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.
The Sycamore Metadata Repository (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.
The Sycamore Clinical Data Repository (Sycamore CDR) is a flexible data repository and secure data exchange hub with pre-built adapters to source systems. Metadata driven transformations allow 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 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.
The Sycamore 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, and includes support for industry standards such as CDISC SDTM & ADaM when used with the Sycamore MDR.
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/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.