For anyone who is a part of the drug development procedure, it is important to know the essentials of clinical trial supplies. Whether you are an organization of twenty or two thousand, clinical trials certainly play a vital part in your drug development.
As is with all the other industries of the world, efficiency is the most crucial element and most especially so for pharmaceuticals and biologics. But with the level of international trials that pharmaceuticals now engage in for accessing larger pools, there can be several logistical and other challenges in the clinical trial supplies.
For every clinical trial, your primary concern is to ensure there are sufficient supplies of study drugs at the study site. But along with this, you also have to ensure you deliver drugs as fast as can be so that subject withdrawals don’t stand a chance and you enhance the subject/patient convenience.
Here are five essential things you should know for managing seamless clinical trial supplies, both on domestic and international levels.
You can never begin the process without generating a production forecast. This helps you plan the packaging components, API, recipients and also planning your third-party resources. A forecast is your most essential tool in planning your requisite operations, whether it is to support a multitude or just one study.
Moreover, you can use this forecast as an instrument when dealing with your external or internal stakeholders. This is turn will ensure unanimous agreement on future and current inventory positions. If you endeavor to proceed without a forecast, you will have no foundation for reactions or inactiveness that is necessary for the every evolving clinical landscape.
As your clinical trial supply company keeps defining its strategies, you can update the production forecast accordingly and include details of study-specific or program of kit designs, lead times, operational assumptions and country specific challenges.
2. Tracking Tool
Clinical trial supplies are largely successful when you back them up with a plan. As with all studies, a project file is a vital component, including details of all the post and pre production activities. This will include the delivery of supplies to the sites and other things.
You can use your project management tool or tracking tool as a template as well, for aiding and socializing in other departments, to reinforce the GMP-compliant CTM drivers. Additionally, in your project tool, make sure you include strategic elements, such as sourcing of material inventory, tertiary or secondary vendors, internal resources and others. This plan will serve as a clear structure of your planned or ongoing studies or even both and ensure perfect alignment of your procurement, manufacturing, clinical supply and clinical demand processes.
3. Know the Rules of Each Country
If you’re delivery clinical trial supplies internationally as well, you need to take into account several factors from start, where you plan the study. You must primarily look at the most budget-friendly and efficient ways of managing your clinical supplies chain for each country and ensure you hold ultimate control of the study.
Secondly, you must also learn in details about the exportation and importation rules of each country and stay updated. By being well aware of the export/import regulation documents and licenses you need, you will be in absolute compliance throughout your trial.
During this, it is vital to bear in mind that regulations are subject to changes and many countries can change them while your trial is underway. By staying in touch with the evolving regulations, you will know whether your trail will have to cater to new demands and adhere to the new requirements accordingly.
4. Distribution Schedule
Once your study drug production is complete and you’re ready to distribute, you must determine how frequently you will have to distribute the trial supplies to the study site and in what quantity. Study designs have a varied nature. Some may only require single drug kit if it is a single dispensation, meaning that the kit will contain the entire amount of drug a subject will need for the length of the trial.
Good examples here are the vaccine and antibiotic trials that are generally only single dispensation. But then many other studies require multiple shipments of medicines too. Hence, you need to be sure of what your distribution methodology will be.
5. Mitigating the Risks
Clinical trial supplies come with plenty of risks. Here is where your company needs to be the most vigilant. You must considering potential risks proactively, such as where they can come from in the protocol, what risks you face outside your protocol and what you consider when enlisting potential risks.
You prepare a risk matrix for this using your company template. The best template is one that divides into three phases of clinical trial supplies. These include:
- Production and
- Post production activities
By identifying the unique risks that each phase entails, you can prepare a sound mitigation methodology. With this, the stakeholders too will be able to rest easy if can identify issues right at the early stages and address them. ‘
In the end, you will smoothly tackle the risks before they can even develop into a problem.
Clinical trial supplies are the process of distributing CTM to study sites. CTM (Clinical Trial Material) is a product that exists in the form of a complete pharmaceutical dosage that manufacturers intend and find it suitable to administer to humans. But before the drugs can be approved for public use, they have to undergo clinical trials with a group of humans, so that they can prove their efficacy for treating a particular condition.
Clinical trial supplies are not for commercial sale or use so they do not include external packaging. A clinical supply chain then undertakes the responsibility of delivering these trial supplies to customers (patients) through worldwide distribution.
The process of production and distribution of CTM is not without challenges. However, the important points in this article will help you smoothen the difficulties and help develop a sound strategy for a seamless supply.
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