Next Generation CRO Technology in the Age of COVID

Q&A with Bloqcube CEO, Rama Raos

Frequently Asked Questions

How has COVID-19 changed clinical trials?

69%

Of
Ongoing
Trials

78%

Of
New
Trials

have been affected by the pandemic

The Pandemic has caused the entire industry to re-evaluate technologies used in Clinical Trials, underscoring the trend away from paper, manual, and homegrown methods, leapfrogging outdated legacy systems, and moving to modern solutions built on modern technologies.

  • Safety is increasingly the center of operations
  • New guidelines stress representation of  diversity in patient recruitment
  • Sponsors are requested to conduct patient centric, remote, decentralized trials

Technology solutions must respond to the need to quickly and remotely manage trials and react to changes while guaranteeing the validity of the data.

How the financial management of Clinical Trials been affected?

As most industries evolve to real time transactions and financial transparency, undoubtedly the Clinical Trials industry would follow suit, eventually.  

But the pandemic has greatly accelerated the need for efficient financial and operational processes and the development of innovative tools, like Bloqcube, that support them.

In addition to standard EDC/eCRF, Blocqube’s combination of decentralized Clinical Trials and Financial Management gives small and mid-sized CROs:

  • Peer-to-peer, performance-based payments based on smart contracts and
  • Real time financial reconciliation for all

A winning combination that can only help the bottom line!

How important are collaboration, integration, and interoperability?

As studies become more decentralized, with greater focus on remote, multi-site data collection, collaboration becomes even more critical. Site personnel should be able to enter data remotely and simultaneously, with geo and time stamping, so everyone with permissions can see the same reality, allowing for true collaboration and response to recruiting and protocol changes on the fly. 

I strongly feel that a tightly integrated real-time financial management system is key to operational efficiency as we embark on this digital journey.

And finally, interoperability, standards like HL7 FHIR, are opening opportunities for transferring relevant data from EHRs directly to and from a clinical trial system without manual re-entering.

In fact, community standards projects are currently working on the automatic translation of FHIR data into CDISC compliant formats for clinical trial reporting and Bloqcube is dedicated to this effort.

How can we streamline and modernize clinical trials?

The pandemic has forced everyone to reevaluate their services and tools. With so much emphasis on distributed data capture from a larger number of sites, variation in data entry has increased and validation of data in real time has become mandatory. 

Keys to successful studies in a decentralized world include remote data capture, fully integrated EDC, process and analytic automation, and accurate, timely, and trustworthy results. The less manual manipulation, the less room for error.

In fact, the Vulcan FHIR Accelerator Project is currently working on the automatic translation of FHIR data into CDISC compliant formats for clinical trial reporting and Bloqcube is dedicated to this effort.
 

Top Drivers to Improve CTMS Were:

What words of advice would you give to CROs?

When looking for clinical trials software that will help you survive and thrive in today’s era, you need a unified platform that offers:

  • automated processes for data and financial management driven by smart contracts, 
  • electronic, geo-tagged consents available in multiple languages, written or verbal,
  • immutable data with a high level of trust and real time access; and
  • automatic payments and budget reconciliation 

Although, cost, complexity, and change are always a barrier to adopting new technologies in any field, those of you using manual, homegrown, or multiple outdated siloed systems have the opportunity to leapfrog legacy systems and jump to modern, mobile technologies, hosted in the cloud.

"The trend is irreversible," said Isaac Rodriguez-Chaves, who leads decentralized trials for PRA Health Sciences, a contract research organization in Raleigh, N.C. "There is a transition happening in the field on a global level."

What are the regulatory benefits of a modern solution?

PK: Few aspects most relevant for business, I believe, are, greater level of compliance with IC issues (generally seen in FDA 483’s), enhanced access to diverse & remote populations leading to broader compliance with evolving themes around diversity in study populations, and greater process efficiencies leading to faster submissions/approvals.

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