Part 3 – Communication
This is the third instalment of our blog series on the strategic impact of vendor management and oversight in clinical trials. In this instalment, we will delve into the crucial role of communication in vendor management and oversight to achieve the strategic objectives clinical trial Sponsors.
Clear and efficient communication practices are essential for achieving the below overarching goals to improve organisational outputs:
- Reducing time to market new drugs
- Reduce cost of clinical development
- Increasing quality of clinical trial outputs
- Decrease inspection findings
By prioritising communication, sponsors can build strong relationships with vendors, foster trust, and achieve optimal outcomes in their clinical trials.
Best Practices
Management consultancies often highlight several key strategic activities that contribute to effective communication in a business. Below are some commonly mentioned ones:
- Defining clear communication objectives: align communication efforts with strategic goals. This requires identifying the purpose, audience, and desired outcomes of each communication initiative.
- Conducting a thorough stakeholder analysis: identify key stakeholders and their communication needs. Engaging stakeholders with regular communication and feedback mechanisms fosters trust, alignment, and effective collaboration.
- Crafting clear, concise, and tailored messages: all communication should be aligned with organisational goals, resonate with the audience, and deliver information in a compelling manner.
- Selecting the appropriate communication channels and tools: including face-to-face meetings, email, intranet platforms, social media, or dedicated communication software. Channels should be chosen based on the audience’s preferences and the nature of the message.
- Encouraging two-way communication channels: actively listening to stakeholders, seeking their input and perspectives, and providing feedback loops for them to express their thoughts and concerns.
- Providing training and development opportunities: this enhances employees to develop their ability to convey messages clearly, adapt to different communication styles, and handle challenging conversations.
- Establishing key performance indicators (KPIs): regularly evaluating and analysing communication outcomes enables continuous improvement and adjustment of strategies as needed.
- Developing a crisis communication plan: enables businesses to respond effectively during challenging situations. Requires pre-determined communication protocols, designated spokespersons, and clear guidelines for addressing various scenarios.
Clear and consistent communication is a cornerstone of successful vendor management and oversight. It enables stakeholders to stay informed, aligned, and engaged throughout the clinical trial journey.
The below sections describe how these examples of communication strategies can impact and support the strategic goals of Clinical Trial Sponsors.
Reducing Time to Market New Products
Two initiatives that would support the vendor management and oversight process for clinical trial sponsors to reduce the time to market new drugs are:
Defining clear communication objectives
By aligning communication efforts with strategic goals, clinical trial sponsors can ensure that all vendor-related communications are focused on achieving specific outcomes.
If the objective is to streamline the vendor selection process, the communication objective may be to clearly convey the selection criteria and timelines to potential vendors.
By defining clear objectives, sponsors can ensure that all communication initiatives are purposeful and contribute to the overall goal of reducing time to market.
Example
A clinical trial sponsor defines a clear communication objective to streamline the process of vendor qualification. They communicate the specific criteria, required documentation, and timelines to potential vendors through a well-structured vendor qualification guide.
By doing so, they provide vendors with clear guidance, enabling them to submit complete and accurate information promptly. This clarity and efficiency in communication expedite the qualification process, saving valuable time in vendor selection and onboarding.
Conducting a thorough stakeholder analysis
By identifying key stakeholders and understanding their communication needs, clinical trial sponsors can ensure effective engagement and collaboration throughout the vendor management process.
Engaging stakeholders through regular communication and feedback mechanisms fosters trust and alignment. This is particularly important when managing vendors who play a critical role in the clinical trial process.
Example
A clinical trial sponsor conducts a stakeholder analysis and identifies the Laboratory Manager from the Lab vendor as a key stakeholder. They recognise the importance of timely and transparent communication with the Laboratory Manager to avoid potential delays in sample management and analysis.
As a result, they establish a dedicated communication channel to provide regular updates on trial progress, submit documentation for review, and address any queries or concerns promptly.
This open and proactive communication approach strengthens the relationship with the Laboratory Manager, leading to smoother laboratory analysis processes and faster time to market.
Reduce Cost of Clinical Development
Initiatives that would support the vendor management and oversight process for clinical trial sponsors to reduce the cost of clinical development are:
Selecting the appropriate communication channels and tools
By choosing the most effective and cost-efficient communication channels and tools, clinical trial sponsors can optimise their communication efforts and minimise unnecessary expenses. This ensures that communication reaches the intended audience in a timely and cost-effective manner.
Example
A clinical trial sponsor recognises that regular face-to-face meetings with all vendors may be costly and time-consuming. Instead, they implement a combination of email updates, virtual meetings, and a dedicated communication software platform.
This allows for real-time communication, document sharing, and collaboration without the need for extensive travel or in-person meetings. By selecting these communication channels and tools strategically, the sponsor reduces costs associated with travel, accommodation, and other logistical expenses
Crafting clear, concise, and tailored messages
Effective communication relies on delivering information in a clear and concise manner, tailored to the specific audience. By ensuring that messages are easily understood and relevant to the recipients, clinical trial sponsors can minimise misunderstandings, reduce the need for follow-up inquiries, and avoid costly errors or rework.
Example
A clinical trial sponsor is communicating a change in a specific vendor requirement that could impact project timelines and costs. Instead of using complex technical jargon, they craft a clear and concise message that outlines the change, its rationale, and the expected implications for the vendor.
By providing this information in a straightforward and easily digestible manner, the sponsor ensures that the vendor understands the new requirements, minimising the risk of misinterpretation or costly mistakes in the vendor’s deliverables.
Increase Quality of Clinical Trial Outputs
Initiatives that would support the vendor management and oversight process for clinical trial sponsors to increase the quality of clinical trial outputs are:
Crafting clear, concise, and tailored messages
Effective communication is crucial in ensuring that all stakeholders involved in the clinical trial understand the requirements, expectations, and deliverables. By crafting clear and concise messages that are tailored to the specific audience, clinical trial sponsors can minimise the risk of miscommunication or misunderstanding.
When communicating with clinical trial vendors, sponsors can provide detailed and specific instructions regarding quality standards, protocols, and timelines. Clear and concise messages help vendors understand the expectations and requirements, leading to improved quality in the execution of their tasks.
Establishing key performance indicators (KPIs)
KPIs provide a measurable way to assess the performance and quality of vendor activities. By establishing KPIs related to critical aspects of the clinical trial, sponsors can set clear expectations for vendors and monitor their performance throughout the trial.
For instance, KPIs related to data accuracy, protocol adherence, and timeliness of deliverables can be defined. Regular evaluation and analysis of the KPIs enable sponsors to identify any gaps or areas of improvement, allowing them to take proactive measures to address quality issues promptly.
Example
A clinical trial sponsor identifies the need to improve the quality of data collected during the trial. They craft clear, concise, and tailored messages to communicate the specific data requirements to the clinical trial vendors responsible for data collection and management.
The messages include detailed instructions on data formats, data entry protocols, and quality control measures. By ensuring that the vendors fully understand the expectations and requirements, the sponsor reduces the likelihood of data quality issues and ensures high-quality clinical trial outputs.
Additionally, the sponsor establishes KPIs related to data accuracy, completeness, and timeliness. These KPIs are regularly evaluated and analysed to monitor the performance of the vendors in meeting the defined data quality standards.
Through ongoing communication and feedback loops, the sponsor actively engages with the vendors to address any issues, provide clarifications, and offer support when needed.
This collaborative approach to communication and performance monitoring significantly improves the quality of the clinical trial outputs by ensuring that vendors meet the defined quality standards and deliver accurate and reliable data.
Decrease Inspection Findings
Initiatives that would support the vendor management and oversight process for clinical trial sponsors to decrease inspection findings are:
Conducting a thorough stakeholder analysis
By identifying key stakeholders involved in the vendor management and oversight process, clinical trial sponsors can understand their communication needs and tailor their communication strategies accordingly.
Engaging stakeholders with regular communication and feedback mechanisms fosters trust, alignment, and effective collaboration, which can help identify and address potential issues before they escalate to inspection findings.
Example
A clinical trial sponsor conducts a stakeholder analysis and identifies the Data Monitoring Committee (DMC) as a critical stakeholder in the vendor management and oversight process. Recognising the importance of transparent communication and timely updates with the DMC, the sponsor establishes a structured communication plan.
This plan includes regular meetings to discuss trial progress, safety updates, and any emerging issues. The sponsor ensures that the DMC has access to relevant data and documentation to fulfil their oversight responsibilities.
By maintaining open and collaborative communication with the DMC, the sponsor minimises the risk of inspection findings related to inadequate communication or delays in sharing critical information. This proactive approach fosters trust and alignment between the sponsor and the DMC.
Establishing key performance indicators (KPIs)
By implementing KPIs related to communication in the vendor management and oversight process, clinical trial sponsors can monitor and evaluate the effectiveness of their communication efforts.
Regularly assessing communication outcomes enables continuous improvement and adjustment of communication strategies, reducing the likelihood of miscommunication or lack of clarity that could lead to inspection findings.
Example
A clinical trial sponsor establishes a KPI related to the timeliness and accuracy of vendor communication. They set a target for vendor response time to queries or requests for information, ensuring that vendors provide complete and accurate information within a specified timeframe.
By monitoring this KPI and promptly addressing any deviations, the sponsor ensures that communication with vendors remains efficient and effective. This proactive approach reduces the risk of inspection findings related to inadequate or delayed vendor communication.
Wrapping up
Good communication practices in vendor management and oversight have far-reaching impacts on clinical trials.
Regular meetings, transparent performance monitoring, stakeholder engagement, and the utilisation of communication tools and templates all contribute to effective communication practices.
By prioritising communication, sponsors can foster collaborative relationships with vendors, mitigate risks, and drive successful clinical trial outcomes. These efforts contribute to the advancement of medical research and the timely delivery of innovative treatments to patients in need.
A Word from Mayet
We hope that you found value from the content in this article and some practical examples for implementing better more effective communication into the vendor management and oversight processes for your clinical trials.
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Our solution at Mayet is designed to provide you with all the benefits described in this article with one centralised solution, enabling you to implement more robust communication with all clinical trial stakeholders. Want to learn more, request a short call to discover if Mayet is the right solution for you and your team.
