Moving from chaos to calm: How a complete CTST solution can simplify your clinical trials

You feel like a ball of anxiety from the beginning to the end of your clinical trials. You have so many competing priorities that you don’t have time to learn new technology. You want to build efficiencies into your studies but don’t know where to begin. You want to keep everything moving, and your plan is already in place.


Whatever challenges you face, your clinical trials can run more smoothly, and your team can save valuable time. You can move away from pen-and-paper or spreadsheet tracking to a single solution for tracking clinical trial samples and consent – reducing risk and building efficient and effective processes for your team.


Clinical trial sample and consent tracking solutions that work


As a clinical trial sponsor, you need complete visibility into each sample as it moves from patient to repository and throughout the distributed clinical trials ecosystem. You must account for every sample during the study. You also need to track consent.


A data-driven approach is critical to streamlining clinical trials. Clinical trial sponsors and CROs must move away from pen-and-paper tracki,ng with a technology designed specifically for them. Some spreadsheet programs offer automated elements but still require hours of manual work – time you could better spend strategizing and conducting life-saving research.


Technology can help ease your mind and put you on a path to success. Don’t gamble with your clinical trial samples and consents. Your results could contribute to breakthroughs in medicine that save lives and turn patients’ hope into the help they need.


Innovative solutions with a partnership approach


Clinical trial sponsors and partners face complex problems in today’s big data environment. Researchers work within a highly regulated industry with dispersed partners, including central labs, sponsors, clinical research organizations (CROs), testing labs and biobanks.


One tool that can help build flexibility into your studies is Labmatrix® Clinical Trial and Consent Tracking (CTST) by BioFortis, a Q2 Solutions company. Q2 Solutions is a global clinical trial laboratory services organization. The unparalleled Labmatrix® software solution tracks samples through their lifecycles across sites, labs, biorepositories and other trial partners.


Labmatrix® takes the guesswork out of the complex logistics specimen management system and boosts productivity by:


  • Providing clear visibility into workflows;
  • Ensuring subject consent while reducing operational and compliance risks; and
  • Offering a well-annotated subject and sample database to support research.


Labmatrix® serves as a hub for data from central labs, third-party testing sites and EDC. The system can help identify discrepancies in the data from different vendors and query and correct them in source systems. Whether data loads through a secure FTP daily or weekly, there’s no need for manual data entry. You set the schedule. BioFortis provides the support.


How much is your data worth?


Patient sample consent enables researchers to quickly determine which samples they can use for what purpose, a vital component of clinical trial research to meet regulatory and ethical requirements. Running tests or storing samples without proper consent can result in non-compliance for organizations and failure to protect the patients involved in your study. Trials that do not effectively track clinical trial samples and consent risk non-compliance and delays in critical trial milestones.


According to the American Clinical Laboratory Association, over 7 million clinical lab tests are performed annually. Common issues that can be detrimental as you execute your trials include lost or unusable patient samples, testing biospecimens without consent, and storing samples after authorization. Some samples require special consent, and only the most recent subject consent applies to future allowable use. Consent parameters change from study to study. It can be agonizing to attempt to assign a true value to your data.


The time invested in tracking samples and consents may be a full-time job, according to the director of clinical research with a large biopharma company that participated in an Industry Standard Research (ISR) study commissioned by Q2 Solutions. The global clinical head of a large biopharma company echoed those sentiments.


Labmatrix® 10 is the latest edition of the technology that helps users accomplish new with new dashboard capabilities, improved performance and enhanced features. The web-based total sample solution enables teams to view real-time data, minimizing lag time attributed to sample verification.


What are the steps to implementing CTST software?


Leading biotech, biopharma and pharmaceutical companies have adopted Labmatrix® for almost 15 years. Since 2019, clients have used the platform for gene-based and gene-therapy medicine trials. Q2 Solutions has a proven, customizable model to ensure superior delivery of a complete sample software solution for all your CTST needs.


A clinical trial typically has three stages: setup, conduct and close. Using Labmatrix® for the setup stage includes identifying inconsistencies in database setup and establishing nomenclature standardization to help align data downstream.


After you identify Labmatrix® as the CTST solution for your clinical trials, you may use a standard setup for speed and lower upfront costs. BioFortis offers comprehensive end-user training to help users understand the standard reports and functionality. Simultaneously, the Labmatrix® team will use the time to understand your needs better and recommend potential customization options.


As you conduct the trial, you can use Labmatrix® to identify and address issues with samples, systems and processes.


Customization is the final step in the adoption lifecycle. After you have hands-on experience in informing your business analysis, you can incorporate targeted customization while maintaining upgradeability.


During the closing stage, you can use centralized reporting, reducing the effort of determining each sample’s final disposition. Standard sample reports also support sample closeout activities.


Q2 Solutions uses a partnership approach and innovative solutions to help develop results that will turn patients’ hope into the help they need. As an experienced strategic partner, Q2 Solutions can work with you on a single study or hundreds of studies using innovative technologies that support flexible study design and reporting.


BioFortis Vice President and General Manager David Kaye will present “Clinical Trial & Consent Management: Too Important to Leave to Chance” at 12:30 p.m. Tuesday, Feb. 7, at the 2023 SCOPE Summit for Clinical Ops Executives. Stop by Booth No. 913 at the summit to learn more.