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Any clinical research sponsor can tell you: every clinical trial and every clinical research site is different with unique needs for supplies, shipping, and subject enrollment in order to adhere to the protocol and any other study-specific documentation. Therefore, the implementation process for an eClinical Supply Chain Management (eCSCM) platform needs to be collaborative and personalized to the individual clinical trial and each of the stakeholders.

Administering a clinical research study comes with considerable risks to achieving a successful trial. These risks are caused by challenges involving data integrity, budget overruns, collaborator productivity, and subject retention, to name a few. An eCSCM platform should mitigate these challenges and reduce risk by replacing manual processes while fostering collaboration between stakeholders, providing real-time visibility into activities and inventory at research sites, ensuring a traceable chain of custody for biological samples and other clinical supplies, and encouraging stronger protocol adherence and regulatory compliance.

Protocols are becoming increasingly complex, and many require multiple amendments, making protocol adherence more challenging for clinical trials. In addition, federal regulations and best-practice guidance are constantly being updated. Without automated support for communicating, coordinating, and controlling collaborator processes, sponsors cannot ensure that research sites and other collaborators are adhering to the protocol. This also applies to regulatory requirements and good clinical practice (GCP) guidance. As a result, required safety checks might be missed, biological samples might not be collected, handled, shipped, or processed according to the protocol, and regulatory requirements and guidance might not be followed. This can cause subjects to drop out due to negative experiences, or the elimination of subjects due to protocol deviations, which can risk the clinical trial’s overall success.

Biological samples from subjects are the most valuable assets that travel across the clinical trial’s supply chain. Any gap in the knowledge in the biological sample's lifecycle can make the subject non-evaluable and jeopardize overall data integrity. If this happens too often, the overall clinical trial can be at risk. When shipping biological samples, clinical research sponsors must have the data they need to conduct biological sample reconciliation—meaning they have documentation to track a biological sample stored in a biorepository back to the lab that analyzed it, the courier that transported it, the research site that collected it, the lab kit that was used and its lot and serial number, and the lab kit’s supplier and manufacturer. This data allows the sponsor to prove that a biological sample is valid and has not been tainted anywhere along the way. As a result, an online platform must maintain an immutable record of all of the steps a biological sample takes throughout its journey from collection through storage, along with the steps taken by each collaborator, including sponsors, contract research organizations (CROs), research sites, suppliers, labs, and couriers. As a result, an eCSCM platform must be able to prove a traceable chain of custody for biological samples, lab kits, investigational product (IP), devices, and ancillary and other clinical supplies, whether in use, transit, or storage.

Data integrity is a massive concern for sponsors of clinical trials. When sponsors cannot trust data because it is manually transcribed from paper to system—then from system to system— and provided after the fact, the clinical trial’s success can be at risk. Unlike error-prone manual processes, an online platform can provide real-time visibility into the execution of a clinical trial. Data relevant to the role of each collaborator—sponsors, contract research organizations (CROs), research sites, distributors, labs—can be provided in real-time so that each collaborator can identify issues before they become major problems. An eClinical Supply Chain Management platform must be able to automate the tracking and reporting of every activity related to clinical trial procedures, biological sample collection and shipping, and the inventory management of lab kits, investigational product (IP), devices, equipment, shippers, and ancillary clinical supplies.

The clinical supplies managed by a supply chain during the course of a clinical trial include lab kits, investigational product (IP), medical devices, ancillary and other clinical supplies, and biological samples. This means there are a number of collaborators involved in making the supply chain work, such as sponsors, contract research organizations (CROs), research sites, labs, suppliers, and couriers. This requires a lot of coordination and communication, which is very difficult with the current chaotic and manual processes that involve spreadsheets, notes handwritten on paper, phone calls, and emails. An eClincial Supply Chain Management (eCSCM) platform must be able to replace these manual processes and have capabilities that streamline the coordination of collaborators and the communication between them.

Two years ago, a good portion of the U.S. population did not know what a supply chain was. Today, with store shelves empty and inflation rising, it's safe to say we do now. For clinical trials, supply chain issues that involve getting lab kit components, investigational product (IP), medical devices, ancillary clinical supplies, and biological samples to the right place at the right time are preventing clinical trials from staying on budget and completing within the planned timeline.

Unlike most unusual (seemingly made up) days of the year, Clinical Trials Day has a great deal of history behind it — centuries, actually. Annually on May 20th, Clinical Trials Day honors the legacy of James Lind, a Scottish doctor, who conducted one of the first ever clinical trials in 1747.Lind was a pioneer of naval hygiene in the Royal Navy, often arguing the health benefits of better ventilation aboard ships, improved cleanliness of sailors' bodies, clothing and bedding, and below-deck fumigation. During his time serving on the HMS Salisbury, British seamen were contracting scurvy at an alarming rate after just two months at sea, with some even succumbing to the disease.

In this blog, the second in our series on clinical supply chain management optimization, we’ll highlight these mistakes and issues and the operational problems they cause that can negatively impact the probability of a successful clinical trial.

Keeping track of investigational product (IP), lab kits, equipment, and other supplies is a clinical operations problem that often results in missing study drugs, expired lab kits, lost biological samples, and delayed resupply shipments—all signs that there is a need for clinical supply chain management optimization.

OCT New England revealed hidden clinical trial supply and sample management challenges

Slope's improvements to clinical trial supply chain management, operations, and logistics just got a big vote of confidence from investors

You probably don't, and it's probably been an issue in previous trials. Why is this such a problem? What is the potential impact? How do you fix it?

It’s 4:45 PM on a Friday and a CRA gets a call. One of their Research Sites is scrambling. They have a patient coming in on Monday, and just discovered that all of the kits they need for a critical baseline visit are expired.

"Doveryai, no proveryai." This old Russian proverb presents an open challenge to the clinical research industry. It translates to "trust, but verify."

Inventory surrounds us. It’s in your house, at your gas station, in your grocer’s freezer, and on the shelves of your Research Site’s supply closets and pharmacy. Inventory is something that demands attention and careful management.