Assay Development Services for Decentralized Clinical Trials
Translating biomarkers into validated tests that generate informative results is a complex process. Additional complexity is generated if tests need to be conducted remotely and in participants’ homes. We help develop, validate and implement protein biomarker tests that enable biotech or pharma companies to obtain high-quality data from remote sample collection in decentralized or hybrid clinical trials. We also have the ability to work with established tests, including therapeutic drug monitoring applications, in remote sample types.
Decentralized Biomarker Assays
Trial decentralization enables more of a clinical trial’s activities to be performed in the patient’s own home rather than the traditional setting of a clinical trial site. Clinical trial sponsors may incorporate trial decentralization to improve participant convenience and experience, with potential benefits for patient recruitment and retention. In addition, at-home biomarker collection may allow trial sponsors to capture informative data that would not otherwise be feasible in a traditional, fully centralized clinical trial.
Nevertheless, it remains a challenge to obtain high yield, quality controlled and mechanistically informative outputs without in-person visits. ProterixBio seeks to address this challenge by validating and developing at-home biomarker tests that would have traditionally required an in-person visit, such as a venous blood draw. We are then able to implement the solution from our high-complexity CLIA laboratory, overseeing the end-to-end process from kit shipping through to data delivery.
Improve patient engagement and capture
analytical quality biomarker information at-home
We begin by determining the technology platform and sample type that best fits the needs of the project. We have expertise with remote sample collection devices such as dried blood spots and plasma/serum separation devices.
Once an appropriate assay methodology and sample type has been determined, we will conduct the sample collections and assay validations required to develop and validate the assay to CLIA standards.
Our high-complexity CLIA laboratory is licensed in all 50 States and will implement RUO/IUO biomarker testing in your clinical trial. We have software solutions which are developed in-house, and we are able to take oversight of all elements of the sample handling process. This includes shipping of kits to trial participants, timely sample accessioning and controlled results reporting, accessibility and interfacing.
If you need to establish an assay for a clinical trial, possibly including remote blood-based protein biomarker collection, please contact us.