PureCDM
PureCDM is a clinical data management company with over 25 years of experience, dedicated to creating high-quality clinical data to support the development of medicines and devices. They focus on collaboration, trust, and teamwork, offering customized, flexible solutions across various therapeutic areas and non-drug trials. Their approach emphasizes quality, speed to market, and stakeholder decision-making, supported by a highly trained team across Asia Pacific and the US.
Industries
Nr. of Employees
small (1-50)
Products
Clinical Data Management
Clinical data management activities that strengthen data integrity, improve oversight, support query resolution, and reduce avoidable delays during data cleaning and database lock preparation.
Biostatistical and Clinical Data Management Services
Comprehensive biostatistical and clinical data management services designed to meet regulatory requirements and support clinical trials with reliable, robust, and compliant data.
Pharmacokinetics
Pharmacokinetic support across sampling strategy, analysis planning, concentration-time data interpretation, and integration of PK insights into clinical and statistical decision-making.
Biostatistics
Biostatistical support across sample size development, protocol input, statistical analysis planning, SAP content, analysis outputs, top line reporting, and interpretation of clinical results.
Biostatistical Advisory, Programming and Analysis
Comprehensive biostatistical consulting, statistical programming, and data analysis services covering the entire clinical data lifecycle.
Advisory
Senior advisory input across study design, objectives, estimands, endpoints, sample size assumptions, protocol development, statistical considerations, and execution readiness.
Clinical Data Management
Clinical data management activities that strengthen data integrity, improve oversight, support query resolution, and reduce avoidable delays during data cleaning and database lock preparation.
Biostatistical and Clinical Data Management Services
Comprehensive biostatistical and clinical data management services designed to meet regulatory requirements and support clinical trials with reliable, robust, and compliant data.
Pharmacokinetics
Pharmacokinetic support across sampling strategy, analysis planning, concentration-time data interpretation, and integration of PK insights into clinical and statistical decision-making.
Biostatistics
Biostatistical support across sample size development, protocol input, statistical analysis planning, SAP content, analysis outputs, top line reporting, and interpretation of clinical results.
Biostatistical Advisory, Programming and Analysis
Comprehensive biostatistical consulting, statistical programming, and data analysis services covering the entire clinical data lifecycle.
Advisory
Senior advisory input across study design, objectives, estimands, endpoints, sample size assumptions, protocol development, statistical considerations, and execution readiness.
Services
End-to-end CDM covering database design, data collection oversight, cleaning, and delivery of analysis-ready datasets.
Platform-agnostic EDC build, configuration and deployment tailored to study requirements.
Statistical planning and analysis services offered alongside CDM to produce reliable, statistically sound datasets.
Implementation of quality management processes, procedures and controls specific to clinical data to support regulatory and internal quality objectives.
Rebuilding or migrating clinical databases to more user-friendly designs while minimising disruption to ongoing trial activities.
Services to integrate data streams, produce accessible datasets and generate tailored reports for decision-making.
End-to-end CDM covering database design, data collection oversight, cleaning, and delivery of analysis-ready datasets.
Platform-agnostic EDC build, configuration and deployment tailored to study requirements.
Statistical planning and analysis services offered alongside CDM to produce reliable, statistically sound datasets.
Implementation of quality management processes, procedures and controls specific to clinical data to support regulatory and internal quality objectives.
Rebuilding or migrating clinical databases to more user-friendly designs while minimising disruption to ongoing trial activities.
Services to integrate data streams, produce accessible datasets and generate tailored reports for decision-making.
Expertise Areas
- Clinical data management
- EDC implementation and customization
- Biostatistics / biometrics
- Data quality management and regulatory readiness
Key Technologies
- Electronic Data Capture (EDC) systems
- eClinical solutions
- Custom clinical database design
- Data integration tools and workflows