Our Services
Inventiv Matrix, Inc. is a Clinical Research Organization focusing on providing data parts of Submission package to FDA, Consulting Service of Data Standards from FDA, Data Standardization in CDISC (SDTM/ADAM) format, Data Management, Biostatistics and SAS programming services to pharmaceutical, biotech, health care and medical device industries.
- Submission Package
- Data Standardization
- Data Management
- Biostatistics
- SAS Programming
Submission Package
- Reviewers' Guide (cSDRG/nSDRG and ADRG)
- Define.xml
- Data transport
- Programs and datasets final review
- TFL for CSR final review
Data Standardization
- SDTM
- ADAM
Data Management
- Data Management Plan
- Data Validation Plan
- Database design and test
- Medical Coding
- DCF Management
- Database cleaning
- Database Blind Review
- Collection system
- Database Softlock/Lock
Statistical Analysis
- Draft the statistical chapter in both of clinical study synopsis and protocol
- Study design
- Sample size calculation
- Draft Statistical Analysis Plan (SAP)
- Provide statistical support for Data and safety monitoring Board (DSMB)
- Draft Statistical Analysis Report and statistical part in CSR (Clinical Study Report)
- Meta analysis service
SAS Programming
- Data manipulation
- Ad-hoc analysis for clinical trial studies
- Generate and validate Statistical TFL (Table, listing and figures)
Check out the following links for additional information and helpful resources.
Food and Drug Administration
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use
Clinical Data Interchange Standards Consortium
An Open Source Community of CDISC Developers and Users