During the study startup, our offerings are:
Protocol Inputs - Our statistical input into protocol includes:
- Statistical consulting for study design
- Statistical Methodology including Hypothesis setup
- Sample size and power calculations
- Consultancy advice
- Randomization and enveloping
- Statistical Analysis Plan (SAP) and Annotated Mock Shells
At study conduct our offerings are:
Clinical Data Management - We pledge to provide our client an efficient and cost effective solution to complete data management solution. Our services include:
- CRF designing
- Database designing
- Data capturing and cleaning
- Coding of data as per the standard dictionaries
- Reconciliation of external data
Clinical Data Interchange Standards Consortium (CDISC) Implementation - Our CDISC Implementation portfolio includes:
- Annotation and validation of CRFs
- Creation and validation of SDTM specification document
- Creation and validation of SDTM datasets from legacy datasets
- Generation and validation of Define documents
- Creation and validation of ADaM dataset including specification writing
- Table, Listing, Graph, other (TLGO) creations and validation
- PK/PD Analysis
- Interim Analysis
- BA/BE Analysis
- QT/QTc Analysis
- Meta data Analysis
- ISS/ISE
At Study closure our offerings are:
- Statistical Report
- Ad-hoc Analysis
Our biostatistics team is well-experienced in the following analyses:
- Mixed models
- Analysis with repeated measurements
- Equivalence/non-inferiority/superiority analysis
- Multiple Comparisons
- Survival Analysis
- Parametric Analysis
- Non-Parametric Analysis
- Analysis of Categorical Data
- Dose Proportionality and Steady State Analysis
Our statisticians are highly qualified individuals with at least the following credentials:
- Ph.D. in Mathematics or Statistics
- Master’s degree in Applied Mathematics or Statistics
- At least 5-year experience in pharmaceutical companies or CROs
For more information on our Biostatistics Department and activities please contact us: info@statsmetrika.com
