From samples to results: what does it take?
- Julie Borghs
- A-Team Manager - Senior Project Engineer
Clinical trials aim to demonstrate the safety and efficacy of a new treatment/drug in healthy patients. These patients often donate samples during the study, which are examined in laboratories and from which important results emerge. Do some quick tests on the samples? Obtaining results is not so straightforward. In this blog, you can read all about the process from samples to results.
The criteria
When a patient donates a sample (blood, saliva, tears, etc.), it should be fully traceable in its journey to the result.
In addition, a good record must be kept of who performed an operation with the sample. It is also crucial to note the time of that operation and the devices used for it.
The devices used in such clinical laboratories must comply with a whole set of guidelines. From scales and pipettes to impressive PCR devices, all instruments follow a whole process.
Step by step: from purchase to commissioning
1. Purchasing: Ordering new devices goes through a predetermined process that may vary from company to company. In any case, it should ensure that orders remain traceable.
2. Installation: The device has arrived and just plug it in and use it? In pharma, nothing is that simple. The supplier of the device has to come into the lab to perform the initial installation. Before this technician is allowed on site, he must of course undergo the correct training and be able to present certificates. Once the technician is in the lab and has the correct PPE (personal protective equipment) on, the installation can begin. The installation involves an IQOQPQ (instrument qualification, operational qualification and performance qualification). This verifies that the instrument complies with the supplier's imposed rules.
3. Validation: After the instrument works for the supplier, it must of course also work as desired for the company where it will be used. This is extensively tested during a validation. Everything must meet certain criteria that are predefined in the instrument procedures.
4. Release: Does the instrument meet all the guidelines of the supplier and of the lab in which it will be used? Then it is finally ready for use.
If all the devices needed to analyse samples in a clinical trial meet all the guidelines, it is finally time to perform the correct tests on the samples to obtain the results of the study.
The aftercare
After the device is in use, it should be checked at regular intervals that it continues to operate as predefined. This is done through calibrations.
The device is tested and must fall within certain acceptance criteria before it can continue to be used. The interval of successive calibrations is recommended by the supplier and described in procedures. Some devices will not only need calibration, but also require periodic maintenance. This maintenance is also recommended from the supplier and will enhance the lifespan of devices.
Conclusion
Results of clinical trials are therefore not obtained easily. Meeting all guidelines to ensure patient health is an intensive process. As a result, there is often a long gap between sample collection and the result to be obtained.
