We understand the high value and importance of the data collected during the drug development process. ZM Group is committed to ensure that important safety information is presented according to the standards (Medical Coding Services), effectively collected, managed, safely stored (Case Report Forms (CRF) and Database (DB) Design Services) and analyzed according to the plan (Biostatistics Services). Our highly professional team with combined expertise in data management, programming, statistical analysis, and drug safety is ready to provide excellent services to guarantee safety, integrity and consistency of data at any phase of drug development.
Data Safety, Integrity and Consistency
Data Management and Biostatistics
CRF and Database Design
Data collection is a cornerstone of clinical trials and pharmacovigilance systems. To meet our client’s needs and project requirements we offer:
- Case Report Form (CRF) Design and Development
- Case Report Form (CRF) Completion Guidelines Development
- Database Design Development
- Database Lock
- Database Archiving
Data Validation
To ensure that high-quality data is delivered on time and meets all the applicable requirements, ZM Group offers:
- Clinical Data Interchange Standards Consortium (CDISC) compliant datasets and documentation (to guarantee data standardization)
- Data Management Plan Development (describing data-flow related procedures for clinical trials or other types of investigations)
- Data Validation Plan Development (manual for data control)
- Automatic and Manual Data Validation (different tools to ensure data integrity)
- Query Management (resolution tools to provide discrepancy-free data)
Medical Coding
Medical Coding is an essential procedure for delivering data in universal terminology accepted by agencies around the globe (FDA, EMA, etc.). ZM Group provides the following coding related services:
- MedDRA Terms Coding (using the latest version of MedDRA dictionary)
- WHO Drug Terms Coding
- Coding Consistency Review (in accordance with MedDRA, WHO Drug and other specific recommendations)
Biostatistics
Our professionals are ready to cover all steps of data analysis and results presentation:
- Statistical Analysis Software (SAS)-Programming (customized programs with a focus on project requirements)
- Protocol Design and Sampling
- Statistical Analysis Plan
- Statistical Analysis Report
- Programming of Tables, Listings, and Figures
