Tag: ELN

For researchers, clinical data management and reporting has historically included manual curation and compilation of datasets from disparate data warehouses. In today’s data-rich environment, manual processing and integration is becoming more and more of a bottleneck.

In order to keep up with the increasing amount of data collected from clinical research, clinicians and statisticians alike need software tools that will centralize their data and help them quickly recognize errors. LabKey Server provides essential tools to overcome these, and other key clinical research challenges including:

Maintaining Clinical Data Integrity

Having an accurate representation of clinical data helps transform discoveries and understanding into patient care and treatment. Centrally-housing data in a compliant environment that enforces data standardization can help clinicians maintain excellent data integrity and provide an authoritative view of their data landscape.

LabKey Server helps maintain data integrity by providing:

• A highly structured data environment with enforceable data fields to ensure data is entered correctly and within range
• Quality control measures such as data flags, QC of datasets and built-in QC reports
• Role and group-based permission levels that allow users only access to what they need access to
• A compliance module, the allows users to set PHI securities, set Terms of Use for users, and provide electronic signatures on data snapshots

Integration of Data from Multiple Sources

Bringing together data from disparate sources into a single system can help clinical research stay on track and on time. Collaborative monitoring of data quality by clinicians, statisticians, and scientists enables quick identification of erroneous data and ensures a reliable, integrated data landscape for comprehensive data analysis.

LabKey Server helps facilitate comprehensive data integration by providing:

• Management of lab data together with clinical data in a single system
• A study module that can recognize and integrate disparate vendor datasets
• Built-in and customizable integration with electronic data capture systems and case report forms
• A clinical document abstraction pipeline, which can extract valuable data from legacy documents

Secure Reporting and Collaboration

A key component of effective clinical data management is the ability to share reports and data with collaborators to improve research, innovation, and ultimately patient care. Maintaining compliance and having the ability to quickly share data and reports is an important topic to tackle in clinical research where patient safety and care is the top priority.

LabKey Server improves reporting and collaboration by providing:

• Dynamic and static reporting tables and visualizations that can be shared as-needed
• Web-based access to a central platform for data sharing
• The ability to remove PHI fields or provide randomized IDs when sharing information with collaborators

With the right tools for clinical data management, research teams can eliminate data integration bottle necks and curate reliable datasets for analysis. Explore our example Longitudinal Study or Sign-up for a free trial to see how LabKey Server can help your team overcome these, and other common clinical research challenges.

Related Documentation

Read more about the features highlighted above on the LabKey Support Portal:

• Data Quality Control
• Security & Permissions
• Compliance Module
• Longitudinal Study Tools
• File Watchers – Automated Directory Monitoring
• Clinical Document Abstraction

The biologics development process is a data-driven endeavor. A vast amount of data is generated from many teams with the hopes of answering questions and informing decision-making along the way. Centralizing this data and their analyses across experiments amplifies the power and impact that data has on biologics research and development. 

Of course, centralizing biologics assay data means much more than simply storing data in the same place. Data centralization increases the value of biologics data beyond one particular experiment or result by defining data relationships. The ability to aggregate data across multiple samples, assays, and experiments, with metadata describing the relationship of all of these to each other, is where modern data science resides. Whereas the analysis of a single value from a single assay shows a distribution, joining that assay with others reveals a richer data landscape that is ripe for analysis. These data landscapes yield even more insights when they are related to one another across many controlled variables and conditions.

Below are more ways that implementing tools and strategies for data centralization can impact the speed and efficiency of biotherapeutic development. 

Data Integrity 

Having a single source of truth for data makes it easier for organizations to track how (and by whom) data is generated, accessed, and modified. With the assistance of a biologics data management application serving as a central hub-  permissions, auditing, and backups provide control over how, when, where, and by whom data is used. Centralization of data also encourages standardization of data formats across research teams. Standardizing data structures helps validate the data being entered and helps preserve the relationships between data. This leads to downstream efficiency and maximizes the utility of experiments beyond the individual or team from which it was derived. 

Collaboration 

Centralizing biologics research data also helps promote collaboration between research teams. By storing data in one central location in standardized formats, scientists can easily find, compare and reference existing data in their research. A central repository for data also makes it much easier to see what data is missing or needed to inform decisions. Hand-offs of data are also made easier when all data is centrally stored. 

About our Biologics LIMS

LabKey Biologics provides researchers with a set of tools to centralize biological entity registration, workflow management, and data exploration. 

• Bioregistry – Register and track molecular entities, nucleotide sequences, protein sequences, expression systems, constructs, vectors, and cell lines
• Biologics Assay Management – Connect design data to related multi-dimensional assay results for a complete data landscape.
• Biologics Workflow Manager – Centrally manage biologics development workflows to help your team collaborate
• Electronic Lab Notebook – Highlight and connect your research entities and data with our biologics ELN

Click Here to take a tour of LabKey Biologics.

An ELN (electronic lab notebook) is an essential software tool for documenting experiments, reviewing compiled results, detailing meaningful conclusions, and collaborating with team members. As scientists work with increasing volumes of data, concerns over data reproducibility, data integrity, intellectual property and security/compliance have led to the wide ELN adoption in nearly every scientific discipline. Once viewed as little more than a paper-on-glass/word-processing application, ELN features have grown to meet the complexities of modern-day research. Below we outline some essential ELN features to look for when evaluating an electronic lab notebook for your organization.

ELN Feature Areas to Consider:

1- Ease of use
The ELN you choose should be easy to use and implement. This is especially critical in driving adoption within the organization. That means the user interface should be intuitive for common functions. Ideally, your new ELN should not require extensive training to learn nor require sophisticated integrations with other software to be useful.

2- Templates
The ability to create and use templates of common notebook forms saves time by reducing duplicative work. The ability to quickly modify templated entry types is an essential feature for saving time and improving overall work satisfaction. By creating templates for specific scenarios such as purifications, cell passaging, or repeated analytical work, your team can save time and standardize the formatting of notebook entries.

3- Data Links/Connection
Compiling data for meaningful write-up and conclusions should not require a huge investment of time and effort. By far the easiest way to surface data is for your ELN to have direct access to your underlying data management system that captures the data. This puts your relevant data at your fingertips while authoring and only external data will require effort to incorporate. Directly referencing data not only saves time, it also promotes data integrity and ensures that valuable data remains at the forefront of the decision-making process during the R&D lifecycle.

4- Attachments and Images
External files and images are important components of complex workflows. It should be easy to incorporate them into notebook entries in various formats such as pressure traces, spreadsheets, images, CoA’s or other QC documents, and SOP’s. The ability to bind these files with your signed notebook contents and view the attachments with a notebook entry can also be a huge time saver.

5- Collaborative Features
In the highly collaborative research environments of today, it is essential to have an ELN that makes it easy to work with other contributing scientists. The ELN should support collaborative authoring and a streamlined sign-off/review process for notebooks. It should be easy to find the notebooks that need your attention, comment or review. You should also receive reminder notifications for these actions when you aren’t in the application. These collaborative features facilitate important discussion and encourage timely and accurate documentation of work.

About the Biologics LIMS ELN
Biologics LIMS includes a full-featured electronic lab notebook seamlessly integrated with the Bioregistry, Assay Data and Workflow Management tools. This user-friendly ELN allows scientists to:

• Save time authoring and reviewing notebooks with templates, notifications and an intuitive interface
• Highlight valuable data by linking directly to bioregistry entities, samples and assays
• Collaboratively document and discuss notebook entries and referenced data

Click here to learn more about LabKey Biologics.