Expert Services

Clinical Data Services

Experienced teams for every stage of your clinical data journey — from raw data capture to global regulatory submission. Serving CROs across BA/BE, Phase 1–3, and Real World Studies worldwide.

Clinical Data Management

End-to-end CDM services from database design through data lock. Our CDM team brings deep domain expertise in BA/BE, Phase 1, and Phase 2/3 studies for both small molecules and biologics.

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Deliverables

  • Data Management Plan (DMP) authoring
  • CRF design and annotation
  • Database build and UAT on leading EDC platforms
  • Edit check programming and validation
  • Discrepancy management and query resolution
  • Coding (MedDRA, WHO Drug)
  • SAE reconciliation
  • Database lock and clean data delivery

Data Programming

SAS and Python-based data programming for clinical trial datasets, listings, and summary statistics. Our programmers are experienced with CDISC standards and FDA, EMA, PMDA, and CDSCO submission requirements.

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Deliverables

  • Raw data review and mapping specifications
  • SDTM and ADaM programming in SAS/Python
  • Define.xml and Reviewer's Guide authoring
  • Statistical output programming (tables, figures, listings)
  • QC programming using double-programming methodology
  • Pinnacle 21 validation and error resolution
  • Conversion of legacy datasets to CDISC
  • Integrated Summary of Safety (ISS) / Efficacy (ISE) datasets

SDTM Mapping & Validation

Compliant SDTM datasets for your regulatory submissions. Our team follows CDISC Implementation Guides and has experience across all common SDTM domains — from DM and AE to PK and custom domains.

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Deliverables

  • SDTM mapping specification authoring
  • Domain-level SDTM programming (SAS/Python)
  • Supplemental qualifier (SUPP--) datasets
  • Trial Design datasets (TE, TA, TV, TI, TS)
  • Pinnacle 21 Enterprise validation to zero critical errors
  • SDTM annotated CRF
  • SDTM Reviewer's Guide (SDRG)
  • CDSCO and USFDA aligned submission readiness

ADaM Datasets & TFLs

Analysis-ready datasets that sit at the heart of your statistical analysis plan. Skaigen's ADaM programming team works closely with biostatisticians to ensure every dataset is fit for purpose and submission-ready.

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Deliverables

  • ADaM specification development
  • ADSL, ADAE, ADEX, ADLB, ADPC, and custom datasets
  • Derivation programming for complex endpoints
  • Tables, Figures, and Listings (TFL) production
  • TFL mock shell review and refinement
  • ADaM Reviewer's Guide (ADRG) authoring
  • ISS/ISE analysis datasets
  • Post-submission query response support

Regulatory Submission

Complete regulatory submission services for FDA, EMA, CDSCO, PMDA, and other global agencies. Our team handles full eCTD assembly, validation, and submission — including responding to agency queries.

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Deliverables

  • eCTD module assembly (Modules 1–5)
  • CDSCO NDA/IND/BA-BE dossier preparation
  • USFDA IND and NDA electronic submissions
  • Publishing and validation using market-leading tools
  • Submission cover letter and forms
  • Agency query response and amendment submissions
  • Lifecycle management and variation submissions
  • Electronic Common Technical Document (eCTD) formatting

Ready to Talk About Your Study?

Our clinical data specialists are ready to scope your project across any study type or regulatory jurisdiction and provide a tailored proposal.

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