Phlexglobal has made it highest corporate priority to support COVID-19 research and is already supporting multiple ongoing studies. During March, we processed several hundred important clinical trial documents related to a study on the evaluation of the efficacy and safety of a COVID-19 treatment.
With so much uncertainty in the world right now surrounding COVID-19, we want to confirm our complete operational team is working remotely and continues to serve clients.
We are available to help you deal with any disruption in your business continuity. Our experience, flexibility and speed of service is focused on global health.
This page will be dedicated to ways that Phlexglobal can help both provide business continuity as you face disruptions due to the virus as well as resources to help you fast track studies in search of a cure while maintaining regulatory standards.
If you have any questions regarding the impact of COVID-19 from a clinical or regulatory standpoint, you can submit them to us 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.
Chief Executive Officer
COVID-19 is impacting our daily lives and has the potential to disrupt ongoing clinical trials. During these situation, regulatory authorities are working to both support the search for a cure and manage the need for quality and standards to ensure patient safety and proper drug testing.
While speed is of the essence, quality is still an imperative. A Trial Master File is a vital part of a clinical trial. The best way to ensure your TMF is complete is to file documents contemporaneously, closing the gab between trial end and submission.
As we navigate this crisis, Phlexglobal is prepared to offer special services for companies fast tracking compounds for COVID-19 testing and those facing business disruptions due to social distancing and office shut downs.
To move faster than ever, leading biotechs and pharmaceutical companies have turned to Phlexglobal for our TMF-as-a-Service solution to free up internal resources from time-consuming TMF management and document processing. In a matter of days, they were able to shift seasoned operational staff to focus 100% of their time and effort on critical study tasks.
To comply with health authoritiy submission requirements, these companies are also turning to Phlexglobal for our Submission-as-a-Service solution to ensure their IND’s, CTA’s, NDA’s and MAA’s are constructed quickly and correctly so they can be submitted as soon as possible.
Customers place their trust in Phlexglobal because of our proven mastery over the TMF-related questions and challenges they face every day. Leverage our expertise to ensure your TMF meets standards for timeliness, quality, and completeness.
Expert global resources to ensure your documents are processed according to your time frame and SOPs.
A thorough quality assessment of your TMF, giving you detailed insight into its quality and completeness.
Easily identify potential TMF problem areas and enable a risk-based remediation approach.
Our TMF Practitioners have successfully mastered the challenges you and your teams face every day.
The Situation: A COVID-19 Office Closure
The Solution: A Phlexglobal Rapid Deployment Team
The Result: Timely filing of study documentation
My recent collaboration with Phlexglobal has been exemplary in all aspects. In response to COVID-19, Phlexglobal has provided 10 documents specialists in 24 hours. They have been trained by our team and started to process documents within 3 days. I have been extremely impressed and pleased by the level of professionalism, support, communication with my team in Wuhan! As a result, we managed to process documents on time and to not have backlog. Wonderful experience!
A top-20 Biotech has started a 400-patient study assessing a compound for hospitalized patients with COVID-19.
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 was engaged to provide document scanning, migration, and quality review services. Working directly with The Company, Phlexglobal streamlined processes to ensure documents would be processed as quickly as possible without impacting quality.
Phlexglobal immediately began support of the trial, 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%.
TMF Expert Marc Webb, who manages the Phlexglobal Study Owner Team, shares ten ways to cope with the stress brought on by working from home when you're not used to it, home schooling your children when you didn't prepare for it, and other situations we weren't expecting just a few short weeks ago.