In today’s ACT Brief, we examine why the future of AI in trials is a trusted orchestration system rather than a single model, how coordinators rate eSource-enabled workflows, and what a bipartisan bill proposes for reusable trial networks.
|Articles|September 1, 2009
- Applied Clinical Trials-09-01-2009
- Volume 0
- Issue 0
eClinical Software: September 2009
Author(s)Lisa Henderson
The latest eclinical software in the clinical trials industry.
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Patient Enrollment Software Updated
TCN 5.0 expands metrics and risk mitigation for key areas
BBK Worldwide (Newton, MA) announces TrialCentralNet (TCN) 5.0, its patient recruitment management system for sites and sponsors. TCN 5.0 features a robust communications infrastructure, tools for proactive planning of enrollment efforts, targeted site selection criteria, a recruitment development and implementation process, efficiencies for patient enrollment, and instant reporting on randomization and retention metrics.
In addition, TCN 5.0 features improved graphical interfaces for study site personnel and improved function across multiple browser platforms. The new version can be integrated with other clinical data systems as well as other TCN eSystems related to patient recruitment.
BBK Worldwide, (617) 630-4477,
Protocol Manager 8.0 Delivers Web Availability
CRAs' needs also addressed in upgraded version of software
Winchester Business Systems (Woburn, MA) announced its Protocol Manager Version 8.0 CTMS, which now features Web-enabled access to authorized users worldwide. Also, a new Clinical Study Portal designed for CRAs joins the already existing portal for investigators.
Winchester CTMS developers have retained the IBM Lotus Domino platform, citing its broad offerings for workflow and application security. In addition, it eliminates the need to obtain separate components to serve as database manager, collaboration manager, email router, security system or Web server.
Winchester customers can purchase or upgrade to Version 8.0 CTMS by Enterprise Adoption, a traditional licensing model, or choose the optional hosting pricing model, featuring Software as a Service and paying on a trial-by-trial basis.
Winchester Business Systems, (781) 203-0200,
Oversight of Global Clinical Trials
Clinical Quality Management Solution addresses process and compliance
Sparta Systems (Holmdel, NJ) announced TrackWise Clinical Quality Management Solution to provide end-to-end streamlining of clinical trial processes and ensure compliance with global regulatory standards. This extension of the TrackWise enterprise quality management system (EQMS) begins with preclinical activities through manufacturing and postmarket operations.
TrackWise Clinical Trial Quality Management Solution provides closed-loop process support to allow issues to be reconciled and corrected before they escalate. The solution manages incidents, structured audit programs specifically tailored around clinical trial execution, the associated CAPA and change control processes, as well as trial registration and trial documentation/SOPs.
Sparta Systems, (888) 261-5948,
Articles in this issue
about 17 years ago
Applied Clinical Trials Digital Edition - September 2009about 17 years ago
The Spotlight Falls on Indiaabout 17 years ago
Into the Aftermath of M&Aabout 17 years ago
EMEA and FDA Team Up on GCPabout 17 years ago
Does Size Matter in Partnershipsabout 17 years ago
An Assessment of Adaptiveabout 17 years ago
Business and People Update September 2009about 17 years ago
eCTD Training Effortsabout 17 years ago
Global Development Challenges Sponsorsabout 17 years ago
Regulating the Generic Drug ProcessAdvertisement
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The Faster Clinical Trials Act would create an FDA Center for Clinical Trial Innovation and aims to cut trial costs and enrollment time by at least 30%.
Standardized measurement across five oncology centers found that clinical research coordinators rated eSource-enabled workflows positively (Overall Mean Satisfaction 5.79 of 7), with reduced manual entry and electronic data transfer earning strong marks, while perceived reduction in sponsor and monitor queries lagged as the one domain below threshold.
In this video interview, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, describes the industry’s trajectory toward a unified intelligence orchestration environment—and explains why the future isn’t one model that knows everything, but a trusted system that brings the right evidence to the right human decision.
In today’s ACT Brief, we examine how sites can avoid both fear-driven and overly aggressive AI adoption, why community-based research needs sustained financial investment, and why patient access matters more than organizational size.
Pacing obesity trial enrollment, anchoring eligibility to stable real-world therapies, and building site and physician relationships improve retention and data quality more than aggressive recruitment or restrictive exclusion criteria do.
In this video interview, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, argues that CROs must act as orchestrators rather than aggregators—and that the real test of any AI ecosystem is whether it reduces sponsor coordination burden or just hands it back to them.
Syneos Health and Optum outline a joint model for trial planning, recruitment and site access, with no financial terms or timelines disclosed.
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