COVID-19 Response Support

Resources to Fast Track Trials and Ensure Business Continuity

Phlexglobal can balance the need for speed with the importance of quality control in a time of crisis. 

A Message from the Chief Executive Officer 

John Mcneill Circle2

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.

Sincerely,

John McNeill
Chief Executive Officer
Phlexglobal 

COVIE-19 Webinar Video FINAL

New Insights into COVID-19 Drug Development

An On Demand Webinar

Watch this recording to see real-life data trends from the COVID-19 crisis, the impact to drug development, and how this will change the future of the industry. 

Watch On Demand

Accelerate your COVID-19 studies and ensure business continuity for existing active trials

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. 

 

Trial Master File Solutions

  • Phlexglobal Rapid Deployment Teams that can ensure documents are filed in a timely, accurate manner during office closures 
  • Automation-enabled technology that streamlines processes and improve effectiveness
  • Pre-validated software configurations get eTMFs running as quickly as possible
  • Phlexglobal Heatmaps and Quality Review tools support inspection-readiness and accelerate the pathway to submission

Regulatory Submission Services  

  • Insights into major health authority updates and how they will impact trials and submissions
  • Methods to fast track IND and CTA filings so you can start trials without delay
  • Planning for NDA and MAA filings to ensure quality submissions and a speedy start to the review process
  • Submission-as-a-Service using advanced Phlex-Submission software with automation capabilities 

 

As companies race to find safe and effective treatments for COVID-19, time is paramount.

 

TMF as a Service WebsiteSubmission as a Service FTo 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.

Phlexglobal customers know they can focus 100% on trial design and conduct, with the reassurance that every aspect of their TMF’s and submissions are being managed by the global authority in Trial Master File and Regulatory best practices.

 

 

Phlexglobal TMF-as-a-Service

Free up study resources and accelerate timelines with Phlexglobal’s TMF-as-a-Service

Downloard the TMF-as-a-Service Infographic

 

 

 

 

Service Resources to Keep your Trials on Track 

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. 

Reference Background

Document Processing

Expert global resources to ensure your  documents are processed according to your time frame and SOPs.

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TMF Quality Review

Quality Review Services 

A thorough quality assessment of your TMF, giving you detailed insight into its quality and completeness.

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TMF
Heatmaps

Easily identify potential TMF problem areas and enable a risk-based remediation approach.

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Study
Owners

Our TMF Practitioners have successfully mastered the challenges you and your teams face every day.

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Phlexglobal COVID-19 Response Support: Pfizer

Providing TMF Document Processing during a Government-Mandated Office Closure

 

A Pfizer facility in Wuhan, China experienced a government-mandated closure due to the COVID-19 outbreak. As documents continued to be produced worldwide, Pfizer faced a serious backlog issue with hundreds of documents going unfilled every day the office was closed.

The Situation: A COVID-19 Office Closure

Phlexglobal mobilized a team of specialist to support Pfizer's document processing needs, along with Study Owners to provide training and direction. Phlexglobal employees worked on broad range of documents across multiple trials.

The Solution: A Phlexglobal Rapid Deployment Team

Phlexglobal processed 9,596 documents in 33 days between February and March, preventing a major backlog that would have slowed trial operations and delayed submission at trial close.

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!

Marie-Christine Poisson-Carvajal

Head of TMF & Registry
Pfizer

 

 

 

Phlexglobal COVID-19 Response Support Example:

Providing TMF Services to Fast Track a COVID-19 Clinical Trial

 

The Situation

COVID-19 Vaccine

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.

The Solution 

Quality Compass

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. 

The Result

Screen

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%. 

10 Ways to Beat Covid-19 Stress

 

Feeling Stressed? We can help.

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. 

Read more

COVID Cure LoRes

 

Get answers to your COVID-19 Questions

Have a TMF or Regulatory-Related question?
Submit here and one of our experts will respond within one business day. 

UPDATES FROM WORLD HEALTH AGENCIES

FDA Logo

 

Coronavirus (COVID-19) Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19 

  • As part of the Trump Administration’s all-hands-on-deck approach across public, academic and private sectors to combat the COVID-19 pandemic, the U.S. Food and Drug Administration stood up a new program to expedite the development of potentially safe and effective life-saving treatments. The program, known as the Coronavirus Treatment Acceleration Program (CTAP), is using every tool at the agency’s disposal to bring new therapies to sick patients as quickly as possible, while at the same time supporting research to further evaluate whether these medical countermeasures are safe and effective for treating patients infected with this novel virus.

    There are a large number of companies and researchers developing and evaluating COVID-19 related therapies. Given the urgent nature of the pandemic, under the FDA’s accelerator program, staff from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are providing regulatory advice, guidance and technical assistance as quickly as possible. As part of this work, the FDA is triaging requests from developers and scientists seeking to develop new drug and biologic therapies, getting the relevant FDA staff in touch with them and providing rapid, interactive input to get studies underway quickly. For example, the FDA has reviewed study protocols within 24 hours in many cases and has reviewed single-patient expanded access requests generally within three hours. The FDA is also collaborating with federal partners, developers and researchers to create protocols that can be used across institutions and programs to streamline efforts.

    Requests for product development for proposed COVID-19 uses and drug development should be sent to covid19-productdevelopment@fda.hhs.gov. 

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

FDA has pulled together some general information that may be useful to sponsors wishing to rapidly initiate interactions with the FDA regarding potential development of therapeutics for the COVID-19 virus.

If you feel your investigational product may have activity against the COVID-19 virus and have relevant cell culture and/or animal model data, you may submit a Pre-IND (PIND) application to the Agency as a “general correspondence.” FDA highly recommends that you include all relevant information for review. If you feel your product’s stage of development warrants a formal Pre-IND meeting, please refer to the Division of Antivirals Pre-IND letter of Instruction website for details.

  • A pre-assigned PIND number can be obtained from the following website: Requesting a Pre-Assigned Application Number
  • Sponsors can submit their PIND submissions(s) either electronically or via paper.
  • Electronic Submission Information (via ESG)
  • For information about submitting electronically to CDER, please see the website: Electronic Common Technical Document (eCTD)
  • For any questions regarding electronic submissions in general, please email CDER’s Electronic Submissions Support Team at ESUB@fda.hhs.gov or call Valerie Gooding at 301-796-0902.
  • Paper Submission Information
  • Please submit 3 paper copies and a CD containing the submission to the following address:
  • Food and Drug Administration
    Center for Drug Evaluation and Research
    Division of Antivirals
    5901-B Ammendale Road
    Beltsville, MD 20705-1266

Note, if you don’t have activity information, but believe your product may have potential against the COVID-19 virus, you may find it useful to consult the National Institutes of Health, Division of Microbiology and Infectious diseases website which contains information about preliminary screening activities that may be available to potential sponsors of antiviral products. If you do not have specific information related to the COVID-19 virus, but still feel that your product warrants a PIND, then please include as much information as you can and a rationale for review.

Please also note the U.S. government has launched a website for stakeholders who wish to submit market research packages related to potential uses of products during the current outbreak: 2019 Novel Coronavirus (Medical Contermeasures.gov).

Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.

Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy, such as:

  • Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes
  • Avoiding serious side effects of an available therapy
  • Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome
  • Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment
  • Ability to address emerging or anticipated public health need
A drug that receives Fast Track designation is eligible for some or all of the following:
  • More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval

  • More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
  • Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met

  • Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA

Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.

Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

 EMA Logo

 

EMA’s Human Medicines Committee (CHMP) has published a statement urging the EU research community to prioritise large randomised controlled studies because they are most likely to generate the conclusive evidence needed to enable rapid development and approval of potential treatments of COVID-19. The statement promotes a harmonized approach to data collection and a robust methodology for COVID-19 clinical trials across the EU to make best use of the available supply of investigational agents. It emphasizes the need to include all EU countries in these trials.

  • EMA says it is working with stakeholders to support the conduct of clinical trials for COVID-19 in Europe and that it will “support medicine developers with all available regulatory tools to advance and expedite the development of effective measures to fight and prevent the spread of COVID-19.”
  • EMA said it would waive fees for its scientific advice to developers of treatments and vaccines for the virus.
  • Companies wishing to submit a CTA to the agency are instructed to submit it both via the normal Common European Submission Portal (CESP) and directly to MHRA via its clinical trial helpline.

expedited Ethics Committee opinion

Points to consider on implications of Coronavirus diseaseGuidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) Pandemic

Global regulators map out data requirements for phase 1 COVID-19 vaccine trials

Implications of coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials

MHRA-Logo

 

The MHRA is ready to prioritise and provide any assistance for clinical trials applications submitted for COVID-19

Prioritising COVID-19 assessments - MHRA have procedures for rapid scientific advice, reviews and approvals and are ready to support manufactures, researchers and other regulators. MHRA have dedicated resources to ensure this happens, as they did during the Ebola crisis when they authorised clinical trial applications within a week.

Submitting COVID-19 applications - Please submit any applications directly to the Clinical Trial Helpline by emailing clintrialhelpline@mhra.gov.uk, as well as through the normal CESP route so MHRA can begin work as soon as possible. MHRA will then liaise closely with any applicants to ensure it’s managed as efficiently as possible.

Naming your study - As requested by the WHO, please ensure that the WHO official acronym for the coronavirus disease (COVID-19) is entered in the title field of the trial registration data set (Annex 1 XML). This will facilitate finding and extracting clinical trials related to COVID-19 from public databases.

More Links:

Advice for Management of Clinical trials in relation to Coronavirus

MHRA Good Practice (GxP) inspections during the COVID19 outbreak

MHRA Guidance on Coronavirus

MHRA guidance on coronavirus (COVID-19)

World Health Organization

 

WHO on 20 March announced the launch of SOLIDARITY, an unprecedented, coordinated push to collect robust scientific data rapidly during a pandemic. The study, which could include many thousands of patients in dozens of countries, has emphasized simplicity so that even hospitals overwhelmed by an onslaught of COVID-19 patients can participate. WHO's website will randomize patients to local standard care or one of the four drug regimens, using only ones available at the patient's hospital. Physicians will simply record the day the patient left the hospital or died, the duration of the hospital stay, and whether the patient required oxygen or ventilation. “That's all,” says Ana Maria Henao Restrepo, a medical officer at WHO's Department of Immunization Vaccines and Biologicals.

Australia Department of Health

 

The Australian Government will provide $13 million to fast-track research into treatments for the novel coronavirus, COVID-19.  The funding from the Medical Research Future Fund (MRFF) aims to support rapid development of safe and effective treatment options for COVID-19, and will be awarded via two open competitive grant opportunities: 
  • $8 million to identify and develop antiviral therapies for people infected with COVID-19.   
  • $5 million for clinical trials to better treat and manage COVID-19 patients with severe acute respiratory distress, which can be fatal. 

This funding is in addition to the $2 million already allocated from the MRFF for research into a vaccine against COVID-19. 

More Links:

COVID-19: Guidance on clinical trials for institutions, HRECs, researchers and sponsors

health-canada-logo-vector

 

Minister of Health approved an Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19. The interim order will enable an expedited review of medical devices indicated to diagnose, treat, mitigate or prevent COVID-19, at no cost

In an effort to facilitate earlier access to a vaccine, or therapeutic product for COVID-19, the Department will expedite the review of any COVID-19 related health product submissions and applications. Doing this will ensure timely access to novel therapies without compromising the safety, efficacy and quality of products.

Sponsors wishing to file a submission or application should contact the appropriate review bureau.

More Links:

Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors

danish-medicines-agency-pic

 

Extraordinary measures for clinical trials due to COVID-19

Ireland HPRA

 

 Health Products Regulatory Authority (Ireland)

The Irish HPRA has postponed all routine compliance inspections at the regulated sites until further notice and has informed all sites that would have received an inspection notice. The conduct of triggered and EMA requested inspections will be decided on a case-by-case basis and may be conducted remotely. Should we believe an urgent on-site inspection is necessary, the HPRA will follow public health advice in relation to any required precautions.


HPRA will give priority review to any submission relating to COVID-19. In order to assist HPRA in the identification of such submissions, the cover letter associated with the submission should be clearly marked “COVID-19 relevant”; a justification as to why the submission is COVID-19 relevant should also be included in the cover letter. Furthermore, the email sent to submissions@hpra.ie should also be clearly marked “COVID-19 relevant” in the subject line. These actions by our stakeholders will ensure appropriate prioritisation of assessment, which may be expedited in line with national and/or EU legal frameworks.

AIFA-Logo

Italian Medicines Agency

Clinical trials’ management in Italy during the COVID-19 (coronavirus disease 19) emergency

Japan

Ministry of Health, Labour and Welfare of Japan (MHLW) issued a notice announcing a waiver of the statutorily-required waiting period after submitting a request for clinical trial to the MHLW in respect of treatments related to COVID-19. Typically, any person or legal entity that submits a request for clinical trial to the MHLW must wait 30 days from the date of request before starting a clinical trial, in order for the MHLW to investigate health and sanitary issues that may occur in connection with the proposed trial (Article 80-2, Paragraph 3 of the Pharmaceuticals and Medical Devices Act). However, the new circular notice enables pharmaceutical companies, medical device companies, and doctors to start clinical trials for drugs or medical devices that are considered necessary to prevent and/or treat COVID-19 without the 30-day waiting period.

Netherlands Central Committee on Research Involving Human Subjects

Netherlands Central Committee on Research Involving Human Subjects

Recommendations for the conduct of clinical research at the time of restrictive measures due to the coronavirus

 

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