SPA - Structured Protocol Authoring

Collaborate on study protocols, trial design, & schedules of activity

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

Unique Benefits:

  • Capture Protocols in machine-readable form

  • Reuse protocol elements from past studies

  • Setup CDP structure & document templates

  • Compare against benchmark studies

  • Sync with Medical Writing in MS Office Online

  • Drive study metadata plans or export .XLS/.DOC

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. 

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