in the types of lost opportunities.)
The third column describes examples of what a future state could be with an organized KM structure. The final column adds the aspect of connection and collaboration across boundaries, which has immense value for organizations.
Connect readily across boundaries of teams, functions and geographies

7. Strong Executive Sponsorship Culture of Knowledge Sharing Behaviors
Strong support & engagement from leadership and a knowledge seeking & sharing culture are critical for success
Main reasons why KM fails:
Lack of strong sponsorship of the KM program by leadership
Lack of reinforcement of desired behaviors
Misconception that KM technology alone is sufficient
Lack of Leadership
Strong Executive Sponsorship
Culture of Knowledge Sharing Behaviors
This slide covers non-content issues, which are nonetheless critical (i.e., the issues of leadership support and culture).
Strong leadership support and sponsorship from executives and senior management is critical for success. Their influence is vital to drive the right culture. Such a culture is one that encourages and reinforces knowledge sharing behaviors so that the organization continuously improves by applying all relevant knowledge, including lessons learned.

8. Continuous Improvement
A proposed solution: a Clinical KM Program across Clinical Development or selected areas based on the CKM framework
Clinical Knowledge Management Framework
Example: Embedding KM into process flows - either by presenting content or providing links to:
SOPs, templates, Job Aides
Names of experts for that process
Links to related training
Search capability for related content
Links to relevant data/ trends or insights
Discussion board to the relevant Disease Area community
Knowledge Management 1 2
Business Process 3 4
People
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
This framework provides the fundamental components of a successful KM approach for organizations of any size.
The business areas in which a company chooses to start CKM - or whether it is a full-scale, functional area or enterprise-wide effort - does not matter.
Organizations are encouraged to refer to the KM manuscript written by the TransCelerate team, which explains the framework in more detail. In addition, there are some basic tools and articles that are also provided to further support implementation. 5
Continuous Improvement
Flexibility
Knowledge-driven learning and improvemennt 6
Culture
Leadership commitment
Promotes knowledge seeking and exchange
Adapted from O’Dell and Hubert, 2011

9. IMPROVED & MOTIVATED WORKFORCE “Think big, start small – but start!”
Effective KM connects the right people to the right information/ expertise at the right time, which positively impacts the business
Implementation of an effective knowledge management program enables avoidance of costs, which can add up to significant annual savings.
Sample benefits:1
CRISIS TEAMS
$100k-$144k for each team
>$10M
EXTENDING PROJECT TEAM
1-6 months
~$650k - $12M
AMENDMENTS
25% avoidable
~$5M
(excl. Phase 1)
IMPROVED & MOTIVATED WORKFORCE
Significant impact for organizations
What are the business benefits of implementing KM?
As discussed earlier, a major benefit is the time that people save by having the knowledge they need readily available.
Other examples are listed here. The actual savings will depend on each organization‘s specific cost structures and circumstances.
Many other benefits are less tangible and not as easily quantifiable. These benefits are best illustrated by showing the problems associated with not having a KM system.
Examples are :
Risk avoidance, e.g. accurate, up-to-date documents with best practices incorporated can ensure compliance, thus reducing risk of non-compliance or repeat audit findings
Cost of experts leaving the organization and re-establishing that expertise
Cost of unmotivated employees who are frustrated due to difficulty in finding information, lack of accurate information, and amount of resulting rework
Interestingly, there are many articles that chronicle the improved effectiveness and improved performance of organizations that do KM well. It is a journey; it takes commitment. That said, the key is to get started. The vision of what an organization ultimately wants to achieve can be big, but it can start small - in a specific area. The key is to get started.
THE KEY IS:
“Think big, start small – but start!”
1 Source: Blinded estimates from a TransCelerate Member Company

10. What might the next steps be for an organization to “get started”?
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 1 3 4 2
Improve and Sustain
Assess performance against anticipated outcomes and adjust as necessary. Assess opportunities for continuous improvement to sustain the framework over time.
Design and Implement Solutions
Define and deploy mechanisms to enable and improve knowledge access and sharing
How should an organization that wants to do KM get started? This stepwise approach can be applied to develop and implement a KM program, then repeated as needed for improvement or expansion of KM efforts.
The presenter should go through each of the 4 sections.
The conclusion of the overview will depend on the engagement that the presenter has had with his/her audience.
At a minimum, he/she can offer to send the manuscript as a next step or even offer to forward the assessment tool for the executive to assess where his/her organization currently is vis-à-vis KM.