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
Mastering Regulatory-Ready Dataset Creation
Achieve Quality and Efficiency in Regulatory Submissions
- NAutomated mapping
- NRobust validation
- NEfficient standardization
- NComprehensive documentation
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
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
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
SDTM/SEND and ADaM dataset compliance validation
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.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
Submission-compliant annotated CRF
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
Statistical analysis report
SDTM/SEND and ADaM dataset compliance validation
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
Submission document creation
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Benefits of our service
Harness the potential of precise dataset generation and 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 by 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
Frequently asked questions
Get the answers you need about our CDISC-compliant serviceWhat 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?
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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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."
"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."
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.