By Clinical Informatics News Staff 

June 28, 2016 News and announcements are coming fast out of the Drug Industry Association meeting in Philadelphia. Highlights here come from DrugDev, Veeva, inVentiv, Bracket, and MasterControl. The roundup will be updated throughout the week.

DrugDev Launches CRO Preferred Partner Program with INC

DrugDev has launched its CRO Preferred Partner program, indicating partners with real-world experience using DrugDev’s SaaS tools to supplement or enhance the value of their provided services.

INC Research was named a Charter Member of the program. INC Research was the first CRO to standardize on the DrugDev Golden Number, the unique identifier that powers the TransCelerate Investigator Registry and Investigator Databank. INC also offers sponsors use of the new DrugDev patient engagement solution, which enables sites to send reminders, documents and notifications to patients via SMS, and provides patients with a comfortable online home for all their study information – using an intuitive interface on a desktop computer or mobile app.

“As an innovation leader, INC Research is committed to investing in solutions that enable us to deliver better and more efficient services for our pharmaceutical customers,” said Jonathan Shough, Chief Information Officer at INC Research in a statement. “We applaud industry-wide collaborative efforts and are proud to be integrated with the DrugDev Golden Number, and to provide our sponsors with direct access to the latest patient engagement solutions.”

“Thankfully, our entire industry has realized that it is no longer acceptable for any company simply to make their trials a little bit better or a little bit faster,” said Ibraheem “Ibs” Mahmood, President and CEO of DrugDev, in the same press release. “We have a collective responsibility to families around the world to dramatically change how we do business, so we can do more trials and bring more helpful therapies – not just a few, but loads and loads of them – to market. The only way to accomplish this is for sponsors, CROs and vendors to work together using common systems with consistent data models and user experiences. Visionary companies such as INC are leading the way and we are honored that they have adopted DrugDev technology so we can continue to transform clinical trials together.”

Veeva Releases Latest Trial Master File Survey

Veeva Systems released its latest survey of trial master file (TMF) owners, the Veeva 2016 Paperless TMF Survey. The 2016 study reveals significant change is underway as the industry shifts from passive to active TMF management and adopts advanced electronic TMF (eTMF) applications to improve inspection readiness and shorten clinical trials.

Since the first Paperless TMF Survey in 2014, there has been a major shift from passive to active TMFs, as sponsors’ adoption of advanced eTMF applications has increased nearly twofold to 24%. Sponsors using local file systems as their eTMF dropped from 26% in 2014 to just 8% today. During the same period, clinical operations departments report the use of paper for most or all TMF documents fell from 41% to 28%.

Nearly one in four (23%) sponsors now use their eTMF application to share documents with CROs, up from 14% in 2014. Similarly, more sponsors use eTMF applications to exchange documents with sites (16%, up from 11% in 2014). On the heels of the MHRA’s mandate for TMF accessibility, the majority (80%) of sponsors using an eTMF application now provide remote access to inspectors and auditors or plan to do so within the next year.

The clinical operations landscape remains highly fragmented with duplicate content and data in multiple systems across different functional areas and partners. Clinical leaders want full visibility and greater control, prompting rapid change toward unifying clinical operations for one process, one system, and one view. This is underscored by the growing demand to integrate eTMF applications with other clinical systems. Half (49%) of sponsors cite integration of their eTMF application with their clinical trial management system (CTMS) as a key need.

Improving inspection-readiness and speeding study startup are the two most cited business benefits driving eTMF adoption among sponsors (67% and 53% respectively). Remote oversight of the TMF (48%) and better visibility into performance metrics (40%) also rate high as motivators for eTMF adoption.

The data show the drivers prompting eTMF adoption are indeed the benefits realized by those using purpose-built eTMF applications. eTMF application users report significant improvements in several areas, including inspection readiness (61%), improved central and remote monitoring (59), and better visibility into performance metrics (55%). Users of other types of eTMFs, such as local or cloud file shares, are significantly less likely to see these benefits.

When asked about the specific benefits in key inspection areas, nearly all (98%) respondents with an eTMF application saw major improvements in at least one area, including duplicate, missing, or incomplete documents.

In addition, organizations that extensively use metrics to improve trial processes see more benefits than those who do not. These include improved audit and inspection readiness (67% vs. 29%), better visibility into performance metrics (53% vs. 14%), and cost savings (47% vs. 10%). Metrics also play an important part in speeding time to market. Respondents using an eTMF and extensively using metrics experienced faster study startup and shortened clinical time as compared to those not collecting data (20% vs. 5% and 23% vs. 5%, respectively).

“eTMF applications are becoming an integral component of clinical operations as sponsors mature their TMF processes,” said Jennifer Goldsmith, senior vice president of Veeva Vault, in the press release. “As the industry pushes toward unifying systems, processes, and stakeholders across clinical operations, the speed of clinical trial execution will continue to accelerate.”

inVentiv Health Selected by Pfizer as Preferred CRO

inVentiv Health was selected by Pfizer as one of its preferred partners in the delivery of clinical operations services to support Pfizer's portfolio. inVentiv Health—comprised of a top-tier CRO and the industry’s only Contract Commercial Organization (CCO)—is now a preferred partner in Pfizer’s sourcing strategy for global clinical operations services. The agreement term is until June 8, 2019 and provides Pfizer with the right to extend the term for up to an additional two years. Financial terms of the agreement were not disclosed.

"Complex science and challenging marketplace dynamics are driving the need for new, accelerated approaches to clinical development,” said Michael McKelvey, Ph.D., President of the Clinical Division at inVentiv Health in a press release. “This agreement is an indication that our leading full-service clinical offerings are value-enhancing and scalable. We designed this approach to deliver patient-centric outcomes in an increasingly competitive environment."

As a preferred provider, inVentiv has expanded its clinical operations presence with Pfizer and is focused on therapeutic excellence in the areas of oncology, pain, neuroscience and respiratory and data and technology-driven efficiencies.

"Our comprehensive clinical services have proved to be an asset in our work with Pfizer,” said Gregory Skalicky, Chief Commercial Officer, inVentiv Health Clinical Division. “The expansion of our relationship under this new preferred provider status will allow us to continue to seamlessly orchestrate our full suite of clinical solutions. We’re committed to realizing improved efficiencies in support of Pfizer’s clinical development activities."

Bracket Announces Next Generation Clinical Outcomes Platform

Bracket announced its newest clinical outcomes platform, eCOASM 6.0, the first electronic Clinical Outcome Assessment product of its kind to fully integrate with RTSM. Bracket eCOA 6.0 is a flexible platform for electronic clinical outcomes assessments that is driving digitization in clinical trials. The platform integrates with industry-leading Samsung Galaxy smartphones and Microsoft’s Surface Pro Windows tablets to support ePro, eClinRO and eObsRO, and features fully integrated clinician and patient-facing tools, to ensure the experience is fully harmonized for any user.

“Bracket eCOA combines science and technology to collect patient information through smartphones or tablets, and ultimately achieve higher quality outcomes and efficiency in clinical trials,” said Jeff Kinell, CEO for Bracket, in a press release. “We are pleased to launch eCOA 6.0 and continue demonstrating our commitment to paper-free clinical trials as we prepare for the mobile revolution.”

MasterControl Demonstrates Clinical Quality Management System

MasterControl is demonstrating the industry’s first Clinical Quality Management System (CQMS) this week. MasterControl CQMS is designed to manage and seamlessly integrate all documents, activities, project tasks, processes, quality events, relationships, audits and training, all of which must be administered and controlled throughout the life of a clinical trial.

“The role of quality can now take its rightful position as a critical element of a properly managed clinical trial,” said Patricia Santos-Serrao, MasterControl’s Director of Clinical and Regulatory Solutions for the Pharmaceutical Industry.