MALVERN, PA — Phlexglobal, a leading innovative technology and services provider for the life sciences industry, recently announced its substantial contribution to COVID-19 clinical trial activities. Since the outbreak of the COVID-19 pandemic, Phlexglobal has provided extensive support for multiple pharmaceutical companies developing effective treatments for those who have been impacted by the virus and vaccines to prevent its spread. These services are vital to developing life-saving treatments for the most important health crisis facing the world today.
As pharmaceutical companies race to develop these vaccines and treatments, they must still follow regulatory guidelines to ensure patient safety and trial legitimacy. To help meet these needs, Phlexglobal is providing specialized technology and services to fast track COVID-19 trials without compromising quality. To date, fifteen different companies have turned to Phlexglobal for clinical or regulatory support for COVID-19 studies or submissions.
“Phlexglobal has made it the highest corporate priority to support COVID-19 research while maintaining clinical and regulatory business continuity for the pharmaceutical and biotech industries,” said John McNeill, Chief Executive Officer of Phlexglobal. “Phlexglobal has processed thousands of clinical trial documents in support of COVID-19 studies and has supported Investigational New Drug (IND) applications for multiple potential treatments during the crisis.”
The disruption of regular clinical trial workflows and the updates from regulatory agencies are creating major challenges for pharmaceutical companies. The FDA alone has issued over 80 guidance updates related to COVID-19, and the EMA almost 40. With so much at stake, companies are turning to Phlexglobal to ensure their trials run uninterrupted and that their submissions meet all regulations.
In the early stages of the pandemic, Phlexglobal began support for a top-20 Biotech Company engaged in a global COVID-19 clinical trial. The Company sought expert support for their TMF to ensure documents were filed in a timely manner with the highest possible accuracy to ensure both speed and quality of the trial. Phlexglobal streamlined processes to ensure documents would be processed as quickly as possible without impacting quality, processing hundreds of documents in the first week. By using electronic signature workflows and taking ownership of metadata requirements, Phlexglobal reduced indexing and quality check timelines to less than 24 hours, increasing the availability of the documents by more than 60%.
One of the world’s leading pharma companies with a Trial Master File processing facility in China experienced a government-mandated closure due to the COVID-19 outbreak. As documents continued to be produced worldwide, the Company faced a serious backlog risk with hundreds of documents remaining unprocessed every day the office was closed. Phlexglobal mobilized a team of in house specialists and utilized technology to support the Company’s document processing needs. Phlexglobal processed nearly 10,000 documents in record time, preventing a major backlog that would have slowed trial operations and delayed submission at trial close.
Phlexglobal has been able to provide seamless support by taking extensive measures to maintain business continuity in support of drug development while ensuring the safety of its employees. The company’s global offices have shifted to a hybrid operational model whereby employees are working remotely. Phlexglobal’s United States office, located 30 miles outside Philadelphia, has been granted “Essential Business” status by the commonwealth of Pennsylvania which allows the company to open its office as needed for high-volume paper scanning projects. This model also facilitates the company’s ability to provide trial continuity services to pharmaceutical company’s facing facility closures.
Phlexglobal’s speed in adapting to pandemic conditions, combined with its innovative technologies and deep clinical and regulatory expertise, make it a crucial partner in COVID-19 drug development as well as ongoing clinical trials. Companies engaged in drug development should contact Phlexglobal at phlexglobal.com/contact for immediate regulatory and clinical support.
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