Tag: Sample Manager

Clinical sample management requires laboratories to put a significant amount of thought and effort into record-keeping and reporting in order to meet compliance requirements. Regardless of the type of compliance (HIPAA, Part 11, GLP, etc),  managing clinical samples requires a commitment to actively maintain an audit ready-state. For many labs that are getting started with clinical sample management, this can be a daunting task. Check out the 3 tips below to get started. 

Clinical Sample Management Compliance Tips

1. Traceability of Clinical Samples 

Your staff should be able to the “what, when, how, who” of every human-derived sample in the lab. Sample tracking should include the capture of all details around the collection, receipt, storage, processing and handling samples.

What? – Document the type(s) of samples you will receive/create including the descriptive metadata that you want to collect for each sample type.
When? – Capture dates for all events in the lifecycle of a sample including when it was collected, received, processed, stored, and shipped.
How? – Track step-by-step how tasks were performed in the lab in relation to a sample. Utilize sample management software to capture SOPs in workflows and audit trails.
Who? – Capture who in the lab performed any work or handling of the samples. This is both valuable for accountability and troubleshooting.

2. Sample Identification & Barcoding

Clinical samples should have clear and unique identifiers that are appropriate to the laboratory type. Among other considerations, do your samples need to be de-identified for a specific laboratory or can they have PHI in the identifier? Do your naming patterns easily provide information and context for a given sample? 

Sample Receipt – Consider how samples will be labeled from the collection site and received into the laboratory. Do they need to be de-identified before use in the lab?

Laboratory-Specific Identification – Define naming patterns that account for the uniqueness of your samples, aliquots, derivatives, and repeat samples. Although you may also use barcoding, consider having your identifier be “human-readable” so that lab staff can identify samples on-the-fly. 

3. Standard Operating Procedures

When managing clinical samples it is essential to have clear SOPs that document sample processing tasks and workflows.  SOPs should accurately document the work to be done in the lab as well as capture any results from sample processing tasks.

Document – With the help of your team, draft an example of the sample lifecycle in the lab. Be sure to capture areas of possible deviation, key variables and decision points.
Create/Update SOPs – Compare the sample lifecycle with your SOPs to ensure procedures are aligned with what is taking place in the lab.
Evaluate – Conduct a “trial run” of your clinical sample intake, processing and storage to ensure SOPs accurately reflect real-world procedures.
Maintain – Define a schedule to regularly review processes and track any changes to SOPs using documented change requests. Internal audits should also be scheduled at set intervals to keep your lab in an “audit-ready” state.

4. Record Keeping

All work performed on clinical samples should be documented and include the same  “what, when, how, who” details mentioned before. This should be a record of the actual work that was done, versus your SOPs, which layout a plan and methodology for the work. Keep regulatory requirements in mind when determining how this documentation will be captured, stored and shared.

Clinical Sample Management with LabKey Sample Manager

Efficient and compliant management of clinical samples requires sample management software that is both powerful and easy to use. Sample Manager is a cloud-based sample management system that helps:

• Track the full history and chain-of-custody for each sample.
• Register and definine samples using all relevant metadata 
• Manage task-based workflows that accurately reflect SOPs
• Support barcoding and unique, human-readable sample ID creation
• Retain records of the complete life-cycle of each sample.
• Easily manage freezers and sample storage 

Click here to learn about Sample Manager and take a product tour!

It’s no surprise that our users are overwhelmingly happy with the ease and efficiency that Sample Manager has brought to their labs. After all, Sample Manager was created in close consultation with labs of all shapes and sizes to ensure that we were creating the best sample management software on the market. We recently asked lab managers what they love most about Sample Manager and how it has impacted their labs. Their responses varied, but all shared a common theme- Sample Manager makes lab work easier and faster.   

“Sample Manager is so easy to use. It makes all of our days easier and more productive.”

With a beautifully simple user interface and intuitive features that are essential for modern laboratories, Sample Manager is designed to bring ease and efficiency to sample management tasks. From bulk importing and storing samples to tracking lab workflows and managing data, Sample Manager makes the management of lab samples faster and easier than ever before. 

“The Sample Timeline is amazing, I can finally see the complete history of a sample and who in the lab has touched it.”

Our Sample Timeline feature provides an audit-ready view of the complete history of each sample. By reviewing the chain-of-custody, you can easily see the “who, what, when and where” for each event in the timeline of a sample. Events may include sample registration, storage changes, sample check-in/check-out events, assay runs and more. The sample timeline can also be exported to Excel for further analysis and review.

“No more searching for lost samples! The freezer management features alone have saved us so much time.”

Helping our users efficiently search their sample inventory and manage their freezer storage is a core function of Sample Manager. Our flexible freezer management tool allows you to create an exact match of your physical freezer storage options within the application. You can also use our Sample Finder tool to build custom queries to search, group and take action on related samples.

“The lineage tracking capability has been a gamechanger. We can now easily tie samples back to their sources and aliquots that have been created.“

Tracking samples and their derivatives has been made as easy and intuitive as possible within Sample Manger. Using a visual lineage tree, users can easily see the context and details of samples including all sources and aliquots. We’ve also streamlined the creation of aliquots from samples to boost efficiency in the lab. 

Learn More About Sample Manager:

• Product Page & Tour
• Freezer Management
• Sample Tracking
• Lab Workflow Management
• Assay Data Management

Clinical sample management poses unique compliance challenges for laboratories. Sample collection, tracking and consent all become more regulated (GLP, GCLP, HIPAA) when managing clinical samples, and require a greater depth of record-keeping and reporting. Although keeping up with these regulations can seem like a daunting task, you can simplify and get a good start on improving regulatory compliance by focusing on 4 basic sample tracking questions: What? When? How? and Who?.

Lab staff should be able to answer these questions for every clinical sample managed in the lab. In order to do this, your lab will need to capture all details around the collection, receipt, storage, processing and handling of samples. With each sample requiring the capture of so many data points, it is essential to have modern sample management software designed to support the management of clinical samples.

What? – Fully and accurately define your samples, sample types and sources.
Document the type(s) of samples you will receive/create including the descriptive metadata that you want to collect for each sample type. Make sure to consider the source of the sample (perhaps a clinical trial participant), derivatives, and any other related details you need to capture. 

When? – Track dates for everything related to your samples.
Capture dates for all events in the lifecycle of a sample including when it was collected, received, processed, stored, and shipped. This data should be readily available and exportable for further analysis during an audit.

How? – Capture everything that has been done to your samples in detail.
Track step-by-step how tasks were performed in the lab in relation to a sample. This includes all of the steps taken during sample receipt, checking of tubes for breakages or possible contamination and documenting storage conditions. Utilize a sample management system to capture SOPs in lab workflows and audit trails.

Who? – Capture who has worked with your samples.
Capture who in the lab performed any work or handling of the samples. This is both valuable for accountability and troubleshooting in the lab as well as for supplying auditors with additional information that they may need.

Clinical Sample Management with LabKey Sample Manager

Efficient and compliant management of clinical samples requires sample management software that is both powerful and easy to use. Sample Manager is a cloud-based sample management system that helps:

• Track the full history and chain of custody for each sample.
• Register and define samples using all relevant metadata 
• Manage task-based workflows that accurately reflect SOPs
• Support barcoding and unique, human-readable sample ID creation
• Easily manage freezers and sample storage 

Click here to learn about Sample Manager and take a product tour!

The Ohio State University is using Sample Manager to manage veterinary samples for its influenza monitoring program.

Presented at the LabKey User Conference, Andrew Bowman, Associate Professor at The Ohio State University shared how his lab is using Sample Manager for veterinary sample management to support a surveillance program monitoring influenza viruses circulating in swine and waterfowl. His presentation provided an overview of the work being done in the lab, their need for a sample management system, benefits they have seen since adopting Sample Manager, and future plans. 

The lab generates more than 10,000 veterinary samples per year and conducts approximately 15,000 tests on these samples annually. The samples being handled by the lab include swabs, environmental samples, serum and PBMC. Projects assigned to the lab have varying data reporting requirements and sample information being captured. As can be expected, one of the major challenges is managing the volume of data and samples.

Prior to Sample Manager, the lab was using an outdated veterinary sample management system based on Filmaker databases. The system was difficult to use and lacked the flexibility needed to adapt to new projects and sample processing requirements. Being an academic lab, there is a continuous turnover of students using the system, creating the need for an easy-to-use application that requires minimal training and IT support.

Sample Manager was chosen as the veterinary sample management system for the following reasons: 

• Sample Research-focused data management and the flexibility to meet data reporting requirements
  
• Sample-centered, alignment with workflow
  
• Easily customizable to meet the needs of new projects and assay
  
• Intuitive and user friendly- requiring minimal training and support

Some of the key features being used include:

• The ability to add multiple sources per sample and general flexibility of the system
  
• The ease by which new assays can be added and data can be managed/tracked
• Customer support- LabKey is incredibly responsive and solution-oriented in its approach!

Click Here to learn more and take a tour of Sample Manager!

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Candel Therapeutics is using LabKey Sample Manager to manage biomarker samples from the clinical sites where they’ve been collected all the way to the externally performed assays.

At the LabKey User Conference, Jessica Dwyer, Biomarker Operations Manager at Candel Therapeutics, shared how her organization is using LabKey Sample Manager for biomarker sample management. Her presentation covers the process of selecting a sample management software, reasons for choosing sample manager, and how Candel is now using the application. 

Candel is an oncolytic viral therapy company producing therapies to target solid tumors. Their approach to immunotherapy centers on oncolytic viruses that induce immunogenic cell death at the site of injection which then unmasks tumor neoantigens. This process has been shown to create a systemic immune response against tumors with evidence of clinical and biomarker activity demonstrated across several solid tumors. The feasibility and tolerability of this approach has been demonstrated in over 700 patients across multiple phases of trials.

Prior to LabKey Sample Manager, biomarker samples from clinical trials were being tracked using excel spreadsheets. The drawbacks of managing biomarker samples in this way included:

• Time wasted searching for the latest versions and interpreting data
• Lack of audit trail and consistency of data between studies
• Ineffiecient processes for registering and tracking samples

Candel Therapeutics evaluated three different biomarker sample management solutions including Sample Manager. They were looking for software that provided a complete and searchable audit trail, required minimal implementation time and had features that met their needs without work-arounds. After evaluating the options, LabKey Sample Manager was chosen as the solution that most closely matched these requirements. Sample Manager was chosen due to:

• LabKey’s specialization in the management of clinical trial samples
• Aliquot features
• Sample relationship features (data from sample types and sources can be tracked)
• General ease-of-use 

Watch the video below to learn more about how Candel Therapeutics is using LabKey Sample Manager.

Want to learn more? Request a demo of LabKey Sample Manager!

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Many researchers are continuously seeking ways to boost scientific collaboration. As with other disciplines, enabling scientific collaboration requires the right tools and processes. This is especially true when researchers are sharing samples that need to be tracked at each step of their lifecycle. For some labs, collaborative sample tracking involves a piecemeal approach of emails, spreadsheets, and whiteboards to give teams some visibility into the next steps, assigned work and upcoming projects. This method of sample tracking is highly prone to error and can easily get unwieldy as a lab grows or the complexity of sample processing increases. 

Finding a sample management software that tracks samples throughout their life cycle while also enabling scientific collaboration is imperative for the modern laboratory. Sample Manager has been designed by scientists, for scientists, to help get work done in the lab. We have created a tool that integrates sample registration, storage, experimental data and work assignment for doing all your sample-related work in a single application. Below are a few features that help enable scientific collaboration in the lab.

Workflow Management for Scientific Collaboration

Our task-based lab workflow management tool allows teams to capture the exact work that needs to be performed on samples. Using customizable templates, labs can easily standardize processes and create workflows that accurately reflect their SOPs. Common lab processes like sample receipt, shipping preparation, processing, and assay requests can all be managed using the Sample Manager workflow tool. For each workflow, samples are selected for inclusion in the job, tasks are assigned to individual team members, and notifications communicating the status are sent. The ability to set due dates and the priority of the work allows teams to plan and prioritize work appropriately. 

Freezer Management/Sample Location Tracking

Our sample-centric freezer management tool gives teams insight into freezer capacity and the physical storage of samples. Team members efficiently work in an intuitively designed virtual freezer environment, capturing notes for freeze/thaws and displaying those in the Sample Timeline. Users can quickly understand storage capacity, relative sample breakdown, and overall sample status across storage units in the lab.

Picklists

Teams can create private or public Picklists of samples to generate pull lists, manifests or any other type of list that would be useful for tracking and sharing samples. Sharing picklists with team members enables visibility into user-curated lists of samples and reduces the need for exporting, printing and emailing lists of samples to team members. Shared Picklists can be used to print labels, check samples in and out storage, and add samples to workflow jobs. 

Click here to learn more about Sample Manager and take a tour!

Most freezer management software aims to be a mirror image of a lab’s freezer space. Samples are assigned location in the freezer at the same time as they are entered into the system, and removed from the system when they are no longer in storage. Although this may be helpful in managing freezer capacity and sample locations, this “mirror image” approach does not always accurately reflect lab workflows or provide a full chain of custody of a given sample. 

In many labs, samples are transported, received, and processed before they are stored. Similarly, samples can also be completely removed from storage, but their data and audit logs may need to persist in the system. The freezer management software described above would be ill-suited to handle both of these scenarios. To fully track a sample and provide an end-to-end history, teams should search for a sample-centric freezer management tool- one that separates a sample’s existence from the physical location in which it’s stored.

A sample-centric freezer management software has the following benefits:

1. Samples can exist outside of a storage framework. This means that teams can:

• Save time and improve visibility of work by registering samples before they arrive
• Easily view consumed, expired or shipped samples without crawling an audit log
• Track chain-of-custody of samples that are never meant for storage

2. Samples can be part of lab tasks before or after they are physically stored. This is useful in cases like:

• Pre-registered samples are part of a “Receiving” workflow job
• Sample processing can be tracked in the system before adding the samples to storage
• Outgoing samples can be tracked in a workflow job

3. Experimental data can be associated with samples at any time. This benefits teams by:

• Adding associated data from external sources to be registered with samples, regardless of storage status
• Removing the need for “staging” freezer space to make updates to samples and their experimental data
• Creating a single space for tracking samples and their associated data, whenever it is available

About LabKey Sample Manager

LabKey Sample Manager includes a sample-centric freezer management solution into the application. This means you can create samples, add metadata and lineage information, perform work and even upload assay data — all without being required to have your sample in freezer storage. Freezer management in Sample Manager can help you:

• Manage your freezer with an end-to-end sample tracking system that stores the entire sample history and chain of custody in one place
• Organize your samples using a customizable structure that accurately reflects the physical freezers in your lab
• Track samples in and out of the freezer (freeze/thaw counts) and automatically calculate and track changes in sample volumes
• Easily find samples in the freezer and move samples between freezers
• Tracking and maintaining full audit logs of the freezer and of the samples

For many laboratories, growth and the changes that come along with it can be both exciting and challenging to sample management operations.

Without careful planning and forethought about sample management, even the most organized lab down can go down a spiral of compounding challenges. Misplaced samples, lapses in data integrity, and confusion on workflow steps are just a few of the difficulties that may arise when a laboratory is experiencing growth. A lab undergoing “growth” may be:

• Processing a higher volume of samples overall or a higher volume of a specific type of sample
• Implementing new sample processing procedures, experiments, and data collection methods
• Expanding their existing operations and the laboratory staff needed to support changes

In this webinar, we present five real-world strategies to help your lab get ahead of the challenges you may face. These include:

1. Change is difficult- be flexible!
   A growing lab will experience many forms of change. Be flexible and ready to adapt at every stage.

2. Plan for your metadata and sample tracking needs.
   Keep the sample information needed for accurate tracking at the forefront of your planning. As your lab grows, the data you need to capture may change.

3. Don’t let your freezers get out of control.
   As your sample storage needs change, be sure to prioritize freezer organization from the start.

4. Standardize your lab processes.
   By taking even small steps toward standardizing processes, labs can optimize their efficiency and ensure a smooth evolution.

5. Research sample management systems.
   Choosing the right (or wrong) sample management system can have a lasting impact on your lab.

With preparation, your lab can successfully navigate change while improving the productivity and efficiency of your sample management operations. Watch the webinar below:

LabKey Sample Manager is an easy-to-use sample management software designed to help labs efficiently track samples, define laboratory workflows, and unify samples with assay data.

Sample Tracking – End-to-end sample tracking features including chain-of-custody tracking,  sample types and sources, and lineage views

Freezer Management – Flexible and intuitive management of freezer capacity and sample storage locations.

Sample Data Integration – Integrate assay data with your samples and assign metadata for a complete picture of your ongoing experiments

Sample Management Workflow – Assign samples to user-defined workflows and monitor the workflow completion status at each stage for every sample

Explore Sample Manager – register to take a product tour!

Migrating data from a freezer management system can be hard. So difficult in fact, that many labs continue to use an outdated system long after it is no longer serving their needs. Sometimes, the legacy system has even become a hindrance to sample management operations. However, this shouldn’t deter you from taking on the challenge of upgrading your freezer management software and reaping the rewards of improved organization and management of your lab samples. Below are a few tips for a painless switch to a new freezer management system. 

Plan and prepare for your new freezer management system.

Develop a plan for migrating to your new system that includes a timetable for which freezer data will be migrated, and roles/responsibilities during the process. Make that your team is trained on the new system and that you are communicating clearly throughout the process.

Backup your legacy data. 

Before anything, it’s important to have a backup of data for record-keeping and disaster recovery. During the migration process, this backup will serve as a record of your legacy system data- some of which may not transfer over to the new freezer management system. Create system-wide backups for recovery, but also human-readable backups for data mining if an unlikely event happens. 

Determine what will be migrated.

Take this as an opportunity to clean up legacy data and items in the freezer. This might even be a good time to defrost and clean your freezers if they are not on a regular defrosting schedule. Focus on the essential samples and related data to keep your system and your freezers clutter-free. For each sample type, determine the list of fields exported from the legacy system and how they will map to the new system. Document data types, field validation (required fields or a specific range of values), and any other requirements such as relationships between samples and sources.

Utilize your resources – ask for help. 

Many vendors offering freezer management system offer migration services, so ask for help! If the system you’re moving to doesn’t offer this, consider hiring a consultant or contractor to help if your team members are too busy or you need advice. When choosing a system, make sure to consider the support you will need to implement your new system.

LabKey Sample Manager provides:

• Easy, straightforward data import format to register your samples and their locations in a single step
• Unlimited user-defined fields allow teams to capture any data necessary
• Migration services and customer support when needed

Click Here to learn more and take a tour!