As we look to the future, we are committed to developing new solutions that efficiently support clinical trials and testing. Bill Hall, Director, Global Specimen Solutions IT and Projects at Labcorp, shared how a virtual biorepository with informed consent data is helping drug development sponsors analyze their stored specimens and plan future research.
Understanding the role of a virtual biorepository
In clinical research, biorepositories are used for long-term storage of biological material after a study is closed. Each stored biospecimen is associated with characterizing data, such as its time of collection, sample type and diagnosis, among many other attributes and metadata.
In many cases, sample storage is decentralized, geographically distributed across several different biorepositories around the world, depending on the type of study.
“A virtual biorepository unites these disparate samples stored across different vendors and provides a single analytics platform where researchers can find, request and examine specimens for future research,” explained Bill.
“Working with these specimens allows drug developers to test new ideas, explore novel biomarkers or examine other potential patterns—without the expense and potential risk of enrolling and treating patients in a new trial.”
Identifying informed consent for biospecimens
Before a volunteer decides to participate in a research study, they are provided with an informed consent document that provides an overview of the study, its procedures and potential risks. In this document, study volunteers can also consent to allow their biospecimens to be used in future research beyond the life of the study.
While an informed consent document is essential to perform any future research, it can be quite arduous to determine if stored biospecimens are available for additional testing.
“When drug development sponsors wanted to use their stored specimens for future research, they have to track down the physical or electronic documents, which are typically very lengthy contracts that the study participant signed,” said Bill. “The sponsor then needs to read through each document and determine whether they are legally allowed to use the patient’s samples for their particular research.”
Saving time with GlobalCODE® virtual biorepository and informed consent modules
Using the existing GlobalCODE platform, many drug development sponsors are managing specimens in their open studies. With the addition of the virtual biorepository module, they can now have one centralized view of all specimens that they have, for both open and closed studies.
“Our sponsors can now use a single inventory system to track biorepository specimens and request shipments or destruction across numerous laboratory service vendors,” said Bill.
The new GlobalCODE virtual biorepository module includes the option for additional GlobalCODE modules, such as informed consent codification, which helps save time in the search process by providing a fully integrated data and analytics experience.
“Instead of individually researching each specimen, our platform has the informed consent information that drug developers can access within minutes,” said Bill. “With informed consent codification, we’re also helping sponsors adhere to evolving regulations in different areas of the world. We can help them easily identify the samples that they can legally use to run future research.”
“We’re always working to make drug development easier for sponsors,” he added. “The ability to have complete biospecimen information all in one platform is just one way we can help our sponsors across the development continuum in our shared mission to advance healthcare.”
Learn more about our complete specimen management solutions through Global Specimen Solutions and how we’re committed to creating solutions that make your job and decisions easier.