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Regulatory Statistical & Clinical Programming Service
Statistical and Clinical Programming
At Altrid, we deliver comprehensive statistical and clinical programming solutions with a focus on precision, efficiency, and regulatory compliance. Our team, with an average of over nine years of experience, specializes in developing reliable, reusable programs that enhance study analysis and streamline reporting. With expertise across multiple computing environments and client systems, we ensure seamless execution tailored to diverse project needs.
Our in-depth understanding of CDISC standards enables us to create high-quality submission packages that align with global regulatory requirements. we provide end-to-end programming expertise that meets the highest industry standards.
Expert Clinical Programming and Automated Submission Reporting for Regulatory Compliance
Clinical Programming
Fully compliant SDTM datasets
Regulatory compliant SDTM datasets are created based on our robust metadata that are always dynamically updated with each up versioning of CDISC guidance and regulatory agency requirements.
Regulatory Compliant define Package
Clear and concise define package, including annotated CRF and reviewer’s guide for regulatory submission.
Machine Readable SDTM Specification
SDTM specifications are developed in a machine-readable format to enhance data traceability, compliance and enabling automation. Moreover, our extensive library of internal checks on top of CDISC Compliance checks eliminates all trivial human errors and transcends better synchronization throughout study cycle.
Automated Checks based on Internal SDTM Standards
Automated quality checks are implemented to ensure SDTM data & their metadata adhere to internal standards and regulatory expectations. We have library of internal checks that ensures our metadata adheres to CDISC compliance and eliminates trivial human errors.
Legacy Data Mapping and Submission Package
Our team of experts can map legacy data to suitable SDTM version that meets regulatory compliance and helps build analysis datasets from it.
Methodological Review of SDTM
Our review is systematic and methodological which enables harmonization amongst aCRF, dataset and define package. The review makes sure proper traceability is established ensuring all data that is submitted is clearly mapped without any ambiguity.
Statistical Programming
Fully Compliant ADaM datasets
Structured ADaM datasets are created enabling efficient reporting and follows regulatory standards to ensure accurate CDISC compliance. We emphasize making sure ADaM datasets have all reporting capabilities reducing efforts at reporting level.
Regulatory Compliant define Package
Clear and well explained define package with reviewer’s guide with detailed algorithms is provided for transparent data interpretation.
Machine Readable ADaM Specification
ADaM specifications are structured in a machine-readable format for efficient data creation and enabling efficient data reporting. Moreover, our systematically structured specification allows us to verify specification content programmatically.
Automated Checks based on Internal ADaM Standards
Automated quality checks are implemented to ensure ADaM data & metadata adhere to internal standards and regulatory expectations. We have library of internal checks that ensure our metadata adheres to CDISC compliance and eliminates trivial human errors.
Analysis Dataset & define based on RAW Data
We can prepare ADaM dataset directly from non-SDTM data as seamlessly as SDTM. We leverage our well structured specification to perform automated checks to ensure ADaM datasets and their submission package are well harmonized and regulatory compliant.
Creation of Tables, Listings, and Figures
Our majority of Outputs are created by automation which enables us to be cost effective. Our reporting workflow directs us to be efficient in validation and review.
Regulatory Standards in Programming
US-FDA (and EMA)
On top of CDISC compliance, we ensure to adhere to U.S. Food and Drug Administration (FDA) standards for regulatory requirements for US and EU specific submissions.
PMDA
On top of CDISC compliance, we ensure to adhere to Pharmaceuticals and Medical Devices Agency (PMDA) requirements for data submission in Japan.
Statistical and Clinical Programming Delivering Excellence in Biometric Analysis and Submission Services
At Altrid we specialise in delivering excellence in Clinical and Statistical programming and preparing their submission components. Our team transforms complex data into clear, regulatory compliant package, ensuring that every piece of information is organised, analysed and presented with precision.
3+
Number of Ongoing Projects
4+
Number of Consulting Projects Supported
9+
Average Staff Experience in Years
9+
Therapeutic Areas Supported
12+
Number of Global Studies Supported
Client Success Stories Get in Touch
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Contact us
India Address
Regus, 13th Floor, 116, Behind Suzuki Showroom,
Ambli - Bopal Road,
Ahmedabad - 380058
USA Address
971 US Highway 202N, STE N Branchburg, NJ 8876