Biostatistics & Clinical Data Management – Precision, Compliance, Results
Precision, Compliance & Efficiency in Clinical Data Management
At QuantiNova, we specialize in scientific writing and medical communication, ensuring that complex data is transformed into clear, engaging, and impactful narratives. Our expert team delivers high-quality publications, data validation, medico-marketing materials, and medical education content to meet global industry standards.
Our Expertise in Biostatistics & Clinical Data Management
- Biostatistics & SAS Programming
- Clinical Data Management
Our Expertise in Biostatistics & Clinical Data Management
Biostatistics & SAS Programming
We deliver robust statistical solutions to enhance clinical trial efficiency and regulatory compliance.
SAS Programming – Customized statistical programming for clinical data analysis
Macro Production, Validation & Optimization – Automating and streamlining statistical workflows
Interim Analysis Support – Real-time statistical insights for decision-making
CDISC Mapping & Conversion – Compliance with industry data standards
CDISC Submission-Ready Dataset Development & QC – Ensuring dataset integrity for regulatory submissions
Analysis Datasets & TLFs Development – Creating standardized tables, listings, and figures
Define.xml Files for SDTM & ADaM – Structured dataset documentation for submission
Submission-Ready Packages – Complete datasets with Define.xml, Reviewer’s Guide & Analysis Metadata
Clinical Data Management
We provide end-to-end clinical data solutions, ensuring quality, integrity, and compliance with regulatory standards.
Data Transfer & eCRF Build – Secure data management solutions for clinical trials
Annotated CRF & Data Management Plan – Structuring and planning data collection strategies
Quality Control of Datasets – Ensuring accuracy and consistency in clinical datasets
CRF Design with SDTM Guidelines – Standardized case report forms for regulatory compliance
Programming & Testing for Data Validation – Automated checks for clean and reliable data
Data Cleaning & Query Management – Detecting and resolving inconsistencies in datasets
Medical Coding (MedDRA & WHODrug) – Standardized terminology mapping for clinical safety data
Lab Data Integration & Patient Diary Management – Managing laboratory data and patient-reported outcomes
EDC System Implementation & Dictionary Setup – Implementing electronic data capture systems for efficient trials
Final Quality Control & Database Locking – Secure and error-free data finalization
Database Archiving – Long-term storage and regulatory compliance for clinical trial data
Why Choose QuantiNova for Biostatistics & Clinical Data Management?
Expert Statisticians & Data Managers
Industry professionals ensuring precision and compliance.
Regulatory Compliance
Aligning with FDA, EMA, CDISC, and ICH guidelines.
Data Integrity & Accuracy
High-quality data analysis, validation, and reporting
Seamless Submissions
Optimized datasets for smooth regulatory review
Optimize Your Clinical Data with Precision & Compliance!
Partner with QuantiNova for expert biostatistics and clinical data management solutions.
