Clinical Development · Data
Submission-Ready
Data. Day One.
Regulatory-grade clinical data management built on CDISC standards from the first day of study setup — not as a retrospective exercise.
CDISCFrom Setup
Overview
The Foundation Every Submission Rests On
Clinical data management is the foundation every regulatory submission rests on. Our CDM services CRO team manages the complete data lifecycle — from CRF design through database lock — applying CDISC standards from setup, not as a last-minute conversion. When your data package reaches a regulatory reviewer, it needs to be clean, traceable, and immediately navigable. Sponsors who work with our clinical data management team get more than data entry oversight — they get a team that understands what a submission-ready clinical database looks like and builds towards it from the moment a protocol is finalised.
- CDISC standards applied from study setup
- CRF/eCRF design and EDC systems management
- Layered validation and formal database lock
- SDTM/ADaM with define files and guides
What We Deliver
Capabilities Across Every Stage
Three integrated disciplines, delivered by senior specialists as one accountable programme.
End-to-End Data Services
Our clinical data services begin with CRF and eCRF design that collects exactly what the protocol requires, without burdening sites with unnecessary fields. EDC systems management covers platform configuration, user access, and ongoing system performance for the duration of the study. Clinical database management is handled through a documented Data Management Plan defining every data collection rule, validation logic, and query resolution process before enrolment opens. CRO data management at this level means your sponsor team reviews data quality metrics — not individual queries — because the operational detail is handled by our team.
CDISC & Compliance
CDISC standards are not an afterthought in our data management model — they are the architecture. CDASH implementation is built into the CRF from the outset, ensuring that data collected at site maps cleanly to SDTM domains without transformation gymnastics at database lock. Clinical data validation is programmed in layers: point-of-entry edit checks, cross-form checks, and periodic data review runs that catch systemic issues early. All datasets are delivered as SDTM and ADaM outputs with define files and reviewer's guides meeting current FDA and EMA technical requirements.
Data Integrity & Quality
Data cleaning clinical trials is a continuous process that our team runs from first patient in — not a stage that happens before database lock. Database lock services follow a formal clean-file process: outstanding query resolution, medical coding review, protocol deviation reconciliation, and final data sign-off, each documented to regulatory submission standard. Trial data integrity is protected throughout by access controls, audit trail monitoring, and regular system-level checks. For sponsors requiring global clinical data management services USA EU under a single quality standard, our CDM infrastructure delivers it — CRO CDM worldwide.
CDISCSDTM · ADaM
4Global Regions
WeeklyData Quality Metrics
ISO 90012015 Quality System
Key Deliverables
What You Receive
Tangible, submission-ready outputs — not status updates.
Data Management Plan (DMP)
Defines all data collection processes, validation rules, coding conventions, and quality standards for the study.
CRF Completion Guidelines
Site-level guidance for accurate and consistent data entry, reducing query volumes at source.
Annotated CRF
Fully annotated CRF mapped to SDTM domains, supporting dataset creation and regulatory review.
Clean Database
Formally locked, query-free database ready for statistical analysis and regulatory submission.
CDISC Datasets (SDTM / ADaM)
Standards-compliant datasets delivered with define files and reviewer's guides for submission.
Why Vigilare
Why Sponsors Choose Vigilare
What sets this engagement apart from a generic vendor.
CDISC From Protocol Stage
CDISC implementation from the protocol stage — not applied retrospectively — reducing the time and cost of producing submission-ready datasets at the end of the study.
EDC-Platform Agnostic
EDC-platform-agnostic capability: our team works across Medidata Rave, Oracle Clinical, Veeva Vault, and other major EDC systems without requiring sponsors to change their platform.
Expert Medical Coding
Medical coding expertise using current MedDRA and WHO Drug dictionary versions, with coder qualifications maintained to industry standard.
Weekly Quality Metrics
Data quality metrics reported to sponsors weekly throughout the study — not — summarised at database lock when it is too late to intervene.
Who We Work With
Configured to Your Model
We engage differently depending on the function you already have in place.
Phase I–IV Sponsors
Challenge
Need regulatory-grade SDTM and ADaM datasets for NDA, MAA, or BLA submission
How We Help
We implement CDISC from the outset and deliver clean, annotated datasets with full audit trails.
NDA / MAA Submitters
Challenge
Require CDISC-compliant data packages meeting current FDA and EMA technical standards
How We Help
Our programmers deliver submission-ready datasets with define files and reviewer's guides.
Sponsors with Legacy Data
Challenge
Have historical datasets needing CDISC conversion or remediation for submission
How We Help
We assess, remap to CDISC standards, and deliver remediated packages with documented gap analysis.
FAQs
Clinical Data Management, Answered.
01
What is clinical data management?
Clinical data management is the end-to-end process of collecting, validating, and preparing clinical trial data for regulatory submission and statistical analysis. It covers CRF design, EDC configuration and management, data validation and query resolution, medical coding, and the formal database lock process that delivers a clean, submission-ready dataset to the statistical analysis team.
02
What are CDISC standards?
CDISC (Clinical Data Interchange Standards Consortium) standards define how clinical trial data should be structured and formatted for regulatory submissions. FDA and EMA require CDISC-compliant datasets — specifically SDTM for collected data and ADaM for analysis datasets — as part of NDA, BLA, and MAA submissions. CDASH defines the collection-level standards that feed into SDTM, and compliance from the outset of a study significantly reduces the effort required to produce submission-ready datasets.
Related Services
Complete the Clinical Programme
Pair this with the other clinical functions that run alongside it — one team, one quality system.
Ready to build a clean database?
Speak to our team about your programme requirements. We respond within one business day.