Faced with increased development costs, delays in studies, and a decrease in the quality of clinical trial outputs, the industry is experiencing an urgent call to transition from a reactive to a proactive mentality – this can also be achieved in vendor management and oversight.
For instance, a study by the Tufts Center for the Study of Drug Development suggested that approximately 80% of clinical trials don’t meet their initial timelines, with vendor oversight playing a significant role in these delays.
Clinical trials live on an everchanging landscape of regulations, designs and new technologies, with a variety of vendors responsible for different parts of a trial.
For trials to succeed, efficient vendor management and oversight is required. This ensures that timelines are adhered to, budgets are maintained, and quality data is generated.
The Days of Reactivity: An In-Depth Look at the Old Ways
The approach to vendor management and oversight in clinical trials has typically been reactive. The primary focus was firefighting, problems were tackled as they surfaced, without a proactive strategy in place to anticipate, identify, and mitigate them in advance of the works undertaken.
The reactive approach to vendor management typically consisted of a series of tasks and duties that were primarily reactive in nature. These include:
- responding to vendor queries
- resolving disagreements over contractual obligations
- handling vendor performance issues
- addressing quality concerns.
This approach prioritises issues instead of strategic planning, leading continuous crisis management.
Adverse Outcomes
Delays:
Issues aren’t identified and mitigated until they’ve already impacted the trial, it can cause significant disruptions.
For example, a problem with the quality of data collected by a vendor might not be detected until a critical analysis phase. At this point, resolving the issue could involve substantial rework, causing delays in trial timelines and even potentially compromising the integrity of the study.
Increased costs:
When problems are not anticipated or mitigated, the cost of fixing them once they’ve occurred is often higher. These costs can be direct, such as the cost of additional resources needed to resolve an issue, or indirect, such as the cost implications of delays to the trial timeline.
Wider impacts (more than just time and money):
- Strained relationship between the sponsor and the vendor
- Impact on team morale
- Teams always in crisis mode
- Higher turnover rate.
The overarching impact of a reactive approach to vendor management can be detrimental to the success of a clinical trial. Worst-case scenario, significant issues can compromise the validity of the trial, leading to reputational damage and undermining trust in the trial sponsor.
Embracing Proactivity: Quality by Design and Risk-Based Quality Management in Detail
Transforming the landscape of vendor management and oversight in clinical trials calls for the adoption of more proactive strategies, such as Quality by Design (QbD) and Risk-Based Quality Management (RBQM). These approaches aim to anticipate and mitigate potential issues.
QbD operates on the principle of integrating quality into every phase of the clinical trial process, from the onset. it emphasises creating a quality roadmap from the start. This roadmap should:
- outline expectations for vendors
- detail robust oversight processes, and;
- establishes effective communication channels
This promotes a proactive approach where potential risks and issues are identified and corrected early on, instead of when corrections may be costly and time-consuming.
Key tasks involved in implementing a QbD approach include:
- drafting comprehensive vendor contracts
- outlining specific performance metrics
- setting up regular communication and review schedules
- developing a quality assurance plan
The objective is to integrate quality assurance as an integral part of the trial. It aims to reduce rework, enhance the efficiency of the trial, and deliver better and more reliable results.
RBQM focuses on the continuous identification, evaluation, and mitigation of risks throughout the trial. RBQM is the understanding that risk is an inherent part of any clinical trial and that proactive risk management is crucial to trial success.
This approach requires understanding of the potential risks in a trial, the ability to detect issues early, and the agility to mitigate these risks promptly and effectively.
RBQM involves a thorough risk assessment at the start of the trial, defining critical-to-quality factors (CTQFs), and setting up a system for ongoing risk monitoring and management. The objective of RBQM is to minimise the impact of any risks that materialise and prevent avoidable issues.
QbD and RBQM represent a shift in mentality, instead of viewing vendor management and oversight as a burdensome necessity, this approach frames it as a strategic function. By emphasising planning and proactive management, vendor management and oversight can become a tool that significantly contributes to the success of a clinical trial.
Key Performance Indicators: Tools for Proactivity
Key Performance Indicators (KPIs) are a critical tool in this proactive approach. KPIs provide measurable performance metrics in areas crucial to the success of the trial. By monitoring KPIs, potential issues can be identified early, and corrective actions can be taken before they escalate.
For example, a KPI could be the percentage of data queries resolved within a certain timeframe. If this KPI begins to decline, it could signal an issue with the vendor’s data management processes that need to be addressed.
Habit Transformation: The Art of Proactive Issue Management
A key factor in proactive vendor management is the commitment to a different approach to issue management. This entails changing from reactive problem-solving to proactive issue prediction, detection, and resolution.
Proactive issue management begins with the identification of potential issues even before they transform into tangible problems. This is achieved by constantly scanning for signs of potential trouble. Identifying irregularities in vendor performance or deviations from key performance indicators (KPIs) serve as early warning signs of potential issues.
Once a potential issue is spotted, clear processes for managing these issues need to be in place. This involves conducting a root cause analysis to understand the source of the issue, determining the best course of action to resolve it, and implementing that action.
Example: a vendor is consistently missing deadlines, proactive issue management approach would involve analysing the cause of the delays, developing a plan to improve their timeliness, and closely monitoring their performance to ensure improvement.
Sponsors must ensure that lessons are learned from each issue. This requires revising strategies, refining processes, and providing additional training to the vendor. The objective is not just to manage issues but to continually improve the process and prevent similar issues from arising in the future.
Regular vendor performance reviews form a crucial part of proactive issue management. Reviews should assess:
- the vendor’s output
- adherence to processes
- responsiveness
- commitment to quality
- Any deviations should be promptly addressed, and plans should be put in place to bring the performance back on track.
A proactive approach still requires escalation processes for issues that arise. These processes should outline who needs to be informed, the steps that need to be taken, and the time frame for resolution. This ensures that issues are identified and handled effectively and in a timely manner.
By identifying and addressing issues early, you can prevent minor issues snowballing into major roadblocks. The proactive approach can lead to streamlined operations, improved vendor relationships, and more successful clinical trials.
Best Practices: Paving the Way Forward
The transition from a reactive to a proactive approach necessitates a shift in habits and mindset. To instigate this change, consider implementing the following best practices:
Early Engagement:
Initiate vendor participation during the trial design phase itself. This ensures that vendors grasp the trial requirements, which, in turn, enables them to plan and execute tasks more effectively.
Example: sharing the trial design with vendors can help them foresee potential challenges and propose solutions ahead of time. Tools such as detailed project plans and mutually agreed upon service level agreements (SLAs) can provide clarity about roles, responsibilities, and expectations from the onset, mitigating the possibility of misunderstandings down the line.
Regular Communication:
Establish a pattern of routine communication with vendors throughout the trial. Regular check-ins, progress meetings, or even informal chats can play a pivotal role in identifying potential issues early and facilitating their swift resolution.
Example: a vendor might reveal during a routine meeting that they are facing resource shortages, allowing you to proactively address the issue before it impacts the trial. Collaborative tools like shared dashboards or regular status reports can be highly effective in maintaining open lines of communication.
Continuous Monitoring:
Implement the use of Key Performance Indicators (KPIs) to continuously monitor vendor performance. KPIs provide quantifiable, data-driven insights into vendor performance, enabling proactive issue management.
Example: a KPI might track the number of protocol deviations by a vendor. An increase in this KPI could indicate a need for retraining or revising protocols. Tools like performance dashboards or automated tracking systems can be invaluable in this regard.
Learning and Improvement:
Treat each issue as an opportunity for learning and growth. Analysing what led to a problem and how it was resolved can provide insights to prevent recurrence and improve the vendor management and oversight process.
Example: a vendor’s error caused a delay, a review might reveal that their training was insufficient. As a result, you might decide to enhance the training provided to vendors. Establishing a culture of continuous learning and improvement requires commitment from all stakeholders, but the payoff in terms of improved efficiency and effectiveness can be substantial.
Sponsors can create an environment of proactive vendor management and oversight, leading to improved trial outcomes, increased efficiency, and stronger vendor relationships.
Wrapping Up
To streamline this transition, it’s advantageous to deploy a centralized vendor management system, assuming one isn’t already functioning. Systems such as this aid in monitoring managing vendor-related risks, performance metrics ,and fortifying effective communication among all stakeholders.
Infusion of technology in this process is a game-changer, providing real-time insights, enhancing collaboration, and automating routine tasks. Zeroing focus on strategic oversight, optimising vendor performance, and delivering quality results.
The pay-outs of this shift are boundless – diminished costs, enhanced timelines, and superior-quality outcomes are just the tip of the iceberg. Embrace this change and steer your clinical trials proactively towards the horizon of success.
