trends & perspectives in clinical research

goBalto Chromosome

A Step Change in Study Startup Efficiency

by Craig Morgan

"Activate features such as: alerts and to-do lists, role based process flows, milestone tracking (including those on the critical path), and IP release checklists helped drive productivity by creating a central repository with the right supporting workflows."

Case Study: A Step-Change in Study Startup Efficiency

Business Problem Statement

In 2012, a large multinational pharmaceutical company turned their attention to increasing transparency and improving collaboration in the study startup (SSU) process. The business process flow required multiple hand-offs between each of the team members to support project management, document management, collection and archiving, as well as, activity/task management. Team members often relied on information stored in individual trackers that were not centrally accessible.

The goBalto Activate Implementation

Activate was selected to help streamline the study startup process, resulting in a standardized data model and centralized system for reporting in real-time. Starting in 2012, Activate was first used in pilot mode, covering three studies and 129 sites. Transparency and activity status tracking was an important capability delivered by Activate that allowed work to move forward even when key staff were out of the office. An average 10-week reduction was achieved in the time between when the RDP was sent to site until the site initiation visit (SIV).

By the fourth quarter in 2013, all priority studies were using the platform, and by Q1 2014, all new studies were relying on Activate for study startup. To support adoption and support for the new system, the implementation team relied on resources from each group to drive the design and decision making processes.

User uptake grew substantially over this period (by 183%). As of December 2015, over 130 studies and 1500+ sites were transitioned to the new system, covering all aspects of the SSU workflow, from feasibility to SIV and beyond (including: amendment tracking, Informed Consent Form (ICF), Institutional Review Board (IRB) approvals, Investigator Brochures, Confidential Disclosure Agreements (CDAs)). System usage reflects this trend: from 2014 to 2015, sites being activated in the system grew by 285%, while the number of studies added increased by 166%.

Tangible Operating Results

Find out by downloading the Novartis case study, which shows the significant improvements in operational efficiencies Novartis has realized since deploying goBalto Activate.

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