eClinical Software: March 2009
Applied Clinical Trials
The latest eclinical software in the clinical trials industry.
Paper Submissions Support Added
Electronic/paper/hybrid modes addressed in new product suite
TAKE Solutions (Raleigh, NC) has added a Paper Submissions Module to its PharmaReady suite of Document & Submission Management products. The new module allows users of hybrid submission modes of electronic and paper to take advantage of an interim solution. The Paper Publishing Module is part of a centralized document management system.
TAKE updated PharmaReady suite
Key features of the system include: Assemble and organize documents based on volumes, modules, and agency-specific classifications; acceptance of all common Microsoft Office and PDF documents; various submission dossiers; agency-specific submission structures; create volume and module headers and separators; review print ready documents; and more.
TAKE Solutions, (609) 720-1002, www.takesolutions.com
Advanced Clinical Trial Operations Planning
New portfolio or program level execution available
ClearTrial (Westmont, IL) has added an advanced planning feature to its Enterprise Edition of Clinical Version 2.7 clinical trial operations planning software. The feature, called ClearTrial Portfolio Planning, allows biopharmaceutical companies and CROs to roll-up protocol-level study plans into portfolio-level forecasts within mintues. This capability provides instant visibility to monthly budgets, monthly resource demand, and timelines across a program, business unit, therapeutic indication, region, service provider, or any other dimension. When protocol-level assumptions change, the software automatically updates the portfolio-forecast within seconds.
ClearTrial Portfolio Planning
ClearTrial Portfolio Planning is designed primarily for professionals in clinical operations, finance, and project/resource management.
ClearTrial, (630) 986-9800, www.cleartrial.com
Platform Supports Processes
Subsequent modules will address eCTD- and CDISC-related activities
Octagon Research Solutions (Wayne, PA) announced its ViewPoint Quantum platform that supports the optional business modules and is the foundation for the ViewPoint Quantum environment for Business Process Management.
Octagon ViewPoint Quantum platform
These capabilities include workflow, issue management, search, metadata, document storage, and integrated connectivity with other content repositories.
It also ensures common function across business modules, which feature dynamic reporting capabilities, issue management capabilities, and workflows. Subsequent business modules include: eCTD, CDISC, and activities relating to these standards, which include global submission publishing, compilation, and lifecycle management.
Octagon Research Solutions, (610) 535-6500, www.octagonresearch.com
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FDA Expands Farapulse PFA Approval to Persistent AF After Strong ADVANTAGE AF Trial Results
July 7th 2025Boston Scientific’s Farapulse Pulsed Field Ablation System is now approved for treating persistent atrial fibrillation, following 12-month data from the ADVANTAGE AF trial showing strong safety, high freedom from AF, and no major complications.
