As the clinical trial landscape becomes increasingly complex, the needs of trials sponsors with respect to ancillary clinical suppliers also become more intricate. Many more types of supplies, including medical equipment and diagnostic tests, are needed for the longer, more geographically dispersed, and often virtual trials required to support modern clinical research. The careful coordination of provision of these supplies along with investigational and comparator drugs has become both more nuanced and more critical. Only a truly integrated clinical trial provider can ensure on-time delivery of all clinical trial materials and supplies throughout these complex trials at an acceptable cost.
Complex Clinical Trial Landscape
The clinical trial landscape has evolved dramatically in recent years. The number of trials and their complexity has increased exponentially. International trials have become commonplace as drug makers seek to establish efficacy in different cultural and ethnic populations and to penetrate new markets. The length of trials has increased as more drugs are developed to treat chronic diseases, which are becoming widespread, including in emerging economies. The need to evaluate investigational drugs in parallel with comparator drugs has climbed, along with the need to demonstrate improved performance over existing products; this has become a necessity for gaining access for new drugs into payer formularies. An increased focus on rare diseases by many drug developers has created a need to access patients in distant and disparate locations, leading to greater use of direct-to-patient solutions. The growth of cell and gene therapies and other personalized medicines is also driving the need for increasingly patient-centric trials.
Modern studies consequently often involve large groups of patients and patient sub-groups, as well as multiple countries and sites per study. This complexity is posing new challenges for the clinical supply chain, including the management of clinical ancillaries.
Impact on Ancillary Supplies
The list of ancillary materials needed for the proper execution of clinical trials is extensive and only growing as trials become more complex and time-sensitive. This is especially true as an increasing number of drug candidates require storage and handling under stringent conditions.
Ancillary supplies include all materials required to conduct a clinical trial beyond the experimental drug and the comparator drug, if relevant. They include simple medical supplies, such as syringes, swabs, surgical knives, gloves, diluents, and any other items that the patient and medical practitioner need to administer the drug and evaluate the safety and efficacy parameters under investigation. Increasingly, protocols require supplies like medical devices, diagnostic and testing equipment, centrifuges, computers, eDiaries, and temperature-control equipment, such as water baths and freezers.
This wide range of equipment and supplies cannot be obtained from a single vendor, and as such necessitates establishing strong relationships with multiple vendors. As trials grow more complex, the number of ancillary suppliers is also increasing, creating additional challenges to ensuring timely and cost-efficient delivery of all materials that are needed. Both the cost and quality must be considered, as in some cases higher-quality ancillary supplies, particularly diagnostic testing equipment, can provide better clinical data for better-informed treatment decisions. In some cases, renting may be preferred over the purchase of certain supplies.
Finally, in addition to delivery to the trial site, ancillary supplies greater than $25 in value must be collected once the trial is complete, according to the requirements of the Sunshine Act.
Added Challenges Due to COVID-19
The COVID-19 pandemic has created additional challenges for both clinical trial operation and the clinical supply chain. A large number of additional trials have been initiated in a short period of time to evaluate COVID-19 therapeutics and vaccines. Many trials – both COVID and non-COVID-related – adopted virtual, direct-to-patient (DTP) trial practices in order to proceed. This change occurred during periods of lockdown and restricted travel, which impacted manufacturing and logistics operations around the world.
The result has been a shortage of some ancillary supplies at a time of heightened demand.1 The United States, the European Union, Japan, and many other countries, in response to the realization of their dependency on China for medical supplies, have begun working to reestablish domestic production and the movement of supply chains within their borders.
Best Practices for Sourcing of Ancillary Supplies
What is needed is a strategic approach to the management of clinical trial ancillary supply that includes risk assessments and demand planning. Developing such an approach requires open collaboration between clinical trial sponsors, investigators, and those involved in the sourcing and supply of clinical trial ancillary materials.1
This type of collaboration is essential, because those responsible for procurement must have an understanding of the clinical trial design and protocols in order to be able to plan in advance, through discussions with ancillary material suppliers, the strategic and cost-effective supply of the equipment and materials needed for a given study over the full length of the trial. Collaboration is also important to ensure that suppliers of ancillary materials have the ability to respond quickly if changes to clinical trials will impact the materials needed or the timelines for existing material requirements.
Knowledge of international customs and shipping regulations is also needed to ensure that all requirements (e.g., country-specific product import and export licenses) are met for each country with trial sites and that ancillary supply deliveries are made on time to all of those locations.
An effective strategic ancillary sourcing approach includes several key components, including the following:
Start early. Plan for study drug and IMPs (comparator drugs, rescue drugs) in parallel with ancillary supplies. Preparing about six months before the site initiation visit (SIV) allows sufficient lead time to source and deliver stock to each regional site.
Know the rules for country-specific regulations and import licenses around ancillary supplies to avoid any delays in delivering the right stock to the right site.
Maintain constant communication with a supplier that uses sophisticated track-and-trace inventory management tools to forecast equipment supplies and keep track of impending stock shortages and oversupplies.
Work with multi-site clinical trial logistics providers. Multi-side logistics providers can keep on top of paperwork, particularly import licenses, shipping, labelling, and stock expiry dates to prevent a shortage of ancillaries at any time during the trial. You also may need to import ancillaries if they are not available locally. A provider can ensure that you have approved ancillaries at the best prices.
Expect the unexpected and factor this into the supply plan in the event of a strike, pandemic, or other emergency that could prevent stock from reaching sites. Backup plans are essential.
Budgeting for ancillaries is frequently overlooked, especially when studies are outsourced or when sites purchase their own ancillaries, as they frequently do.
Be flexible as the needs of your trial change. Ancillary management is important at every stage of the clinical trial life cycle.
Yourway: A Diverse, Robust and Integrated Supplier
At Yourway, we know that clinical trials sponsors and site investigators are faced with huge challenges and are looking for logistics partners that can provide more than just delivery of clinical trial materials and ancillary supplies. Yourway is a trustworthy and well-informed partner that can be called upon for advice in a space that is notoriously difficult to navigate.
A partnership with Yourway, the only truly integrated clinical trial provider focused on supporting the pharmaceutical industry, can ensure access to the necessary knowledge, skills, and expertise and optimal management of clinical material supply, from comparators to the increasing diversity of ancillary supplies.
Integrating as many services as possible within Yourway not only streamlines the supply chain and reduces sources of risk but also provides an additional layer of organization and oversight to ensure that the right materials are delivered at the right time and in the right sequence. With Yourway as a partner, it is possible to effectively coordinate delivery of materials for the entire duration of the trial, reducing both risk and cost.
Yourway offers dedicated teams focused on the purchasing, procurement, management, delivery, reclamation, and recalibration of ancillary supplies worldwide. We not only source ancillary supplies from multiple vendors but coordinate their delivery with the experimental and comparator drugs using our premium courier service. We go beyond demands for basic supplies and provide sizable clinical and laboratory equipment and devices, both of which are in high demand. Additionally, Yourway has longstanding global and domestic industry relationships that serve as a support network with respect to ancillary services and allow access to clinical trial supplies at the most cost-effective prices possible.
Rather than simply delivering advanced pharmaceutical equipment via a conventional courier, Yourway leverages its specialized courier capabilities to provide white-glove, tailored support, including delivery of all associated materials and installation/placement of equipment and supplies in the appropriate locations. With our comprehensive warehousing capabilities, we are also positioned to reclaim equipment and supplies at the end of a trial and store them until they can be sanitized and calibrated for reclamation and repurposing.
Our global, integrated network of depots allow the support of both large and niche trials regardless of trial size, location, or treatment constraints. Access to storage facilities in North and South America, Western and Eastern Europe, and across Asia, Asia Pacific, Africa, and the Middle East allows for ready shipment of ancillary suppliers to trial sites around the world and also provides places for ancillary equipment regardless of whether it is being calibrated or sanitized for reclamation and repurposing.
Most importantly, since Yourway focuses solely on the pharmaceutical industry, we have a deep understanding of how sensitive clinical trial materials and ancillary supplies are and treat every shipment as an extension of our own business. We do whatever is required to ensure that all clinical trial materials, equipment, and supplies are stored and delivered without issue and in a timely manner — whether that means charting a private jet or pushing for treatments to be delivered directly to the patients that need them.
Overall, clients can depend on Yourway to consistently ensure that all materials and the necessary supporting equipment are exactly where they belong. By doing so, we enable clinical trials to proceed as smoothly door-to-door as they do at a predetermined site. Additionally, because we are the only truly integrated clinical packager and premium courier, we provide service faster than what our clients have traditionally come to expect, which allows trials to begin more rapidly. We rely on our team, including our highly skilled program managers, to ensure that the studies we help facilitate take place more efficiently without compromising quality.
Considering the uncertainties and rapid developments taking place constantly within the clinical trial space, a partnership with Yourway can make the difference between a trial that is a success or a failure, which can determine whether or not a drug makes it to the market and into the hands of the patients who need it. Since we keep that focus in mind across our operations, we not only provide the optimal service across all of our integrated capabilities but constantly evaluate new ways to expand our capabilities and to find novel connections and efficiencies to benefit our customers and patients.
Author: Tim Brewer
President, Biopharma Services
1. Ilancheran, Mathini. “COVID-19's Impact On The Clinical Trial Ancillary Supplies Industry.” Clinical Leader. 4 Sep. 2020.