Part 2: Resource Optimisation

Welcome back to our series on the strategic impact of vendor management and oversight in clinical trials. In part one, we discussed the importance of risk management. In this article, we explore how resource optimisation in vendor management and oversight impacts:

• Reducing time to market new drugs
• Reduce cost of clinical development
• Increasing quality of clinical trial outputs
• Decrease inspection findings

Below is a list of some common methods that businesses employ for resource optimisation:

1. Automating repetitive tasks can help save time and increase efficiency. This can be done using technology, such as software or machinery.
2. Delegating tasks to team members who are best suited for them can help ensure that work is completed efficiently and effectively.
3. By identifying areas of a process that can be simplified or eliminated, businesses can reduce the amount of time and resources needed to complete the process.
4. Outsourcing non-core functions can help businesses save time and money. For example, outsourcing accounting or IT functions can allow businesses to focus on their core competencies.
5. Project management tools can help businesses track progress, set timelines, and allocate resources effectively.
6. Implementing a risk-based approach, identifying and mitigating risks associated with a project can help reduce delays and save resources.
7. By analysing the costs and benefits of different options, businesses can make informed decisions about where to allocate resources.
8. Negotiating pricing with vendors can help businesses save money on goods and services.

Effective management of vendors can save time and costs, prevent delays, and ensure compliance with regulatory requirements.

Achieving these benefits requires a clear understanding of roles and responsibilities, and optimising the use of various resources to achieve the objectives of vendor management and oversight.

The examples listed in this blog are not exhaustive, and the principles of resource optimisation listed below can impact each of the strategic objectives of clinical development in multiple ways.

Reducing Time to Market New Products

Time efficiency is a critical factor in clinical development programs, and resource optimization can significantly reduce the time it takes to bring new drugs to market. Some examples that enable this include:

• Streamlining processes, eliminating unnecessary tasks, and focusing on critical aspects of the clinical trial is achieved by adopting a systematic approach to vendor management and oversight. This is achieved by identifying the various processes involved in clinical trial management and mapping out the workflow. This identifies areas where processes can be streamlined, eliminated, and prioritised.
• A risk-based quality management approach to vendor management can build quality into the Sponsor-Vendor relationship and ensure that vendors have the necessary resources to perform their tasks. This approach involves identifying and mitigating risks that have the greatest potential impact on the success of the clinical trial.
• Automation tools/Software to reduce manual tasks and improve efficiency. Sponsors can implement a tool to monitor and manage vendor performance, such as a vendor scorecard, KPI or deliverables tracker. Automation can reduce the risk of errors and inconsistencies in the data collected.

Automated tools can take the form of dashboards, coded spreadsheets, bespoke vendor management software, project management task and objective tracking software.

Reduce cost of clinical development

Resource optimization in clinical trial vendor management and oversight can reduce costs for Sponsors by:

• Streamlining processes, eliminating unnecessary tasks, and focusing on critical aspects. By doing so, Sponsors can reduce the workload on their teams and avoid the need to hire additional staff. This can result in significant cost savings, which can be allocated to other areas of the business.
• Use project management tools, such as Trello or Asana, to automate task assignment and notification. This can help streamline communication, eliminate unnecessary meetings, and reduce the workload on team members.
• Conduct cost-benefit analyses of vendors to compare pricing and quality of service. By selecting vendors that provide value for money, Sponsors can save money, but most approach with caution because cost does not = value.

An impact of saving costs means that resources can be reallocated to help improve overall efficiency, increase profitability, and enable Sponsors to invest in new projects and initiatives.

Increasing quality of clinical trial outputs

To achieve improved quality of clinical trial outputs through resource optimisation of vendor management and oversight, clinical trial Sponsors can take several steps:

• Streamlining the vendor selection and qualification process by using a standard library of tools and templates for vendor assessments. Ensuring that vendors are systematically and consistently qualified and teams have the ability to perform robust oversight.
• Implementing risk-based quality management approaches to identify and mitigate risks associated with vendor non-compliance. Including continuous monitoring of vendor KPIs, and deliverable trackers and scorecards to evaluate quality and performance.
• Optimising communication and collaboration between clinical trial Sponsors and vendors can be improved using project management tools and automation. Ensuring that vendors are aligned with the objectives of the clinical trial and deliverables to the expected standards.
• Utilisation of vendor oversight software to monitor vendor performance and ensure that documentation and records are properly maintained. This can help prevent quality issues and manage identified issues more effectively.

Decrease Inspection Findings

A combination of the applicable points mentioned above can be applied to vendor management and oversight processes to achieve decreased inspection findings.

• A risk-based approach can be implemented. This approach involves identifying the risks that may impact the success of the clinical trial and implementing measures to address them. For example, vendors can be selected based on their track record of quality and their ability to meet the regulatory requirements.
• Documentation and record-keeping can be optimised to ensure that all records related to vendor management and oversight are complete, accurate, and easily accessible. This can include implementing electronic documentation systems, using standardized templates for vendor assessments, and maintaining a centralized repository for all vendor-related records.
• Communication and collaboration with vendors can be established to ensure that all parties are aligned with the overall objectives of the clinical trial. This could mean implementing a comprehensive communication plan to ensure that all stakeholders are informed about important developments.

Additionally, implementing an effective vendor management and oversight software can help automate and streamline these processes, enabling Sponsors to achieve improved outcomes more efficiently.

Summary

If you reached this part of the article, I am hopeful that you found it useful and further identified Vendor management and oversight in clinical trials as essential for achieving strategic objectives of clinical development.

To achieve these objectives, clinical trial Sponsors must deploy methods such as streamlining processes, delegating tasks, outsourcing non-core functions, utilizing project management tools among the others listed in the article.

An undeniable driver of this mandate is the use of vendor management and oversight software to streamline these processes, enabling Sponsors to achieve improved outcomes more efficiently. By effectively managing vendors, Sponsors can ensure that their trials are completed on time, budget, and to the highest quality standards.

A Word on Mayet

At Mayet, the core aspects of these strategic objectives are central to why we exist. Our platform emphasises automating repetitive tasks, streamlined vendor assessment, and implementing risk-based quality management to ensure efficiency, cost-saving, and top-tier quality outputs.

By utilising Mayet, clinical trial Sponsors are equipped to achieve their strategic objectives more efficiently, ensuring treatments reach patients faster and within the highest standards.