Fundamentals of a cQMS - transceleratebiopharmainc.com · •Anticipating resource and expertise...

Copyright ©2018 TransCelerate BioPharma Inc., All rights reserved. 1

Fundamentals of a

cQMS

03


TransCelerate’s

Clinical Quality Management System Purpose

+ Efficiently achieve an organization’s quality and organizational objectives.

+ Reduce recurring quality-related issues that undermine patient safety and data integrity, and consume resources.

+ Increase confidence in clinical research and its results.

+ Integrate individual trial-level quality and risk management activities to provide a holistic view of whether clinical quality objectives are being met, and risks to subjects and data quality are appropriately addressed across the enterprise.

Ann Meeker-O’Connell, Maria Magdalena Borda, Janis A. Little, Leslie M. Sam, “Enhancing Quality and Efficiency in Clinical Development Through a Clinical Development through a Clinical QMS Conceptual Framework: Concept Paper Vision and

Outline,” Therapeutic Innovation & Regulatory Science, p. 8. June 2015. http://dij.sagepub.com/content/49/5/615.abstract

A Clinical QMS is an integrated framework through which organizations systematically define quality objectives linked to their broader strategic goals

Purpose of the Clinical QMS

http://dij.sagepub.com/content/49/5/615.abstract


TransCelerate’s

Clinical QMS Framework

• The framework includes elements that, through our research and interviews, were reported to contribute to success in the clinical arena

• Seven elements prospectively developed to integrate quality into clinical development activities

• Two elements provide ongoing monitoring of the achievement of quality objectives and the performance of the QMS

Proactive, Risk-based, Flexible

Foundational Aspects

ProcessesProcesses

Resources, Roles & ResponsibilitiesResources, Roles & Responsibilities

Risk ManagementRisk Management

Issue ManagementIssue Management

Knowledge ManagementKnowledge Management

PartneringPartnering

Elements of a Clinical QMS Conceptual Framework

Documentation Supporting Achievement of QualityDocumentation Supporting Achievement of Quality

Ass

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the

CQ

MS

Man

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evi

ew

Understand the ContextLeadership

Commitment to Quality

Organizational

Commitment to Quality

Continual Improvement

of the Framework


What’s the Relationship of QMS, QBD and RBM?

Copyright ©2016 TransCelerate BioPharma Inc., All rights reserved.

cQMS Foundational

Aspects Overview


Understand the Context

Value Proposition

• Design of the Clinical QMS and its elements

will be “fit for purpose”

• Will highlight the organization’s strengths,

weakness, opportunities and threats,

facilitating continuous improvement.

What is “Understand the Context”

External environment survey identified:

• Evolving customer needs (patient & sites) which

required advancements in the use of social media in

Clinical Development.

• An evaluation was performed to identify which if any

QMS elements might be optimized to support this

new innovation.

Example

• Changes in the environment, both internal and external,

can influence how an organization operates – this is

“the context”. It may include factors such diversity of

the organization’s portfolio and changing regulations.

• Provides insight into design and maintenance of a

clinical QMS that is most appropriate for the

organization.Foundational Aspects

ProcessesProcesses








Ass

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the

CQ

MS

Man

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Understand the

Context

Leadership

Commitment to

Quality

Organizational

Commitment to

Quality

Continual

Improvement of the

Framework


Leadership Commitment to Quality

Value Proposition

Promotes a culture of quality within the

organization which leads to:

• Employee engagement and pride

• Improved organization reputation

• Achievement of business goals

What is “Leadership Commitment to Quality”

• Development of an organization credo that sets the vision for quality for the organization

• Leaders who refers to credo/vision in daily

activities and employee interactions

• Leaders that use credo/vision to guide their own

decision making

Example

Active commitment by leadership to quality through:

1. Setting clear quality standards for the organization and

the expectations for meeting the standards

2. Leads by example, demonstrates the commitment;

embodies the principlesFoundational Aspects

ProcessesProcesses








Ass

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ing

the

CQ

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Man

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Understand the

Context

Leadership

Commitment to

Quality

Organizational

Commitment to

Quality

Continual

Improvement of the

Framework


Organizational Commitment to Quality

Value Proposition

• Drives quality as an integral part of the

organization’s culture

• Avoids rework and errors by building quality into

daily activities

• Promotes the concept that quality is owned by all –

it is not limited to a group or function (i.e., a Quality

organization)

What is “Organizational Commitment to Quality”

Employees can answer yes to the following questions:

• My colleagues and I feel comfortable raising

concerns over quality

• My colleagues and I feel empowered to make

decisions to ensure quality in my work

• My colleagues and I are frequently involved in

activities to create and enhance quality

performance

Example

• Active commitment to quality at all levels within an

organization

• Individuals take ownership and feel empowered to

drive quality in their day to day activities and decision

makingFoundational Aspects

ProcessesProcesses








Ass

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the

CQ

MS

Man

age

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Understand the

Context

Leadership

Commitment to

Quality

Organizational

Commitment to

Quality

Continual

Improvement of the

Framework


Continual Improvement of the Framework

Value Proposition

• Allows for recognition of potential positive

changes within the organization that can

enhance the framework

• Allows for a nimble QMS that keeps pace with

the evolving clinical development

environment

What is “Continual Improvement of the Framework”

• An organization piloted an eConsent

approach.

• Evaluation of the pilot identified unrealized

opportunities to streamline the monitoring of

informed consent forms.

Example

• An intentional approach to enhance and evolve

the effectiveness/efficiency of the organization’s

Clinical QMS

• Promotes adjusting the framework to changes in

the internal and external environment Foundational Aspects

ProcessesProcesses








Ass

ess

ing

the

CQ

MS

Man

age

men

t R

evie

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Understand the

Context

Leadership

Commitment to

Quality

Organizational

Commitment to

Quality

Continual

Improvement of the

Framework

cQMS Elements

Overview


Processes

Value Proposition

• Focus on end-to-end clinical development process

approach provides greater assurance of meeting

customer requirements

• Documentation strategy is commensurate to level of

inherent process risk

• A modern learning approach should be leveraged to

best enable staff to perform their tasks

What is “Processes”

• Study start-up Impact analysis evaluated to understand overall impact prior to proceeding with a continuous improvement process change.

• Risk-based methodology applied to critical processes used to streamline documentation assuring compliance

• Using a knowledge management repository, staff understand

the end-to-end process and are able to access learning to execute the steps required.

• Learning effectiveness was displayed through improved outcomes (e.g., fewer issues, inspection findings, improved quality)

Example

• Understanding the steps an organization carries out

to complete a Clinical Development activity,

• Determining whether and to what degree these

steps should be documented, and importantly,

• Determining the most effective training to ensure

consistent and compliant process outcomes Foundational Aspects

ProcessesProcesses








Ass

ess

ing

the

CQ

MS

Man

age

men

t R

evie

w

Understand the

Context

Leadership

Commitment to

Quality

Organizational

Commitment to

Quality

Continual

Improvement of the

Framework


Resources, Roles & Responsibilities

Value Proposition

• Minimizes the potential for activities to be duplicated

or omitted due to lack of understanding one’s

responsibilities

• Anticipating resource and expertise needs that

underpin successful execution of key strategic

objectives

What is “Resources, Roles & Responsibilities”

A new risk-based process required:

• redirection and intentional review of current resources,

• identification of new skillsets to support the new

process and,

• required prospective development of related IT

systems

Example

• Ensuring appropriate resources - both material and

people- are in the right places to achieve clinical

strategy and quality goals

• For staff, this includes identifying necessary skillsets,

defining responsibilities and accountabilities associated

with roles to enable the execution of assigned duties

and tasksFoundational Aspects

ProcessesProcesses








Ass

ess

ing

the

CQ

MS

Man

age

men

t R

evie

w

Understand the

Context

Leadership

Commitment to

Quality

Organizational

Commitment to

Quality

Continual

Improvement of the

Framework


Partnering

Value Proposition

• Facilitates and optimizes clinical development

collaborations

• Enables an effective and successful partnership

based on open communication and mutual

understanding of the risks, roles, responsibilities,

accountabilities and approach to quality oversight

What is “Partnering”

• Proactively defining the criteria/pathway for issue escalation gives all parties

• A common understanding of the significant issues that need to be quickly communicated, to whom, and what

the expected actions are.

• Will save time and ensure that critical information is shared

appropriately, in a timely manner, and with the right people.

Example

• Strategic relationships with external partners

(outside the organization)

• Each party (e.g., vendors, sites, and co-

development partners) taking ownership of the

quality of its contributionsFoundational Aspects

ProcessesProcesses








Ass

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ing

the

CQ

MS

Man

age

men

t R

evie

w

Understand the

Context

Leadership

Commitment to

Quality

Organizational

Commitment to

Quality

Continual

Improvement of the

Framework


Risk Management (1 of 2)

Value Proposition

• Shifts the organization from a reactive to a proactive mindset, thereby decreasing the probability of a significant

error/event from occurring

• Provides senior leadership with confidence that strategic objectives will be met

• Focus resources on significant risks rather than those with minimal impact on human subject protection, regulatory

compliance, reliability of study results, quality and public trust in the organization

What is “Risk Management”

• Framework for integrated management and

oversight of risks across clinical development.


ProcessesProcesses








Ass

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ing

the

CQ

MS

Man

age

men

t R

evie

w

Understand the

Context

Leadership

Commitment to

Quality

Organizational

Commitment to

Quality

Continual

Improvement of the

Framework


Risk Management (2 of 2)

Example below demonstrates how study requirements and study level risks,

impact and mitigation may roll up to R&D Level via Risk Management processes

Study LevelSubjects must undergo imaging procedure, results must be rapidly available to direct patient dosing.

STUDY REQUIREMENT

Imaging vendor may not provide data results in a timely manner to support dosing. (Cause)

STUDY LEVEL RISK

Inability to dose patients according to schedule due to delays in process. Potential impact on patient continuity, study timelines, protocol compliance, data quality/integrity, etc. (Risk) Direct impact is that patient may undergo an unnecessary procedure if not able to randomize which is against GCP guidance.

STUDY LEVEL IMPACT

Imaging facilities will be required to demonstrate proficiency in imaging procedures with first subject screened in order for the site to be opened for full screening activity. If issues occur, the site may be required to find a new imaging technician or could be closed to future enrolment.

STUDY LEVEL MITIGATION

Study LevelMultiple studies are using several imaging vendors with various requirements.

R&D Level Risk

R&D Level Impact: Non-standard requirements for multiple studies could lead to confusion and impact the relationship with the vendor.

R&DLEVEL

IMPACT

In order to sustain a positive relationship with vendors, clear requirements and expectations are described in the individual clinical trial agreements. This includes contract language for all vendors to meet requirements for speed, integrity, etc.

R&DLEVEL

MITIGATION


Issue Management

Value Proposition

• Provides end-to-end management of issues and

support an effective Corrective and Preventive

Actions (CAPA) process commensurate with the

impact of the issue

• Issues That Matter should not recur, drugs may get to

patients faster, and resource requirements for drug

development may be reduced, all contributing to

the improvement of the quality of clinical studies

What is “Issue Management”

• By gathering information from various sources (e.g.,

sites participating in a trial, trials in a project), a

seemingly isolated issue when viewed in aggregate

was shown to be an issue that mattered.

• The issue was addressed effectively across the

clinical development enterprise through root cause

analysis, impact assessment, and CAPA.

Example

• A framework for Identifying and managing issues that impact human subject protection, rights and well-being; regulatory compliance; reliability of study results; and quality and trust in the organization

• The framework should identify the level of tolerance for issues, assign significance to issues, and differentiate between significant (issues that matter) and non-significant issues.


ProcessesProcesses








Ass

ess

ing

the

CQ

MS

Man

age

men

t R

evie

w

Understand the

Context

Leadership

Commitment to

Quality

Organizational

Commitment to

Quality

Continual

Improvement of the

Framework


Knowledge Management

Value Proposition

• Increases productivity and enhances decision making

by enabling employees to quickly locate and apply the

most relevant information whether explicit or tacit

• Enhances quality of clinical development by learning

from the past and avoiding repeated mistakes

• Improves efficiency and consistency of process

execution by enabling knowledge connectivity across

an organization

What is “Knowledge Management”

• An organization did not have a systematic way to leverage

protocol design “lessons learned” across development programs, resulting in

• Multiple protocol amendments and delays which could have been avoided if “Team A” knew what “Team B” knew.

• The organization established a KM strategy (Communities of Practice and a Subject Matter Expert Network) that enabled & promoted routine and effective knowledge seeking and sharing across teams.

• Enabled faster protocol development and study execution.

Example

• Connects people to knowledge and people to each otherto leverage existing content and experience

• Approaches for capturing, sharing and applying information to improve organizational performance and enable other elements of the QMS


ProcessesProcesses








Ass

ess

ing

the

CQ

MS

Man

age

men

t R

evie

w

Understand the

Context

Leadership

Commitment to

Quality

Organizational

Commitment to

Quality

Continual

Improvement of the

Framework


Documentation Supporting Achievement of Quality

Value Proposition

• By defining the expected level of documentation,

organizations can

• Focus on core activities that support quality objectives

• Eliminate non-value added documentation

• Facilitates readily demonstrating that quality

objectives have been met (e.g., concise

documentation readily available for a regulatory

agency inspection).

What is “Documentation Supporting Achievement of

Quality””

• An organization looked at the volume of monitoring

documentation in the Trial Master File (TMF),

• conducted a gap analysis against the current

monitoring plans to ensure

• documentation aligned with expectations set forth

in the monitoring plans.

Example

• Documentation that substantiates achievement of quality

objectives (e.g., documentation of study activities, CAPA

effectiveness checks).

• The level of documentation should be commensurate with

the level of risk and significance to achieve quality

objectives. Foundational Aspects

ProcessesProcesses








Ass

ess

ing

the

CQ

MS

Man

age

men

t R

evie

w

Understand the

Context

Leadership

Commitment to

Quality

Organizational

Commitment to

Quality

Continual

Improvement of the

Framework


Assessing a Clinical QMS

Value Proposition

• Provides objective evidence of whether or not the

clinical QMS is working effectively in a manner

envisioned by best practices in the industry

• Provides insight into the maturity of the Clinical QMS

relative to principles commonly viewed as effective

within the industry

• Provides opportunities for continual improvement

and moving from a reactive to a proactive mode

What is “Assessing a Clinical QMS”

A gap analysis of an organization’s Clinical QMS vs the

TransCelerate conceptual framework showed that:

• Each element was performing optimally in isolation.

However,

• Identified opportunities to enhance the links between

elements (e.g., knowledge management feeds into issue management and risk management).

Example

• Allows organizations to assess how well their

current and future clinical QMS incorporates the

principles set out in TransCelerate’ s Clinical QMS Concept Paper


ProcessesProcesses








Ass

ess

ing

the

CQ

MS

Man

age

men

t R

evie

w

Understand the

Context

Leadership

Commitment to

Quality

Organizational

Commitment to

Quality

Continual

Improvement of the

Framework


Management Review

Value Proposition

• Provides an opportunity for management to identify,

support, and communicate any necessary changes

to achieve organizational priorities

• Facilitates demonstration of leadership commitment

to and oversight of quality

What is “Management Review”

A presentation of the risk profile of all clinical

development processes:

• Provided management with visibility into how risks

were being managed and

• Supported a decision to realign resources to mitigate

the highest risk.

Example

• Periodic management evaluation of the outputs

of the Clinical QMS elements (e.g., key risks and

issues) as well as the overall performance of the

Clinical QMS to ensure continued alignment with

organizational strategy and prioritiesFoundational Aspects

ProcessesProcesses








Ass

ess

ing

the

CQ

MS

Man

age

men

t R

evie

w

Understand the

Context

Leadership

Commitment to

Quality

Organizational

Commitment to

Quality

Continual

Improvement of the

Framework


WHAT NEXT?

READ ASSESS EMBED

What is a cQMS? What cQMS elements

already exist?

&

What do I need to be

inspection ready?

How do you embed

a cQMS in your

company and

within your culture?

TransCelerate

Resources

TransCelerate

Clinical QMS

Assessment Tool

Document the cQMS - develop

a quality manual/plan and

cQMS education, focus on

quality culture and behaviors

Fundamentals of a cQMS - transceleratebiopharmainc.com · •Anticipating resource and expertise...

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