Orphan Reach Expedites Phase II COVID-19 Study With TransPerfect’s Trial Interactive eTMF and Remote Monitoring Solution

Due to the urgent demand to expedite processes to respond to the COVID-19 pandemic, Orphan Reach needed to launch their eTMF and remote monitoring solutions as quickly as possible.

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Thursday, May 28, 2020
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Data management, Other Communications, Other Health, Technology, Public relations, Investor relations, Marketing, Pharmaceutical, Communications, Infectious diseases, Other Technology, Biotechnology, Science, Software, Other Science, Research, Health, Clinical trials, Electronic trial master file, Trial master file
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Summary
Key Points: 
  • Due to the urgent demand to expedite processes to respond to the COVID-19 pandemic, Orphan Reach needed to launch their eTMF and remote monitoring solutions as quickly as possible.
  • Trial Interactive was selected for its fast implementation and track record of successful regulatory inspections and approvals.
  • They are using the remote site monitoring room to enable 21 CFR Part 11 compliant source document verification and management.
  • In addition to using the platforms eTMF solution, Orphan Reach has implemented myTI, TransPerfects mobile eTMF app, to allow site personnel to upload documents in real time from anywhere in the world.


TransPerfect Life Sciences, a leading provider of technologies and services to support clinical trials and product development for the biopharmaceutical industry, today announced that Orphan Reach selected TransPerfect’s Trial Interactive cloud-based platform for remote site monitoring, eTMF, and mobile eTMF in support of a phase II COVID-19 study that received rapid MHRA start-up approval.

Orphan Reach is based in the United Kingdom and is a full-service CRO focused on accelerating global clinical development for rare diseases. They tailor their approach to supporting clinical research in small patient populations, developing orphan drugs, and working in areas of high unmet medical need. Due to the urgent demand to expedite processes to respond to the COVID-19 pandemic, Orphan Reach needed to launch their eTMF and remote monitoring solutions as quickly as possible.

Trial Interactive was selected for its fast implementation and track record of successful regulatory inspections and approvals. They are using the remote site monitoring room to enable 21 CFR Part 11 compliant source document verification and management. In addition to using the platform’s eTMF solution, Orphan Reach has implemented myTI, TransPerfect’s mobile eTMF app, to allow site personnel to upload documents in real time from anywhere in the world. Additionally, CRAs can perform remote reconciliation. TransPerfect recently announced that remote site monitoring functionality would be offered at no charge for organizations conducting COVID-19 studies.

“We were up and running in two weeks with Trial Interactive. This also coincided with a 48-hour MHRA approval after final protocol submission,” said Thomas Ogorka, Orphan Reach Founder and CEO. “Our CRO/Sponsor team and partnership with Trial Interactive made it possible to expedite this critical, time-sensitive research.”

TransPerfect President and CEO Phil Shawe stated, “Bringing viable treatments to patients quickly is a key factor in defeating COVID-19. We commend Orphan Reach on advancing their research during this challenging time.”

About Trial Interactive

TransPerfect’s Trial Interactive is an industry leader in practical eclinical innovation that simplifies and automates clinical processes for sponsors, CROs, and sites around the world. The 21 CFR Part 11 compliant unified platform delivers an author-to-archive collaboration experience with solutions for clinical document management, site selection, site activation, elearning, compliance training, quality, and more with seamless solution interoperability and indexing to the eTMF. Trial Interactive is consistently selected by clinical professionals for providing the most comprehensive yet intuitive experience with the most complete offering of technology and expert TMF services. Trial Interactive helps study teams streamline their operations by cutting unnecessary expenses, expediting timelines, reducing compliance risks, and improving operational excellence. For more information on Trial Interactive, please contact [email protected] or +1 212.400.8848, or visit www.trialinteractive.com.

About TransPerfect

TransPerfect is the world’s largest provider of language and technology solutions for global business. From offices in over 100+ cities on six continents, TransPerfect offers a full range of services in 170+ languages to clients worldwide. More than 5,000 global organizations employ TransPerfect’s GlobalLink® Product Suite to simplify the management of multilingual content. With an unparalleled commitment to quality and client service, TransPerfect is fully ISO 9001 and ISO 17100 certified. TransPerfect has global headquarters in New York, with regional headquarters in London and Hong Kong. For more information, please visit our website at www.transperfect.com.

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