Introduction
In the fast-paced world of life sciences validation software, accurate and compliant data validation is crucial for successful clinical and nonclinical study submissions. Ensuring the integrity of Clinical SDTM, ADaM datasets, and Nonclinical SEND data is no easy task, considering the complexity and vastness of datasets involved. In this blog, we introduce you to a game-changing validation tool that simplifies the process and empowers your team to achieve flawless data validation – eDataValidator (eDV).
Understanding eDataValidator – validation for clinical SDTM, ADaM, and Nonclinical SEND Data
The eDataValidator (eDV) is a powerful and comprehensive validation tool, specifically designed to handle the validation of Clinical (SDTM, ADaM), Nonclinical (SEND) datasets and define files. This versatile tool caters to both clinical and nonclinical study submissions, ensuring seamless compliance with regulatory agencies like the FDA and PMDA.
Comprehensive Validation Capabilities
One of the most remarkable features of eDataValidator is its limitless validation capabilities. With eDV, you can conduct thorough validations for SDTM, ADaM & SEND datasets and define validations, all within a single solution. Say goodbye to juggling multiple tools for different datasets – eDataValidator streamlines the process and brings efficiency to your data validation efforts.
Supported Validation Rules
eDataValidator comes equipped with support for various sets of validation rules, including but not limited to:
– FDA Validator Rules v1.6 (SDTM, SEND)
– FDA Validator Rules v1.5 (SDTM, SEND)
– PMDA Validation Rules v4.0 (SDTM, ADaM, Define)
– CDISC SEND Conformance Rules v4.0
– CDISC SDTM Conformance Rules v2.0
– CDISC ADaM Conformance Rules v4.0
– CDISC Conformance Rules for Define 2.1/2.0
eDataValidator – Empowering Life Sciences Data Validation:
1. Comprehensive Validation: eDV offers limitless validation capabilities for Clinical SDTM and ADaM datasets, as well as Nonclinical SEND data. From IND to NDA and BLA preparation, eDataValidator provides a one-stop solution for all your validation needs.
2. Supported Validation Rules: Our powerful tool supports various sets of validation rules published by various regulatory authorities including FDA, PMDA, CDISC.
3. Quality Checks Dashboard: eDV comes with an interactive quality checks dashboard to view, review and provide notes on the validation outcomes. Notes can be assigned to users for data corrections and can also be prefilled to an SDRG.
4. Versatile File Formats: eDV seamlessly validates study data in various formats such as CSV, XPT, SAS7BDAT, and EXCEL, providing flexibility and ease of use for biometrics teams, biostatisticians, SAS, or R programmers.
5.Compliant with Regulatory Standards: Rest assured that eDataValidator is 21 CFR Part 11 compliant, meeting the strict requirements for electronic records and signatures.
6. No Validation Cycle Limitations: Unlike other tools, eDV lets you run unlimited validation cycles, enabling you to thoroughly verify your datasets without any constraints.
7. Affordable Subscriptions: With eDataValidator, individual subscribers can access the service for just $170 per user per month. Further discounts are available for larger groups or enterprise subscriptions within an organization.
The Power of Versatility
eDataValidator shines when it comes to accommodating different file formats. It can seamlessly validate study data in various formats, including CSV, XPT, SAS7BDAT, and EXCEL. This versatility provides the flexibility that biometrics teams, biostatisticians, SAS, or R programmers need to efficiently validate their datasets.
Scalable and Reliable
Worried about handling large datasets? Fret not! eDataValidator is designed to be scalable and reliable, making it the ideal choice for life sciences organizations dealing with massive datasets. The cloud-based Software-as-a-Service (SaaS) application allows it to leverage cloud infrastructure resources for efficient processing, ensuring high performance without compromising on reliability.
Ensuring 21 CFR Part 11 Compliance
Data integrity and security are paramount in life sciences. With eDataValidator, you can rest assured that your data validation process adheres to 21 CFR Part 11 compliance, meeting the stringent requirements for electronic records and signatures.
Ease of Use and Flexibility
eDataValidator provides a user-friendly interface, available both as a SaaS monthly subscription and a companion desktop version. The desktop version works offline, catering to remote users and programmers who need to work with clinical trial data on the go.
Can eDataValidator handle large datasets?
Absolutely! eDataValidator (eDV) is designed to handle large datasets efficiently. It has been developed to meet the rigorous demands of the life sciences industry, where datasets can often be vast and complex.
Key features that enable eDataValidator to handle large datasets effectively:
1. Scalability: The underlying architecture of eDV is built for scalability, allowing it to process large datasets without compromising performance. It can efficiently handle the validation of data from diverse sources and formats.
2. Cloud-Based SaaS: Being a cloud-based Software-as-a-Service (SaaS) application, eDataValidator can take advantage of cloud infrastructure resources to accommodate large-scale validation tasks. Cloud-based solutions can easily scale up or down based on the volume of data being processed.
3. High-Performance Algorithms: eDataValidator incorporates high-performance algorithms optimized for data validation. These algorithms enable quick processing and validation of large datasets, minimizing processing time and enhancing overall efficiency.
4. No Validation Cycle Limitations: eDataValidator does not impose any limitations on the number of validation cycles. This means you can perform multiple validation runs on your large datasets until you are satisfied with the results.
5. Streamlined Data Consistency Checks: The tool efficiently performs data consistency checks on your study datasets, ensuring that even large datasets are validated for structural and metadata correctness.
6. Continuous Updates: eDataValidator regularly updates its validation rules and software to adapt to evolving data standards and requirements, ensuring compatibility with the latest datasets and formats.
7. Flexibility in File Formats: eDV supports various file formats, including CSV, XPT, SAS7BDAT, and EXCEL. This flexibility allows you to work with the data in formats that suit your needs and data size.
Considering the critical nature of life sciences data and the need for comprehensive validation, eDataValidator is designed to be robust and capable of handling the challenges posed by large datasets. Whether you are working with clinical SDTM, ADaM datasets, or nonclinical SEND data, eDV can efficiently process and validate your data, streamlining the validation process for large-scale clinical and nonclinical studies.
Conclusion
In conclusion, eDataValidator is a true game-changer in the realm of life sciences data validation. Its ability to handle Clinical SDTM, ADaM datasets, and Nonclinical SEND data in a single solution, coupled with its scalability, versatility, and compliance, makes it an indispensable tool for biotech, pharma, and CROs. So, embrace the power of eDataValidator and streamline your data validation process to achieve flawless clinical and nonclinical study submissions.
Whether you need to validate SDTM, ADaM, SEND datasets and define files, eDataValidator is your go-to solution. Download eDV directly and get started with a free 30-day trial (No credit card required). For any queries or assistance, contact our support team, and we’ll be more than happy to help you optimize your data validation process.