What are clinical trials
Clinical Trials are a way to test new methods of diagnosing, treating, or preventing health conditions. The goal is to determine whether something is both safe and effective. Before doing a Clinical Trial, investigators conduct preclinical research using human cell cultures or animal models. If the reclinical research is promising, they move forward with a Clinical Trial on humans.
What is evaluated through these Clinical Trials?
- Combinations of medications
- New uses for existing medications
- Medical devices
What happens during clinical trials
Clinical Trials happen at several phases during which different questions are asked:
- Done with a very small number of people, less than 15
- Very small dose used to make sure it isn’t harmful to humans before using it in higer doses in later phases
- If medications acts differently than expected => back to preclinical research
- Several months looking at effect of medication on 20 to 80 healthy people
- Aim of this phase is to find out what the highest dose is these humans can take without serious side effects + look at the best way to take the drug (eg orally)
- Very detailed monitoring of every participant
- Several hundreds of participants who are living with the conditions that the medications is meant to treat with same dose as in Phase I
- Up to 3,000 participants who have the condition that the medication is meant to treat
- Trials in Phase III can last for years
- Purpose is to evaluate how this new medication works in comparison with existing medications for the same condition
- To move to Phase IV investigators need to proof with the trial that the medication is is at least as safe and effective as existing ones
- Can happen only after Governmental body (eg FDA) has approved the medication
- Involves thousands of participants during many years
- Aim is to get more info about medication’s long-term safety, effectiveness and any other benefits
Clinical Trials and their individual phases are a very important part of clinical research. They allow the safety and effectiveness of new drugs or treatments to be properly assessed before being approved for use in the general public.
Why TemaxPharma+ for your clinicial trials packaging?
With our +20 years of experience in Pharmaceutical Packaging business, having a global coverage, we as Temax Pharma+ understand much better than anyone your needs and are able to react and deliver very quickly.
Based upon your clinical study design, we customise and optimise packaging strategy to meet your timelines and desired outcome. The timely delivery of your trial supplies and the efficient use of available materials is our focus and expertise.
Having our own production centers in Europe, with daily transports to our main hub In Belgium, we are able to produce, change , adapt at the fastest possible way to your product needs.
Packaging brings together our expertise in material science, industrial design and information technology to develop solutions that protect and properly identify study drugs during storage, distribution and use.
As Temax Pharma+ we have fully owned facilities supporting ambient and refrigerated packaging and are strategically situated around the globe to accommodate local or regional sourcing needs. An integrated IT system links each packaging facility to give clients control of inventory through bar coding standards.
Assurance of quality comes from our long history of serving pharmaceutical companies with practical yet innovative packaging.