SME
Description
AdWare Research is a trusted provider of clinical data management and biostatistical services, with more than 25 years of experience supporting non-clinical and clinical research projects. We are committed to delivering high-quality, reliable, and fully compliant solutions tailored to the needs of sponsors and research organizations.
Our operations adhere strictly to international regulatory requirements, including FDA 21 CFR Part 11, as well as ICH E3, E6 (GCP), and E9 guidelines. All processes are governed by well-established Standard Operating Procedures (SOPs), ensuring consistency, traceability, and full audit readiness.
Data Management Services
We provide comprehensive, end-to-end data management services covering the full clinical trial lifecycle.
Our proprietary Mythos CDMS (Clinical Data Management System) is designed to support the entire data lifecycle. It enables efficient study setup, secure data collection, and streamlined data cleaning workflows.
Key features include:
Intuitive eCRF design and study configuration
Secure and compliant data capture and monitoring
Integrated data cleaning and validation workflows
Visual reporting capabilities via Power BI
Structured data export for statistical analysis
Key benefits:
User-friendly interface requiring no advanced IT expertise
Full compliance with FDA 21 CFR Part 11 and GCP
Regular system validation and successful sponsor audits
High-level security ensured through periodic penetration testing
Fast access to clean, analysis-ready datasets
Biostatistics Services
Our experienced biostatistics team provides expert support across all phases of clinical development. Our services include:
Sample size calculation and study design support
Statistical input to study protocols, including ICH E9(R1) estimands
Randomization design and envelope preparation
Development of Statistical Analysis Plans (SAPs)
Mock table, listing, and figure (TLF) creation
CDISC ADaM dataset preparation
Statistical programming using SAS® and SPSS
Generation of Tables, Listings, and Figures (TLFs)
Preparation of Clinical Study Reports in compliance with ICH E9
Full quality assurance in line with ICH E6 (GCP)
We also support statistical analysis of externally managed databases, ensuring flexibility and seamless collaboration with sponsors and partners.
