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CDISC-Compliant Dataset Generation

Submission-Ready Datasets. Zero Rejections.

We transform clinical data into complete regulatory submission packages — SDTM, SEND, ADaM, Define.XML, and reviewer guides. Our integrated team of data managers, biostatisticians, and programmers ensures validation, accuracy, and compliance with FDA, PMDA, and NMPA standards.

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ISO 27001SOC 2FDA 21 CFR Part 11GDPR & HIPAA

Standardized Metadata from eCRF

Biostatistical Expertise in Creating TFLs from ADaM

Validated Mapping

Comprehensive Documentation

Achieve Compliance

Wemedoo provides end-to-end CDISC-compliant dataset generation and documentation, transforming clinical data into complete submission packages for regulatory review. We deliver SDTM, SEND, ADaM datasets, Define.XML files, and supporting documents — ensuring accuracy, validation, and efficiency through our expert team of data managers, biostatisticians, and medical writers.

End-to-End CDISC Dataset Generation & Documentation

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Our Proof of Quality

We are ISO 9001 and ISO 27001 certified. Our commitment to robust information security & superior quality management is at the core of our innovative solutions, ensuring reliable & efficient trial management for our clients.

Main Areas of CDISC-Compliant Dataset Generation & Documentation

We transform clinical trial data into regulatory-ready formats with tailored solutions. Our streamlined process covers annotated CRFs, SDTM/SEND, ADaM databases, Define.XML metadata, validation checks, and CDISC-compliant submission documents. We ensure full regulatory compliance (FDA, PMDA, NMPA) to support investigators, data managers, and research teams throughout the trial.

Annotated CRFs are an essential CDISC regulatory submission deliverable, dictating the contents of SDTM/SEND databases. Wemedoo's clinical data management and statistical programmers work together in creating study CRFs and their CDISC annotations in parallel, expediting the process for you. Our well-trained team ensures swift and precise aCRF development, consistently meeting both regulatory and industry requirements with efficiency and excellence.

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Benefits of Our Service

Wemedoo’s collaborative team of data managers, biostatisticians, and medical writers delivers complete CDISC-compliant datasets and documentation services—from annotated CRFs to SDTM/SEND, ADaM, Define.XML, and reviewer guides. Rely on our dedicated experts to simplify submission prep and ensure smooth, compliant regulatory submissions.

Harness the Potential of Precise Dataset Generation & Documentation

Standardized Data Formats

Our service facilitates the use of SDTM and ADaM, the industry-standard data models, to enhance the consistency and quality of clinical trial data generated.

Efficient Review Process

We help streamline the data review process for regulatory authorities, thanks to the well-structured and clearly defined datasets provided by our service.

Accurate Data Mapping

Our service offers precise and effective conversion of clinical trial data into standardized formats, minimizing errors during the process.

Enhanced Data Transparency

We provide a comprehensive and clear understanding of the trial data and analysis methodologies through Define.XML, promoting transparency throughout the research process.

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Frequently Asked Questions

Get the answers you need about our CDISC-compliant service

What types of regulatory submissions does Wemedoo support with CDISC standards?

Our services cover a wide range of regulatory submissions, including those to the FDA, PMDA, and NMPA. Whether it's for new drug applications, investigational new drug submissions, or post-marketing activities, we ensure that your data aligns with CDISC standards for regulatory compliance.

Can Wemedoo outline the steps involved in creating a CDISC regulatory submission package for clinical trial data?

The process typically involves CRF creation, data collection, SDTM/SEND data mapping and creation of databases and their metadata specification, ADaM dataset creation and their metadata specification, Define.XML generation, SDTM/SEND/ADaM/Define.XML validation, and the creation of study data and analysis data reviewer’s guides. Typically, most of these steps occur simultaneously, all thanks to our well connected team of experts – clinical data managers, biostatisticians, and medical writers. Our goal is to provide a comprehensive, well-organized CDISC submission package that ensures a smooth regulatory review process.

How does Wemedoo handle discrepancies or issues identified during the CDISC submission package creation process?

Our process includes thorough quality checks at each stage by multiple experts from different departments, making it transparent and easy to quickly identify discrepancies. We foster open communication both within our company and with the client in resolving any issues.

How does Wemedoo handle updates and changes in CDISC standards over time?

We stay up-to-date with the latest developments in CDISC standards and regulatory requirements. Our team is proactive in implementing updates and changes, ensuring that your data remains current and compliant. We work closely with clients to navigate any transitional phases, providing support and guidance throughout the process.

Does Wemedoo ensure data security and confidentiality during the CDISC-regulated submission process?

We prioritize data security and confidentiality throughout our processes. Our company adheres to industry best practices and internal standards of practice to safeguard your sensitive clinical trial data. We employ encryption, access controls, and secure data transfer protocols to protect information at every stage of the submission deliverables creation process, ensuring the integrity and confidentiality of your data.

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Explore Related Services

Beyond protocol development, Wemedoo offers a comprehensive suite of integrated data operations services for clinical trials. At each step, we ensure your trial meets the highest quality and regulatory standards, while streamlining your clinical trial processes and saving you time and money. Discover our other services, all focusing on innovation and excellence in clinical research.

Protocol Development Clinical Data Management Risk-Based Monitoring & Source Data Review eTMF Setup & Administration Biostatistics & Statistical Programming Medical Writing & Documentation

Proud to be a Member of CDISC

Since November 2020, we have been a part of the Clinical Data Interchange Standards Consortium. It is our concern to improve the quality and efficiency of clinical research.

Resources

CDISC resources

CDISC Compliant Dataset Generation