Gathering of key industry executives provides forum for open dialogue on issues affecting the initiation of clinical trials
SAN FRANCISCO, October 5, 2017 -- goBalto, Inc., the leading provider of cloud-based clinical study startup (SSU) solutions, announced today the successful conclusion of its inaugural, invitation only, Pharmaceutical Executive Exchange Roundtable (PEER) event held at The Modern in Manhattan, New York City, one of the city's most prized locations designed to capture the iconic feel of the MoMA.
The event hosted a select group of leading pharmaceutical executives and prominent members of the press, including: Pfizer, Bristol-Myers Squibb, Johnson & Johnson, Novartis, Allergan, Bloomberg and others, brought together to discuss the outcomes of the recently completed comprehensive study - Start-up Time and Readiness Tracking (START) II - conducted by The Tufts Center for the Study of Drug Development (CSDD) into the entrenched silos and bottlenecks that remain in SSU, which ultimately impact overall study timelines and outcomes.
"The results of the study provide valuable insights into the inefficient, inconsistent and unsophisticated practices implemented by sponsor and CRO companies to identify, select and manage investigative sites. In addition, the study results highlight best practices and tactical areas most associated with study start-up cycle time improvements including outsourcing and investment in technology," said Ken Getz, Director of Sponsored Research Programs and an Associate Professor at Tufts CSDD.
Existing eClinical solutions, such as CTMS, eTMF, focus on specific pieces of the clinical trial continuum, yet, they overlook aspects unique to SSU, a multifaceted (cross clinical trial technologies and countries) process that continues to stumble and stall clinical trial timelines.
To this end, an SSU application is a critical addition to the ongoing automation of clinical trials, highlighting the value of technology that streamlines bottlenecks allowing stakeholders to better adhere to established timelines and budgets, cutting runaway costs and speeding the delivery of life saving medicines to those in need.
This sentiment was evidenced by Paul Williamson, Director of Strategy & Planning, Novartis, who presented on the successful outcomes from the implementation of goBalto's Activate. 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 gains at Novartis by creating a central repository with the right supporting workflows.
The outcomes from the START II research clearly show the impact of technology on SSU. Nearly, 80% of respondents who have invested in technology report time savings and those companies with the fastest cycle times rely more on technology to manage their processes than their counterparts, thereby providing them with a competitive edge. Unfortunately, nearly 40% of respondents are still using unsophisticated methods, mainly spreadsheets, which may contribute to their lower satisfaction levels with their internal processes.
"The goBalto PEER event brought together some of the industry's brightest and most innovative minds to discuss the important topic of eliminating study startup obstacles, while still focusing on getting quality treatments to patients that need them," stated Lorena Gomez, Director, Global Study Start Up & Essential Documents, Allergan.
According to Jeffrey Kasher, President, Patients Can't Wait, "The process of initiating clinical trials remains unwieldy, challenging, and often behind schedule, making SSU one of the poorest performing aspects of clinical trials. Key to stemming inefficiencies endemic in the industry are open forums, like the goBalto PEER event, which provided an excellent forum to get pivotal insights into the latest research on factors influencing the initiation of studies and their ultimate downstream effects, as well as an opportunity to discuss these issues with my executive peers."
"A SSU application that can unify interoperability within the eClinical stack, especially an industry proven platform than spans the study startup continuum from site identification through to activation, is of paramount importance to streamlining operational expenses and reducing study durations," said Jae Chung, goBalto's founder and president. Adding, "These integrations ensure downstream quality, compliance and breakdown organizational silos that continue to stymie the industry - an industry eager to address stakeholder concerns over delays, cost overruns and lack of operational transparency."