Statistical Programming Deliverables That Make a Difference in Life Sciences Innovation
Navigating complex clinical data and adhering to evolving regulatory standards pose serious challenges to the Life Sciences industry. Companies struggle with clinical trial statistical programming, ensuring CDISC programming services compliance, and managing large-scale data.
A respite from these hurdles, ACL Digital offers full-range statistical programming services that address the major pain points of the industry. Our team provides tailored solutions that meet regulatory standards and improve data accuracy. With specialization in SAS statistical programming and extensive experience in clinical trials, we furnish reliable and timely deliverables that support your research and compliance requirements.
Statistical Programming Services for Clinical Data
CDISC Implementation – CDASH, SDTMs and ADaMs
Our statistical programming solutions include precise CDISC Implementation for CDASH, SDTMs, and ADaMs, promising compliance with industry standards.
- Compliance with regulatory standards
- Expertise in clinical data management
- Streamlined data processes
CDISC Conversion of Legacy Data
Transform legacy data with our expert CDISC conversion, all the while maintaining data integrity and regulatory compliance throughout the process.
- Preserved data quality
- Efficient conversion methods
- Regulatory adherence
QC/ Validation
Ensure data accuracy with our rigorous QC and validation services. Our solutions are tailored to provide reliable quality checks to meet the highest industry standards.
- Comprehensive quality checks
- Industry-standard methodologies
- Custom validation processes
TLF Generation
Streamline the generation of tables, listings, and figures (TLFs) with rigorous support from our experts. We deliver precise, timely results that support your clinical trials and reports.
- Timely delivery of TLFs
- Accurate data representation
- Support for regulatory submissions
Creating ADaM and TLF Specifications
We offer comprehensive services for creating ADaM and TLF specifications. Our offerings ensure clarity and compliance in all your clinical trial documentation.
- Clear documentation standards
- Regulatory compliance guaranteed
- Expert guidance throughout the process
Ad-hoc Analyses
Benefit from flexible statistical programming solutions for ad-hoc analyses. We provide customized insights to address specific research questions and regulatory requirements.
- Tailored analytical solutions
- Quick turnaround on requests
- Informed decision-making support
In-house Statistical Computing Environment Available for Client Needs
Utilise our in-house statistical computing environment for tailored life sciences requirements. We ensure secure, efficient data processing to meet your unique needs.
- Secure data handling
- Customized computing resources
- Efficient processing capabilities
Patient Profiles and Narratives Generation
Create detailed patient profiles and narratives with our specialized solutions. We ensure comprehensive, compliant documentation for your clinical studies.
- Comprehensive patient insights
- Compliance with regulatory standards
- Streamlined documentation process
R-Programming Expertise
Leverage our R-programming expertise for advanced statistical analyses. We utilize R to deliver precise and innovative insights for clinical research.
- Advanced analytical techniques
- Customizable programming solutions
- Expertise in statistical modeling
BMI OSI Listings
Obtain accurate BMI OSI listings with our industry-grade experience and expertise from our team. We ensure precise data representation and adherence to industry benchmarks.
- Accurate data representation
- Compliance with industry standards
- Efficient data processing
Generate define.xml
Generate compliant define.xml files efficiently with our expert statistical programming solutions. We ensure that your data meets regulatory requirements and standards.
- Streamlined file generation
- Regulatory compliance ensured
- Accurate data documentation
Pinnacle 21 Report Compliance for Datasets, Authoring Reviewer’s Guide
Achieve Pinnacle 21 report compliance guided by industry specialists and veterans. Our team ensures your datasets meet regulatory standards and provides detailed authoring and reviewer guides.
- Comprehensive compliance support
- Detailed reviewer guidance
- Industry-standard documentation
Clinical Pharmacology – PK/PD Programming Including PopPK Analyses
Our statistical programming solutions support clinical pharmacology with expert PK/PD programming and PopPK analyses.
- In-depth pharmacokinetic analysis
- Support for drug development
- Expertise in clinical research
Epidemiology and RWE Programming Support, Support for Medical Affairs and Commercial Requests
Access robust statistical solutions for epidemiology and RWE programming. We offer support for medical affairs and commercial requests.
- Comprehensive programming support
- Insights for medical affairs
- Data-driven decision facilitation
Implementation of DMP (Data Management Plan) and SAP (Statistical Analysis Plan)
- Thorough plan implementation
- Regulatory compliance focus
- Customized strategy development
Safety and Efficacy TLFs for CSR, and Regulatory Agencies Submissions
Generate accurate safety and efficacy TLFs for CSR and regulatory submissions with our comprehensive solutions.
- Accurate TLF generation
- Regulatory submission support
- Compliance with industry standards
Safety Monitoring, Interim Analysis, and DSUR Support
Rely on our services for effective safety monitoring, interim analysis, and DSUR support, providing critical insights to ensure ongoing trial safety and efficacy.
- Real-time safety monitoring
- Data-driven interim insights
- Ongoing trial support
Exploratory Analysis
Conduct a thorough exploratory analysis with our detailed insights that uncover trends and support informed decision-making in your research.
- In-depth data exploration
- Trend identification
- Informed strategic recommendations
Integrated Summary of Safety and Efficacy Analysis (ISS/ISE), Data Pooling
Our statistical programming solutions provide integrated summaries of safety and efficacy (ISS/ISE) and data pooling.
- Comprehensive data integration
- In-depth safety and efficacy insights
- Support for regulatory compliance
BMI OSI Listings
Ensure accurate and compliant BMI OSI listings with precise data representation in line with industry standards.
- Compliance with benchmarks
- Accurate data handling
- Efficient reporting process
Statistical Programming Deliverables for Clinical Excellence
Why Choose ACL Digital’s Statistical Programming Services
Expertise
Quality & Compliance
Efficiency & Innovation
Client Focus
End-to-End Solutions
