What is clinical trial logistics – and why is it important?
Clinical trial logistics is about making sure everything needed for a clinical trial gets where it needs to go. It involves managing and coordinating resources, materials, and procedures involved in moving, storing, and distributing supplies for clinical trials. The goal is to plan and carry out supply chain operations in a way that all necessary materials are delivered on time to research sites. This makes sure clinical trials can be carried out successfully.
The process of clinical trial supply and logistics includes keeping a close eye on sourcing, packaging, labelling, storing, and distributing investigational medicinal products (IMPs), medical devices, and related materials essential for a clinical trial. This planning needs to meet regulatory requirements while also ensuring the integrity of supplies and timely delivery globally. Efficient management of clinical trial supplies also means dealing with potential challenges like temperature control, expiry date monitoring, and customs regulations.
Moving medicine forward with clinical trial shipping solutions
We have developed a proprietary network and global footprint that meets the constantly evolving shipping requirements of clinical trial logistics today. When you’ve invested valuable resources into developing a product that improves global health and pharma logistics, you deserve a partner that treats your patients and shipments as well as you would, at every step.
Explore customizing your program with a leading international clinical trial supply company that allows for tailored solutions that precisely fit your unique needs.
Navigating customs regulations
Our team members help minimize risk to clinical trial materials by planning ahead for customs regulations before crossing the border. If complications arise, our expert teams are available around the clock to help speed up the import process, all while maintaining our exact compliance standards.
The challenges of clinical trial logistics
Clinical trials can encounter challenges that impact their success. These can range from regulatory hurdles to logistical complexities and compliance issues. In addition, this can include import/export regulations, geographical challenges, and compliance requirements.
- Import and export regulations — Regulations vary across countries and regions, demanding customized approaches to requirements. Clinical trial supply services must overcome these complexities to ensure smooth transportation.
- Geographical challenges — Trials can be conducted across multiple locations, sometimes in remote areas. This can impact the timely delivery and storage of essential materials. International clinical trial couriers must navigate these challenges, sometimes dealing with issues such as diverse climate conditions, transportation infrastructure issues, and accessibility constraints. These can all affect the integrity and efficiency of clinical trial supply chains.
- Compliance — Maintaining consistency and integrity in the storage, handling, and transportation of clinical trial materials needs close following of good clinical practice (GCP) guidelines. Otherwise, the success of the trial may be impacted. Clinical logistics must manage and monitor each stage to ensure compliance.
Providing visibility and insight
As part of our clinical trial supply chain management, we have built powerful inventory management, ordering, and tracking tools that deliver performance data. Through our Customer Portal, real-time tracking information is available for shipments. Users can also quickly and easily book new shipments.
- Bio-STAR℠ is a smart clinical trial management program that facilitates the communication of study protocols while streamlining permits and optimizing shipping routes and packaging to achieve optimal clinical trial logistics.
- CTM-STAR™ is our depot inventory management system, which gives clients visibility into stock location and temperature. This high level of visibility gives you peace of mind and also facilitates clinical trial processes with multiple dependencies. This system is CFR21 Part 11 Compliant.
Case study
A sponsor relied on their existing courier partner to handle temperature-controlled shipments to many countries in Southeast Asia
Situation
A trial sponsor’s shipments reached a temperature deviation rate of 50 percent and the existing courier was unable to advise on the cause.
The trial sponsor contacted World Courier to ask for assistance in analyzing the data and to temporarily take over the handling of shipments.
Solution
We worked with the sponsor to analyze the temperature data collected and the type of temperature-controlled packaging used, determining the package originally selected was not suitable for the hot and humid climate in Southeast Asia.
We recommended an alternative packaging solution as well as specific shipment handling procedures, including localizing the language on the handling labels pasted on the boxes.
Outcome
World Courier handled and delivered over 50 shipments using the new packaging and protocols with no temperature deviations recorded.
Personalizing the supply chain
Direct-to-patient trials
Meeting patients where they are
We are revolutionizing clinical logistics through direct-to-patient services including delivery of medication, pickup of specimens, and drug/ancillary supply returns. As a clinical trial courier bringing life-saving treatments directly into patients’ homes, we help ease patient recruitment and retention.
Cell and gene therapy trials
Anticipating the next frontier
As more cell and gene therapies move into clinical trials, we have helped secure the clinical trial supply chain for these promising, yet logistically demanding treatments. Each life-saving shipment is customized for a single patient, making anything less than perfect execution and delivery unacceptable.
Navigate logistics complexities with a certified Customer Success Project Manager
Today's increasingly complex — and sometimes volatile — supply chains require a logistics partner who understands your specific needs and can help navigate complexities with care, from project set-up through the entire project lifecycle. Working with a professionally certified Customer Success Project Manager (CSPM), you will experience a best-in-class solution that ensures flawless delivery for your highly complex projects.
Insights
White paper: Cell and gene therapy trials — The synergy of CRO and specialty logistics collaboration
Discover the value of partnership between contract research organizations (CROs) and logistics provider in navigating logistical challenges and driving innovative strategies for cell clinical trials with our enlightening white paper.
Clinical trial logistics FAQs
What is the clinical trial supply chain?
The clinical trial supply chain is a specialized process that ensures the timely delivery of pharmaceuticals, medical equipment, and materials required for clinical trials. It includes the sourcing, manufacturing, packaging, labeling, storage, distribution, and management of these supplies for research and clinical purposes. The clinical supply chain manages logistics, regulatory compliance, and quality control, ensuring that products reach trial sites globally.
What are clinical trial logistics?
Clinical trial logistics involve the planning, execution, and management of transporting vital medical supplies, samples, and documentation required for clinical trials. This process, often facilitated by specialized clinical couriers, ensures secure, timely, and compliant delivery of investigational products between research sites, laboratories, and sponsors.
What is a CRO?
A contract research organization (CRO) is a company providing research services to the pharmaceutical, biotechnology, and medical device industries. CROs conduct various aspects of clinical trials on behalf of these organizations, offering services such as protocol development, site selection, patient recruitment, data management, and regulatory submissions.
