Community, Collaboration and Impacting Clinical Research

Shree Kalluri
Founder & CEO, Forte
March 21st, 2018

At this year’s Spring Onsemble Conference, we’re celebrating our 25th Onsemble Conference, the success we’ve had as a community and the progress we’ve made in clinical research. Without the community, Forte wouldn’t be where we are today, so I am forever grateful and in awe of what we have accomplished together.

From our first conference in 2006 with just 14 institutions, the Onsemble Community has grown and evolved tremendously over the years, with 250 attendees from 71 research organizations joining us at our largest conference to date. This past year alone, we’ve welcomed nine new institutions to the Onsemble Community. Now, more than ever, we have the ability to make a powerful impact on the clinical research industry.

Our industry perspective

At Forte, we believe in conversations and collaboration with our customers to provide ground-breaking solutions to research challenges. With their input, we evolve our software and services to keep pace with the research industry’s ever-changing needs and regulations. This is why the heart of our business is to closely collaborate with our customers throughout the year.

To ensure we are able to holistically support institutional research, we are reframing how we think about the research industry and focusing our efforts on helping customers in three key areas:

  • Clinical Trial Management
  • Clinical Data Management
  • Research Administration

In each of these important areas, we’ve created turn-key packages with complementary software and services to deliver comprehensive solutions for customers to help reach operational goals faster and realize value sooner.

Progress & plans

In line with this new industry perspective, we’re continuously working to reduce administrative burden for our customers and further centralize operations across systems. I’m happy to announce that OnCore Enterprise Research system now integrates with our electronic data capture system, Forte EDC and our automated participant payment system, Forte Participant Payments.

The OnCore and Forte EDC integration streamlines data collection and promotes data integrity by eliminating the possibility for error caused by entering data into multiple systems. Research organizations can now import protocols, subjects and organizations from OnCore to Forte EDC, linking three critical parts of both systems.

Similarly, the integration between OnCore and Participant Payments centralizes subject and protocol information to enable operational efficiencies and reduce the amount of time spent managing the payment process.

In addition to these exciting updates to OnCore, we announced our Research Evaluation System (EVAL) will feature Member Scenarios, a tool created to help organizations demonstrate programmatic collaboration for CCSG grant applications and renewals. This new tool allows cancer centers to more easily evaluate and manage their membership by showing the implications of moving members from one program to another and presenting the resulting data in real time.

Another software built in collaboration with 17 institutions is our regulatory management system, eReg. To help with enterprise roll out and full portfolio management, we announced to the community that we’ve launched the Master Delegation of Authority log in the system and an integration with OnCore. The Master Delegation of Authority helps increase regulatory compliance by standardizing delegated tasks at the system level, reducing errors and delays in gathering individual signatures for every protocol. Integration with OnCore this year will decrease duplicate data entry, increase data quality and streamline protocol operations. Our new Validation Services ensure that customers are using a validated, 21 CFR Part 11 system to manage their essential trial documents.

We also continue to develop services alongside our software solutions to help lift the administrative burden that our customers are facing and create access to expertise that bolsters their internal teams. In addition to our Calendar Build Services and Budget Build Services, we are offering Validation Services, OnCore Optimization and Staff Augmentation. Specifically with Staff Augmentation, we want to bridge the gaps within your teams during implementations and create business continuity instead of outsourcing to a third party with limited knowledge of Forte solutions.

Changing the focus of clinical research

Finally, I’m excited to announce a concept I’ve been thinking about for the past 15 years. At Forte, we’ve worked hard to help individual institutions create unprecedented operational efficiencies and achieve institutional goals. Now, we want to take it to the next level and create inter-institutional efficiencies. We’re launching a new invitation-only initiative and collaboration called DiReCT – Digital Research through Connected Technology –  that will facilitate inter-institutional data exchanges between the coordinating center and the participating sites for multi-site investigator-initiative trials. More to come about our philosophy and plans for this new initiative.  

As we look back and celebrate past Onsemble Conferences and look forward to exciting future collaborations, I’m grateful to the Onsemble Community for helping us move clinical research forward as we change the industry for the better.

Onwards and upwards!

Shree Kalluri

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