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Vaccine Breakthrough Could Finally Bring COVID to Its Knees

Photo Illustration by Erin O'Flynn/The Daily Beast/Getty
Photo Illustration by Erin O’Flynn/The Daily Beast/Getty

With new COVID variants and subvariants evolving faster and faster, each chipping away at the effectiveness of the leading vaccines, the hunt is on for a new kind of vaccine—one that works equally well on current and future forms of the novel coronavirus.

Now researchers at the National Institutes of Health in Maryland think they’ve found a new approach to vaccine design that could lead them to a long-lasting jab. As a bonus, it also might work on other coronaviruses, not just the SARS-CoV-2 virus that causes COVID-19.

The NIH team reported its findings in a peer-reviewed study that appeared in the journal Cell Host & Microbe earlier this month.

The key to the NIH’s potential vaccine design is a part of the virus called the “spine helix.” It’s a coil-shaped structure inside the spike protein, the part of the virus that helps it grab onto and infect our cells.

Lots of current vaccines target the spike protein. But none of them specifically target the spine helix. And yet, there are good reasons to focus on that part of the pathogen. Whereas many regions of the spike protein tend to change a lot as the virus mutates, the spine helix doesn’t.

That gives scientists “hope that an antibody targeting this region will be more durable and broadly effective,” Joshua Tan, the lead scientist on the NIH team, told The Daily Beast.

Vaccines that target and “bind,” say, the receptor-binding domain region of the spike protein might lose effectiveness if the virus evolves within that region. The great thing about the spine helix, from an immunological standpoint, is that it doesn’t mutate. At least, it hasn’t mutated yet, three years into the COVID pandemic.

So a vaccine that binds the spine helix in SARS-CoV-2 should hold up for a long time. And it should also work on all the other coronaviruses that also include the spine helix—and there are dozens of them, including several such as SARS-CoV-1 and MERS that have already made the leap from animal populations and caused outbreaks in people.

To test their hypothesis, the NIH researchers extracted antibodies from 19 recovering COVID patients and tested them on samples of five different coronaviruses, including SARS-CoV-2, SARS-CoV-1 and MERS. Of the 55 different antibodies, most zeroed in on parts of the virus that tend to mutate a lot. Just 11 targeted the spine helix.

But those 11 that went after the spine helix worked better, on average, on four of the coronaviruses. (A fifth virus, HCoV-NL63, shrugged off all the antibodies.) The NIH team isolated the best spine-helix antibody, COV89-22, and also tested it on hamsters infected with the latest subvariants of the Omicron variant of COVID. “Hamsters treated with COV89-22 showed a reduced pathology score,” the team found.

The results are promising. “These findings identify a class of… antibodies that broadly neutralize [coronaviruses] by targeting the stem helix,” the researchers wrote.

Don’t break out the champagne quite yet. “Although these data are useful for vaccine design, we have not performed vaccination experiments in this study and thus cannot draw any definitive conclusions with regard to the efficacy of stem helix-based vaccines,” the NIH team warned.

It’s one thing to test a few antibodies on hamsters. It’s another to develop, run trials with and get approval for a whole new class of vaccine. “It is really hard and most things that start out as good ideas fail for one reason or another,” James Lawler, an infectious disease expert at the University of Nebraska Medical Center, told The Daily Beast.

And while the spine-helix antibodies appear to be broadly effective, it’s unclear how they stack up against antibodies that are more specific. In other words, a spine-helix jab might work against a bunch of different but related viruses, but work less well against any one virus than a jab that’s tailored specifically for that virus. “Further experiments need to be done to evaluate if they will be sufficiently protective in humans,” Tan said of the spine-helix antibodies.

There’s a lot of work to do before a spine-helix vaccine might be available at the corner pharmacy. And there are a lot of things that could derail that work. Additional studies could contradict the NIH team’s results. The new vaccine design might not work as well on people as it does on hamsters.

The new jab could also turn out to be unsafe, impractical to produce or too expensive for widespread distribution. Barton Haynes, a Duke University immunologist, told The Daily Beast he looked at spine-helix vaccine designs last year and concluded they’d be too costly to warrant major investment. The main problem, he said, is that the spine-helix antibodies are less potent and “tough to induce” from their parent B-cells.

The harder the pharmaceutical industry has to work to produce a vaccine, and the more vaccine it has to pack into a single dose in order to compensate for lower potency, the less cost-effective a vaccine becomes for mass-production.

Maybe a spine-helix jab is in our future. Or maybe not. Either way, it’s encouraging that scientists are making incremental progress toward a more universal coronavirus vaccine. One that could work for many years on a wide array of related viruses.

COVID for one isn’t going anywhere. And with each mutation, it risks becoming unrecognizable to the current vaccines. What we need is a vaccine that’s mutation-proof.

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Hackensack Meridian to migrate Epic workloads to Google Cloud

The move will make it “simpler for our IT and developers, and will allow them to focus more on uncovering creative ways to improve patient care,” said the health system’s chief digital information officer.

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Comment mieux appliquer les guides ?

Le KCE trace quelques pistes pour faciliter l’application des guides de pratique cliniques (Le Journal du Médecin).

Le saviez-vous ? Medline, la célèbre base de données de la National Library of Medicine (USA) s’enrichit tous les jours de plus de 2.000 nouvelles publications. Comment les professionnels de la santé se retrouvent-ils dans cette masse d’informations ? Pardi! Grâce aux “guides de pratique clinique” (guidelines). Mais qui ne sont pas toujours, selon le KCE, simples à utiliser.

A la base de cette recherche du KCE, la constatation que les médecins ne suivent pas souvent… les guidelines du KCE.
87% des médecins les utilisent

“Une vaste enquête a été lancée en septembre 2016 auprès des professionnels de santé belges (médecins, infirmiers, sages-femmes et kinésithérapeutes) pour voir s’ils utilisent les guidelines, dans quelle mesure ils les apprécient et comment ils souhaitent les voir améliorés. Les pratiques dans sept autres pays européens ont également été analysées. Des 2.500 réponses valables recueillies lors de cette enquête, il ressort que 87% des médecins, 68% des kinésithérapeutes, 67% des infirmiers et 61% des sages-femmes font un usage régulier des guidelines.”

Ce qui laisse un champ pour ceux qui ne les utilisent pas.

Pour quelle raison ? Selon le KCE, c’est d’abord parce qu’ils sont rébarbatifs car très codifiés. Normal lorsqu’il s’agit de recommander telle classe de médicament ou tel traitement. L’implication sur le patient est immense. “Il faut au contraire analyser l’ensemble des publications parues dans la littérature scientifique internationale, sélectionner celles qui sont au-dessus de tout soupçon et en analyser le contenu selon des procédures codifiées et enfin rédiger des recommandations dans un langage clair, non équivoque et compréhensible par tous les utilisateurs potentiels.”

87% des médecins, 68% des kinésithérapeutes, 67% des infirmiers et 61% des sages-femmes font un usage régulier des guidelines.

D’où l’idée d’offrir aux médecins des arbres décisionnels simples sous forme d’application informatique. Le KCE en a lancé une en janvier dernier pour déterminer les examens à prescrire à un patient (ou pas) avant une intervention chirurgicale http://preop.kce.be/. “Le nec plus ultra, ce sont les evidence-linkers, sortes de “pop-ups” qui apparaissent dans le dossier médical informatisé en fonction des caractéristiques du patient pour informer le praticien de l’attitude et/ou des actions spécifiques indiquées dans son cas précis.” Ensuite, il faut les rendre intelligibles pour le patient afin d’augmenter son empowerment.

“Un autre facteur critique pour l’usage des guidelines est la confiance dans l’organisme qui les produit. Les prestataires de soins ont tendance à privilégier les guidelines émanant de leur propre institution ou société scientifique (locale, nationale ou internationale).”

Le KCE souhaiterait donc une participation plus étroite avec par exemple les sociétés scientifiques.

Enfin, on attend beaucoup du cadre cohérent de guidelines belges existants décidé par Maggie De Block. “Actuellement, en effet, les acteurs qui produisent des guidelines sont nombreux et, même si les recommandations émises sont généralement de bonne qualité, l’image d’ensemble est assez incohérente : il est difficile de comprendre qui fait quoi. Le futur plan pourra notamment s’appuyer sur une initiative déjà en place : EBMPracticeNET. Ce net incorpore les recommandations dans les dossiers médicaux électroniques (contextual aids, evidence linkers).”

Les formulaires eMEDICS sont génériques et permettent de contenir l’intelligence de la codification, permettant ainsi au corps médical d’utiliser efficacement  n’importe quel guide médical

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Philips to become a global leader in patient care management solutions for the hospital and the home through the acquisition of BioTelemetry, Inc.

December 18, 2020

  • Philips to acquire BioTelemetry, Inc. for USD 72.00 per share; implied enterprise value of USD 2.8 billion (approx. EUR 2.3 billion)
  • Acquisition is a strong fit with Philips’ strategy to transform the delivery of healthcare: combination of Philips’ leading patient monitoring position in the hospital with BioTelemetry’s leading cardiac diagnostics and monitoring position outside the hospital
  • With 2019 sales of USD 439 million, BioTelemetry annually monitors over 1 million cardiac patients remotely; its portfolio includes wearable heart monitors, AI-based data analytics and services
  • Combination will result in significant synergies driven by cross-selling opportunities, geographical expansion, portfolio innovation synergies, and productivity gains
  • BioTelemetry business is expected to deliver double-digit growth and improve its Adjusted EBITA margin to over 20% by 2025; acquisition will be sales growth and adjusted EBITA margin accretive for Philips in 2021

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, and BioTelemetry, Inc. (NASDAQ: BEAT), a leading U.S.-based provider of remote cardiac diagnostics and monitoring, today announced that they have entered into a definitive merger agreement. Pursuant to the agreement, Philips will commence a tender offer to acquire all of the issued and outstanding shares of BioTelemetry for USD 72.00 per share, to be paid in cash upon completion. This represents a 16.5 percent premium to BioTelemetry’s closing price on December 17, 2020. The implied enterprise value is USD 2.8 billion (approximately EUR 2.3 billion), inclusive of BioTelemetry’s cash and debt. The board of directors of BioTelemetry has approved the transaction and recommends the offer to its shareholders. The transaction is expected to be completed in the first quarter of 2021.

The acquisition of BioTelemetry is a strong fit with Philips’ cardiac care portfolio, and its strategy to transform the delivery of care along the health continuum with integrated solutions. The combination of Philips’ leading patient monitoring position in the hospital with BioTelemetry’s leading cardiac diagnostics and monitoring position outside the hospital, will result in a global leader in patient care management solutions for the hospital and the home for cardiac and other patients. Philips’ current portfolio includes real-time patient monitoring, therapeutic devices, telehealth and informatics. Moreover, Philips has an advanced and secure cloud-based Philips HealthSuite digital platform optimized for the delivery of healthcare across care settings. Every year, Philips’ integrated solutions monitor around 300 million patients in hospitals, as well as around 10 million sleep and respiratory care patients in their own homes.

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Cerner, Xealth simplify digital tool orders for telehealth, remote patient monitoring

From their EHR workflows, clinicians will have a centralized system enabling them to order and prescribe apps, devices or other digital therapeutic tools for virtual care management.By Mike Miliard December 11, 202002:57 PM

Person in medical wear at computer

Cerner announced Thursday a new offering developed through the investment it made this summer in digital prescription platform Xealth. 

It will now offer its customers a centralized digital ordering and monitoring system, delivered right from the electronic health record, to help providers more easily deploy and manage digital tools and smartphone applications for their patients.

The tool enables clinicians to see an array of digital therapeutics and apps in the Cerner EHR, assess their cost and clinical value, and prescribe them for patients from within their workflows. HIMSS20 Digital Learn on-demand, earn credit, find products and solutions.

Additionally, it can help them track how well the connected health tools are working as part of a telehealth, remote monitoring or other virtual care program.

Among the tools on offer via Xealth’s platform: Babyscripts, Glooko, SilverCloud Health and Welldoc.

The platform, by linking digital health tools such as these with EHR data, allows clinicians to monitor how the apps are being used and can send care plans to patients’ smartphones.

THE LARGER TREND

Cerner announced its $6 million investment in Xealth, a Providence spinoff, back in August.

Among the use cases that can be tackled when the tool is deployed in the EHR and in the patients’ own portal: chronic disease management, behavioral health, maternity care and preparation for surgery. As telehealth and remote patient monitoring continue to be major modalities of care during the pandemic, digital tools and app prescriptions will offer enhancement treatment options for those areas and others.

Since then, Phoenix-based Banner Health has been one of the first Cerner customers to put the platform to work within its physicians’ workflows. 

“Banner Health is known for providing leadership and embracing technology to improve patient care in this rapidly transforming health care environment,” said Scott Nordlund, chief strategy and growth officer for Banner Health, in a Cerner statement. “Our patients expect to be treated like consumers. Mindful of that expectation, we are utilizing new capabilities and expanding our formulary to make digital health easier for our doctors to deploy and monitor.”

Earlier this year, Healthcare IT News Features Editor Bill Siwicki explored how UPMC is using Xealth with its Epic EHR platform.

“Xealth offered the ability to integrate with our Epic EHR, sending content seamlessly from the platform, where providers already are used to working,” said Dr. Glenn Updike, medical director of clinical informatics for the women’s health service line at UPMC. “Providers would feel like they are sending materials from Epic, but Xealth would actually be collating information from vendors and UPMC alike into one streamlined package.”

He added: “While patients are not required to download additional apps to access their educational information, one of the successes of our Xealth implementation is our ability to prescribe monitoring apps for patients to better track their individual pregnancy experience,” he continued. “Xealth has allowed us to rapidly scale the prescription of this type of content because of the integration into the EHR.”

ON THE RECORD
“As digital tools are increasingly included in care plans, health systems seek a way to organize and oversee their use across the health system,” said David Bradshaw, senior vice president, consumer and employer solutions at Cerner. “Digital health has extraordinary potential to reshape the way we care for patients and, working with Xealth, we are answering the need and helping providers create more engaging and effective patient experiences.”

“Now more than ever, extending care teams to meet patients where they are is critical,” said Mike McSherry, CEO and cofounder of Xealth. “As digital health programs roll out, they should elevate both the patient and provider experience. Cerner, building out a digital formulary, with Xealth at its core, is listening to its strong clinician base by delivering tools to enhance patient care, without adding additional steps for the care team.”

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Veridata EDC: Elsevier’s electronic data capture software puts compliance front and centre

For more than two decades Elsevier, a global information and analytics company specialising in scientific and medical content, has supported clinical research with its electronic data capture (EDC) software. Its latest development is Veridata EDC, a cloud-based platform designed to simplify the process of data gathering, analysis and compliance.

Veridata EDC: Elsevier’s electronic data capture software puts compliance front and centre
The Veridata electronic data capture software is intuitive, reducing the chances of human error

Here, Elsevier’s commercial manager Philip Dunlop talks to Pharmaceutical Technology about the challenges of compliance in clinical research, how COVID-19 is disrupting the sector and how Veridata EDC can help businesses manage compliance.

Q: Why is compliance so important to clinical research?

The simple answer is patient safety, with regulations in place to ensure that everyone participating in a clinical trial conducts themselves ethically and safely. It is also vitally important to learn from past mistakes, particularly in instances where clinical trials were not as safe as they should have been, or where patients were endangered in accidents or by trial organisers acting in financial self-interest.

Even though regulations add significant overheads to a clinical research programme, they do help make it very clear where a failure has occurred and what needs to be done so it never happens again. Veridata EDC has been designed to keep those key safety aspects while reducing time spent on data entry, analysis and compliance.

Q: What makes data compliance such a challenge in clinical research?

Whenever I think about compliance, I’m always reminded of GDPR. The world was shocked by how much extra work was required but in clinical trials, researchers have needed to meet many aspects of GDPR’s high level of scrutiny for many years. Compliance is a difficult thing to get right because regulations are so often set to a very high standard. One of the major reasons for this, in clinical research, is that a study needs to be repeatable.

Q: What compliance hurdles do clinical research companies tend to face?

There are regulations around how data is stored, so obviously that has to be secure. There must also be checks and balances on the person who is entering the data, to determine if they are who they say they are, and that their account hasn’t been compromised. And then there’s the audit trail. If data has ever changed in the system, we know who has changed it, when they changed it and why they changed it. Veridata EDC makes all that easier.

Q: How can Veridata EDC help clinical research projects with their compliance?

Veridata EDC helps businesses meet their compliance requirements in several ways. Firstly, the software has been assessed by NHS Data Security and Protection (DSP), meaning that it is held to a very high standard. It is also ISO 27001-certified, which is the international standard on how to manage information security. It is also compliant with GCP, FDA CFR 21 Part 11, HIPAA and GDPR.

The software is also intuitive, in that it makes running clinical trials, studies and registries easier to manage, and in turn there are fewer opportunities for human error. Its API-programmable design allows interoperability with existing systems and it’s designed with our MACRO system in mind, which has been in operation for more than twenty years. We have taken our experiences over twenty years and updated them for the modern software application, making collecting clinical trials data simpler and more accessible.

Q: How has COVID-19 changed things from a compliance perspective?

COVID-19 has changed the way clinical trials are conducted in that some of the rules seem to have been relaxed or adapted. In the past, some participants would finish a clinical trial and not receive another call for a decade. But COVID-19 has changed this attitude, with patients now constantly monitored over much longer periods. We’ve also seen an acceleration of experimental treatments with shortened timescales within each phase of the study.

The pandemic has also driven collaboration between universities, hospitals and other clinical research institutions. Together, they’ve formed strong partnerships in joint quality research. Regulatory sign-off on new treatments has accelerated too, to cope with the need for a quick, effective and safe response to COVID-19 globally.

Q: What does the future hold for EDC software in terms of compliance?

At Elsevier, compliance is one of the main focuses of the Veridata EDC team. We continually adapt to the requirements of regulators to guarantee patient safety.

As the world of clinical trials changes due to COVID-19 – with patients visiting hospitals and clinics far less often (if at all) for non-critical care, for example – continuing clinical trials has been a challenge. However, with the use of technology, we’ve overcome many obstacles.

We continue to listen to our customers’ problems and respond with easy to use and accessible solutions, that are both compliant and of high quality.Free Whitepaper

Excel vs EDC: The myths and realities of capturing clinical trial data

Many researchers depend on tools such as Excel and Google Forms to capture, manage and analyse trial data. Based on the findings of a 2019 study, Excel is used by 78% of CROs to study startup processes, despite 60% believing that the use of spreadsheets and manual processes should be reduced. There are a number of factors that are pushing the decision not to switch to electronic data capture (EDC) solutions, such as it is perceived as harder to use or it is less secure, but these are myths.

This whitepaper outlines the myths behind manual spreadsheets and how researchers can navigate the truths and falsehoods of excel and EDCs.

Enter your details here to receive your free whitepaper.

https://ww2.verdict.co.uk/l/375012/2020-05-04/6fnh68?VMS_Company_Name=Elsevier&VMS_WhitePaper_URL=https://www.pharmaceutical-technology.com/wp-content/uploads/sites/10/2020/07/Elsevier-MACRO_Myths-Vs-Truth-C-020520-FINAL.pdf&VMS_Title=Excel%20vs%20EDC:%20The%20myths%20and%20realities%20of%20capturing%20clinical%20trial%20data&VMS_Post_ID=117321&VMS_Site_ID=10&VMS_Site_Name=Pharmaceutical%20Technology&Verdict_company_email=leads@verdict.co.uk&VMS_site_logo=https://www.pharmaceutical-technology.com/wp-content/uploads/sites/10/2017/09/PHarmaceutical-tech@2x.png&Content_Type=Whitepaper

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YFORM builder exemples

eMEDICS could now implement any form using the YFORM WP fluent form builder.

Here are some examples:

Intuitive & Easy To Use Form Builder

The experience of creating an online form has never been so fluent. The intuitive design of WP Fluent Forms puts all the tools right where you need them!

Pre-built Form Templates

WP Fluent Forms offers 3 form templates that are already designed for you, so that you don’t have to plan, design and create a form from scratch. Most used forms like Contact Form, Support Form and Event Registration Form are ready to use for you, anytime!

All The Input Fields You Need

WP Fluent Forms comes with all the possible input fields you might need to create a form. From Simple Name input fields to Customisable Text fields and Checkboxes, Repeat Fields or Custom HTML- everything is within your hand’s reach, waiting to be deployed!

Multi-column Form Layout

Don’t make your audience go through long scary forms when you have the options to arrange them in a smart way. Deploy your input fields in two or three columns whenever necessary, and give them a more compact and professional look.

100% Responsive

Don’t worry about your forms breaking up awkwardly in different devices with different screen ratios. Online forms created with WP Fluent Forms are by default compatible for devices with all kinds of screen sizes, including- Smartphones, Tablet PCs, Desktops etc.

Conditional Logics

Why irritate your users with unnecessary fields that they do not need? Use WP Fluent Forms’ Conditional Logic feature to make your forms more efficient and user-friendly. Show and hide specific fields according to users’ behaviour so that they do not have to be bothered with unnecessary fields they do not need to fill up. You can show and hide entire sections or steps (in step forms) if you need using WP Fluent Forms’ Conditional Logic. Whereas, in most of the Form Plugins available, this Conditional Logic is a Premium Feature. But in WP Fluent Forms, you can enjoy this feature in our free version! So, why wait to smarten up?

File & Image Upload

Taking in Files and Images from users and subscribers has never been easier. Just create a form with WP Fluent Form and integrate our File Submission Field or Image Submission Field just by Dragging and Dropping. All the submitted files be will automatically stored in your WordPress admin panel! You can view those files from WP Fluent Form’s “Entries” section. Not only that, we also enable you to save your server from running out of space due to heavy submission of files and images. While creating a form using WP Fluent Form, you can easily set the limit of files a user can upload and what the maximum size of an uploaded file/image might be. Download WP Fluent Form Pro to avail this feature!

Step Forms

Need to roll out a form to your audience that is long and requires a gazillion input fields to be filled up? Usually, such forms are scary for users and people tend to avoid these forms. But not if you smarten up and handle these situations nicely. WIth the Step Form feature that WP Fluent Form offers, you can easily sort your input fields in a smart way. This feature enables you to fragment your input fields in separate “pages” that your users fill up one by one. Organizing your input fields in such pages will make your form compact, smarter; and help reduce exit rate. To be honest, you want your website to be user-friendly, and so do we. Don’t wait up. Download WP Fluent Form now and try out this amazing feature!

Block Spams & Blank Entries

It is safe to say that online forms were once way too much vulnerable to spamming. But not anymore! Along with spammers, the good guys have evolved over time and various anti-spamming tools are already in action as we browse the internet everyday. That’s why, WP Fluent Form comes with the state-of-the-art anti-spamming tool reCAPTCHA and promises to keep on upgrading and adding more anti-spamming tools as soon as they roll out. And not only bots, keep your forms safe from annoying real humans as well! Just use the “Empty Submission Blocking” feature, so that the blank submission forms can be thwarted even before they enter your entries list and bother you with unnecessary hassles.

Form Scheduling & Restricted Form Submission

Now and then, often you might need to restrict the form submission only to a certain amount of users or for a certain amount of time. Suppose, you are taking in registration applications for a limited time exclusive webinar for just 100 people. In that case, you definitely need to make sure that no more than 100 people register for the program, and that too within a certain period of time. With WP Fluent Form’s Form Scheduling feature, you can set the time from when the form submission opens for your users, if your users need to be logged in to fill up the form, what welcome/countdown message needs to be shown prior to the form activation period, and what message to show once the activation date expires. Similarly, you can also limit the number of users that can fill up the form daily, weekly, monthly, or in total. And all of these can be set up in just a couple of minutes!

Form Notification & Confirmation

Whenever someone fills up a form, you and your team can be notified real time, if you want to. Not only that, you can also send you new user a welcome/confirmation message and customize them! And setting up the process is real simple. From real life experience, we have observed that exhibiting a simple success message to your users is oftentimes not enough and can be considered a bad user experience. That is why you might need to send your users a follow-up email confirming them of their form submission. This email can be detailed and you can customize this emails very easily while setting up. Along with that, if you and your team members (say, admins of your website) needs to be notified every time someone submits a form, that can be arranged as well! And those notification emails can be detailed and exactly to the point as you need. With WP Fluent Form, communicating with your users have never been easier!

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