Clinical Data Management
We deliver robust clinical data management solutions that ensure accurate, compliant, and high-quality data across all trial phases—accelerating analysis, insights, and decision-making for sponsors.
In the dynamic landscape of the clinical industry, our solutions cater to
biopharmaceutical, biotech, and medical device companies, emphasizing data integrity and employing
innovative technologies. Our skilled teams, adhering to ICH E6 R2 guidelines, excel in clinical data
management activities—from designing eCRFs to delivering accurate datasets for statistical analysis.
With a commitment to quality and regulatory compliance, we prioritize clean and reliable data, fostering
strong customer relationships through professionalism, flexibility, and exceptional expertise in
therapeutic and regulatory domains.
Clinical Data Management
Services Include:
Our clinical data management team delivers accurate, compliant, and high-quality data through standardized processes, rigorous validation, and efficient collaboration.
We offer flexible engagement models, including dedicated resources and full-service outsourcing, tailored to your clinical trial needs.
Data Management Planning
CRF Design (Paper & eCRF)
Double Data Entry (Paper Studies)
Continuous Data Quality Review
Data Validation
Data Review & Cleaning
Medical Coding (Standard Dictionaries)
Data Migration & CDISC SDTM Conversion
Database Design
Data Entry
Data Reconciliation (Labs & SAE)
CDISC & SDTM Compliance
Multi-EDC Platform Expertise
Data Integration (All Sources)
Query Management & Data Cleaning
Edit Check Programming (Online & Offline)
Real-Time Clinical Trial Metrics
Clinical Data Management
Services Include:
Our data management team comprises skilled professionals, including data managers, data coordinators, clinical database programmers, and clinical data reviewers. In addition, we have experts specializing in quality assurance and regulatory compliance. This diverse and dedicated team ensures efficient collaboration, high-quality data, and adherence to the most rigorous standards in clinical data management. Our clinical data management service operates based on project specifications, offering adaptable environments, procedures, supervision, and resources. We provide options to either deploy staff as part of the client's workforce or follow an outsourcing model.
Data Management Plan
Design of Case Report Form (Paper)/electronic Case Report Form as per CDASH Standard
Double data entry for paper CRF–based studies
Continuous data quality review
Validation of Data
Data Review and Cleaning
Medical Coding using standardized dictionaries.
Data Migration, Consolidation to CDISC SDTM transformations
Database Design
Data Entry
Data reconciliation across central labs and SAE
Adhere to Clinical Data Interchange Standards Consortium (CDISC) and Society for Clinical Data Management (SCDM) standards by delivering clean and analyzable databases.
Experience across multiple EDC platforms
Data integration from all sources
Data cleaning with query management
Online and Offline edit check programming
