Clinical Sample Tracking for Labs and Researchers

When conducting vital research in clinical trials, a functional and efficient sample tracking system is crucial for success.

While many labs make do with paper solutions, a software system can bring a lab up-to-date, bringing efficiency, data validation, quality control, and data security to an otherwise burdensome task. What software systems fit the bill here? Look for clinical sample inventory tracking and sample management softwares, specifically designed for science and developed along with scientists to be truly useful.

Clinical sample tracking software helps scientists and research teams know where samples are in the receiving, storage, testing and analysis process. This kind of a program allows researchers to quickly identify information regarding the patient/study participant, previous assay runs, derivative samples, storage location, history, and more.

 

Contents: Challenges | Necessary Questions for Choosing a System | Clinical Sample Tracking Solution

 

Clinical Sample Management Challenges

When dealing with human-derived samples in a trial, tracking the chain of custody and storing sample-related data in a secure environment is vital. Unfortunately, many research groups are still relying on paper trails for clinical sample tracking due to the low cost and familiarity of the approach. These “paper solutions” are highly error-prone, difficult to scale, and difficult to adapt to increasing complexity in the lab. Beyond the lack of convenience and potential issues with accessibility, this can greatly reduce productivity, delay execution of a research study, and pose regulatory compliance risks. For these reasons, selecting a sample management software designed for clinical sample tracking is critical for success. 

Using paper or spreadsheet tracking methods for clinical sample tracking are:

• Error-prone
• Difficult to scale
• Don’t adapt well to increasing complexity
• Inconvenient
• Hard to share securely
• Not easily audited

 

When looking for a clinical sample tracking system, consider the following:

• Is clinical sample data being stored securely with the proper safeguards to ensure regulatory compliance?
  Each tracking system will have their own levels of regulatory compliance for trial and sample data. LabKey Sample Manager offers CFR Part 11, HIPAA and FISMA compliant software and cloud hosting, used by leading life science organizations and the FDA. This includes built-in methods to restrict PHI/PII data access, and e-Signing data, managing sensitive data in a secure way is easy and transparent.
• Is the sample’s chain of custody captured in the system and easy to retrieve?
  Some systems aren’t equipped for a true chain of custody to be ready at the drop of a hat, while others make audit trails easy to find and export. Not only does Sample Manager create audit-ready logs for all sample events, we have a unique Sample Timeline that allows users to easily browse a sample-centric chain of custody for auditing and troubleshooting.
• Can you customize fields and add built-in validation to ensure correct data entry?
  Look at each product you are considering for built-in validation. Sample Manager allows administrators to add validators to both numeric and text fields to ensure correct data entry. Quality Control tools allow assay data to be reviewed before it’s shared to ensure that only relevant data is displayed to teams.
• Can the clinical sample tracking system provide built-in reporting capabilities that create custom reports unique to your lab’s needs?
  Depending on the product you choose, you can find reporting options that work for you. Some trial sample tracking systems may have limited functionality. For more robust systems, look for an API to connect to, allowing you to create custom reports in the software your lab prefers. LabKey has built-in reporting and charting tools to quickly assess the data, as well as many advanced tools such as built in R and SQL reporting, integrations with Tableau, Spotfire, etc.
• Can you capture participant clinical trial data within the same tool?
  If you choose the right clinical sample tracking tool, you can centralize your data easily. LabKey has an extensive CDMS software that integrates with our clinical sample tracking system that allows teams to capture all clinical data. We integrate with REDCap and Medidata RAVE as well. Our study publishing capabilities allow teams to share information with collaborators in a secure way including date-shifted and de-identified data.

 

Want to learn more about our clinical sample solutions?

LabKey Sample Manager is a robust, easy-to-use, and up-to-date solution to clinical sample tracking challenges. Whether you are starting fresh with a setup or looking to import thousands of existing data sets from a spreadsheet, LabKey can get your clinical trials up and running, with support from our product and account managers as you need it.

Read about and take a tour of our product here: LabKey Sample Manager – product overview and tour

Ready to talk to one of our product experts? Request a Demo