Centralized procurement involves making all purchasing decisions through a single, dedicated organization or team. Here we explore the significance of centralized procurement in decentralized clinical trials (DCTs). Emphasizing the need for adaptation in the evolving landscape of clinical research, particularly in the era of DCTs that leverage technology for remote data collection.
To address these challenges, businesses can integrate specialized delivery models like Just-In-Time (JIT) and Straight-To-Site (STS) with their central procurement strategy to enhance supply chain efficiency and cost-effectiveness. This strategic approach is recommended to balance the advantages of centralized procurement with the unique demands of DCTs, ultimately contributing to more efficient and patient-centric clinical research.
Short Cuts
The Fundamentals of Centralized Procurement in Decentralized Clinical Trials
Studies have shown that central procurement slashes the costs of clinical trials by a whopping 30%. Not only that but researchers have discovered that it enhances the overall quality of these trials by an impressive 25%.
In a world where clinical trials are not only advancing but evolving, embracing the power of technology, and adapting to new regulatory landscapes is vital for success. This evolution has given rise to the exciting era of Decentralized Clinical Trials (DCTs), a fresh approach that’s redefining how we conduct crucial research.
Serving as the backbone of the smooth execution of these innovative clinical trials, procurement models have taken center stage. One such star player is central procurement, a game-changer that wields the power to transform the functionality and efficiency of modern trials.
So, what’s stopping clinical trials from adopting this new, innovative approach?
Let’s uncover the intricacies of centralized procurement for decentralized clinical trials, navigating the terrain where the latest fundamentals of procurement are reshaping the landscape of cutting-edge research.
What is Centralized Procurement?
When procurement is fully centralized, all purchasing decisions are made through a single, dedicated organization at some designated level. The authority to make purchasing decisions is ultimately centralized.
On a more granular level, central procurement means utilizing centrally established purchasing from one source for distribution into multiple destinations to fulfill the needs of various locations. Sometimes, this goes so far as to offer a single purchase hub that is distributed to numerous destinations worldwide. With Centralized procurement, there is no local or independent procurement of any kind. Instead, the procurement happens at a higher level and trickles down to all other relevant parts of the organization.
Studies have shown that when it comes to procurement, bigger is better. The idea of centralized procurement brings with it a world of benefits, from the economic advantages of bulk buying to amplified purchasing power.
To make this powerhouse system work, we need to consider a host of practical factors, including regulatory requirements, trade compliance, and, of course, the intricacies of efficient logistics.
What are Decentralized Clinical Trials?
Decentralized clinical trials (DCTs) are a type of clinical trial that brings the trial to the participant rather than the participant to the trial. This means that some or all aspects of the trial are conducted outside of traditional clinical trial sites, such as hospitals or research centers. DCTs leverage technology, such as telemedicine, wearable devices, and mobile apps, to enable remote data collection, patient monitoring, and communication between participants and study staff. This has vastly diversified the nature of clinical trials and opened global access to clinical trials.
Clinical trials now face a new host of procurement, supply chain, and logistical demands that require new routines and procedures to overcome. The sheer versatility of decentralized clinical trials results in an evolved compliance landscape that requires a new way of conducting many aspects of the clinical trial.
How Does Centralized Procurement Fit into Clinical Trials?
When it comes to decentralized clinical trials, centralized procurement takes on the crucial role of managing everything from the selection and procurement of essential medical products to their smooth distribution. But it’s not all smooth sailing. Juggling the logistics for trials spread across multiple regions poses its own set of unique challenges.
Primary, the challenge of moving centrally procured Investigational Medical Products(IMPs), such as investigational drugs, medical device prototypes, and diagnostic test kits, and Non-Investigational Medical Products, such as commercially available medical equipment, personal protective equipment, and smartphones or tablets are twofold.
On the one hand, trade compliance and regulatory requirements for decentralized clinical trials are exponential. This is because each destination has its own set of intricate import parameters for medical products and tech-related gear. These need to be carefully managed to avoid customs delays and even costly shipment seizures. One response to this challenge is the emergence of specialized import and trade compliance project managers that will handle these details on behalf of the Sponsor, CRO, CMO, or Vendor responsible for the distribution.
On the other hand, the trial coordination requirements are also substantially more complex. This is due to a large-scale shift in practical requirements for decentralized clinical trials. As a response, Just-in-Time(JIT) and Straight-to-Site(STS) delivery models have emerged to simplify the pragmatic features of a centrally procured supply chain for these clinical trials.
Ultimately, the central procurement for clinical trials has returned to the drawing board and created a new and improved operational solution that perfectly tailors to the evolved decentralized clinical trial supply chain.
What are the Centralized Procurement Benefits for Clinical Trials?
Imagine a system where all the purchasing decisions for a complex operation like clinical trials are brought under one roof. This strategic approach, known as centralized procurement, isn’t just a business tactic but a game-changer in the world of clinical research. It simplifies the intricate web of supplies and services, offering a multitude of benefits that are crucial for the smooth sailing of clinical trials.
The Benefits of Central Procurement Include:
Increased Visibility and Standardization
Centralized procurement provides a single point of contact for all purchasing activities, making it easier to track spending and identify opportunities for savings. This increased visibility fits perfectly within the scope of standardization, where working with a trusted supplier ensures simplified adherence to standard policies, procedures, and suppliers and, ultimately, a more efficient supply chain with fewer stockouts and overall delays.
Inventory Management and Improved Control
Holding excess inventory can be risky due to the unpredictable nature of clinical trials. In cases where trials are canceled or postponed, or patient numbers do not meet expectations, inventory can become stuck and sometimes abandoned. Centralized procurement allows for a more streamlined flow of inventory and greater control over purchasing processes for specific trial sites. Additionally, the system works towards limiting soft efficiencies such as mismatched time zones and language barriers. It ensures that projects are simpler and more efficient to reduce the administrative burden on individual sites.
Carefully selected inventory management strategies such as JIT and STS models are the key to highly efficient central procurement functions in decentralized clinical trials.
Consistency of Materials and Reduced Risk
Due to the nature of clinical research, consistency in as many areas of the trial as possible tends to offer the most reliable outcomes. By adhering to approved channels and ensuring compliance with all trial requirements, central procurement offers the fundamental feature of consistency to improve data quality, protect the integrity of the trial, and ensure the safety of the patients. This level of sameness and predictability is a cornerstone of successful clinical trials – helping to meet grueling deadlines and avoid delays.
Cost Management and Economies of Scale
Central procurement often offers the establishment of trusted relationships at scale. These economies of scale offer leverage for better pricing, standardized rates, and priority distribution. Historically, decentralized procurement models have tended towards rogue spending, but centralized procurement can instead facilitate collaboration between multiple sites and vendors. This can lead to more efficient outcomes and help build relationships that can be leveraged in the future.
In essence, centralized procurement is the ultimate ally for clinical trials, weaving together a tapestry of benefits ranging from cost savings and enhanced efficiency to reduced risk and improved control. However, this strategy requires careful planning and execution, especially during the distribution phase to various trial sites across different regions, ensuring a smooth journey for all involved.
What Are the Limitations Of Centralized Procurement For Clinical Trials?
In the intricate world of clinical trials, the efficiency of procurement can make all the difference between seamless operations and potential hurdles. While centralized procurement stands as a promising beacon for streamlining processes, it also harbors a multitude of challenges that can cast shadows on the otherwise smooth landscape.
The Disadvantages of Central Procurement Include:
Supply Chain Delays
The early stages of developing institutional policy and procedures may cause delays in the central procurement process. This has knock-on effects for later logistical implementation, particularly in areas of distribution such as customs and import clearance, which are highly time-sensitive. Even after establishing these policies, the naturally delicate supply chain can still experience delays because of the time it takes to follow standard procedures. By working with reliable, efficient suppliers and service providers, you can help safeguard each feature of your supply chain and avoid costly delays.
Limited Flexibility and Reduced Responsiveness
In the purchasing universe, centralized solutions can be less flexible than decentralized ones. This is because it can take longer to make purchasing decisions and respond to local needs. Ultimately, the nature of centralized procurement has a trickledown structure with slowed responsiveness, making for an often inflexible output. The result? A sluggish supply chain. Partnerships with vendors that can accurately predict their time and cost requirements are one of the most effective ways to avoid added costs and delays in your supply chain. Effective partnerships help to mitigate the implications of limited flexibility and reduced responsiveness.
Partnership Vetting
As DCTs have limited infrastructure to support a robust physical presence, pharma companies must be careful when selecting partners. It’s crucial to involve procurement — with the expertise to sift through data, assess third parties, and negotiate —right from the start in every facet of the clinical trial. International compliance partners, for example, should be able to support your trial Importer of Record (IOR) and trade compliance parameters. So, establishing solid and capable partnerships and ensuring that your partners and suppliers are up to the challenge is paramount for success in the central procurement arena.
As we chart the course for the procurement gold standard in clinical trials, it’s essential to navigate these pitfalls with a strategic mindset. While centralized procurement brings bountiful benefits, it’s crucial to address these challenges smartly and strategically, ensuring a smooth journey for all involved.
What Is the Best Centralized Procurement Model for Decentralized Clinical Trials?
DCTs present unique challenges for inventory management due to their distributed nature and the involvement of multiple sites and participants. To curb these challenges, specialized delivery models have been tailored to maximize efficiency and combat practical setbacks. As a result, effective inventory management is crucial to ensure the availability of investigational products (IP) and supplies, maintain compliance with regulatory requirements, and minimize costs. Straight-to-site (STS) and just-in-time (JIT) inventory management systems are models that can be effectively integrated with central procurement to optimize supply chain efficiency and cost-effectiveness for clinical trials.
Central procurement provides a centralized decision-making structure for purchasing and managing inventory. At the same time, STS and JIT strategies streamline the delivery and distribution of investigational products (IP) and supplies to clinical trial sites.
Just-In-Time Delivery Model
Just-in-time (JIT) delivery is an inventory management strategy that aims to minimize inventory and increase efficiency by receiving goods only as needed. This approach helps to reduce storage costs, eliminate waste, and improve cash flow.
Just-in-time delivery can be a valuable strategy for businesses seeking to reduce inventory costs, improve efficiency, and increase responsiveness to customer demand. However, it requires careful planning, strong supplier relationships, and effective communication to mitigate potential risks and achieve successful implementation.
Straight-To-Site Delivery Model
The straight-to-site (STS) delivery model for DCTs involves direct shipment of IP and supplies from the manufacturer or distributor to individual clinical trial sites, bypassing traditional central depots or warehouses. This approach offers several advantages in terms of efficiency, flexibility, and cost savings.
By implementing these principles, organizations can effectively manage STS deliveries for decentralized clinical trials, ensuring the timely, compliant, and cost-effective delivery of IP and supplies to support the trial’s success.
Key Takeaways
Centralized procurement offers a viable approach for streamlining supply chain management in DCTs. While it presents potential drawbacks, strategic implementation and careful consideration of local needs can mitigate them, reducing flexibility and responsiveness.
The key to success lies in balancing the benefits of centralized procurement, such as cost savings and improved efficiency, with the flexibility required for DCTs. Integrating strategies like STS and JIT delivery can further optimize supply chain efficiency and cost-effectiveness.
By carefully considering the unique challenges of DCTs and implementing centralized procurement strategically, organizations can reap significant benefits while minimizing potential risks. This will contribute to the overall success of decentralized clinical trials, paving the way for more efficient and patient-centric clinical research.
Interested in streamlining your clinical trials? Reach out to TecEx Medical today.
