Critical to Quality Factors and Vendor Oversight: A Systematic Redirection Towards Proactive Management

In the constantly evolving arena of clinical trials, integrating risk-based quality management, and identifying and managing critical to quality factors is rapidly becoming a core tenet of successful trial delivery.

If you’re part of a clinical trial team or a clinical trial sponsor organisation, you’re likely well-acquainted with the challenges and problems that accompany the requirements of vendor oversight.

In this article, we’re covering the transformation towards proactive vendor management and oversight in clinical trials. Specifically, the application of risk-based quality management and critical to quality factors in this domain.

We will also discuss applications of a data-driven, targeted risk management approach that emphasises how the identification, accountability, and review of these aspects can vastly improve the overall quality and delivery of clinical trials.

The Age-Old Problems with Vendor Oversight

Vendor oversight in clinical trials has typically been burdened with significant impacts on study quality issues. This includes delays due to rework required by vendors, to burdensome preventable issues.

These factors can often lead to a negative impact on study quality and even regulatory submission quality.

To manage these issues, the trial sponsor must act in a reactive manner. Remedial activities include extensive reviews and rectifying of the work delivered by the vendors, which can lead to substantial delays in the trial timeline.

They also deal with regulatory authorities, addressing and correcting submission quality issues or inspection findings that arise due to these vendor-induced setbacks, adding further to the burden and potentially jeopardising the approval of the product.

Dealing with problems as they occur, is costly and inefficient. It delays trials, increases administrative burden, and compromises the overall integrity of the study.

In an era where regulatory agencies are increasingly scrutinising the quality and integrity of clinical trials, such a reactive approach isn’t acceptable.

The Power of Proactivity in Vendor Oversight

Sponsors must shift from reactive to proactive, using a risk-based quality management strategy. Risk-Based Quality Management (RBQM) is a holistic approach focusing on the early identification and mitigation of risks, ensuring data integrity and patient safety.

The process begins with the identification of Critical to Quality Factors (CTQFs) – aspects of the clinical trial that have a direct impact on patient safety and the reliability of trial results. These CTQFs must be identified in the protocol design stage and form the basis for the proactive risk management plan.

In application to the oversight of vendor activities sponsors can reduce the potential of costly and time-consuming issues down the line. And by identifying Critical to Quality Factors at the protocol design stage, sponsors can align vendor activities with these critical aspects of the study.

As clinical trial teams and sponsor organisations, the onus is on you to deliver these new ways of working. Through proactive risk management and a data-driven approach, we can ensure that clinical trials are conducted with the highest standards of quality and integrity.

Quality by Design: The Way Forward

A proactive approach to vendor oversight, applying the principles of RBQM, can become a core component of the Quality by Design (QbD) approach to clinical trials. This approach emphasises the importance of designing quality into the trial from the beginning, rather than trying to ‘inspect’ quality in at later stages.

A proactive, risk-based approach to vendor oversight minimises preventable issues and reduces rework, and results in trials that are more efficient, cost-effective, and compliant with regulatory expectations.

It contributes to better study quality, enhancing the credibility of the data and supporting regulatory submission quality.

Remember, vendor oversight is not just a regulatory requirement; it’s a strategic imperative that has a direct impact on the success of your clinical trials.

Harnessing Critical to Quality Factors for Enhanced Vendor Oversight

Once CTQFs are identified, the next step is to integrate these into a data-driven approach to risk management.

This targeted risk management approach—integral for effective vendor oversight—is underpinned by the core principles of identification, prioritisation, accountability, and review.


Pinpointing potential risks early, to enable pre-emptive mitigation strategies that reduce the likelihood of delays or quality issues linked to vendor activities.


Assess risks based on their potential impact on CTQFs, enabling more efficient allocation of resources to mitigate the most critical risks to the study that are related to vendor activities.


Assign ownership of each identified risk, especially those tied to CTQFs, ensuring effective execution of mitigation strategies and preventing oversight gaps in vendor-related risks.


Regular review of risks and associated mitigation strategies, especially those concerning CTQFs and vendor performance, maintaining the risk management strategy throughout the trial.

Embracing Proactive Vendor Oversight for CTQFs: A Step-By-Step Guide

Transitioning to proactive vendor oversight, for activities impacting critical to quality factors, can be challenging, however with a structured approach, it becomes manageable.

Here is a step-by-step guide to help you navigate this journey:

Step 1: Understand your vendors

Begin by thoroughly understanding your vendors. This understanding includes not only who they are but also their capabilities, particularly in tasks affecting CTQFs. What is their track record in ensuring quality in these critical areas?

Comprehensive knowledge of your vendors allows you to identify potential risks and implement mitigation strategies to address them.

Step 2: Establish clear expectations

These expectations should emphasise the importance of CTQFs.

  • What standards must be maintained to ensure these factors are not compromised?
  • Which processes are contribute to the CTQF?
  • What timelines need to be followed?

By defining expectations clearly, you confirm that your vendors align with your priorities and commit to a RBQM strategy.

Step 3: Implement a robust, data-driven monitoring system

Proactive oversight of vendor activities impacting CTQFs requires a robust and data-driven monitoring system. This should enable you to track vendor performance against CTQFs, identify potential deviations early, and take immediate action to mitigate risks.

Utilising a data-driven system, you gain the insights necessary to manage your vendors effectively, particularly around these critical areas.

Step 4: Foster open communication

Regular check-ins, status updates, and feedback sessions focused on CTQF performance facilitates identification of any potential issues. By addressing issues promptly, you can prevent them from escalating and impacting the quality of your clinical trials.

Step 5: Regularly review and revise your strategy

When reviewing your strategy you must evaluate its effectiveness, particularly around maintaining oversight of vendor associated CTQFs, make revisions when gaps are identified.

Continuous improvement in vendor management practices will ensure your clinical trials meet the highest quality standards.

Wrapping Up: Proactivity as the Key to Quality

As clinical trial teams and sponsor organisations, you need to embrace a proactive, data-driven approach to vendor oversight and risk management.

Focusing on CTQF identification, prioritisation, accountability, and review, you can ensure that trials are conducted with a risk-based approach to improving quality, efficiency, and integrity.

Remember, proactive vendor oversight isn’t about avoiding problems; it’s about creating a more efficient, and more reliable clinical trial process. Prioritise quality by design and put the power of proactivity to work in clinical trials.


Guest blog by
Tom Lazenby
August 2023

Tom is the Founder and CEO of Mayet, solution provider transforming the clinical research sector through advanced vendor management solutions. Using his experience in streamlining operations and driving innovation in clinical research, Tom is dedicated to enhancing the efficiency, cost-effectiveness, and risk mitigation strategies in vendor management.

Mayet Blog 

Tom on LinkedIn 


2 thoughts on “Critical to Quality Factors and Vendor Oversight: A Systematic Redirection Towards Proactive Management

  1. Thank you Tom. A nice summary of how to use CTQ factors in vendor oversight. One of the challenges I see in the industry is in identifying those CTQ factors. I have seen very few examples of what they might look like and I’ve even seen organizations confusing them with critical risks. Really, CTQ factors are the “hazards” to which there are a number of risks. Some of those risks relate to vendors. Have you seen any good proactical examples of CTQ factors? Keith

    1. Hi Keith, good question and I would be very interested to get your views on this given your experience at Cyntegrity, an RBQM specialised organisation, where I assume you should have a strong definition for these already.

      My views and suggestions are based upon the definitions that we see in ICH E6 and E9, that is “A Critical to Quality Factor is an aspect of the clinical trial protocol or the procedures required to achieve the protocol, that when carried out have the greatest impact on the success of the clinical trial in terms of Patient Safety and wellbeing, Quality of data and compliance to all regulations and guidelines.” – These should also in my opinion be defined in terms of the study and are not arbitrary, as I hope my examples will demonstrate.

      To give some examples:
      1. A primary endpoint that involves a biopsy and pathology test, this output might be considered as a critical to quality factor, however we can also see that there are some key processes within the required output, including:
      – The procedure for taking the biopsy
      – Sample management and handling
      – The pathology testing of the biopsy
      – Data Management and data security of transferred biopsy data

      2. Informed consent for a paediatrics clinical trial, typically although Informed Consent is a Critical Regulatory requirement, I would not consider a standardised process across the industry such as this as a CTQF, however in the right setting such as paediatrics where we have to consider the multi stage, consent and assent completed by both the patient and the parent/legal guardian/representative, this is where the impact of the process on the overall success of the study is raised to a level that might bring it to consideration as a CTQF.

      3. Endpoint related to Complex mathematical or statistical data analysis e.g. Bioinformatics, Genomics etc. It is a common trend that most people would select the study endpoints as a CTQF, however as above these are really outcomes and the CTQFs themselves are more in the detail of how these are achieved, and so for this example you might consider the following processes or aspects of these processes as the CTQFs:
      – Data Transfer
      – Data Tranformation
      – Data QC Checks
      – Data Analysis/Reporting

      I hope that these examples prove useful and if you have any more questions please get in touch via the links at the end of the blog.

Leave a Reply

%d bloggers like this:
search previous next tag category expand menu location phone mail time cart zoom edit close