STATISTICAL REPORTING
We provide on-site and off-site statistical reporting services tailored to client requirements in a cost-effective manner. Our experienced team supports clinical research organizations, pharmaceutical companies, and healthcare institutions with comprehensive statistical analysis, reporting, and regulatory compliance solutions.
Our Statistical Reporting Services
TLF Programming
Development of Tables, Listings, and Figures (TLFs) for clinical study reports and regulatory submissions.
CDISC Data Mapping (SDTM & ADaM)
Conversion and mapping of clinical trial data into CDISC-compliant SDTM and ADaM datasets.
Clinical Data Repository
Centralized management, validation, and maintenance of clinical study data.
Pooled Data Analysis & Reporting
Integration and analysis of data from multiple studies for comprehensive reporting.
Feasibility Analysis
Statistical evaluation of study designs, endpoints, and operational feasibility before trial initiation.
Safety (ADR) Reporting
Comprehensive adverse drug reaction analysis and safety reporting.
Patient Profiles & Data Cleaning Reporting
Creation of patient profiles and implementation of robust data cleaning processes to ensure data integrity.
Regulatory Query Support
Accurate and timely responses to statistical and regulatory authority queries.
SAP & TLG Development
Preparation of Statistical Analysis Plans (SAPs), TLG mock shells, and implementation of CDISC, SDTM, and ADaM standards.
EDC Uploads & Blinded Envelope Management
Support for Electronic Data Capture (EDC) uploads and blinded envelope management.
PK/PD Calculations
Pharmacokinetic (PK) and Pharmacodynamic (PD) calculations and analysis.
Statistical Analysis & Reporting
Comprehensive statistical analysis and preparation of detailed reports.
Preliminary Results Review
Interim data reviews and preliminary analysis reporting to support decision-making.
Regulatory Compliance
Stay aligned with the latest statistical methodologies and guidelines approved by global regulatory authorities including USFDA, EMA, and CDSCO.
BIOSTATISTICS
SCIT's Biostatistics division is supported by highly qualified professionals with strong academic backgrounds and extensive scientific expertise across various therapeutic areas. We provide scientifically sound statistical solutions that ensure data accuracy, regulatory compliance, and meaningful clinical insights.
Core Biostatistics Services
Randomization
Design and implementation of randomization schemes to ensure unbiased treatment allocation in clinical studies.
Sample Size Estimation
Accurate determination of sample sizes to achieve adequate statistical power and optimize study outcomes.
Trial Design Inputs
Expert statistical consultation during protocol development and clinical trial design phases.
Statistical Analysis Plan (SAP)
Development of detailed Statistical Analysis Plans outlining methodologies, reporting requirements, and analysis populations.
Statistical Analysis
Comprehensive analysis of clinical and observational study data using validated statistical methodologies.
eCTD SERVICES
SCIT works with leading global vendors and regulatory experts to deliver high-quality Electronic Common Technical Document (eCTD) solutions that support successful regulatory submissions worldwide.
Regulatory Dossier Development
Preparation and compilation of complete regulatory dossiers, including:
eCTD Publishing
Non-Clinical Overviews
Clinical Overviews
Regulatory Summaries
Quality Documentation
Submission Readiness Reviews
Centralized Regulatory Management
Development and management of centralized submission processes in compliance with global regulatory authorities.
Global Regulatory Compliance
Preparation of submission packages that meet country-specific requirements and international regulatory standards.
eCTD Publishing & Validation
Document formatting and bookmarking
Hyperlink creation
XML backbone generation
Technical validation
Lifecycle management
Publishing support
Regulatory Submission Support
Initial Submissions
Variations & Amendments
Renewals
Responses to Regulatory Queries
Submission Lifecycle Maintenance
Key Benefits
Experienced Regulatory & Statistical Experts
Global Regulatory Compliance Expertise
CDISC, SDTM & ADaM Specialists
Advanced Statistical Analysis Capabilities
End-to-End eCTD Publishing Services
Cost-Effective Support Models
Timely Project Delivery
Quality-Focused Processes
Delivering Statistical Excellence & Regulatory Compliance
SCIT combines scientific expertise, advanced statistical methodologies, and regulatory knowledge to provide reliable Statistical Reporting, Biostatistics, and eCTD services that support successful clinical development, regulatory approvals, and global market access.