Our client, a large pharmaceutical company, co-presented with us at the recently concluded SCOPE 2023 conference on how they used the Appian Low-code Process automation platform to improve their Clinical Supply Chain significantly. This encouraged me to articulate my thoughts on how Low-code Process Automation can address some of the major challenges with the Clinical Supply Chain.
I encourage you to watch the video of this presentation here.
Clinical supply chain management is the process of planning, sourcing, manufacturing, packaging, labeling, storing, distributing, and managing clinical trial materials (CTMs) used in clinical research studies. CTMs can include investigational drugs, biologics, devices, and diagnostics, as well as ancillary supplies and equipment used in the clinical trial. The clinical supply chain plays a critical role in ensuring that clinical trials are conducted safely, efficiently, and in compliance with regulations. A well-designed and executed clinical supply chain can help reduce the time required to bring a drug to the market.
Despite its importance, the clinical supply management process is faced with a range of challenges that can impact the pace of clinical trials and their outcome. From ensuring the timely delivery of materials to navigating global logistics and regulations to managing costs and risks, pharmaceutical companies must navigate a wide range of supply chain challenges to ensure their clinical trials are successful.
At SCOPE 2023, our client talked about how they leveraged Appian, a leading Low-code Process Automation technology platform, to address some of these clinical supply chain challenges.
What is Low-code Process Automation?
Low-code Process Automation provides a unified view of your enterprise data thru real-time integration with your existing applications, and flexible and dynamic workflow and business rules to automate and optimize your most strategic and complex lab, clinical, regulatory, and manufacturing processes. Appian brings technologies like workflow, BPM, Case Management, RPA, and real-time data integration into a single unified Low-code development platform to deliver customized enterprise applications in weeks that provide a modern customer experience, improved operational performance, and greater process transparency. A solution architecture diagram is provided at the end of this blog for those of you who are more technically inclined.
Let’s talk about some of the key clinical supply chain challenges and how Appian Low-code Process Automation can help address them.
Timely delivery of clinical trial materials
One of the biggest challenges that impact clinical trials is the need to ensure the timely delivery of clinical trial materials. Clinical trials often involve multiple sites and many participants, handling specialized materials that are difficult to obtain. This can make it difficult for pharmaceutical companies to ensure that they have the necessary materials on hand when they are needed.
Low-code Process Automation creates a unified view of data across a variety of systems and provides the needed real-time visibility into the global supply chain. Access to the most current inventory levels across the globe for example can greatly enhance the ability to deliver critical material to sites. Workflow automation improves the cycle time of deliveries, ensuring quicker turnaround times. Easily configurable business rules provide agility to take quick actions in case of exceptional events in the supply chain, avoiding potential delays.
GxP and Regulatory Compliance
Pharmaceutical companies must comply with complex GxP and local Health Regulatory requirements that govern the use of clinical trial materials. These regulations can vary widely from country to country. The potential cost of non-compliance can be high.
Low-code platforms can help you comply to these requirements in the following ways:
- Data Integrity: Control over data access through a granular permissions model prevents unauthorized access to data. Out-of-the-box audit trail to track who did what and when. This helps maintain the integrity of data.
- Process Control: Automated workflows and business rules that can be customized to meet specific regulatory compliance requirements. This helps ensure processes are consistent and repeatable, and deviations from established procedures are identified, automatically documented, and addressed in a timely manner.
- Validation: Documentation and testing tools to streamline the validation process, reduce the time and effort for validation activities and help demonstrate compliance with GxP guidelines.
Limited Process Transparency and Optimization
Since clinical trials are often conducted globally and involve many external SMEs, it is critical to have complete end-to-end process visibility across the entire clinical supply chain in order to meet the complex logistics requirements efficiently and in a timely manner. Good communication between legacy systems can improve the process visibility across the supply chain and allows the business to proactively make informed decisions relating to clinical supplies.
Low-code process automation provides much-needed real-time visibility into supply chain operations. It builds a unified data fabric by connecting all systems in the supply chain without writing much code. Supply chain managers get personalized and interactive dashboards that give them deep visibility into supply chain processes across the globe. Tasks on the verge of getting delayed are highlighted proactively so that delays can be avoided with appropriate actions. Since nothing is hard-coded, low-code applications give you the ability to continuously identify areas of improvement and implement them rapidly, without any disruptions to normal supply chain operations.
Safe and Secured Storage and Handling
Another challenge that pharmaceutical companies face is the need to manage clinical trial materials safely and securely. These materials are often highly sensitive and must be stored in specific conditions to maintain their integrity.
Low-code applications provide you the ability to monitor these conditions on a real-time basis and take quick actions if storage conditions, such as temperature, pressure, humidity, etc., deviate from the specified acceptable range for the materials. Have a look at Princeton Blue’s Temperature Excursion solution to see this use case in action.
Managing costs with clinical trial logistics
The cost of clinical trials can be significant, and pharmaceutical companies must carefully manage the costs associated with the transportation, storage, and handling of trial materials – which encompasses the management of the clinical supply chain. Operating on a tight budget without compromising the integrity of the trial is never easy.
Workflow Automation enabled by Low-code Process Automation brings large-scale efficiencies across the supply chain. For example, a client was scheduling clinical supply chain orders using Excel and emails. Our solution built on the Appian platform provided fully automated workflows, needing manual interventions only on an exception basis, thus reducing the overall cost significantly.
Learn more about clinical supplies job readiness | Learn more about clinical supplies scheduling.
Outdated User Experience of Legacy Applications
Clinical supply management is sometimes supported by legacy applications. The dated user experience provided by these systems can bring in fatigue and inefficiency.
Low-code Process Automation can modernize your legacy applications with superior and modern user experience, by augmenting them (not replacing them). They provide a responsive user interface across multiple devices, form factors, operating systems, and mobile platforms. This allows your field teams to stay connected and provide real-time inputs, enabling rich collaboration to get work done from anywhere, thereby improving the overall efficiency of business operations.
In conclusion
Low-code process automation can play a critical role in addressing the challenges faced by clinical supply chain management. By streamlining and automating manual processes, reducing errors, increasing efficiency, and providing real-time visibility, low-code process automation can help organizations deliver clinical trial materials more efficiently and with greater transparency.
Appian is the leading platform for Low-code Process Automation. Princeton Blue has worked with some of the largest pharma and biotech companies to streamline their most strategic business processes using the Appian Platform. Here is the summary of Appian’s capabilities that have helped us deliver these solutions quickly.
- Workflow, BPM, and Case Management make your processes efficient, agile, and transparent.
- Ability to build a unified Data Fabric across all your legacy applications breaking down silos between your existing systems.
- Configurable Business Rules that can be maintained by business teams, reducing dependency on IT.
- Robotic Process Automation (RPA) to automate high volume, routine, and repetitive human tasks with software bots.
- Intelligent Document Processing for automating data extraction from your business documents quickly and accurately.
- Mobile, Portals, and Modern UI/UX enable external users to connect to your applications to submit forms, approve orders, view documents, and more.
- Process Mining capabilities to identify inefficiencies, and bottlenecks in your processes and optimize them to increase overall efficiency.
Appian delivers all these technologies via a single unified Low-code platform allowing applications to be created in weeks/months. Most of the logic is modeled into configurable business processes and business rules that can be easily changed when the business needs change.
The diagram below shows the Appian Low-code solution architecture:
If you’re looking to learn more about streamlining your clinical supply chain using the Appian Low-code Process Automation platform, send us a message.
