Clinical Trials are complex and even more so when multiple key deliverables are outsourced by Sponsors. It is critical for Sponsors to ensure regulatory compliance and patient safety and data integrity. The cost of non-compliance can be significant and anxiety-inducing to the most diligent clinical research professionals.
Regulatory inspection findings can lead to increased scrutiny, delays, and even trial termination. In this blog, we will discuss best practices for maintaining regulatory compliance in vendor management and oversight, specifically addressing the costs associated with inspection findings.
According to a report by the Tufts Center for the Study of Drug Development, the average cost of a regulatory inspection finding for a clinical trial sponsor is $1.8 million. The report also found that the average delay in approval for a drug due to regulatory non-compliance is 7.4 months.
Source: “Impact of Regulatory Compliance Issues on Investigational Site Selection and Start-Up Delays,” Tufts Center for the Study of Drug Development (2014).
Sponsors are ultimately responsible for the conduct of their clinical trials, including oversight of vendors and service providers. This oversight involves:
- selecting and qualifying vendors
- establishing clear expectations and deliverables
- monitoring vendor performance throughout the duration of the trial
Effective sponsor oversight can mitigate risks associated with vendor non-compliance and ensure regulatory compliance, leading to more efficient and high-quality trials, which is something that we all take pride in delivering.
The Costs of Non-Compliance
Non-compliance with regulatory requirements can lead to several types of losses for sponsors.
Delays in trial completion and regulatory approval
Regulatory inspection findings can result in the suspension of clinical trials until corrective actions are taken. This can lead to significant delays and increased costs for sponsors as they must spend additional time and resources to address the issues and resubmit their applications for regulatory approval.
Increased monitoring and oversight from regulatory authorities
Significant non-compliance can trigger additional audits and inspections, which can consume valuable time and resources that sponsors will otherwise have invested in advancing their clinical programs.
Trial termination
In some cases, non-compliance can result in trial termination, requiring sponsors to start over and incur additional costs. This is a worst-case scenario that can have significant financial and reputational consequences for sponsors.
Best Practices for Maintaining Regulatory Compliance
Establishing clear expectations and deliverables for vendors
Sponsors must clearly outline requirements for data management, patient safety reporting, and adverse event reporting in contracts and quality agreements with vendors. This sets expectations and establishes the consequences of non-compliance.
Contracts and quality agreements must include clauses that allow sponsors to terminate contracts if vendors fail to meet regulatory requirements.
Conducting ongoing vendor assessments
Assessments must be conducted on an ongoing basis to ensure that vendors are meeting expectations and regulatory requirements. Site visits, audits, and documentation reviews are all essential components of an effective vendor assessment program.
For example, if a sponsor is working with a clinical research organisation (CRO), the sponsor conducts audits to review CRO processes for managing clinical trials, such as site monitoring, data management, and safety reporting.
Implementing a risk-based quality management approach
Sponsors use a risk assessment framework to identify and prioritise risks associated with vendor non-compliance. This includes assessing risks related to data integrity, patient safety, and regulatory compliance. Once risks are identified, sponsors must develop risk mitigation plans.
For example, if a sponsor is working with a vendor to manage clinical trial data, the sponsor will conduct a risk assessment to identify risks related to data security and then develop a risk mitigation plan that includes security protocols for data transfer and storage.
Effective communication and engagement with vendors
Successful communication and teamwork aid the prompt and successful identification of issues or concerns. Sponsors set up frequent channels of communication with suppliers, such as weekly or biweekly conference calls or progress updates. This could be detailed in a communication plan.
This gives the sponsor the opportunity to resolve any difficulties or concerns that may develop, such as unforeseen delays or safety concerns.
Detailed documentation of vendor management and oversight activities
Detailed documentation and records are evidence of compliance and mitigate risks associated with regulatory inspections.
For example, documentation can include detailed records of vendor assessments and audits, as well as copies of quality agreements and contracts.
By maintaining detailed records, sponsors demonstrate their commitment to regulatory compliance and provide evidence of their efforts to ensure compliance throughout the clinical trial.
Tools and Templates for Implementing Best Practices
To implement these best practices, sponsors can use a variety of tools and templates. These include:
Quality Agreements
A quality agreement is a written agreement between a sponsor and vendor that outlines each party’s responsibilities regarding quality management and regulatory compliance. Quality agreements are useful because they clearly define the expectations of both parties and establish a framework for addressing issues related to compliance.
By implementing a quality agreement, sponsors and vendors can prevent potential losses associated with regulatory inspections and delays in trial completion.
Vendor Assessment Forms
Vendor assessment forms are tools to evaluate vendor performance and identify risks and non-compliance. They include questions related to vendor qualifications, experience, resources, and compliance with regulatory requirements.
By using a vendor assessment form, sponsors can identify potential risks associated with vendor non-compliance and take corrective action to prevent losses such as trial delays, regulatory sanctions, and reputational damage.
Risk Assessment Templates
A risk assessment template is a tool for identifying and assessing risks related to vendor noncompliance, as well as developing risk mitigation actions. A list of potential hazards and a scoring system to measure the possibility and impact of each risk are often included in the template.
Sponsors can proactively identify potential risks and take measures to manage them by employing a risk assessment template, avoiding losses such as regulatory findings, trial delays, and reputational damage.
Communication Plan
A communication log is a tool for documenting all communication between sponsors and vendors during the trial. Emails, phone calls, and meetings are all examples of this. Communication logs are useful because they keep track of all communication and can be used to establish regulatory compliance.
Sponsors can avoid losses related to regulatory inspections and vendor disputes by keeping a communication log.
Summary
Sponsors are required to establish a robust system for Vendor Management and Oversight which enables them to maintain regulatory compliance in the regions in which they operate. To meet the minimum expectations, they must create processes to:
- establish clear expectations and deliverables in contracts and quality agreements
- conduct ongoing vendor assessments
- implement a risk-based quality management approach
- maintain strong communication and collaboration
- document all activities
Using tools and templates like quality agreements, vendor assessment forms, risk assessment templates, and communication logs can significantly improve the effectiveness and efficiency of these best practises, ultimately lowering the significant costs associated with inspection findings.
A word on Mayet
If you made it to the end of this blog, I hope that you were able to take a few nuggets of value away with you. At Mayet, we want to improve clinical trial delivery globally, regardless of whether it is with paying clients or people making use of our resources.
Mayet has been developed to enable Clinical Trial Sponsors to perform all these tasks without thinking, becoming a first-of-its-kind tool for ensuring compliance through design for vendor management and oversight. Leading to greater efficiencies in trial management and oversight with the bonus of improved compliance for the Sponsor and the Vendor and increased quality of deliverables from vendors, all culminating in efficient trials with robust data and safe patients.
If you want to learn more about the processes, regulations, and best practices for vendor management and oversight and how using technology boost the gains of robust process, check out our whitepaper “The Missing Piece to Clinical Trial Success: Why Vendor Management and Oversight Matter More Than You Think”.
