This blog post is inspired by an analogy brought up by Terttu Haring from Syneos who was sitting on a panel discussion. Terttu interestingly compared outsourcing strategies and selection of service providers with how we do grocery shopping (I’ll clarify below).
This made me think more about the end-to-end process of vendor management and oversight from grocery shopping (selection) to plating a perfect meal for your loved ones (publishing trial results). Interestingly in this analogy those working in the Sponsor managing these providers have the most important role as the Chef.
The chef must keep everything neat, weight their ingredients, taste for quality and much more. It is in all these processes where if the ingredients or tools are not fit for purpose then the outcome does not meet the requirements.
At the Grocery Store: Vendor Selection
For routine, everyday meals, we often rely on supermarket ingredients. They’re convenient, accessible, and cover all our basic needs. This is like using full-service offering (FSO) outsourcing strategy in clinical trials, where a single Contract Research Organisation (CRO) manages the entire process.
Conversely, preparing a special meal often involves a trip to specialist shops: the butcher for the perfect cut of meat, the grocer for the freshest produce, and maybe a spice shop for that secret ingredient. This mirrors a functional service providers (FSP) strategy in clinical trials, where each task or function is handled by a specialised vendor, ensuring top-notch quality and expertise for each component.
There is also a hybrid approach, combining the convenience of FSO with the precision of functional service providers (FSPs) for niche areas. Here, you use a full-service provider to cover most of your needs but bolt on specialised services for critical areas.
This would be like buying most of your ingredients from the supermarket but visiting specialist shops for gourmet touches.
N.B the FSO itself will leverage its own network of outsourcing partners, effectively shopping in the FSP model to deliver your study with enhanced efficiency and quality.
In the Kitchen: Managing Delivery
Now that the ingredients have been purchased everything needs to be prepared and delivered, this is where Clinical Operations, Outsourcing Managers and Quality must work together to ensure that every service that has been contracted works harmoniously to deliver the best possible clinical trial outcome.
Mise en Place: Planning and Coordination
In the kitchen, mise en place (everything in its place) is crucial. Similarly, thorough planning and coordination are essential in clinical trials:
- Creating a Detailed Plan: The chef meticulously plans each stage of meal preparation, you need to develop a comprehensive trial plan. Outline every step, from patient recruitment to data analysis. Define clear timelines, responsibilities, and deliverables for each provider. This detailed planning ensures that every element of the trial is accounted for.
- Risk Management: Just as a chef anticipates and mitigates potential issues in the kitchen, you must identify and manage risks throughout the trial. Implement a risk management plan to foresee potential challenges, develop contingency strategies, and ensure that every team member knows how to handle unexpected problems effectively.
- Coordinating with Teams: In a kitchen, all team members must work in harmony to prepare a meal efficiently. Ensure seamless communication and collaboration among all providers involved in the trial. Regular meetings, clear communication channels, and collaborative tools can help synchronise efforts.
- Leveraging FSO Partners: Remember that even full-service outsourcing (FSO) providers often use their own network of specialised partners. It’s similar to a head chef who oversees sous chefs and line cooks, each contributing their expertise to the final dish. Maintain oversight and clarity on all involved parties to ensure everyone is aligned with the trial’s objectives.
Execution: Managing the Process
As the trial progresses, your role is to oversee the execution, like a chef managing and performing the cooking processes and steps:
- Monitoring Progress: Just as a chef monitors the cooking process to ensure each dish is prepared perfectly, you need to regularly track each provider’s performance against timelines and quality benchmarks. Implement regular check-ins and status updates to keep the project on track. This vigilance helps identify potential issues early, allowing for timely adjustments.
- Quality Control: Continuously review processes and data for accuracy and compliance, much like a chef tastes and adjusts dishes throughout cooking. Implement quality control measures at each trial phase to ensure that all data collected is accurate and reliable. This proactive approach helps maintain the trial’s integrity and credibility.
Adjustments: Flexibility and Problem-Solving
Even the best-laid plans can encounter challenges. A chef adjusts seasoning or cooking times as needed, and you must be ready to:
- Address Issues Promptly: Quickly resolve any problems, such as delays or compliance concerns, to keep the trial on track. This is akin to a chef quickly correcting a dish that’s not turning out as expected. Prompt action ensures that issues are contained and do not escalate, safeguarding the trial’s progress.
- Stay Flexible: Be adaptable in your approach, ready to pivot strategies or providers if necessary to maintain progress and quality. Just as a chef might substitute ingredients based on availability or adjust cooking techniques, your flexibility ensures that the trial can adapt to changing circumstances without compromising its integrity.
Presentation: Delivering the Final Product
The culmination of a chef’s work is the presentation of a beautifully plated dish. In clinical trials, this is the delivery of high-integrity data, on budget, and in compliance with regulations:
- Final Review: Conduct thorough final checks of all data and reports, ensuring completeness and accuracy. This is like a chef’s final inspection before a dish is served. Ensure that every aspect of the trial is thoroughly reviewed and validated, guaranteeing the quality of the final output.
- Effective Communication: Clearly present findings to stakeholders, ensuring they understand the results and the integrity of the trial, including peer review like a food critic trying the meal.
Continuous Improvement: Refining Your Approach
Great chefs continually refine their recipes and techniques. Similarly, Pharma and Biotech trial Sponsors should:
- Learn from Each Trial: Analyse what worked well and what didn’t, applying these lessons to future studies. This ongoing learning process is crucial for continuously improving your trial management strategies, much like a chef perfecting their culinary skills over time.
- Stay Updated: Keep up with industry trends and innovations to enhance your approach continually. Just as chefs stay current with culinary trends and new cooking techniques, staying informed about the latest developments in clinical research ensures that your strategies remain cutting-edge and effective.
By deploying your clinical trial strategy with the precision, creativity, and diligence of a master chef, you can manage providers effectively and deliver exceptional results. Each step, from selecting providers to presenting final data, contributes to the overall success of your clinical trials.
The Chef’s Tools: Enhancing Vendor Management with Technology
In the culinary world, a chef’s tools are essential to crafting exquisite dishes. High-quality knives, precise scales, reliable pans, and a consistent oven all contribute to the seamless execution of a meal. Similarly, in clinical trials, using the right tools for vendor management can make all the difference between a smooth, efficient process and a chaotic, disjointed one.
Various tools, including clinical trial management software (CTMS), centralised communication platforms, data analytics tools, and compliance monitoring systems, play pivotal roles in this process. Among these, we also have bespoke vendor management software for clinical trials such as Mayet.
Mayet: The Chef’s Professional Kitchen
Mayet serves as the professional kitchen for outsourcing managers, procurement, clinical operations, and clinical quality teams. Just as a chef relies on an array of tools to perfect their culinary creations, these professionals can rely on Mayet to streamline and enhance their vendor management and oversight processes.
Knives: Precision in Selection
A chef’s knives are vital for precision cutting, allowing them to prepare ingredients to exact specifications. Mayet acts as the sharp knife in your toolkit, enabling you to:
- Precisely Evaluate Vendors: Cut through the clutter with detailed insights into vendor performance, capabilities, and history. Mayet provides clear, organized data that helps you make informed decisions about which vendors to select for your clinical trials.
Scales: Accurate Measurement
Just as a chef uses scales to measure ingredients accurately, ensuring the right proportions and consistency, Mayet ensures:
- Accurate Tracking and Reporting: Maintain precise records of vendor activities, risks, performance metrics, and compliance. This accuracy helps in monitoring progress and making data-driven decisions, ensuring your trial stays on track and within budget.
Pans and Ovens: Reliable Execution
High-quality pans and ovens are essential for reliable cooking, providing even heat and consistent results. Mayet functions as your dependable kitchen equipment, offering:
- Consistent Process Management: Streamline workflows and standardize processes across all vendors. Mayet’s platform ensures that every aspect of vendor management is handled consistently, reducing the risk of errors and enhancing overall efficiency.
Comparisons to Manual Systems
Using manual, disparate systems for vendor management is akin to a chef trying to cook a gourmet meal with mismatched, unreliable tools. Here’s how Mayet stands out in comparison:
- Efficiency vs. Fragmentation: Manual systems often lead to fragmented processes, where information is scattered and difficult to manage. Mayet consolidates all vendor-related data into a single platform, making it easy to access, track, and manage.
- Consistency vs. Variability: Disparate systems can result in inconsistent processes and outcomes. Mayet provides a standardised approach, ensuring that every vendor is managed with the same level of scrutiny and precision.
- Visibility vs. Obscurity: With manual systems, gaining a clear overview of vendor performance and compliance can be challenging. Mayet offers real-time visibility into all vendor activities, allowing for proactive management and quick issue resolution.
- Integration vs. Isolation: Manual processes often operate in silos, hindering collaboration and communication. Mayet integrates all aspects of vendor management, fostering better collaboration and coordination among teams.
Wrapping Up
Managing clinical trials is like preparing a gourmet meal, requiring meticulous planning and execution. Inspired by Terttu Haring’s analogy, it involves selecting the right vendors (ingredients) and ensuring seamless coordination and quality control.
Pharma and Biotech Sponsors, as the chefs, must choose between full-service outsourcing (FSO), functional service providers (FSPs), or a hybrid approach. Execution requires detailed planning, coordination, risk management, and continuous monitoring, akin to mise en place in the kitchen.
Tools like Mayet act as essential kitchen equipment, offering precision, accuracy, and real-time visibility. By using these tools and strategies, you ensure efficient, compliant, and high-quality clinical trials, achieving culinary mastery in trial management.
