Human biospecimen in pre-clinical trials & quality assurance during biospecimen collection
Billions of dollars are spent every single year on pre-clinical trials which give irrelevant or poor results. It is not just a waste of time and budgets, but also a significant slow-down in the development of innovative medicines, treatment, and diagnostic solutions. As preclinical trials are based on human biospecimen, the high quality of these materials is a cornerstone for scientists’ future success.
Needless to say, running a pre-clinical study is not an easy task. Scientists are looking for a particular kind of human biospecimen processed appropriately in a way that increases the chances to get valuable study results. Three questions need to be answered:
• What type of biospecimen fits you more?
• What sample processing will lead to better results?
• Which patient cohort do you need?
Even patient selection may be pretty challenging. Many inclusion and exclusion criteria have to be defined: a certain age, ethnicity, particular disease stage, symptoms, habits, and treatment status. But this part of the exercise is more or less technical and may be managed by the procurement manager.
Choosing the right type of sample is also important and if you want to be flexible in this area it is better to opt for prospective collection, rather than choosing samples already available in biobanks. By selecting a prospective collection you may spend more time vs. using archived materials, but perfectly fine-tune collection criteria in line with your scientific goal. We at BIOMEDICA CRO highly recommend the prospective type of collection to you, however, try to maintain in our biobank the most wanted conditions like Lung, Ovarian & Prostate Cancer, and collect matched sets of frozen tissue, FFPEs, serum, and plasma so our clients do have a choice to meet their project requirements.
Let us assume that we defined patient criteria, selected type of biospecimen and collection method. Now you need to ensure that your samples are processed in the way you need them. Although proper processing is one of the crucial parts of study success it may be neglected and usually outsourced to the clinical site responsible for collection.
We at BIOMEDICA CRO use different mechanisms to assure high processing quality. Our laboratory with experienced staff is involved in the most complicated projects, so we are 100% sure that all processing details are followed. When processing has to be done in the hospital or partnering lab, our Site Managers with medical background together with the Head of BIOMEDICA CRO Laboratory spend hours discussing collection SOPs with local staff, until everything becomes crystal clear. Having direct access to the clinics we may organize virtual training (Zoom, Google, or MS Teams based) with the involvement of scientists from the customer side.
Direct communication is the best way to clarify processing requirements. Such training sessions are widely used in our company and highly appreciated by our customers and project owners.
Please contact the BIOMEDICA CRO team for more details.
Due to our business model and direct way of communication with clinical sites you will get the highest quality of human biospecimen and ensure all project details are followed. Feel free to conduct additional meetings with Primary Investigators, their team, and lab technicians to build a solid understanding of your needs.
Indeed quality is our DNA!
