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Biometric Services

EDC System Setup

eCRF Design

Randomization

IWRS

Data Entry

Data Management Plan

Data Validation Plan

Edit Checks + DM Reports

Query Generation and Management

Database Clean

Database Lock

Clinical Data Repository

CDISC Services

- SDTM

- ADaM

STAT

- SAP/ Mock-ups

- TFL

- ISS/ISE

- Adhoc and Exploratory Analysis

MedDRA Coding

WHODrug Coding

Medical Coding Library and Standardization

Submission (Package of Module 5)

Quality Data Metrics

SAE Reconciliation

Patient Profile

DMC Service

Drug Stability Analysis

System, Software, Tools Development

SAS System (environment) Validation

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Biostatistics and SAS Programming

eSubmission/CDISC

Medical Writing

Clinical Data Management