Trusted Experience. Proven Results.
EMB is a senior-level contract research organization specializing in data management, statistical programming and statistical analysis for the pharmaceutical and biotechnology industries. As a specialized CRO, our experienced team is prepared to collaborate on your project, bringing a proven history of delivering high-quality services in clinical research.
EMB is the trusted partner you can count on for success.
Powered by Experience
Studies supported
%
Returning client rate
Clients
Studies serving in support of IDMCs
Oncology studies supported
Data Management
EMB’s data management team is committed to ensuring the highest quality of your data. Our team is highly adaptable and responsive to changes in study parameters, providing expert management for complex studies. Additionally, we offer data management oversight to ensure seamless project execution.
Our experienced data managers offer a comprehensive suite of services, maintaining data quality and compliance throughout your clinical trials:
- Protocol review to CRF design
- CDISC compliance (CDASH/SDTM)
- Electronic data capture (EDC) system design, maintenance and closeout
- Creation of data management plans (DMP) and eCRF completion guidelines
- EDC system training and user access maintenance
- Ongoing data quality reviews throughout the study
- Data edit check creation and validation
- Continuous data review
- Use of data visualization tools to identify trends and detect outliers
- Custom site and query status report creation
- Vendor data reconciliation (SAEs, labs, PK, etc.)
- Dictionary coding using standardized dictionaries (MedDRA, WHODrug)
- Data management trial master file maintenance
- Study archival
EMB has been recognized as a CCDM® Industry Partner by the Society for Clinical Data Management for its commitment to quality clinical data management and certified clinical data manager (CCDM®) credentialing.
SAS Programming
Our programming team is seasoned in information technology and pharmaceutical research data analysis. Many on the team hold advanced degrees in math, science, or computer science.
In addition, our programmers have advanced knowledge of Clinical Data Interchange Standards Consortium (CDISC) standards and requirements to ensure new drug application (NDA) submission-ready data.
- SDTM specifications/programming
- ADaM specifications/programming
- Define.xml and reviewers guides
- CDISC validation and compliance
- Safety lab conversion/standardization
- TLF generation (appendix or in-text)
- ISS/ISE data integration (US/global)
- Data surveillance
- Adjudication support
- Patient profiles
A member of the Clinical Data Interchange Standards Consortium, EMB is committed to supporting and implementing CDISC standards, thereby ensuring our clients’ projects are submission-ready.
Statistical Analysis
Members of EMB’s statistical team are experts in the field and provide comprehensive clinical development planning from protocol design and sample size calculation through clinical study report (CSR) writing and review.
The statistical team has extensive NDA experience across many therapeutic areas.
- Early study planning
- Power/sample size estimation
- Randomization (static or adaptive)
- Statistical Analysis Plan + mock TLFs
- Analysis (interim, final, meta, exploratory)
- PK/PD analysis and reportinga
- Statistical writing (protocol, CSR, publications)
- ISS/ISE support for global submissions
- DMC/DSMB support (blinded or unblinded)
- IRT validation
- US/EU/Canada/Japan submission defense
Your Trusted Partner
EMB fosters a collaborative partnership with our clients, working closely to understand your unique requirements and goals.
Our experts are specialists in their respective areas, and our clients appreciate that.
“Thank you all very much for all your hard work, dedication and continued support on our study.”
