CDISC Services

CDISC Services

Rancho Biosciences’ CDISC Services

Rancho BioSciences is a leading international data service company specializing in the curation and management of life science data, across clinical and preclinical domains. We recognize the critical significance of adhering to CDISC standards in clinical research and preclinical toxicology. These standards not only streamline drug development and regulatory submission processes but also uphold the highest standards of data quality and interoperability. 

Our dedicated suite of services is uniquely poised to assist organizations in navigating the intricate landscape of CDISC standards.

Rancho BioSciences is Your Trusted Partner for CDISC Standards and Data Management Excellence:

  • Expertise: Our team possesses profound expertise in handling diverse life science data, encompassing both clinical and preclinical domains.

  • Combining Automation and Human in the loop: We leverage a combination of cutting-edge commercial tools and internal resources, complemented by meticulous manual curation and quality control conducted by our subject matter experts.

  • In-Depth Knowledge: We have a deep understanding of CDISC formats, including SDTM and SEND, ensuring that your data maintains its integrity and remains fully compliant with CDISC standards.

What is CDISC?

In the rapidly evolving realm of clinical research, ensuring data standardization and interoperability is crucial. The Clinical Data Interchange Standards Consortium (CDISC) has established itself as the gold standard in this sphere, laying down comprehensive guidelines and structures for the collection and submission of clinical trial data that have been adopted by regulatory agencies. With the myriad of components developed within the CDISC suite, including SDTM (Study Data Tabulation Model), ADaM (Analysis Data Model), and CDASH (Clinical Data Acquisition Standards Harmonization), researchers and pharmaceutical organizations are better equipped than ever to create more efficient, transparent, and consistent clinical trials. Moreover, with the SEND (Standard for Exchange of Nonclinical Data) framework in place, the same rigorous standards can be applied to nonclinical animal study data, ensuring a seamless and holistic approach to both clinical and preclinical research phases.

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Regulatory agencies worldwide, such as the FDA (U.S.) and PMDA (Japan), have recognized the significance of CDISC standards. They mandate the use of these standards in data submissions, reinforcing the importance of a structured approach to clinical data. This underscores the necessity for expertise in CDISC for any entity involved in the clinical trial and drug approval process.

At Rancho Biosciences, we pride ourselves on our deep understanding and proficiency in CDISC services. With a dedicated team of professionals well-versed in the nuances of CDISC components and regulatory requirements, we stand at the forefront of clinical data standardization, ensuring our clients' data is robust, compliant, and positioned for success in regulatory submissions. Whether you are initiating a new clinical trial or navigating the complexities of meeting CDISC standards, our expertise is here to guide you every step of the way.

Offered Services:

CDISC Data Services:

  • Establishing Data Models: Rancho crafts data models tailored to your unique requirements, ensuring fluidity and consistency with CDSIC in data workflows.

  • Terminology Management: Establishing controlled terminology within your data models that align with CDISC data interoperability standards.

  • Data Harmonization: We unify datasets from varied sources or studies, ensuring uniformity in sync with CDISC standards.

  • Applying AI: Automated Mapping Suggestions: Leveraging semantic embeddings to map documents and your unique data to CDISC-controlled terminology, our state-of-the-art AI tools offer automated mapping advice, hastening the SDTM mapping progression.

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Data Capture Deployment Services:

  • CDISC Adoption Advisory: Our specialists guide organizations through deployment of CDISC-compliant data capture systems, stressing compliance and streamlined change management.

  • Business Analysis Expertise: Bridging the divide between scientific requisites and vendor solutions, our analysts play an indispensable role, further liaising with vendors for customized demos and configuration quotes for your team by establishing system requirements.

  • SEND LIMS & EDC Product Management: Entrust us with the complexities of system configuration management, be it SEND LIMS or EDC setups, ensuring alignment between users, vendors, and CDISC standards.

Data Science Services:

  • Insight Generation from CDISC Data: We delve deep into CDISC-compliant datasets, gleaning actionable insights that directly influence your clinical strategies.

  • Quality Monitoring Tools: Implementation of state-of-the-art processes and tools for ongoing data quality assessment, ensuring consistency and adherence to standards.

At Rancho BioSciences, we are committed to delivering top-tier data curation and management solutions ensuring CDISC compliance and data excellence.