Biospecimen procurement can be challenging, but technology, planning and new procurement strategies can make it easy and efficient. Many companies run into issues when trying to procure samples, from difficulties finding enough to documentation challenges and everything in between. How can mistakes and delays in biospecimen procurement be avoided?
By Emily Newton
Prioritize Biospecimen Procurement Planning
Many of the most common mistakes in biospecimen procurement are simply due to a need for adequate planning. This may be because the R&D team is unfamiliar with biospecimen procurement or because a project started hastily. Whatever the reason, poor planning can cripple the procurement process and potentially jeopardize the entire project.
To minimize the likelihood of any procurement issues, plan out as many factors as possible as far in advance as possible. R&D teams should have a detailed kit and training process for sample collection, especially if the samples require special care, such as a temperature-controlled environment or rapid delivery to the lab. A clear kit and advanced training for collection personnel will streamline the acquisition process and minimize the risk of improperly collected samples disrupting research processes.
Similarly, R&D teams need to take a critical look at the timeline they have in mind for their procurement process and project as a whole. Project timelines are more likely to be overly optimistic, setting unrealistic expectations about how quickly a certain quantity of samples can be collected. Bioprocessing 4.0 innovations — such as smart analytics programs and remote sample monitoring — can help make the R&D process as a whole more efficient.
Unfortunately, there are countless possible delays research teams can face when trying to acquire biospecimens. They might need patients with particular traits or an exceptionally large quantity of a certain biospecimen. Even collecting plasma and blood samples takes time when more than a handful of samples are necessary. Planning for delays and a lengthy procurement process allows everyone to use their time and funding efficiently.
Consider Direct-to-Patient Procurement
A lack of adequate information on the origin of samples can pose a particular risk of R&D mistakes. This is especially true if certain patient information is necessary for accurate results, such as info on a patient’s race, ethnicity or any environmental factors they might have.
Unfortunately, brokers may be reluctant to share this information, creating issues for researchers. Rather than go through a broker, companies and researchers should consider forming direct relationships with hospitals and biobanks. Some industry leaders are even building directories for biobanks and research companies to connect directly with one another. This saves time and money and ensures R&D teams have all the necessary information concerning sample origins.
Direct-to-patient biospecimen procurement is also another option. Patients are the ones providing biospecimens, so why not go directly to them? This method requires highly detailed planning, but it can be far more efficient than conventional procurement methods.
Direct-to-patient biospecimen procurement proved highly effective early in the COVID-19 pandemic when labs worldwide worked to develop vaccines as quickly as possible. Platforms like the popular LabCorp Patient Direct network connected labs directly to patients willing to provide samples and participate in clinical trials. Since then, more broad platforms like iSpecimen Marketplace have launched to help companies connect directly with specimen providers, indicating the high potential for this procurement method.
Direct-to-patient biospecimen procurement helped make the COVID-19 mRNA vaccines the fastest developed in history. It is important to note that part of why direct-to-patient procurement methods worked so well for COVID-19 vaccine development was patient awareness.
When large numbers of samples were necessary, everyone was aware of the COVID-19 pandemic and the urgent need for a vaccine. This awareness likely played a role in the number of patients who volunteered for sample collection campaigns and clinical trials.
Any company or research group can employ direct-to-patient biospecimen procurement, but it requires comprehensive planning and marketing efforts to raise awareness of the project’s goal. Patients will need highly detailed kits instructing them how to collect and handle samples properly. Companies will also need an efficient process to obtain samples from patients.
Digitize Procurement Processes
Digitalization is becoming increasingly popular in the biotechnology and pharmaceutical industries. IRB approval and documentation are among the most common procurement issues companies and research groups face. It isn’t always possible to speed up IRB approval, but organizations can streamline document collection and processing.
Moving documents to digital platforms makes them easier to deliver to patients and collect once signed. This streamlines documentation and compliance audits. However, companies and research groups need to ensure they follow IRB electronic documentation guidelines. Electronic signatures are legally binding, but the way electronic signatures and documents are obtained and collected is vital for patient privacy.
Similarly, HIPAA compliance regulations apply when using digital documentation. The platform used to deliver, obtain and collect electronic documents from patients needs to follow specific security and privacy regulations. While verifying compliance may take some time, electronic documentation ultimately saves time.
With a digital documentation platform, the startup could email patients a link to a patient portal where they can type in their e-signature and submit the forms, a process that takes a matter of minutes from start to finish. This method is especially useful when paired with an at-home collection method where the patient can complete the entire collection process without needing to visit a physical collection facility.
Simplifying Biospecimen Procurement
Effective planning, technology and patient and biobank outreach can help companies avoid the most common biospecimen procurement mistakes. By simplifying the procurement process with a few key strategies, samples are less likely to be damaged, lost, improperly collected or processed without crucial information. The procurement process can be frustrating at times, but a little innovation can go a long way toward making it easy and efficient.
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