Clinical Trial Supply & Logistics

Narration

Robust. Flexible. Personalized. Parexel and its global network of depots are part of a cross-functional team of clinical operations and supply chain experts.   

We provide the knowledge, systems, and connections for end-to-end and vein-to-vein clinical trial supply chain management for the most advanced therapies. 

Country-specific knowledge within purpose-built facilities, like our Singapore location, connects Parexel’s global clinical trial engine with sites and with patients throughout the Asia Pacific region. 

Jeff Ten

Asia Pacific is an increasingly important region in the global clinical trial landscape. Because of the connectivity of Singapore, being an international air hub, it allows us to reach key cities within 4 to 6 hours. 

Parexel operates on the same global harmonized SOP using the same platform, system and processes, coupled with our regional expertise and local knowledge that allow us to have a reliable and predictable outcome.

Narration

Cell and gene therapies are a critical step toward personalized medicine. A successful supply chain strategy for these advanced therapies requires heightened attention to the chain of custody, environmental conditions, packaging, and customs requirements.  

Our Project Teams are trained to proactively manage the many handoffs throughout the process where the supply chain can be compromised.  

Jeff Ten

We know our patient. We know our study. We know your product. And Singapore being part of that global network allow us to pivot to deliver the necessary treatment to our patient in the fastest possible way because disease doesn’t wait. This is where we differentiate ourselves from the rest. 

Narration

Our project teams mitigate risk to ensure safe, reliable, and speedy transport of every supply, clinical drug product, or personalized therapy to its intended destination. Our ultimate deliverable is patient safety. 

Learn more how effective end-to-end, and vein-to-vein, clinical trial supply chain management can advance your therapy and support a range of new trial models.

Parexel Global Clinical Trial Supply Management: Getting supplies to patients who need them the most

0:00 – 0:25

Parexel Voice Over

Parexel operates a worldwide network of depots staffed by dedicated logistics experts. These facilities, like this U.S. depot in Quakertown, Pennsylvania, integrate decades of supply chain expertise, along with clinical operations and regulatory services, to provide packaging, labelling, and global distribution of clinical trial materials.

0:26 – 2:06

Vincent Santa Maria, Vice President, Worldwide Clinical Trial Materials & Depot Operations, Parexel:

Parexel’s ability to support decentralized trials through our depot network offers the sponsors and the regulatory authorities the commonality, consistency in what we do and the way in which we execute. So, from incoming good, to the flow of the material, to the actual packaging, the storage and distribution, no matter where it came from, a North American distribution center, Brazil, or any of our facilities, it was prepared in the same compliant manner.

Each of our depot operations consist of very similar capabilities. From a harmonized environmental monitoring system, that’s the actual management of the facility, to tell us at any point in time that the temperature conditions within the controlled ambient, the refrigerator space which is 2 to 8 degrees, the freezer areas, and our ultra-low freezers themselves. It is a very key and critical factor within clinical trials.

We have an inventory management system which is an electronic system. Which tracks and traces the materials as it come into our facility, throughout our facility as it changed from a work in process to finish good, to the actual deliverable, to the site, and ultimately to the patient.

Because Parexel has both the clinical operations as well as the depot operations in-house we have the ability to source material locally or globally. It’s the understanding of the protocol. It’s the understanding of the execution. Parexel depot model underpins the compliance of the clinical trial. It could by my mother, my father, my child that’s going to have such a need.

 So, we all come to work with that mindset, to improve the quality of life, to improve that unmet need, to deliver the right drug, right patient, on time. Always with that ultimate care of patient safety, it’s at the forefront of what we do.

2:09 – 2:30

Parexel Voice Over

Parexel’s global presence, harmonized SOPs, chain of custody and regionalized distribution strategy, ensures your trial materials align with the needs of patients and sites.

Rely on Parexel for your supply chain integrity myclinicalsupplies@parexel.com

Effective supply chain management creates a path to success

Voice Over: Precision. Time. Accuracy – getting the right supplies to the right sites and patients.  Parexel’s state-of-the-art pharmaceutical hub and distribution center help you efficiently manage clinical supply logistics. Our comprehensive, global, and regionalized approach to clinical logistics ensures that clinical trial supplies, ancillary supplies, and central lab services are delivered on time and within budget.”

Scaling DCTs creates unique challenges, particularly within the pharmaceutical clinical supply chain.  Parexel’s services represent an opportunity to expand the possibilities of the traditional clinical supply chain process. With deliveries directly to patients in addition to sites, we can help create a better study experience, greater patient participation, and potentially improve clinical trial outcomes.

Robert Mueller, Head of Operations, European Distribution Center: Our location here in Berlin allows the delivery to any site inside Europe. Good manufacturing practice and good distribution practice is that what we deliver. Our QPs are going to take personal liability in the sense that everything has been according to that what is described. We are able to not only store the product at two to eight degrees, we also do our secondary production at two to eight degrees. We apply the same rigid regime for documentation end to end. We live up to the promise which we make. This is the reliability of the shipment arriving on time, arriving in full, and arriving in quality. I’m proud to be a part of the supply chain, part of an element which is going to deliver an improvement of our lives, of patient lives, and being available for a better future.

Voice Over: Learn more about how effective supply chain management creates a path to success for your study, getting the right drug to the right patient at the right time in the right condition.

Rely on Parexel for your supply chain integrity myclinicalsupplies@parexel.com