Industry 4.0 Clinical Trial Supply Chain: Leveraging the Power of Every Stakeholder

Clinical studies may be more practical for patients and thus more effective for sponsors when quantitative data collection methods are performed electronically, but there are additional challenges involved. The operations of transport and the handling of supply chains is foremost on the list as there’s no space for compromise.

Stakeholders must ensure that the appropriate individuals with the necessary tools are available at the scheduled times since policies and procedures are meticulously prepared down until the final serum sample extraction or perhaps more specific clinical outcomes. That much less throws patient care, safety standards, and data integrity in jeopardy.

Nevertheless, when hybrid and decentralized clinical trials (DCT) depend on a network of many manufacturers, subcontractors, and delivery companies, supply chain grow into an important organizational nightmare for backers and facilities together. The likelihood of crucial operations being overlooked amongst suppliers is indeed very substantial considering the large amount of moving elements.

For this reason, it’s imperative to employ a comprehensive design strategy to telehealth and delivery.

Testing the Waters   

Hybrid and DCT advantages have a solid track record of success. This paradigm, which substitutes digital record keeping at most several site inspections in the COVID-19 outbreak, was developed more quickly at that time. A veritable treasure trove of statistics came to light as a consequence, demonstrating how well these trials had been more practicable for patients and effective for financial backers. These could aid in increasing hiring and keeping employees, as well as streamlining the process of developing new drugs.

The model’s typical flaws are, however, less frequently covered in the literature. The industry must be aware of the inevitable roadblocks and be able to adeptly navigate obstacles to effectively extract all of the value from this innovative method of doing clinical business.

The supply chain management labyrinth that DCTs and hybrid clinical trials provide funders is one potential risk with the utility of such a simplistic approach.

Quandary in Coordination

Albeit lesser facet of a clinical trial, supply chain is crucial and will only grow more so as the clinical enterprise transitions to decentralized clinical trials and mixed set-ups.

For instance, it has consistently proven to be a major consideration that there might not be hematologic extraction apparatus available on the scheduled venipuncture that is stipulated in the guidelines. Relatively similar argument is necessarily applicable to a telehealth consultation, even if a facility has a back – up plan readily in place. The remote visit might then need to be rescheduled, which could incur the customer money and be inconvenient for the respondent. Moreover, the trial’s records could perhaps be deleted, that would prevent any subsequent warning alerts from being spotted.

Eliminating such problems can be quite challenging because of the inherent characteristics of a remote setup. Enterprise wide tasks, including domiciliary care, centralized diagnostic assessment, technology procurement, or transport, are largely carried out by independent firms. Although they all operate within a single distribution network, these organizations might not oftentimes engage effectively among themselves. Rather, they compile a list of possible strategies that financiers may track and control.

However, certain participants in this pipeline, as with the shippers, are likely to be of limited know-how in the scientific endeavor. They frequently require that they are notified of the pertinent laws and also how crucial prompt record keeping and shipment can be for the success of a trial.

At the moment, key stakeholders shoulder a major overhead expense that involves connecting the suppliers. This could entail a handful of calls or messages to various contact points both prior to and following each planned trial site visit. It is compounded from all over the company’s repertoire, contributing to the enormous labor and financial commitment. However still, an aspect or two will eventually get overlooked.

Leveraging the Power of Every Stakeholder

The comprehensive project management style to supply chain must be employed when facing a cornucopia of variables since the optimal course of action must be to leverage as many as are necessary. By introducing research elements within the company before assuming on the decisive role of the clinical logistics system, frictionless, streamlined systems might bridge the gaps amongst various stakeholder groups.

Via domiciliary healthcare systems, market collaborators could perhaps offer the competent candidates. These companies can also guarantee that these competent and skilled specialists are perfectly trained and equipped for any concern or approach that is required for each encounter with patients thanks to their own distribution channels, logistics providers, and deep ties with locations, vendors, and regional research laboratories.

A various leveled solution can indeed fulfill multiple requirements from such an unique specification, for instance if the criteria mandates that a patient introduction be prepared and given prior to the actual participant’s initial day on the program and a hypertension check be conducted on the fifth. Similarly, when an eleventh hour strategy modification is warranted, divisions that have open communication lines can swiftly respond, and financial backers just have to notify a single responsible point of contact.

These service providers can take care of security and regulatory issues, such as readjusting medical supplies in accordance with protocol described and, when necessary, disinfecting, discarding, and quarantining equipment, together while maintaining that the healthcare professionals on the scene have enough of they require.

These vendors might additionally employ their own consignments who are familiar with the clinical trial guidelines and have the ability to effectively organize, handle, and set up testing kits—necessary duties that would take up valuable time and storage resources at the locations of clinical trial operations.

All For One, Not All At Once

Undoubtedly, one of the main difficulties confronting the companies and clinical trial locations designing and running mixed set up and decentralized trials may very well be supply chain. Whether the location, the time, or the task at hand, healthcare personnel must always be equipped with all they require to get the job done. It is indeed pivotal to get these details correct from the start, yet achieving this goal is evolving to be more complicated and chronistically laborious. Nonetheless, in this industry, there is definitely no room for error.

A dependable supplier can facilitate communication between patient populations, domiciliary care, trial locations, technology providers, regional facilities, and transporters using the joined-up methodology to managing the clinical trial. All of this integrates the complete logistical infrastructure, eliminating the hazards associated with data integrity, regulatory non-compliance, and security among suppliers. Additionally, it eliminates the significant managerial pressure put on shareholders and institutions where the trials are held, thus paving the way for a successful implementation of decentralized trials.

Engr. Dex Marco Tiu Guibelondo, BS Pharm, RPh, BS CpE

Editor-in-Chief, PharmaFEATURES