Part 1 – Risk Management
Clinical trial sponsors face numerous challenges in managing vendors and ensuring the success of their trials.
Clinical trial sponsors must take a strategic approach to vendor management. This involves aligning vendor management with business strategy to ensure that vendors are selected, managed, and evaluated in a way that supports the overall goals of the trial.
By taking this approach, sponsors can:
- Reducing time to market new drugs
- Reduce cost of clinical development
- Increasing quality of clinical trial outputs
- Decrease inspection findings
In this article we will discuss Risk Management process in vendor management and oversight and how it supports the strategic goals listed above, we will analyse examples of pains, competitive advantages and practical examples.
By aligning vendor risk management with business strategy, sponsors can mitigate the challenges posed by vendor management and oversight.
Clinical trial delays affect not just study costs but subsequent sales, causing potential losses of $600,000 to as high as $8 million per day, according to a CenterWatch study. This highlights the importance of effective vendor management in clinical trials and the potential costs associated with non-compliance and delays.
Reducing time to Market New Products
Risks associated with vendor non-compliance can lead to delays in trial completion and regulatory approval, which can significantly extend the timeline of drug development.
Delays in trial completion and regulatory approval can result in significant costs for sponsors and loss of potential revenue for the drug. It can also prolong the time it takes to bring a new drug to market, which can be frustrating and demotivating for sponsors.
By implementing effective risk management practices, sponsors can reduce the likelihood of delays and accelerate the time to market for new drugs. This can give them a competitive advantage by allowing them to bring their drugs to market faster than their competitors.
Example:
A pharmaceutical company is developing a new drug for a rare disease. The drug has the potential to be a game-changer in the market, but the company is working with several vendors to conduct the necessary clinical trials. If one of the vendors fails to comply with regulatory requirements, it could delay the completion of the trial and the drug’s approval, costing the company significant amounts of money and time. By implementing a risk-based quality management approach, the company can identify and mitigate potential risks associated with vendor non-compliance, reducing the likelihood of delays and accelerating the time to market for the new drug.
Reduce cost of clinical development
By implementing a risk-based quality management approach, sponsors can identify and mitigate risks early on, reducing the likelihood of delays and reducing the cost of developing new products.
Developing new drugs is an expensive and time-consuming process. Implementing a risk-based quality management approach can help sponsors reduce costs associated with potential delays in trial completion and regulatory approval.
Sponsors that can bring new drugs to market faster than their competitors can gain a competitive advantage in the market and capture a larger share of the market.
Example:
A biotech company is developing a new cancer drug. The company is working with several vendors to conduct the necessary clinical trials, but there are potential risks associated with non-compliance that could delay the completion of the trial and regulatory approval. By implementing a risk-based quality management approach, the company can identify and mitigate potential risks early on, reducing the likelihood of increased costs related to rework and resources spent on remedial actions.
Increasing quality of clinical trial outputs
Effective risk management practices can lead to higher quality clinical trial outputs.
Poor quality clinical trial outputs can lead to delays in drug development and regulatory approval, resulting in significant costs for sponsors. It can also lead to a loss of potential revenue for the drug.
Sponsors that consistently produce high-quality clinical trial outputs can gain a competitive advantage by building a reputation for reliability and quality.
Example:
A medical device company is developing a new product and is working with several vendors to conduct clinical trials. Effective risk management practices can help the company identify and mitigate potential risks associated with vendor non-compliance, resulting in higher quality clinical trial outputs. This, in turn, can lead to a faster time to market for the new medical device and a stronger reputation for quality and reliability.
Decreased Inspection Findings
Implementing a risk-based quality management approach for vendor management and oversight can reduce the number of regulatory inspection findings, which can save sponsors significant amounts of money in the long run.
Regulatory inspection findings can lead to costly delays, additional monitoring, and even trial termination, resulting in increased expenses and wasted resources. By reducing the number of regulatory inspection findings, sponsors can avoid these negative consequences and save valuable time and money.
By minimizing regulatory inspection findings through effective risk management practices, sponsors can establish a reputation for compliance and quality, which can differentiate them from competitors and increase their chances of regulatory approval.
Example:
A clinical trial sponsor implemented a risk-based quality management approach to identify and mitigate potential risks associated with vendors. As a result, the sponsor was able to avoid multiple regulatory inspection findings, which saved them a significant amount of money and time, and ultimately helped them to bring their drug to market faster.
Summary
Effective vendor management and oversight are critical to the success of clinical trials. By aligning vendor risk management with strategic goals, sponsors can mitigate risks associated with vendor non-compliance and optimize the use of their resources.
This approach can result in reduced time to market for new drugs, reduced costs of clinical development, increased quality of clinical trial outputs, and decreased inspection findings.
It is essential for clinical trial sponsors to adopt a strategic approach to vendor management and implement risk management practices to ensure the success of their clinical trials. By doing so, they can gain a competitive advantage and differentiate themselves in a highly competitive market.
