Collaborate with your partners on metadata specification and drive reuse in study build by connecting to EDC systems. Refine your standards using the Sycamore MDR Governance.
Accelerate your EDC build, data transformations and statistical programming using semantically aware Sycamore MDR.
Sycamore MDR facilitates the exchange and use of metadata across multiple functions and comes with industry standard models including BRIDG and CDISC SDTM metadata definitions. Sycamore MDR manages study, therapeutic and related metadata as well as an organization’s internal metadata standards and definitions. The metadata is managed in reusable libraries, which can be used in a study or project specific context. Sycamore MDR manages the model relationships down to the variable level and maintains the integrity of the relationships between the models, their use in studies and orchestrates the movement of metadata between multiple systems. The impact of changes to study, model and variables can be easily assessed and visualized. Sycamore MDR tracks and versions all changes to study, model and variables making it simple to see what has changed in a study over time and how the metadata has changed during the course of a study. Sycamore MDR allows organizations to use and work with multiple versions and releases of standards such as CDISC SDTM and SDTMIG.
Centralize, secure, store, share and deliver your clinical trial operational and study data.
Sycamore CDR allows you to securely work with clinical trial operational and study data and related assets, collaborate with partners and maintain compliance, transparency and data provenance required by regulators.
Sophisticated versioning combined with traceability between the received and transformed data along with all related assets ensures that the lineage, integrity and provenance of data are always available and reproducible.
Sycamore CDR is a semantic aware repository with pre-built adapters to source systems. Semantic aware transformations allow automation of data transformations from multiple sources into common standards. The transformed and source data are exposed to users through built-in tools and reports and integrations with third party tools. Sycamore CDR allows distributed team to share data across departmental and organizational boundaries.
Automate the highly complex, collaborative and mostly manual practices in clinical trials biostatistics and programming using a controlled statistical computing environment.
Sycamore SCE employs version control, audit trails, traceability, dependency management, impact analysis, role-based security, workflow and tasks to create an environment for clinical reporting and analysis. Sycamore SCE includes support for several programming languages, implements industry standards such as CDISC SDTM & ADaM and allows the generation of define.xml and exports such as the m5 section of the eCTD.
Sycamore Private Cloud
Sycamore applications are delivered
in the secure Sycamore Private Cloud.
Sycamore Private Cloud is built on a cloud infrastructure with data centers in the US and the EU, with its own dedicated servers, private networks, applications and services. The Sycamore Private Cloud is designed to meet industry requirements for data protection, change control and compliance with regulations including US 21 CFR Part 11 and EU Annex 11. A Hybrid Cloud deployment is also available for Sycamore applications where customer's data and compute resources may reside in customer's data center.