Driving Innovations with Open-Source Solutions
We have extensive experience working with R and Python packages. These are approved and available under the CDISC Open Source Alliance (COSA) directory and the pharmaverse platform where we provide support on the following packages:
ggplot2
A data visualization package used to create complex and customized graphs and charts for data analysis.
dplyr
A data manipulation package used to streamline data management tasks such as filtering, grouping, and summarizing data.
tidyr
A data manipulation package used to reshape data into tidy formats for analysis.
shiny
An R package used to create interactive web applications and dashboards for data visualization and analysis.
OAK
An open-source project to map CDASH to SDTM and generate synthetic data.
admiral
(ADaM In R Asset Library) - Modular framework to generate ADaM via R functions relying on community contributions
CORE
An easy to use rule editor to allow data scientists to author rules in YAML, check and test the rule against the Conformance Rule Schema standard, and then publish the rule.
Open study builder
A new approach to working with studies that once fully implemented, will drie end-to-end consistency and more efficient processes.
Tfrmt
A table formatting framework that provides the means to flexibly design and build mock results summaries.
In addition to utilizing open-source solutions, we are also a member of the CDISC Open-Source Alliance (COSA), a community-driven platform that promotes the use of open-source software in clinical research. The COSA project directory includes a wide range of open-source solutions, including data management and analysis tools, standardization tools, and regulatory submission tools.
By leveraging open-source solutions and being part of the R, Python and COSA community, we are able to provide flexible and customized solutions to our clients that are both efficient and cost-effective. We are committed to staying up-to-date with the latest open-source technologies and techniques to ensure that our clients have access to the most innovative solutions for their clinical trial needs.
Got Questions? We've Got Answers
What is open source software (OSS) and how is it different from proprietary software?
Open source software (OSS) is software that is distributed with a license that allows anyone to access, modify, and share the source code. Proprietary software, on the other hand, is software that is owned and controlled by a specific entity, and whose source code is usually not available to the public.
What are the benefits of using OSS in a regulatory environment?
OSS can offer several benefits in a regulatory environment, such as:
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Cost savings: OSS can reduce the costs of licensing, maintenance,
and support for software products.
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Flexibility: OSS can provide more options for customization,
integration, and interoperability with other systems.
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Innovation: OSS can foster collaboration, creativity, and knowledge
sharing among developers and users.
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Transparency: OSS can enhance the trustworthiness, reproducibility,
and quality of software products by allowing peer review and
verification of the source code.
Cost savings: OSS can reduce the costs of licensing, maintenance, and support for software products.
Flexibility: OSS can provide more options for customization, integration, and interoperability with other systems.
Innovation: OSS can foster collaboration, creativity, and knowledge sharing among developers and users.
Transparency: OSS can enhance the trustworthiness, reproducibility, and quality of software products by allowing peer review and verification of the source code.
What are the challenges of using OSS in a regulatory environment?
OSS can also pose some challenges in a regulatory environment, such as:
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Compliance: OSS must comply with the relevant regulations and
standards for safety, security, privacy, and performance.
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Validation: OSS must undergo rigorous testing and verification to
ensure its functionality, reliability, and accuracy.
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Support: OSS may not have the same level of technical support,
documentation, and training as proprietary software.
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Licensing: OSS may have different types of licenses that impose
certain obligations and restrictions on the use, modification, and
distribution of the software.
Compliance: OSS must comply with the relevant regulations and standards for safety, security, privacy, and performance.
Validation: OSS must undergo rigorous testing and verification to ensure its functionality, reliability, and accuracy.
Support: OSS may not have the same level of technical support, documentation, and training as proprietary software.
Licensing: OSS may have different types of licenses that impose certain obligations and restrictions on the use, modification, and distribution of the software.
How can I validate OSS for use in a regulatory environment ?
The validation process for OSS depends on the specific requirements and
guidelines of the regulatory authority and the intended use of the software.
However, some general steps that can be followed are:
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Define the scope and purpose of the software.
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Identify the applicable regulations and standards.
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Select an appropriate OSS license.
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Evaluate the quality and suitability of the OSS.
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Perform testing and verification of the OSS
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Document the validation results and procedures
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Maintain continuous monitoring and improvement of the OSS
Define the scope and purpose of the software.
Identify the applicable regulations and standards.
Select an appropriate OSS license.
Evaluate the quality and suitability of the OSS.
Perform testing and verification of the OSS
Document the validation results and procedures
Maintain continuous monitoring and improvement of the OSS
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