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Overview

At StatsMetrika, we provide high quality biostatistics services. With our wide-extensive knowledge and expertise in the field, our experienced biostatisticians and certified statistical SAS programmers provide guaranteed high-quality statistical solutions required for every phases(aspects) of drug development based on the current methods and regulatory standards for successful execution of projects and provide all our clients the best matching up to the standards of their company’s and regulatory requirements at lower cost.

Why Us

Technology expertise and in-depth knowledge of the industry.
Increasing quality, competence & optimizing productivity throughout the process of developing drugs with our talented workforce & well-defined processes.
Not only we bring the products faster at the market but also at reduced cost by providing optimal statistical designs
Complying with the regulatory guidelines being set globally.
Coming up with programming related strong ideas and innovations to help your business grow well.
We provide strong technical support for complex statistical methodology and implementation of adaptive designs, biosimilar study designs and methodology, handling of missing data & regulatory guidance for strategic planning.
At StatsMetrika our brilliant team of seasoned SAS Certified professionals prepare, test, review and validate analysis datasets, tables, listings, figures and other outputs used for the analysis and reporting of clinical study data.

What We Offer

During the study start-up, 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
Endpoints and analysis strategies.
Creation and quality control of the study reporting data sets.

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
- Creation of SDRG (Study Data Reviewer’s Guide) and ADRG (Analysis Data Reviewer’s Guide).
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 conduct our offerings are:

CRF designing
Database designing
Data capturing and cleaning
Coding of data as per the standard dictionaries
Reconciliation of external data
Our biostatistics team is well-experienced in the following analyses:
- Mixed models
- Analysis with repeated measurements
- Equivalence/non-inferiority/superiority analysis
- Multiple Comparisons (Different Models)
- 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.