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Strategic CDISC Implementation and other Consulting & Guidance
Efficient CDISC Implementation, Workflow Optimization and Automation
Consulting is an essential part of our services, and we are committed to supporting clients in making informed decisions. Our team has actively contributed to CDISC and PHUSE, playing a key role in industry-leading innovations. From adapting evolving data standards and enhancing tool development to designing macro ecosystems and refining SoPs, we have successfully executed various projects. Clients can collaborate with us on projects of any size, based on their specific requirements.
On-Demand CDISC and Regulatory Consulting for Confident & Compliant Decisions
CDISC Consulting
Review of SDTM & ADaM Data Specifications
Our experienced programmers have deep understanding of CDISC and other regulatory agency requirements. With our methodological approach for review, we ensure specification content is error free and always in sync with our data & define package.
Review of SDTM & ADaM Data & Submission Package
We emphasize on harmony and synchronization between data and define.xml. Our team of expert focuses on review to ensure define package is well up to submission standard and adheres to all necessary compliances. We ensure that the data and define are in well sync and ready for agency submission.
CDISC Standard Document Generation
As we understand standards and make balanced decision. We provide comprehensive support on development of certain standardized documentation such as generation of SDTM aCRF and its specification and ADaM specification. We leverage our internal standardisation and automation to ensure all documents are CDSIC compliant.
Therapeutic Area Specific Consulting
It is necessary to follow therapeutic area guidance on top of implementation guidance. We consult with our clients to better structure their SDTM aCRF, and both SDTM and ADaM specification to ensure datasets are CDISC compliant.
Other Consulting
Input to Tool Development from CDISC Point of View
We transcend our deep CDISC expertise to help develop tools that provide greater efficiency in automation and standardisation. We assist and provide input to several IT service provides to achieve this.
Internal Workflow and Guidance
We have hands-on working experience in several client systems. Our collective experience have helped us to guide our clients on optimal workflow that achieves required compliance with cost-effectiveness.
Input to SoP Development and Enhancement
We have worked with and supported creation of several computing environments. These experiences enabled our team to better equipped with requirements of data analysis and reporting. With vast experience, we provide guidance on development of Standard Operating Procedures that aligns with our client's tool, system and internal workflow.
Input to Computing Environment Setup
We have worked with several client systems and gained valuable experience on different components of computing environment. We provide input, recommendations and best practices to setup cost-effective yet secure computing environment that aligns regulatory requirements. This also includes the study/project folder structure and archival process.
CDISC & Other Consulting Delivering Excellence in Biometric Analysis and Submission Services
Our team of experience consultants provide seamless insights crafting actionable plans to achieve our client’s operational as well and technical objectives. Our team transcend their deep CDISC understanding to clear and actionable submission strategies.
3+
Number of Ongoing Projects
4+
Number of Consulting Projects Supported
9+
Average Staff Experience in Years
7+
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