Introduction to CTM Logistics
Clinical trial materials (CTM) logistics is an important business that manages the transport and delivery of biospecimens and tissue samples. The business of tissue preservation, meeting demands, and shipping these specimens from places like a biorepository to their destinations does not come without challenges.
Challenges facing CTM Logistics
Besides the conventional logistics and supply-chain challenges, those involved in CTM logistics also face:
Many countries do not have standard protocols for the entry of trial supplies. Due to the demands of clinical materials worldwide, the challenge of shipping CTMs include the extraordinary constraints of import and export.
Those involved in CTM logistics have very little to no notice when it comes to knowing when the materials need to be shipped out. The issue of material suppliers being disconnected can also cause delays at trial sites due to a supply chain issue.
3) Product Standards
There are many trials that need both comparator or placebo drugs along with the trial drug. However, these trials are usually “randomized” throughout the course of the trial. This means that different labels will be needed for different trial protocols or different locations.
4) Handling and Transport
Since the quality of these materials can be affected during handling and transport, companies involved in CTM logistics need to have the equipment and manpower that are suited to deal with the supplies.
5) End Users
There is also the issue where some end users (such as researchers and physicians who conduct trials at investigator sites) who are not trained supply chain managers.
Companies providing CTM logistics services also have a high risk of overrunning their cost due to difficulty addressing all cost drivers, inefficiencies in the system, and potential expenses when corrective actions need to be taken.
Just like any other field, poor communication and coordination of the supply chain can result in action gaps, duplication of efforts, and delays. Frequent plan revisions are required if there are errors.
Many studies often face the risk of delays and the need to lengthen their timeline in situations where there is the unexpected expiration of products or out of stock situations.
The industry has adapted to some of the challenges and constraints over the years. Although the clinical trials can be affected by issues in the supply chain, the successful completion of these researches has led to the better diagnosis, therapy, and prevention of diseases.
Supply Chain Stages
The following are critical supply chain stages:
Planning: Those that are responsible forecast and come up with a strategy.
Sourcing: This is done to acquire the necessary materials such as ancillary supplies, drugs, and lab materials.
Manufacturing: Once ready, the necessary packaging and labels that are needed are manufactured.
Storage: The CTMs are stored in the appropriate condition using the proper equipment (if needed).
Distribution: The CTMs are imported or exported according to local authority regulations.
Site: The CTMs are stored, samples managed, and data processed.
Return: The company manages the shipment along with final CTM reconciliation.
Destruction: The CTMs are recycled or destroyed accordingly.
Analytics: All accumulated data are processed and analyzed.
Individuals who are interested in positions such as clinical supply chain managers or supervisors and those interested or new to the CTM industry. Employees that go through special training pertaining to CTMs are more efficient in their duties in the company and industry. They learn about:
The overview of the supply chain from beginning to end
The appropriate packaging and labeling that suits the needs of a specific study design
Having a plan of action to prepare the materials
Implementing their plan and troubleshooting
The logistics involved for distribution of CTM to trial sites that are located worldwide
How to outsource vendors for the labeling and packaging purposes
Interactive Response Technology
The different roles of their team members and their expectations for the CTM group
Current Good Manufacturing Practices (cGMP)
The implementation of cGMP in the packaging process
The company that is in charge of CTM logistics generally provides services for:
The receiving, storage, and distribution of the materials
Obtaining the necessary import and export licenses from the authorities
Acquiring custom clearance for the CTM
Data management (verification, validation, query, tracking, coding for diseases or medications, result presentation)
Biostatistics (Statistical analysis, writing, result presentation, and more)
Importing and exporting CTMs
Short or long-term storage of specimens
More clinical trials are conducted globally. This creates a significant logistical challenge as the management of CTMs and the supply chain require tactical knowledge and a vast commitment of resources to avoid delays. There are many who would find that it is much more efficient to hire CTM service providers to manage the logistics as there are many challenges in this industry.
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2) CTM logistics. Geneticist. Accessed 9/5/2018. https://www.geneticistinc.com/ctm-logistics/
3) Clinical research services: clinical logistics. Parexel. Accessed 9/5/2018. https://www.parexel.com/files/6714/1155/2827/CLS_Supply_Chain_Poster_Sept14.pdf
4) Clinical trial materials training course. ISPE. Accessed 9/5/2018. https://ispe.org/training/classroom/clinical-trial-materials