Clinical Data Management · Biostatistics · Analytics
Clinical Data Management Services That Deliver Clean, Submission-Ready Data
Shen Clinical Services designs, collects, cleans and analyses clinical trial data to ICH E6(R3) and CDISC standards. From the first case report form to the final statistical tables, our data management and biostatistics teams give you a locked, traceable database and results you can submit with confidence.
ICH E6(R3)Data governance and quality
CDISC SDTM and ADaMFDA and PMDA standards
MedDRA and WHODrugConsistent medical coding
Audit TrailsTraceable electronic records
On this page
Across the Trial
Clinical Data Management Across the Trial Lifecycle
Our data managers handle every step from study start-up to analysis:
| Stage | What we do | Standard |
|---|---|---|
| Study start-up | Case report form (CRF/eCRF) design, electronic data capture (EDC) database build, edit checks and the data management plan | CDISC CDASH; ICH E6(R3) |
| Trial conduct | Data review, query management, SAE and lab data reconciliation | ICH E6(R3) |
| Medical coding | Adverse events and medical history coded to MedDRA, medications to WHODrug | MedDRA; WHODrug Global |
| Database lock | Final quality checks, sign-off, lock and archiving with full audit trail | ICH E6(R3) |
| Submission datasets | SDTM and ADaM datasets with define.xml | CDISC SDTM, ADaM |
| Analysis and reporting | Statistical analysis plan, tables, listings and figures, statistical report | ICH E9, E9(R1) |
Biostatistics
Biostatistics and Statistical Programming Services
Our biostatisticians handle clinical trial data analysis with your clinical team, from protocol design to the final report:
- Sample size calculation and randomisation schedules
- Statistical analysis plans written to ICH E9 and E9(R1)
- SAS and R programming of tables, listings and figures
- Interim analyses and data monitoring committee support
- Integrated summaries of safety and efficacy
- Statistical analysis for BA/BE studies
See how this links into our clinical trial protocol design service.
Data Analytics
Pharmaceutical Data Analytics and Consulting
Beyond single trials, our analysts turn data into decisions for your development and commercial teams:
Aggregated Data and Dashboards
Ready-aggregated data that integrates with your internal platforms, with dashboards for quick interpretation.
Competitive Landscape and Benchmarking
Monitoring of competitor programmes and benchmarking of trial timelines to plan realistic schedules.
Investigator and Site Identification
Data-driven identification and prioritisation of investigators and sites, feeding our site selection and management service.
Compliance
Data Standards and Compliance We Work To
| Requirement | Rule / timeline |
|---|---|
| Data integrity | Attributable, legible, contemporaneous, original and accurate data (ICH E6(R3)) |
| Electronic records and audit trails | US 21 CFR Part 11 and EU GMP Annex 11 principles |
| Submission datasets | CDISC SDTM and ADaM, required standards for US FDA and Japan PMDA submissions |
| Medical coding | MedDRA, the ICH medical terminology; WHODrug for medications |
| Statistical principles | ICH E9 and E9(R1) estimands |
| Indian trials | Data and reports that support CDSCO review under the NDCT Rules, 2019 |
Our Process
How Our Data Management Process Works
STEP 01
Plan
We write the data management plan and design the CRF around the protocol and the analysis you need.
STEP 02
Build and Validate
We build the EDC database and edit checks, then test them before the first participant is enrolled.
STEP 03
Clean and Code
We review data as it arrives, raise and resolve queries, code terms and reconcile safety and lab data.
STEP 04
Lock, Analyse and Report
We lock the database, produce SDTM and ADaM datasets and statistical outputs, and hand results to our medical writing team for the clinical study report.
Why Shen
Why Sponsors Choose Shen for Clinical Data Management in India
Comparing clinical data management companies in India? These are the reasons sponsors choose a CRO that runs the data alongside the trial itself:
Integrated With Trial Conduct
Data managers sit alongside our clinical trial and monitoring teams, so queries are resolved at the source quickly.
Physician Review
Clinicians review coding and safety data, not just programmers.
Submission-Ready Standards
CDISC from the start, so global submissions need no costly conversion.
One Team, Protocol to CSR
Design, data, statistics and writing with one accountable partner.
What We Cover
Our Data Management and Biostatistics Services
Data management plans
CRF and eCRF design
Database build and validation
Edit checks and query management
Medical coding (MedDRA, WHODrug)
SAE and lab reconciliation
Database lock and archiving
CDISC SDTM and ADaM datasets
Statistical analysis plans
Tables, listings and figures
Interim analyses
Data analytics and dashboards
FAQs
Clinical Data Management: Frequently Asked Questions
What is clinical data management?
Clinical data management is the process of collecting, checking, coding and locking the data from a clinical trial so that it is complete, accurate and ready for statistical analysis. It covers case report form design, database build, data cleaning and queries, medical coding, reconciliation and database lock.
What does a data management plan include?
A data management plan describes how trial data will be collected, entered, validated, coded, reconciled, stored and locked, who is responsible for each step, and the timelines and quality checks that apply. ICH E6(R3) expects sponsors to manage data quality in a planned, documented way like this.
What are CDISC SDTM and ADaM?
SDTM (Study Data Tabulation Model) is the CDISC standard for organising collected trial data, and ADaM (Analysis Data Model) is the standard for analysis-ready datasets built from it. Both are required standards for submissions to the US FDA and Japan’s PMDA.
What is MedDRA coding?
MedDRA is the international medical terminology, developed under ICH, used to code adverse events, medical history and indications so they can be counted and compared consistently. Medications are usually coded with the WHODrug dictionary.
Do trials in India need CDISC data standards?
CDSCO does not prescribe a dataset format for Indian clinical trials, but if the data will support a US, Japanese or other global submission, CDISC standards will be needed. We recommend building the study to CDASH and SDTM from the start, as converting later costs more.
Can you take over data management from another vendor?
Yes. We review the existing database, data management plan and open queries, agree a transition plan with you, and migrate or continue the database without losing audit trails.
Resource Spotlight
Running a safety-critical study? Our pharmacovigilance and drug safety team works from the same database for SAE reconciliation and safety reporting, and our regulatory affairs team prepares the data packages for CDSCO.
Get Clean, Submission-Ready Trial Data
Starting a new study? Ask for a data management and biostatistics quote with your protocol.
Changing vendor? We will review your database and plan a smooth takeover.
+91 98968 89927 · info@shenclinicalservices.com · A 302, Urban Square, Sector-62, Gurugram, Haryana 122098
Sources: ICH E6(R3), E9 and E9(R1); CDISC standards (CDASH, SDTM, ADaM); MedDRA; New Drugs and Clinical Trials Rules, 2019 (CDSCO). General regulatory information, not legal advice.