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New SMART feature provides CRAs with efficient control of modification requests, eliminates delays and regulatory concerns over site staff activation and deactivation
TrialNetworks will announce enhancements to the innovative Directory™ app within its cloud-based Clinical Trial Optimization System at the Summit for Clinical Ops executives next month in Miami. 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 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 accounts causes a chain reaction of delays in other areas such as training, safety letter distribution, enrollment and communication
• Failure to de-activate site staff in a timely manner as they depart the study team can result in a potential audit finding
TrialNetworks aims to solve these issues by transforming how contact and role information is collected and shared. The Directory app – now enhanced with the new SMART feature, which allows 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. Far more than providing a simple catalog of names, email addresses, site assignments and roles, Directory also:
• 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 deleted
• 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
• Eliminates reliance on inconsistent, contradictory and outdated spreadsheets
• Replaces the need for sites 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.”
Angela Kramer, Project Specialist at INC Research, said: “As a leading global CRO using innovative technology, the TrialNetworks Directory app with the 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.”
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.