Sycamore CDR

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Centralize, secure, store, share and deliver your clinical trial data. Sycamore CDR allows you to securely store clinical trial and real world data and related assets, share with partners with granular role-based access and version control, including blinding/unblinding, and maintain 21CFR11, EU Annex 11, and ICH E6 compliance such as around data provenance and data chain of custody.

The Sycamore Clinical Data Repository (Sycamore CDR) is a secure and scalable data repository and data exchange hub. Sycamore CDR is integrated with multiple data visualization applications such as JReview™, Spotfire™, Qlik™, Tableau™, RShiny™ etc. With add-on modules such as Sycamore Managed File Transfer (Sycamore MFT) and Sycamore Enterprise Integration Module ( Sycamore EIM), Sycamore CDR enables controlled and audited ingress and egress of data and content from and to multiple internal and external systems and facilitates distributed teams to securely share data and content across departmental and organizational boundaries.

 

Sycamore SCE

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Automate the highly complex, collaborative and mostly manual practices in clinical trials biostatistics and programming using a controlled statistical computing environment.

Sophisticated access control, versioning combined with traceable execution between the received and transformed data and analysis outputs ensures that the lineage, integrity and provenance of data are always available and reproducible

Sycamore Statistical Computing Environment (Sycamore SCE) is the highest ranked SCE application with the most number of successful proven production deployments and with several thousand active global users. Sycamore SCE employs version control, audit trails, traceable analysis execution, dependency management, impact analysis, role-based security, workflow and tasks to create an environment for clinical reporting and analysis. Sycamore SCE can work with different programming languages such as R, Python, the SAS language, Julia and multiple ML/AI algorithms. Sycamore SCE is agnostic to programming editors and can work with multiple web based and desktop editors such as Posit (RStudio), UltraEdit, Notepad++, VS Code, PyCharm and SAS language editors including using command line.

Sycamore SCE’s Data Transformation Module (Sycamore DTM) enables metadata driven transformations and facilitates automation of data transformations from multiple sources into common standards for near real time access to transformed and validated data. The transformed and source data can be made available  to users through built-in tools and reports and integrations with third party tools.

 

Sycamore MDR

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.

Ensure compliance of study metadata to standards and mappings with Sycamore MDR’s AI/ML based Conformance Checking Module.

Accelerate your EDC build, data transformations and statistical programming using Sycamore MDR.

The Sycamore Metadata Repository (Sycamore MDR) is industry's leading application for defining, governing, managing, consuming and delivering clinical trials data standards, metadata and mappings. Sycamore MDR supports industry standards including multiple versions and releases of CDISC metadata definitions and controlled terminology as well as an organization’s internal metadata standards. Sycamore MDR manages study, therapeutic and related metadata definitions and facilitates the use of metadata across different functional areas. The metadata is managed in reusable libraries, which can be used in a study or project specific context.

Using Sycamore's proprietary technology, Sycamore MDR manages the relationships between different models down to the variable level and maintains the integrity of the relationships between these models, their use in studies and orchestrates the bi-directional movement of metadata between multiple systems such as DCIs, EDCs and Clinical Data Repositories. 

Sycamore MDR's proprietary Machine Learning and AI algorithms enable instantaneous auto-generation of end-to-end Study Instance Metadata (SIM). The generated SIM includes variables from Collection (Forms) to Submission to Analysis and the associated mappings from Source to Data Review to SDTM to ADaM. Sycamore MDR tracks and versions all changes to studies, models 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. Any impact of proposed changes to studies, models and variables can also be easily previewed and visualized.

 

Sycamore SPA

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Author Clinical Trial Protocols, Clinical Development Plans and and design Clinical Studies using Structured Content and Clinical Data Standards with powerful catalog search and comparison against benchmark studies. 


The Sycamore Structured Protocol Authoring application (Sycamore SPA) is a collaborative Clinical Trial Protocol Authoring and Structured Study Design environment that provides standard templates, libraries and powerful search tools along with familiar editing using Microsoft Word. Using the Sycamore SPA it is possible to generate Clinical Development Plan and author Clinical Trial Protocol documents on demand using customer specific or industry standard templates such as TransCelerate’s Common Protocol Template (CPT) and the NIH-FDA Clinical Trial Protocol Template.  The Sycamore SPA keeps track of constraints and connections between Study Design Elements such as Objectives, Endpoints/Variables, Inclusion/Exclusion Criteria, Activities and Trial Parameters. Users can view, edit and review all elements in the application in a familiar Microsoft Word-Online interface, export the study design in machine readable CDISC standard format or export the Clinical Development Plans and Clinical Trial Protocol documents in Microsoft Word or PDF format. With the native integration with the Sycamore MDR organizations can incorporate company and industry approved clinical trial standards early on in the study design process. 

 

Sycamore Secure Private Cloud

Sycamore applications are delivered in the Sycamore Secure Private Cloud.

Sycamore Secure 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.

 

ISO 9001:2015 and ISO/IEC 27001:2013 Certified

Sycamore is an ISO/IEC 27001:2013 certified organization. ISO 27001 is globally recognized security management standard that specifies security management best practices and comprehensive security controls. The basis of this certification includes the development and implementation of an Information Security Management System that defines how security is managed in a holistic, comprehensive manner at Sycamore Informatics.

  • We maintain a comprehensive security management program to manage threats/risks, opportunities, protecting data confidentiality, data integrity and accessibility to authorized users.

  • We ensure customer satisfaction through an emphasis on service management, business continuity, competent team, and verified vendors.

  • We maintain a comprehensive management process of continual improvement through regular monitoring to ensure that the information security controls continue to meet our needs.