Have you ever wondered what actually goes on inside a clinical research unit? Well this article would give you some insight in general!
The essential aspect of a Clinical Research unit is the laboratory and the lab team.
In the clinical facilities, laboratory experts might be both men and women. They are responsible for protocol review, creating documents for the lab, labeling and setting up all requirements for sample collection, processing them and shipping them to respective labs worldwide, or get them in their own labs if the equipments are available.
They process many samples every month, which includes blood, urine, stool and saliva going through the lab on a daily basis. The busiest hour is during the morning when protocols often dictate tight timeliness for sample collection.
Lab staff must work together with the clinical teams to ensure that blood samples are collected, handled properly and make them to the centrifuge and the refrigerators in time. It is very essential for each and every tube to be labeled correctly and processed promptly.
Some clinical labs, use a Watson sample tracking system, which allows the team to track every single test tube as it is processed through the clinic, into the freezer, and then into shipping. Watson helps the lab teams to create tube labels and barcodes for aliquot tubes, track storage, and create shipping manifests. These ensures that every sample is handled appropriately and quality samples are processed for every study.
All the equipment are calibrated regularly and continually monitored for quality analysis. In some labs, refrigerators and freezers are monitored with a Rees temperature monitoring system, which notes the temperature every 5 minutes and alerts the staff with an email and phone call when temperatures vary from the range.
The clinical staff plans in order to make sure that the thousands of samples are kept straight. Moreover quality control looks over the plans and source documents. Maintaining quality data is the mission, and with a vigilant lab team the mission gets accomplished.
In many facilities, it is open 24/7 with a capacity to analyze over 50,000 study samples per month! There are 15% of resources allocated for R&D, 30+ scientists are dedicated for developing complex methods for small molecules, oligonucleotides, biomarkers, proteins, and peptides.
They also have the scientific evaluation/knowledge to advise sponsors on the appropriate assay platform.
The clinical research labs are proud of the quality and innovative work of the scientists and analysts! They are credited to analyze over 400,000 samples each year and access numerous methods.
Many clinical labs develop robust bioassays for novel molecular entities and commercially available compounds analyzed in various biological fluids and tissues for various animals and humans.
In your University days, the students should try to arrange a visit toorganizations and institutes where good clinical research is undertaken. This would add more to your knowledge and also practically help you in pursuingyour career. Sometime things are different from what we read in books. A practical hands on in a specific environment would help you to nurture your knowledge and enhance your skill. It would be very exciting and inspiring to watch the experts making plans, playing with the samples and managing a well planned database.
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