Jian, Wang CEO
Precision Medicine provides accurate treatments to patients based on their unique molecular biomarkers. This emerging paradigm requires new capabilities in clinical trials and is making its mark in the e-clinical domain. Since the process includes patient segmentation based on biomarkers, patient samples are becoming critically important to conduct any precision medicine trial, compared to non-targeted therapies. The resulting data from sample analyses are required to be properly stored and tracked, so they can be accurately presented for patients’ treatment and other clinical trial decisions. Therefore, disparate and just-in-time data are needed to track the variety of clinical trial samples across the trial ecosystem. The major challenge is to upgrade the current infrastructure from paper and Excel, which is non-scalable and difficult to monitor during clinical trials. BioFortis, a Maryland-based company, provides clinical trial biospecimen and patient informed consent tracking solutions as an important addition to the e-clinical space. “Our platform enables clients to monitor the health of the clinical trial from a sample-centric perspective,” begins Dr. Jian Wang, CEO of BioFortis.
The firm’s Labmatrix™ platform is a web-accessible clinical and translational research database software system used for information management and integration of clinical, molecular, and operational support data. With the ability to integrate these data sets, Labmatrix provides flexibility, security, and data access control that is required for accurate sample and informed consent tracking for biomarker-driven trials. “Labmatrix provides holistic views on clinical trial sample and informed consent data through integrated information hubs,” says Wang. Labmatrix manages data in a secure and centralized repository, enabling clinical trial and research teams to conform to regulatory compliance standards, while its ease of use and configurability helps to increase user adoption.
The clinical trial sample management solution of the firm is a centralized, comprehensive sample tracking database application built on the Labmatrix platform.
Labmatrix provides holistic views on clinical trial sample and informed consent data through integrated information hubs
“BioFortis has a purpose-built database application that enables clients to overcome the challenges of clinical trial sample and informed consent tracking,” says Wang. This helps clinical trial stakeholders to get up-to-date information, including patient informed consents, on the collected samples. Another feature of the BioFortis solution is managing biobanks, where physical operations on the samples are managed and their associated assay data stored.
The best-of-breed solution of BioFortis' is in use by pharmaceutical clients who face challenges in their targeted therapy trials, for example, in oncology and rare diseases. Currently, most pharmaceutical companies are not able to fully and efficiently track their clinical trial samples and corresponding patient informed consents for both in-study and extended future-use. This often results in operational and regulatory problems that adversely affect trial conduct as well as the ability to utilize these samples for additional precision medicine research. As a specific example, with the help of the BioFortis solution, one of their clients was able to uncover missing samples, find the root cause, and remediate in a timely fashion, which is a feat not previously possible by simply tracking data with Excel spreadsheets and other ad hoc tools. “We discovered samples and patient informed consents that were either missing or mis-attributed to study subjects, both of which had profound effects on the client’s trial operations and outcome,” cites Wang.
As the line between pharmaceutical and academic research is blurring, BioFortis’ solution bridges the gap between academic medical centers and clinical trial sponsors. “Our clinical trial sample and consent tracking solution has created an important addition to the e-clinical domain. As precision medicine fundamentally changes the clinical trial landscape, we will be successful in contributing towards development of new drugs for curing diseases,” concludes Wang.