StatDoc ensures that every submission deliverable — from Define files to Reviewer’s Guides — reflects precision, consistency, and clarity. Our e-Submission solutions help transform well-programmed data into a complete, regulator-ready story that inspires confidence and accelerates approval.
In today’s highly regulated clinical research environment, accurate and timely electronic submissions are critical for regulatory approval. Our e-Submission Deliverables services ensure that you’re clinical and regulatory data are compiled, validated, and submitted in full compliance with global health authority requirements. We support end-to-end preparation of electronic submission packages for regulatory bodies such as FDA, EMA, PMDA, and other global agencies. Our team of experienced clinical data specialists and regulatory experts ensures that all deliverables meet CDISC, ICH, and regional regulatory standards. Our e-Submission Expertise Includes
Clinical Data Package Preparation
We prepare submission-ready datasets including SDTM, ADaM, and SEND formats, along with define.xml files and supporting documentation to ensure regulatory acceptance.
Tables, Listings, and Figures (TLFs)
Creation of high-quality statistical outputs aligned with study protocols and regulatory expectations, ensuring clarity and accuracy of clinical trial results.
Clinical Study Reports (CSR) Support
Comprehensive support in generating data outputs, appendices, and integrated summaries required for CSR submissions.
eCTD Submission Components
Preparation of electronic Common Technical Document (eCTD) modules including clinical study data, analysis datasets, and metadata files.
Data Validation & Quality Checks
Rigorous validation processes to ensure datasets pass regulatory review tools such as Pinnacle 21 and other compliance software.
Define.xml & Metadata Documentation
Creation of complete metadata documentation describing dataset structures, variables, derivations, and controlled terminology.
Integrated Summary of Safety & Efficacy (ISS/ISE)
Development of pooled analyses and summary datasets for integrated submission packages.
Develop fully linked Define.xml and Define.pdf files containing complete variable- and value-level metadata. Include hyperlinks to annotated CRFs, data structures, and reviewer documents for seamless navigation. Validate against Study Data Technical Conformance specifications and CDISC Define-XML standards.
• Prepare Study Data Reviewer’s Guide (SDRG) and Analysis Data Reviewer’s Guide (ADRG) to explain dataset structures, derivations, and controlled terminology usage. • Describe known data considerations, special derivations, or sponsor-defined conventions in clear, concise language. • Ensure guides provide reviewers with immediate orientation and contextual understanding.
• Assemble datasets, metadata, programs, and documentation into an electronic structure compliant with regulatory folder hierarchies. Maintain consistent naming conventions, file metadata, and cross-referencing. Apply quality checks to confirm file integrity, dataset linking, and cross-document references.
• Validate all deliverables against FDA, EMA, and PMDA conformance checklists. • Run full-scope compliance checks using internal and external tools before submission. • Document validation results and resolutions for transparency and audit readiness.
• Manage e-Submission preparation for multi-study programs or integrated summaries (ISS/ISE). • Coordinate with biostatistics, programming, and data management teams for consistent submission flow. • Provide post-submission assistance, addressing reviewer questions or follow-up requests efficiently.
• Maintain standardized metadata repositories for reuse across future submissions. • Implement traceability matrices connecting SDTM, ADaM, and TLF deliverables to submission files. • Support version control, archiving, and documentation of updates for long-term compliance.