{"id":2526,"date":"2021-06-24T09:15:48","date_gmt":"2021-06-24T09:15:48","guid":{"rendered":"https:\/\/www.voluntis.com\/?post_type=crb_solution&#038;p=2526"},"modified":"2022-01-06T15:45:13","modified_gmt":"2022-01-06T13:45:13","slug":"our-approach","status":"publish","type":"crb_solution","link":"https:\/\/www.voluntis.com\/solution\/our-approach\/","title":{"rendered":"Our Approach"},"content":{"rendered":"\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<h3 class=\"has-text-align-left wp-block-heading\"><strong>Our expert and cross-functional teams support pharmaceutical partners at every stage of the&nbsp;DTx&nbsp;life cycle, implementing the industry\u2019s best practices.&nbsp;&nbsp;<\/strong><\/h3>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-group alignwide\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:100%\">\n<section class=\"section section--tabs\">\n\t<div class=\"shell shell--wide\">\n\t\t<div class=\"section__content\">\n\t\t\t<div class=\"slider slider--tabs js-slider-tabs\" data-aos=\"fade-up\">\n\t\t\t\t<nav class=\"slider__nav\">\n\t\t\t\t\t<ul>\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t<li class=\"active\">\n\t\t\t\t\t\t\t\t<a href=\"#\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span>\n\t\t\t\t\t\t\t\t\t\t\t01\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<strong>\n\t\t\t\t\t\t\t\t\t\t\tDesign\t\t\t\t\t\t\t\t\t\t<\/strong>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t<li class=\"\">\n\t\t\t\t\t\t\t\t<a href=\"#\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span>\n\t\t\t\t\t\t\t\t\t\t\t02\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<strong>\n\t\t\t\t\t\t\t\t\t\t\tDevelopment\t\t\t\t\t\t\t\t\t\t<\/strong>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t<li class=\"\">\n\t\t\t\t\t\t\t\t<a href=\"#\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span>\n\t\t\t\t\t\t\t\t\t\t\t03\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<strong>\n\t\t\t\t\t\t\t\t\t\t\tValidation\t\t\t\t\t\t\t\t\t\t<\/strong>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t<li class=\"\">\n\t\t\t\t\t\t\t\t<a href=\"#\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span>\n\t\t\t\t\t\t\t\t\t\t\t04\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<strong>\n\t\t\t\t\t\t\t\t\t\t\tRegulatory approval\t\t\t\t\t\t\t\t\t\t<\/strong>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t<li class=\"\">\n\t\t\t\t\t\t\t\t<a href=\"#\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span>\n\t\t\t\t\t\t\t\t\t\t\t05\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<strong>\n\t\t\t\t\t\t\t\t\t\t\tDeployment &amp; Operations\t\t\t\t\t\t\t\t\t\t<\/strong>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t\t\t\t<\/nav><!-- \/.slider__nav -->\n\n\t\t\t\t<div class=\"slider__clip swiper-container\">\n\t\t\t\t\t<div class=\"slider__slides swiper-wrapper\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"slider__slide swiper-slide\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"slider__slide-number\" data-aos=\"fade-up\">\n\t\t\t\t\t\t\t\t\t\t01\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__slide-number -->\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t<div class=\"slider__slide-body\" data-aos=\"fade-up\" data-aos-delay=\"200\">\n\t\t\t\t\t\t\t\t\t<div class=\"slider__content\">\n\t\t\t\t\t\t\t\t\t\t<div class=\"slider__content-title\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<strong>\n\t\t\t\t\t\t\t\t\t\t\t\t\tDesign\t\t\t\t\t\t\t\t\t\t\t\t<\/strong>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__content-title -->\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"slider__content-top\">\n\t\t\t\t\t\t\t\t\t\t\t\t<p>We design our solutions in close collaboration <strong>with patients and healthcare professionals<\/strong>, implementing the <strong>best practices in <a href=\"https:\/\/www.voluntis.com\/expertise\/solutions-design\/\">usability and human factors<\/a> engineering<\/strong>.<\/p>\n<p>We leverage the best available science and evidence to design our solutions and the <a href=\"https:\/\/www.voluntis.com\/expertise\/medical-design\/\">medical algorithms<\/a> they embed to ensure alignment with standards of care.<\/p>\n\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__content-top -->\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"slider__content-bottom hidden\" id=\"read-more-1\">\n\t\t\t\t\t\t\t\t\t\t\t\t<p>Through robust and proven processes and proprietary design tools adapted to Software-as-a-Medical Device, we collaborate with you to design digital solutions and algorithms adapted to your therapy. Our goal is to help deliver personalized education and real-time recommendations aligned with clinical best practices and validated guidelines. We work closely with key opinion leaders (such as members of our international <a href=\"\/company\/our-clinical-board\/\">Medical Advisory Board<\/a>) to implement decision-support functions that align with routine clinical practice.<\/p>\n\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__content-bottom -->\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__content -->\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"slider__slide-actions\" data-aos=\"fade-up\" data-aos-delay=\"400\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"#read-more-1\" class=\"btn-more\">\n\t\t\t\t\t\t\t\t\t\t\t\t<strong>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span data-text=\"Read less\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\tRead more\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<\/strong>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__actions -->\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__slide-body -->\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"slider__slide-image\" data-aos=\"fade-up\" data-aos-delay=\"200\">\n\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/www.voluntis.com\/wp-content\/uploads\/2021\/06\/design-our-approach.svg\" class=\"attachment-crb_full_width size-crb_full_width\" alt=\"Design phase of DTx project\" \/>\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__slide-image -->\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__slide swiper-slide -->\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"slider__slide swiper-slide\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"slider__slide-number\" data-aos=\"fade-up\">\n\t\t\t\t\t\t\t\t\t\t02\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__slide-number -->\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t<div class=\"slider__slide-body\" data-aos=\"fade-up\" data-aos-delay=\"200\">\n\t\t\t\t\t\t\t\t\t<div class=\"slider__content\">\n\t\t\t\t\t\t\t\t\t\t<div class=\"slider__content-title\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<strong>\n\t\t\t\t\t\t\t\t\t\t\t\t\tDevelopment\t\t\t\t\t\t\t\t\t\t\t\t<\/strong>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__content-title -->\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"slider__content-top\">\n\t\t\t\t\t\t\t\t\t\t\t\t<p>We develop DTx based on our dedicated \u200b<a href=\"\/solutions\/theraxium-platform\/\">Theraxium<\/a> platform, leveraging off-the-shelf modules addressing common needs of digital therapeutics out-of-the box.<\/p>\n<p>Our platform accelerates and de-risks the development of digital solutions. It also facilitates custom developments to deliver unique features adapted to patients treated with specific drugs. Through an agile process, our expert teams of <a href=\"https:\/\/www.voluntis.com\/expertise\/engineering\/\">software engineers<\/a>, <a href=\"https:\/\/www.voluntis.com\/expertise\/medical-design\/\">clinicians<\/a>, risk managers, graphic designers and <a href=\"https:\/\/www.voluntis.com\/expertise\/solutions-design\/\">human factors specialists<\/a>, work hand in hand to develop solutions in accordance with <strong><a href=\"https:\/\/www.voluntis.com\/certifications\/\">standards and guidelines<\/a> applicable to \u200bSoftware-as -Medical Devices. <\/strong><\/p>\n\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__content-top -->\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"slider__content-bottom hidden\" id=\"read-more-2\">\n\t\t\t\t\t\t\t\t\t\t\t\t<p>While building our solution, we implement the industry\u2019s best practices to offer an optimal user experience, accessible, easy to use and adapted to each culture. Our design and labeling teams a work hard to deliver user-friendly solutions for every kind of users, across ages, languages and social determinants of health.<\/p>\n<p>We use agile methods to develop our devices. Our functional experts are embedded in our development teams and work directly with our Android, iOS and web developers to create solutions that are ready for the real-world.<\/p>\n<p>From <a href=\"https:\/\/www.voluntis.com\/expertise\/quality-regulatory\/\">quality assurance<\/a> to <a href=\"https:\/\/www.voluntis.com\/expertise\/privacy-security\/\">data privacy<\/a> and cybersecurity, from human factors engineering to medical affairs, all our experts are directly involved in the development of our solutions.<\/p>\n\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__content-bottom -->\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__content -->\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"slider__slide-actions\" data-aos=\"fade-up\" data-aos-delay=\"400\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"#read-more-2\" class=\"btn-more\">\n\t\t\t\t\t\t\t\t\t\t\t\t<strong>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span data-text=\"Read less\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\tRead more\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<\/strong>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__actions -->\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__slide-body -->\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"slider__slide-image\" data-aos=\"fade-up\" data-aos-delay=\"200\">\n\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/www.voluntis.com\/wp-content\/uploads\/2021\/06\/dev-our-approach.svg\" class=\"attachment-crb_full_width size-crb_full_width\" alt=\"Development of DTx projects\" \/>\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__slide-image -->\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__slide swiper-slide -->\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"slider__slide swiper-slide\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"slider__slide-number\" data-aos=\"fade-up\">\n\t\t\t\t\t\t\t\t\t\t03\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__slide-number -->\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t<div class=\"slider__slide-body\" data-aos=\"fade-up\" data-aos-delay=\"200\">\n\t\t\t\t\t\t\t\t\t<div class=\"slider__content\">\n\t\t\t\t\t\t\t\t\t\t<div class=\"slider__content-title\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<strong>\n\t\t\t\t\t\t\t\t\t\t\t\t\tValidation\t\t\t\t\t\t\t\t\t\t\t\t<\/strong>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__content-title -->\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"slider__content-top\">\n\t\t\t\t\t\t\t\t\t\t\t\t<p>We verify and <strong>validate<\/strong> our solutions through robust processes, based on <strong>international standards<\/strong> for Software-as-a-Medical Device. Their validation often involves <a href=\"https:\/\/www.voluntis.com\/expertise\/solutions-design\/\">human factors studies<\/a> to confirm usability by the intended population. When necessary, <strong>rigorous clinical studies<\/strong> such as randomized controlled trials are conducted to demonstrate the <strong>safety, efficacy, acceptance and technical performance<\/strong> of our solutions.<\/p>\n\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__content-top -->\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"slider__content-bottom hidden\" id=\"read-more-3\">\n\t\t\t\t\t\t\t\t\t\t\t\t<p>Each product we build follows strict requirements for performance and safety. Once the product is developed, our Verification &#038; Validation team conduct thorough test campaigns to confirm that it meets its specification. Its final validation is subject to extensive risk management and human factors analyses and, when needed, a dedicated clinical evaluation is performed to generate the appropriate evidence.<\/p>\n\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__content-bottom -->\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__content -->\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"slider__slide-actions\" data-aos=\"fade-up\" data-aos-delay=\"400\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"#read-more-3\" class=\"btn-more\">\n\t\t\t\t\t\t\t\t\t\t\t\t<strong>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span data-text=\"Read less\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\tRead more\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<\/strong>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__actions -->\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__slide-body -->\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"slider__slide-image\" data-aos=\"fade-up\" data-aos-delay=\"200\">\n\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/www.voluntis.com\/wp-content\/uploads\/2021\/06\/validation-our-approach.svg\" class=\"attachment-crb_full_width size-crb_full_width\" alt=\"Validation pathway for DTx projects\" \/>\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__slide-image -->\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__slide swiper-slide -->\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"slider__slide swiper-slide\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"slider__slide-number\" data-aos=\"fade-up\">\n\t\t\t\t\t\t\t\t\t\t04\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__slide-number -->\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t<div class=\"slider__slide-body\" data-aos=\"fade-up\" data-aos-delay=\"200\">\n\t\t\t\t\t\t\t\t\t<div class=\"slider__content\">\n\t\t\t\t\t\t\t\t\t\t<div class=\"slider__content-title\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<strong>\n\t\t\t\t\t\t\t\t\t\t\t\t\tRegulatory approval\t\t\t\t\t\t\t\t\t\t\t\t<\/strong>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__content-title -->\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"slider__content-top\">\n\t\t\t\t\t\t\t\t\t\t\t\t<p>The majority of the solutions we build are <strong>regulated as medical devices<\/strong>. Based on our successful track record of 14 regulatory approvals for DTx, we design and implement <a href=\"https:\/\/www.voluntis.com\/expertise\/quality-regulatory\/\">regulatory strategies<\/a> to secure approval from relevant authorities.<\/p>\n<p>Our <a href=\"https:\/\/www.voluntis.com\/solution\/theraxium-platform\/\">platform<\/a> and quality management system have supported DTx <a href=\"https:\/\/www.voluntis.com\/certifications\/\">approvals<\/a> in the US, EU and Canada. Through the MDSAP-certification, we can support our partners in additional geographies such as Japan, Australia, Brazil and more.<\/p>\n\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__content-top -->\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"slider__content-bottom hidden\" id=\"read-more-4\">\n\t\t\t\t\t\t\t\t\t\t\t\t<p>The road to successful regulatory approval of DTx solutions starts on day 1, through appropriate planning and documentation of all activities required to develop Software-as-a-Medical-Device. Our platform, tools, processes and methods have proven their ability to secure market authorizations for DTx such 510(k) clearances and CE marks.<\/p>\n<p>Voluntis can act as <a href=\"https:\/\/www.voluntis.com\/expertise\/quality-regulatory\/\">legal manufacturer<\/a> of the solutions co-develop with pharma partners and can lead regulatory activities such as pre-submission meetings, submission and maintenance of the regulatory dossier throughout the life cycle of the solutions once commercialized.<\/p>\n\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__content-bottom -->\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__content -->\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"slider__slide-actions\" data-aos=\"fade-up\" data-aos-delay=\"400\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"#read-more-4\" class=\"btn-more\">\n\t\t\t\t\t\t\t\t\t\t\t\t<strong>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span data-text=\"Read less\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\tRead more\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<\/strong>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__actions -->\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__slide-body -->\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"slider__slide-image\" data-aos=\"fade-up\" data-aos-delay=\"200\">\n\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/www.voluntis.com\/wp-content\/uploads\/2021\/06\/regulatory-our-approach.svg\" class=\"attachment-crb_full_width size-crb_full_width\" alt=\"regulatory pathway for DTx projects\" \/>\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__slide-image -->\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__slide swiper-slide -->\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"slider__slide swiper-slide\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"slider__slide-number\" data-aos=\"fade-up\">\n\t\t\t\t\t\t\t\t\t\t05\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__slide-number -->\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t<div class=\"slider__slide-body\" data-aos=\"fade-up\" data-aos-delay=\"200\">\n\t\t\t\t\t\t\t\t\t<div class=\"slider__content\">\n\t\t\t\t\t\t\t\t\t\t<div class=\"slider__content-title\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<strong>\n\t\t\t\t\t\t\t\t\t\t\t\t\tDeployment &amp; Operations\t\t\t\t\t\t\t\t\t\t\t\t<\/strong>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__content-title -->\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"slider__content-top\">\n\t\t\t\t\t\t\t\t\t\t\t\t<p>As patients and healthcare professionals use our digital solutions in the real-world, we work in the background to ensure an optimal user experience. For our pharma partners, it means that we offer <strong>an end-to-end solution once the DTx is commercialized<\/strong>, covering <a href=\"https:\/\/www.voluntis.com\/expertise\/secure-hosting\/\">secure hosting<\/a>, device vigilance, <a href=\"https:\/\/www.voluntis.com\/expertise\/support-maintenance\/\">customer support<\/a>, software maintenance and <a href=\"https:\/\/www.voluntis.com\/expertise\/data-services\/\">data management<\/a> and analytics.<\/p>\n\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__content-top -->\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"slider__content-bottom hidden\" id=\"read-more-5\">\n\t\t\t\t\t\t\t\t\t\t\t\t<p>Our work does not stop with the validation and approval of the DTx. <strong>We support our partners across the life cycle of the digital solution<\/strong>. Once the product is in market, we take care of technical operations such as hosting in our secure cloud infrastructure, app publishing on stores and technical support.<\/p>\n<p><strong>As legal manufacturer of the majority of the DTx we co-develop with pharma partners<\/strong>, we are in charge of device vigilance and contribute to <a href=\"https:\/\/www.voluntis.com\/expertise\/support-maintenance\/\">pharmacovigilance activities<\/a>. We also process data in accordance with applicable data privacy regulations.<\/p>\n<p>Finally, <strong>we provide maintenance services<\/strong> to ensure that the digital solution is compatible with new phone models, browsers and operating systems as they become available on the market. Through post-market surveillance and post-market clinical follow-up, we monitor changes in clinical evidence and best practices to adapt our solutions accordingly.<\/p>\n\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__content-bottom -->\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__content -->\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"slider__slide-actions\" data-aos=\"fade-up\" data-aos-delay=\"400\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"#read-more-5\" class=\"btn-more\">\n\t\t\t\t\t\t\t\t\t\t\t\t<strong>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span data-text=\"Read less\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\tRead more\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<\/strong>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__actions -->\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__slide-body -->\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"slider__slide-image\" data-aos=\"fade-up\" data-aos-delay=\"200\">\n\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/www.voluntis.com\/wp-content\/uploads\/2021\/06\/deployment-our-approach.svg\" class=\"attachment-crb_full_width size-crb_full_width\" alt=\"deployment of DTx project\" \/>\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__slide-image -->\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__slide swiper-slide -->\n\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.slider__slides swiper-wrapper -->\n\t\t\t\t<\/div><!-- \/.slider__clip swiper-container -->\n\n\t\t\t\t<div class=\"slider__actions\" data-aos=\"fade-up\" data-aos-delay=\"600\">\n\t\t\t\t\t<a href=\"#\" class=\"slider__btn slider__btn--prev\">\n\t\t\t\t\t\t<svg width=\"13\" height=\"11\" viewBox=\"0 0 13 11\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n\t\t\t\t\t\t\t<path d=\"M5.27106 9.80078L0.971063 5.51878L5.27106 1.44178M11.4141 5.51878H2.20006H11.4141Z\" stroke=\"#293968\" stroke-width=\"1.371\" stroke-linecap=\"round\" stroke-linejoin=\"round\"\/>\n\t\t\t\t\t\t<\/svg>\n\t\t\t\t\t<\/a>\n\n\t\t\t\t\t<div class=\"swiper-pagination\"><\/div>\n\n\t\t\t\t\t<a href=\"#\" class=\"slider__btn slider__btn--next\">\n\t\t\t\t\t\t<svg width=\"13\" height=\"11\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n\t\t\t\t\t\t\t<path d=\"M7.73 9.8l4.3-4.282-4.3-4.077M1.585 5.518H10.8 1.586z\" stroke=\"currentColor\" stroke-width=\"1.371\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><\/path>\n\t\t\t\t\t\t<\/svg>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div><!-- \/.slider__actions -->\n\t\t\t<\/div><!-- \/.slider js-slider -->\n\t\t<\/div><!-- \/.section__content -->\n\t<\/div><!-- \/.shell -->\n<\/section><!-- \/.section -->\n<\/div>\n<\/div>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-group wp-block-group--callout wp-block-group--small\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<hr class=\"wp-block-separator has-css-opacity\"\/>\n\n\n\n<h6 class=\"wp-block-heading\">Get in touch!<\/h6>\n\n\n\n<p>Would like to partner with us? Got a question or a comment?<\/p>\n\n\n<a href=\"https:\/\/www.voluntis.com\/contact-us\/\" class=\"btn section__btn\" target=\"\" rel=\"noopener\"><span>Contact us<\/span><\/a><\/div><\/div>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Leveraging our experience across multiple digital solutions for pharma partners, our unique approach involves a close collaboration between many functions required to successfully implement and operate DTx globally.<\/p>\n<p>From inception to real-world operation, we support our partners across their DTx journey to deliver a differentiating treatment experience to patients and care teams.<\/p>\n","protected":false},"featured_media":2784,"menu_order":0,"template":"","class_list":["post-2526","crb_solution","type-crb_solution","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Our Approach - Voluntis<\/title>\n<meta name=\"description\" content=\"Our approach of drug-digital combinations offers both a robust technology platform and a unique expertise to de-risk DTx projects.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.voluntis.com\/solution\/our-approach\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Our Approach - 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