(PR Web Via Acquire Media NewsEdge) Needham, MA (PRWEB) February 05, 2014
TrialNetworks today announced enhancements to the innovative Directory™ app within its cloud-based Clinical Trial Optimization System. Directory is an efficient trial contact management solution which improves the efficiency of collaboration between sponsors, vendors, CROs and sites and eliminates delays in site staff system account activations, modifications and deactivations.
Managing contacts efficiently is a critical (and often overlooked) aspect of running a successful clinical trial. The manual and redundant processes typically used have created a time-consuming and tedious workflow which presents significant challenges:
• Inefficiencies in provisioning site staff access to the required study systems causes a chain reaction of delays in other areas such as training, safety letter distribution, enrollment and communication
• Failure to deactivate site staff from the study systems in a timely manner as they depart the study team can result in a potential audit finding
TrialNetworks solves these issues by transforming how contact information, role responsibilities and system account requests are collected and shared. The Directory app – now enhanced with the exclusive self-service SMART feature allowing site staff and CRAs to request account activation, deactivation and modification – is a secure and permissions-based centralized master database of individuals on the study team which…
• Eliminates reliance on inconsistent, contradictory and outdated spreadsheets for contact names, email addresses, site assignments and roles
• Ensures timely study team additions, deactivations, contact information updates and system access permissions
• Automatically notifies all appropriate vendors when user accounts need to be created, modified or removed
• Tracks account requests and acknowledgements in a detailed audit trail
• Provides dynamic search filters to help trial managers quickly find reliable contact information for individuals and companies
• Replaces the need for sites, sponsors and vendors to exchange flurries of easily-ignored and untraced emails
In addition to serving as a reliable cloud-based contact database, Directory reduces the time spent waiting for system access permissions to be approved, reconciling conflicting spreadsheets and emails, manually searching archives to verify user lists, and answering redundant questions from vendors and sites.
Kathleen Hanlon, Senior Project Manager at Infinity Pharmaceuticals, said, “Streamlining vendor awareness and processing of individual site user account details for all of the systems used on clinical trials has consistently been a challenging task in the industry. Our study team worked with TrialNetworks to develop ‘SMART,’ a system whereby primary site study coordinators have a user friendly tool to request new user accounts and changes to existing user accounts for all study systems. These updates are then immediately sent to each vendor for implementation via a change request queue. We have experienced real efficiencies in project administration hours and vendor communications and our sites feel secure that the user account changes needed are being implemented in a timely manner that is transparent to all.”
Said Angela Kramer, Project Specialist at INC Research: “As a leading global CRO using innovative technology, the TrialNetworks Directory app with its self-serve SMART feature helps us improve the efficiency and service we provide to our pharmaceutical customers. We are able to process requests as soon as they occur and save significant time which can be spent on more strategic priorities. It also helps sponsors comply with regulatory requirements and provides a convenient method to notify other vendors of who needs to be granted access to certain systems or should be deactivated right away.”
Molly Woehr, an accomplished associate clinical trial manager with experience working with large and small pharmaceutical companies, added, “Historically, contact and study system access management has been a very time-consuming ineffective manual process that often resulted in delays in account setup or deactivation, or errors and omissions on trackers which could lead to an audit finding. I worked closely with TrialNetworks during the design and development of the SMART feature to ensure the system solved operational issues from both the site and sponsor perspective. The beauty of this enhancement is the workflow is automatically tracked in the background, with an exportable listing of who has access to which systems, the level of access for each user, when the accounts were created, and when they were deactivated – providing confidence that these essential data access records are accurately maintained and properly stored.”
TrialNetworks Co-Founder and CEO Eric Silberstein explained, “Reliable and efficient contact management may not be the most high-profile success factor for a clinical trial, but it is among the most important. Like all of the apps in our Clinical Trial Optimization System, we created Directory to solve a tedious and time-consuming function by replacing manual and redundant processes with innovative modern technology.”
The TrialNetworks Clinical Trial Optimization System is a unified, cloud-based platform of integrated study management apps and site-facing tools. Pharmaceutical sponsors and CROs leverage the platform to optimize operations including feasibility, site activation, patient recruitment and retention, site engagement, trial conduct, online training, and document management from study startup to closeout.
TrialNetworks provides sponsors and CROs the industry's only Clinical Trial Optimization System. Using this modern and intuitive technology, customers such as Merck & Co. and Infinity Pharmaceuticals are able to transform the quality and efficiency of clinical operations at each stage of a trial from feasibility through closeout. TrialNetworks apps, including Checklist™, Training™, Document Library™, Visit Guide™, Action Items™ and Directory™, are available in a unified and secure cloud-based interface. Customers ranging from biotechs to Top-10 pharma companies have implemented the TrialNetworks platform for use in Phase I-IV trials by more than 25,000 site staff in 60 countries. To learn why sponsors and CROs rely on TrialNetworks to optimize clinical trial operations, request a guided online demo at http://www.trialnetworks.com.