REGULATORY-READY DATASET CREATION

Achieve Quality and Efficiency in Regulatory Submissions

  • NStandardized metadata from eCRF
  • NValidated mapping
  • NComprehensive documentation
  • NBiostatistical expertise in creating TFLs from ADaM
Regulatory-Ready Dataset Creation

Achieve Quality and Efficiency in Regulatory Submissions

  • NStandardized metadata from eCRF
  • NValidated mapping
  • NComprehensive documentation
  • NBiostatistical expertise in creating TFLs from ADaM

Achieve Compliance in Documentation with Our CDISC-Compliant Dataset Generation

Wemedoo offers CDISC-compliant dataset generation and documentation services, covering all steps and deliverables. Our meticulous approach transforms collected data into a thorough and complete clinical study data submission package, ready for regulatory authorities. This includes Standard Data Tabulation Model (SDTM), Standard for Exchange of Nonclinical Data (SEND) and Analysis Data Model (ADaM) databases, Define.XML files, and associated reviewers guides and documentation.

Discover how our team of clinical data managers, biostatisticians, and medical writers ensure smooth, efficient, accurate and validated generation of submission deliverables.

Main areas of CDISC-compliant dataset generation and documentation

Unlock the potential of our service offerings

Our tailored solutions include the crafting, managing, and transforming of clinical trial data into regulatory-approved formats. With a well-structured and streamlined process, we cover the creation of annotated CRFs, SDTM/SEND, and ADaM databases, along with generating essential adjunct metadata for Define.XML creation. Our standard service also includes validation checks, as well as standard CDISC regulatory submission documents creation. Effortlessly meeting the stringent requirements of regulatory bodies such as the FDA, PMDA, and NMPA, our services guarantee complete coverage to support principal investigators, clinical data managers, clinical research associates, and many more responsible persons during a clinical trial.

Submission-compliant annotated CRF

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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.

Statistical analysis report

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From the annotated CRF to final tables, listings, and figures programing, we enclose the CDISC regulated submission for you with a detailed report.

SDTM/SEND and ADaM programming and dataset generation

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Our team of biostatisticians and programmers integrate with the data management team, enabling SDTM/SEND and ADaM program generation well before data collection completion. In addition, our seasoned team of biostatisticians and clinical programmers have developed a streamlined process that ensures speed and precision in validated dataset creation.

SDTM/SEND and ADaM dataset compliance validation

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Validation and its reporting is a regulatory requirement for FDA, PMDA, or NMPA submissions. Using the industry leading validation software, we ensure that all submission deliverables are in compliance with CDISC standards and regulatory agency demands, thus increasing submission acceptance likelihood at the end of the process.

Metadata specification, and Define.XML creation and validation

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The Define.XML serves as a crucial regulatory submission component; without it, regulatory agencies will reject the submission of a clinical study. To ensure a comprehensive and accurate Define.XML, our expert team has streamlined the process of metadata specification. Specifications of every database, every variable, every method, and every value are marked up as SDTM/SEND and ADaM databases are being created. These are then used to create Define.XML files, simplifying a traditionally painstaking and detailed process, and reducing errors.

Submission document creation

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We promptly create all CDISC regulatory compliant documents. These documents include the study data reviewer’s guide and the analysis data reviewer's guide. They contain all information on the SDTM/SEND and ADaM databases, as well as the programs used to create them and the validation results. For FDA submissions, we will provide you with a study data standardization plan, detailing the expected CDISC standards used for data in completed or upcoming clinical and pre-clinical trials.

Submission-compliant annotated CRF

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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.

SDTM/SEND and ADaM programming and dataset generation

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Our team of biostatisticians and programmers integrate with the data management team, enabling SDTM/SEND and ADaM program generation well before data collection completion. In addition, our seasoned team of biostatisticians and clinical programmers have developed a streamlined process that ensures speed and precision in validated dataset creation.

Statistical analysis report

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From the annotated CRF to final tables, listings, and figures programing, we enclose the CDISC regulated submission for you with a detailed report.

SDTM/SEND and ADaM dataset compliance validation

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Validation and its reporting is a regulatory requirement for FDA, PMDA, or NMPA submissions. Using the industry leading validation software, we ensure that all submission deliverables are in compliance with CDISC standards and regulatory agency demands, thus increasing submission acceptance likelihood at the end of the process.

Metadata specification, and Define.XML creation and validation

:
;
The Define.XML serves as a crucial regulatory submission component; without it, regulatory agencies will reject the submission of a clinical study. To ensure a comprehensive and accurate Define.XMLs, our expert team has streamlined the process of metadata specification. Specifications of every database, every variable, every method, and every value are marked up as SDTM/SEND and ADaM databases are being created. These are then used to create Define.XML files, simplifying a traditionally painstaking and detailed process, and reducing errors.

Submission document creation

:
;
We promptly create all CDISC regulatory compliant documents. These documents include the study data reviewer’s guide and the analysis data reviewer's guide. They contain all information on the SDTM/SEND and ADaM databases, as well as the programs used to create them and the validation results. For FDA submissions, we will provide you with a study data standardization plan, detailing the expected CDISC standards used for data in completed or upcoming clinical and pre-clinical trials.

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Benefits of our service

Harness the potential of precise dataset generation and documentation

Our services are driven by an exceptionally well-connected and collaborative team comprising clinical data managers, biostatisticians, and medical writers. We seamlessly cover the entire CDISC-compliant dataset generation and documentation service – from the annotated CRF to Define.XML, SDTM/SEND, and ADaM dataset creation and validation, along with the production of reviewer’s guides and reports. Entrusted to our dedicated, responsible, and meticulous team, this comprehensive approach lifts the burden of submission deliverables generation and preparation. Choose Wemedoo for a streamlined and successful journey through the intricacies of regulatory compliance.
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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?

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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?

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The process typically involves a 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 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?

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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?

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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?

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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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Learn more about how we can support your cinical trials.

Explore related services

Discover comprehensive solutions for your clinical trial needs

Beyond CDISC-compliant dataset generation and documentation, 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, 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 and Source Data Review
eTMF Setup and Administration
Biostatistics and Statistical Programming

Medical Writing and 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.

What our clients say

Read more about the experiences from those who have partnered with us

"All jobs, both large and small, are performed with the same dedication to quality, detail, innovative thinking, and rigor. It is always a pleasure to work with the Wemedoo team."

Georg Mathis, PhD

CEO Appeltree CI Group AG

"Wemedoo embodies all the traits desired in a partner in the clinical trial industry – expertise, innovation, reliability, compliance, and attention to detail."
Martina Diminic Smetisko, DMD

Managing Director at Marti Farm Ltd

"Their dedication to, and support of, our projects has resulted in clear quality deliverables. They are always there to answer any questions with expertise in a timely manner. I am looking forward to our next project together."

Volodymyr Stus, MD

Biopharmaceutics and Clinical Research Department Manager at Polpharma SA

Considering unified clinical trial software?

Experience oomnia, our all-in-one clinical trial software which unifies tools, such as EDC, RTSM, eTMF, ePRO, eCOA, and CTMS. In combination with our professional services we can provide end-to-end support to transform your clinical research.