Phlexglobal Supports Synairgen’s COVID-19 Clinical Trial with Implementation of Advanced eTMF Solution in Just 16 Days

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Innovative respiratory disease company joins more than 15 customers drawing on Phlexglobal’s support to help develop promising COVID-19 therapies and vaccines

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Synairgen took just 16 days to go live with Phlexglobal’s advanced PhlexTMF SaaS software to support a COVID-19 trial.

Given the speed and quality of the service, going with Phlexglobal was absolutely the right decision. Jody Brookes Head of Clinical Operations Synairgen

Phlexglobal, a leading innovative technology and services provider for the life sciences industry, today announces that Synairgen – a drug discovery and development company developing novel therapies for respiratory disease – took just 16 days to go live with Phlexglobal’s advanced PhlexTMF SaaS software to support a COVID-19 trial. Thanks to Phlexglobal’s innovative technology and industry-leading Trial Master File expertise, Synairgen was able to quickly ensure compliance with regulatory mandates while maintaining an accelerated pace for its novel COVID-19 therapy SNG001 (inhaled interferon-beta).

After being chosen by Synairgen as the preferred vendor for provision of an eTMF, Phlexglobal lost no time in implementing its widely adopted, best-of-breed SaaS eTMF software. As part of its ongoing contribution to helping fight the COVID-19 pandemic, Phlexglobal’s corporate commitment is to provide complimentary services. The company’s global team of TMF experts and highly experienced project managers applied its proven Gold methodology to go from project kickoff on June 16 2020, to go-live on July 1 2020 – a total of just 16 days.

“Since the outbreak of the COVID-19 pandemic, Phlexglobal has provided extensive support for multiple biopharmaceutical companies developing effective treatments for those who have been impacted by the virus, as well as promising vaccines to prevent its spread,” said John McNeill, Chief Executive Officer of Phlexglobal. “We’re honored to be able to provide critical software and services to help address the most important health crisis facing the world today.”

With 120 home-based patients to be recruited into the trial and 100 hospital-based patients already recruited into the trial, the ease of use of Phlexglobal’s eTMF technology and support services were key factors in Synairgen’s decision.

Phlexglobal’s advanced eTMF includes built-in best practices to improve TMF health, including embedded quality review, event management, wizard-driven completeness, intelligent placeholders, and more. This singular focus on customer-driven innovation frees life sciences companies to put more resources behind their primary goal: bringing safe, life-improving new therapies to patients faster, and with less risk.

In addition, PhlexTMF features the industry’s only AI-assisted TMF indexing technology, which reduces document processing time significantly. Leveraging pre-trained neural networks of sophisticated algorithms to identify and extract attribute values from TMF documents, the feature allows study teams to focus on critical tasks rather than on repetitive and time-consuming manual effort.

“Discussions with multiple people at Phlexglobal gave us the confidence that they were the right match for our company, our study, and our very tight timeline,” said Jody Brookes, Head of Clinical Operations at Synairgen. “Like us, they have a tremendous culture of innovation, and a spirit of genuine collaboration that has made a real difference in the project. Given the speed and quality of the service, going with Phlexglobal was absolutely the right decision.”

COVID-19 Support: Phlexglobal Resources to Fast Track Trials and Ensure Business Continuity
If you have any questions regarding the impact of COVID-19 from a clinical or regulatory standpoint, you can submit them to Phlexglobal and we will provide answers within one business day. If you need support for your research, Contact us today to receive COVID-19 study help tomorrow.

About Synairgen
Synairgen is a respiratory drug discovery and development company founded by University of Southampton Professors Stephen Holgate, Donna Davies and Ratko Djukanovic. The business, focused primarily on lung viral defence in asthma and COPD, uses its differentiating human biology BioBank platform and world-renowned international academic KOL network to discover and develop novel therapies for respiratory disease. For more information about Synairgen, please see http://www.synairgen.com.

About the Synairgen COVID-19 Study
Synairgen’s clinical trial in COVID-19 patients (SG016) is a randomised, double-blind, placebo-controlled trial. The 220-patient trial comprises 100 patients initiated in hospital and 120 patients to be initiated in the home setting. The patients participating in the hospital setting, which completed recruitment in May, have been recruited across a number of NHS trusts and the trial has been adopted by the NIHR Respiratory Translational Research Collaboration. Synairgen announced positive preliminary results from the hospital setting on 20 July 2020 (https://www.synairgen.com/wp-content/uploads/2020/07/200720-Synairgen-announces-positive-results-from-trial-of-SNG001-in-hospitalised-COVID-19-patients.pdf).

About Phlexglobal
Phlexglobal is the leading technology and services organization for clinical and regulatory matters with a focus on helping clients to master their digital agenda via proven AI solutions. Phlexglobal combines software and leading expert services to offer a unique solutions portfolio with easy to achieve automation via data generation that lifts organizations to a new level of effectiveness.

PhlexTMF is the company’s Trial Master File software. Regulatory solutions including PhlexSubmission for eCTD and CTD, PhlexIDMP, PhlexEVMPD, and PhlexRIM are considered highly innovative in the industry for out-of-the-box best practices capabilities, automation technology, and user-focused design.

PhlexDistiller, a machine learning platform that reads documents and converts unstructured content into structured data, achieves automation of regulatory and clinical processes and completes the end-to-end solutions offering from Phlexglobal.

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Christopher D Englerth
Phlexglobal
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