Overview: What are CTM Logistics?
CTM Logistics is a quick reference to Clinical Trial Materials management services. CTM related management includes many moving parts and casts a wide net over the total breath of clinical management in general. In many ways, CTM logistics plays a crucial role in respect to meeting the needs of clinical environments.
It goes without saying the priority is making sure specimens are getting to where they need to be with the integrity of the clinical product held intact. Protecting the viability is the most important thing to manage when it comes to implementing protocols for tissue transportation. Increasing the awareness of CTM details that require an additional layer of focus helps everyone involved become more solution minded.
An Open Look at What Makes the CTM Logistics Process Effective and Cost Productive
Meeting Volume Demands: This translates into being able to predict product demand and availability for the number of potential patients recruited for a clinical trial.
Global Management: There is much to think about when shipping overseas. Seasoned CTM managers need to be able to anticipate dealing with import/export restrictions and potential delays resulting in possible compromised environment and housing needed to optimize samples.
Labeling Challenges: Most companies do have some sort of data management in place. However, the failure comes into meeting the advance systems that allow for error-free end-to-end logistics. These systems address verification, validation, query, tracking, and coding for diseases or medications.
Training and Performance: Training is a game-changer and it extends to anyone who is in contact with transportation, processing, or handling of any type of biospecimen. Figuring out how to effectively manage a biorepository and meet the supply-chain demands is largely dependent upon training. Quality biorepository services plan for worst-case scenarios, preparation in ways that meet the GMP standards, and also maintaining best practices and SOP’s.
Biorepositories: What Role They Play in CTM Management
At Geneticist, we place our emphasis on end-to-end logistical approach for all areas of clinical handling. We make sure we address every possible thing that might affect what really matters – and that is patient outcomes. As a major partner for most research endeavors, we understand how vital clinical specimen materials are to the overall big picture. Interestingly, this big picture can become very blurry when faulty handling measures are not overcome.
Our role: What Geneticist does differently to help your project flow smoother.
We focus upon the notification process by implementation of sophisticated technology and communication services.
Our approach means placing our end-users as priorities and active within our communication loops. We integrate these people into the entire scope of the logistics process for seamless CTM strategizing and implementation.
We focus on standards and safe handling. The goal is to provide the highest standards available to protect the biospecimens from start to finish.
A quote below from a respected market-leader helps drive home the fact the clinical trial platform has changed and is growing exponentially. CTM providers need to understand where we are and where we are going as far as being able to answer this big upswing.
“In the past 10 years and especially in the past five, the complexity of running clinical trials has grown enormously,” says Robert Pizzie, president of a newly formed consulting organization, Brizzey LLC (www.brizzey.com), expressly for clinical trial supply management.”
Global CTM Logistics: How to Service Hard to Reach Locations
In today’s current pharmaceutical landscape, there is something of an upswing going on and the need to focus on storage locations is a big deal. The market is driving the need to meet large capacities and heavy shipment volumes and frequencies. For large CTM outfits, this might be figuring out how to expand out to far-reaching places such as Latin America, Europe, and even Australia and creating what might be referred to as a global CTM network. This also includes in-country delicate transportation services where temperature-controlled vehicles will have to be provided and could the cause for potential delays. i
CTM Logistics and Fragile Biologics
Investigational Medicinal Products (IMP’s) must be manufactured, stored, and distributed in accordance with the Good Manufacturing Practices, while also incorporating labeling and packaging that correspond with the appropriate clinical protocol. With sensitive biologics, there must also be special attention paid to optimizing the health of the specimen. This may include temperature controls, limited time frames, and specific housing environments or accommodation.
Conclusion
Clinical trials and related research are stretching beyond U.S. borders and also encompasses a strong global network. This indicates a significant logistical presence for anyone who is involved in the management of CTM’s. What we know is that as a full-service biorepository that we have to gain insight as to what our end users need in the way of fulfilling the demand in such a way that everyone benefits. With this in mind, we welcome strategic partnerships and will lend our expertise in any CTM logistics arena. Efficiency paired along with a strong service commitment is what will bring momentum to this long-neglected area.
References
Expediting Clinical Trials with a Global Transportation Footprint and Clinical Packaging: https://www.pharmasalmanac.com/articles/expediting-clinical-trials-with-a-global-transportation-footprint-and-clinical-packaging
FDA Resource for Best Practices Manual Update: http://www.aaei.org/wp-content/uploads/2015/12/FDA-Best-Practices-Manual-Update-FINAL-Sept-2015.pdf
Educational Resource for SOPs: https://biospecimens.cancer.gov/resources/sops/
