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border-color; } /* Style new checked item */ ul.inputs-list.multi-container li.hs-form-checkbox label span::after, .hs-form-booleancheckbox-display span::after { content: ""; border: 2px solid #d9d9d9; border-radius: 3px; height: 20px; left: 0px; position: absolute; top: 0px; width: 20px; background: #fff; z-index: 0; display: block; transition-property: background-color, border-color, -webkit-box-shadow; -o-transition-property: background-color, border-color, box-shadow; transition-property: background-color, border-color, box-shadow; transition-property: background-color, border-color, box-shadow, -webkit-box-shadow; } /* Show when checked */ ul.inputs-list.multi-container li.hs-form-checkbox label input:checked + span::after, .hs-form-booleancheckbox-display input:checked + span::after, ul.inputs-list.multi-container li.hs-form-checkbox label input:checked + span::before, .hs-form-booleancheckbox-display input:checked + span::before{ opacity: 1; } .hs-form-booleancheckbox-display input:checked+label:after, .hs-form-booleancheckbox-display input:checked+label:after { background: #fff; border-color: #157479; } /* Style when focused */ ul.inputs-list.multi-container li.hs-form-checkbox label input:focus + span::after, .hs-form-booleancheckbox-display input:focus + span::after { outline: 3px solid transparent; /* For Windows high contrast mode. */ box-shadow: 0 0 .3125rem rgba(0, 0, 0, .3); border-color: #157479; } .hs_contact_country{ clear: both; } .hs-button { border-radius: 65px !important; font-size: 14px; line-height: 1.3; letter-spacing: 1.12px; font-family: "Roboto Slab", helvetica, arial, sans-serif; font-weight: 700 !important; padding: 19px 23px !important; border: 2px solid; display: inline-block; text-decoration: none; text-transform: uppercase; -webkit-appearance: none !important; -moz-appearance: none !important; appearance: none !important; } .hbspt-form textarea{max-width: 100% !important; height: 186px !important; resize: none;} .hbspt-form textarea:focus{border: 1px solid #74cbc8 !important;} .hs-fieldtype-textarea .invalid.error{border: 2px solid #E74949 !important;} .hbspt-form fieldset{max-width: 100% !important; margin-bottom: 60px;} .hbspt-form .field {margin-bottom: 27px} .hs_recaptcha{ margin-top: 23px !important; margin-bottom: 27px !important; } .hs-button, .hs-form-field input[type=text], .hs-form-field input[type=email], .hs-form-field input[type=phone], .hs-form-field input[type=number], .hs-form-field input[type=tel], .hs-form-field input[type=date], .hs-form-field textarea { appearance: none; -webkit-appearance: none; -moz-appearance: none; } .hs-default-font-element, .hs-main-font-element { font-family: "Roboto Slab", helvetica, arial, sans-serif; } .hbspt-form .hs-button { white-space: pre-wrap } .hbspt-form .hs-richtext { word-break: break-word } .hbspt-form.submitted-message { overflow: auto } .hbspt-form fieldset.form-columns-1 .hs-input { width: 95% } .hbspt-form fieldset.form-columns-1 .input { margin-right: 0px !important } .hbspt-form fieldset.form-columns-1 input[type=checkbox], .hbspt-form fieldset.form-columns-1 input[type=radio] { width: auto } .hbspt-form fieldset.form-columns-2 .hs-form-field { width: 50%; float: left } .hbspt-form fieldset.form-columns-2 .input { margin-right: 0px !important; } .hbspt-form fieldset.form-columns-3 .hs-form-field { width: 32.7%; float: left } .hbspt-form fieldset.form-columns-3 .input { margin-right: 8px } .hbspt-form label.hs-hidden { visibility: hidden } .hbspt-form .hs-field-desc { width: 100% } .hs-custom-style .hs-input, .hs-custom-style fieldset { max-width: 100% } .hs-custom-style>div.form-columns-3 .hs-form-field, .hs-custom-style fieldset.form-columns-3 .hs-form-field { width: 33.3% } .hs-custom-style>div>div:last-of-type .hs-input:not([type=checkbox]):not([type=radio]), .hs-custom-style fieldset>div:last-of-type .hs-input:not([type=checkbox]):not([type=radio]) { width: 100%; max-width: 100% } .hs-custom-style>div input:not([type=image]):not([type=submit]):not([type=button]):not([type=radio]):not([type=checkbox]):not([type=file]), .hs-custom-style fieldset input:not([type=image]):not([type=submit]):not([type=button]):not([type=radio]):not([type=checkbox]):not([type=file]) { box-sizing: border-box; padding: 0 15px; min-height: 27px } .hs-custom-style>div textarea, .hs-custom-style fieldset textarea { padding: 10px 15px } .hs-custom-style .hs-dependent-field>div .hs-input:not([type=checkbox]):not([type=radio]) { width: 100% } .legal-consent-container .field.hs-form-field { margin-bottom: 8px } .legal-consent-container .hs-field-desc.checkbox-desc { margin: -12px 0 0 21px } .legal-consent-container .hs-form-booleancheckbox-display input { float: left } .legal-consent-container .hs-form-booleancheckbox-display>span { display: block !important; margin-left: 30px !important; } .legal-consent-container .hs-form-booleancheckbox-display p { margin: 0; display: inline } .legal-consent-container .hs-error-msgs label { color: #f2545b } .legal-consent-container~.hs_recaptcha { margin-top: 18px } .cookie-reset-container { font-size: 14px; margin-bottom: 10px; text-align: right } #hs-outer-captcha-target, #hs-outer-captcha-target * { display: none; height: 0; width: 0 } .hubspot-link__container { font-size: 14px; padding-bottom: 40px; position: relative; color: #9fa0a2; font-family: "Roboto Slab", helvetica, arial, sans-serif; } .hubspot-link-text { color: #00a4bd; font-weight: 400 } .hubspot-link__container.sproket { color: #9fa0a2 } .hubspot-link { color: #9fa0a2 } .hubspot-link, .hubspot-link:hover { text-decoration: none } .hubspot-link:hover .hubspot-link-text { text-decoration: underline } .hubspot-link__icon { margin-bottom: -1px; margin-right: 5px } .hubspot-link__container.sproket .hubspot-link__icon { width: 30px; margin-right: 0; float: left; margin-top: -9px; margin-left: -5px } .hubspot_signup_form .hs_email{margin-bottom: 0px !important; width: 80% !important; float: left !important;} .hubspot_signup_form .hs_submit{width: 20% !important; float: left !important; } .hubspot_signup_form .hs-button{padding: 12.5px 15px !important;} .hubspot_signup_form .hs_email label{display: none !important;} .hubspot_signup_form ul.no-list{position: absolute !important; top: 48px !important;} .hubspot_signup_form {position: relative !important;} .hubspot_signup_form .submitted-message{color: #ab8940 !important; font-size: 22px !important; } .hubspot_white .hbspt-form label, .hubspot_white .hs-form-required { color: #fff; } .hubspot_white .hs-input, .hubspot_white ul.inputs-list.multi-container li.hs-form-checkbox label span::before, .hubspot_white .hs-form-booleancheckbox-display span::before{ background-color: #fff !important; } .hubspot_white .hs_submit { text-align: center; } .hubspot_white .hs-form select.is-placeholder { opacity: 1; } .hubspot_white ul.inputs-list.multi-container li.hs-form-checkbox label span::after, .hubspot_white .hs-form-booleancheckbox-display span::after { border-color: #3f4852; } input[type=submit].hs-button.primary.large{ color: #fff; background: #00181e; border-color: #00181e !important; } input[type=submit].hs-button.primary.large:hover { background: #74cbc8 !important; border-color: #74cbc8 !important; } /***/ .hbspt-form .hs-input[type=checkbox]{ cursor: pointer; } .hs-form-booleancheckbox-display input:checked + span::after{ background: #fff; border-color: #157479; } .hbspt-form .form-columns-2 { display: flex; flex-flow: row wrap; -webkit-box-direction: normal; } .hbspt-form .hs_firstname { flex: 1; -webkit-box-flex: 1; } .hbspt-form .hs_submit{ margin-top: 60px; } .newsletter-form .hs_submit{margin-top: 45px;} .newsletter-form form .gfield_consent_description { border: none !important; } /*New Landing page*/ .landing-middle-section{ padding-right: 0px !important; } .left-col{max-width:93%} .left-col-para{padding-right:30px;} .left-col video{border-radius:4px;} /* Kit asssesment */ .kits_form_col .hbspt-form .hs-input[type=checkbox] { height: 20px !important; width: 20px !important; } .kits_form_col {padding-bottom: 45px;} .hs-richtext h4 {margin-bottom: 15px !important;} .kits_form_col label.hs-form-checkbox-display {margin-bottom: 15px;} .kits_form_col .hbspt-form li.hs-form-checkbox label span{ margin-left: 0px !important; padding-left: 31px; } .hbspt-form label.hs-form-radio-display { position: relative; padding: 4px 31px; } .hbspt-form .hs-form-radio-display span, .hbspt-form .hs-form-checkbox-display span { position: relative; cursor: pointer; font-size: 15px; font-weight: 300; } .hbspt-form .hs-input[type=radio] { position: absolute; left: 0; z-index: 2; width: 20px !important; height: 20px !important; outline: none; cursor: pointer; background-color: transparent !important; border-radius: 50%; } .hbspt-form .hs_protocol_synopsis_upload .input{position: relative;} .hbspt-form input[type="file"]::-webkit-file-upload-button { cursor: pointer; background-color: #157479; padding: 10px 20px !important; border: 1px solid #157479; border-top-left-radius: 0px; border-bottom-left-radius: 0px; border-top-right-radius: 6px; border-bottom-right-radius: 6px; color: #fff; position: absolute; top: 0; bottom: 0; right: 0; } .hbspt-form input[type="file"] { cursor: pointer; padding: 10px 20px !important; position: relative; top: 0; bottom: 0; right: 0; } /*Form Responsive CSS*/ @media only screen and (min-width: 1024px) and (max-width: 1366px){ .hs_email, .hs_contact_country { clear: both; } } @media only screen and (min-width: 992px) and (max-width: 1024px){ .hs_email, .hs_contact_country { clear: both; } } @media (min-width: 640px) and (max-width: 1120px) { .hbspt-form h1{font-size: 36px !important;} } @media screen and (min-width: 1120px) { .hbspt-form h1{font-size: 45px !important;margin-bottom: 17px !important;} .hbspt-form .gform_heading p{font-size: 17px !important;} } @media only screen and (min-width: 768px) and (max-width: 992px){ .hs_email, .hs_contact_country{ clear: both; } } @media (min-width: 767px) and (max-width: 1024px) { body .hubspot_signup_form .hs_email{width: 66% !important; float: left !important;} } @media screen and (max-width: 992px){ .assay-kit-hbspt-form .fl-col { width: 100%; } } @media screen and (max-width:812px){ .assay-kit-hbspt-form .fl-col { max-width: 100%; } .hbspt-form .hs-fieldtype-select .input:before{ right: 20px !important; } } @media screen and (max-width: 767px){ .hs_submit .actions{padding-top: 0px !important; margin-top: 0px !important;} body .hbspt-form fieldset.form-columns-2 .input {margin-right: 0px !important;} body fieldset.form-columns-3 .input{margin-right: 0px !important;} .hs-form-field .hs-input { width: 100% !important; } .hs-fieldtype-textarea .input{margin-right: 0px !important;} .hs_firstname, .hs_phone, .hs_development_area{ width: 100% !important; } } @media screen and (min-width: 640px){ .hbspt-form .hs_firstname, .kits_form_col .hs_email{ 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href="https://www.bioagilytix.com/"><i class="home-icon"></i><span class="screen-reader-text">Home</span></a></span> <span class="breadcrumb-separator"></span> <span><a href="https://www.bioagilytix.com/solutions/">Solutions</a></span> <span class="breadcrumb-separator"></span> <span><a href="https://www.bioagilytix.com/solutions/phases/">Phases</a></span> <span class="breadcrumb-separator"></span> <span class="breadcrumb_last" aria-current="page">Clinical</span></span></div></div></section><div id="block_cfece50a307bbf99a389b902d189f2df" class="wp-block em-media-content em-mb--xl alignwide"><div class="em-media-content__inner em-media-content__inner--media-left has-none-background-color em-media-content__inner--content-has-padding"><div class="em-media-content__media em-media-content__media--left"> <img fetchpriority="high" decoding="async" src="https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_1924516382-1380x1035.jpg" alt="scientist filling tubes" class="object-fit--cover" srcset="https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_1924516382-1380x1035.jpg 1380w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_1924516382-1120x840.jpg 1120w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_1924516382-850x638.jpg 850w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_1924516382-640x480.jpg 640w" width="1380" height="1035"></div><div class="em-media-content__content em-media-content__content--right em-media-content__content--add-padding"><p class="has-large-font-size">The clinical stage is a critical part of the drug development process, where potential therapies are tested on human subjects to evaluate safety, efficacy, and dosage. Companies developing therapeutics face distinct challenges during the clinical stage of development, including:</p><ul class="has-medium-font-size wp-block-list"><li class="">Safety and efficacy concerns</li><li class="">Regulatory requirements</li><li class="">Immunogenicity issues</li><li class="">Growing competitive landscape</li></ul><p class="">BioAgilytix is the leading CRO partner to help sponsors overcome these challenges. We are the partner trusted most by leading biotechnology and pharmaceutical organizations for our unrivaled program experience and deep scientific expertise in both large and small molecule clinical development. We have the depth and breadth of experience to optimize resource utilization, ensuring successful delivery of data for clinical trials.</p></div></div></div><div class="wp-block-emagine-background alignfull has-gray-xxl-background-color has-background-dim em-pt--xl em-pb--xl em-mt--lg em-mb--none"><div class="wp-block-emagine-background__content"><div class="wp-block-emagine-background__content-inner"><div class="wp-block-group alignwide is-content-justification-left is-layout-constrained wp-container-core-group-is-layout-1 wp-block-group-is-layout-constrained"><h2 class="has-text-align-left h2">What is the clinical phase in drug development?</h2><p class="has-text-align-left has-medium-font-size">The clinical stage of drug development involves testing potential therapies on human subjects to evaluate their safety, efficacy, and dosage. It consists of three distinct phases: Phase 1, 2, and 3</p></div><div id="block_a6f15110bd386cc2fd47551bfd8cc54b" class="wp-block em-tabs is-style-vertical em-mt--lg alignwide"><div class="em-tabs__inner"><div class="em-tabs__tablist" role="tablist"></div><div class="em-tabs__tabpanels"><div id="em-tabpanel-674086fe2ecc6" class="em-tabpanel" tabindex="0" aria-labelledby="em-tabpanel-674086fe2ecc6-control" > <button id="em-tabpanel-674086fe2ecc6-control" class="em-tab-control" type="button" role="tab" aria-selected="false" aria-controls="em-tabpanel-674086fe2ecc6" tabindex="-1" > <span class="em-tab-control__text">Phase 1 clinical trials</span> </button><div class="em-tabpanel__inner has-none-background-color"><div class="em-tabpanel__content em-pt--default em-pr--default em-pb--default em-pl--default"><h3 class="h3">Phase 1 clinical trials</h3><p class="">Phase 1 of the clinical trial process involves testing a potential therapy on a small group of healthy volunteers. The primary objectives are to evaluate the drug’s safety, determine the appropriate dosage, and identify any potential side effects. This phase also helps in understanding the drug’s pharmacokinetics鈥攈ow it is absorbed, distributed, metabolized, and excreted by the body. The main goal of Phase 1 is to establish a safe starting dose that can be used in subsequent trials.</p></div></div></div><div id="em-tabpanel-674086fe2ef97" class="em-tabpanel" tabindex="0" aria-labelledby="em-tabpanel-674086fe2ef97-control" > <button id="em-tabpanel-674086fe2ef97-control" class="em-tab-control" type="button" role="tab" aria-selected="false" aria-controls="em-tabpanel-674086fe2ef97" tabindex="-1" > <span class="em-tab-control__text">Phase 2 clinical trials</span> </button><div class="em-tabpanel__inner has-none-background-color"><div class="em-tabpanel__content em-pt--default em-pr--default em-pb--default em-pl--default"><h3 class="h3">Phase 2 clinical trials</h3><p class="">Phase 2 expands the study population to include patients who have a targeted disease or condition. This phase aims to assess the effectiveness of the drug in treating the specific condition and to further evaluate its safety and dosage regimens. It provides valuable preliminary data on the potential benefits and side effects of the drug in a more targeted patient population.</p></div></div></div><div id="em-tabpanel-674086fe2f228" class="em-tabpanel" tabindex="0" aria-labelledby="em-tabpanel-674086fe2f228-control" > <button id="em-tabpanel-674086fe2f228-control" class="em-tab-control" type="button" role="tab" aria-selected="false" aria-controls="em-tabpanel-674086fe2f228" tabindex="-1" > <span class="em-tab-control__text">Phase 3 clinical trials</span> </button><div class="em-tabpanel__inner has-none-background-color"><div class="em-tabpanel__content em-pt--default em-pr--default em-pb--default em-pl--default"><h3 class="h3">Phase 3 clinical trials</h3><p class="">Phase 3 trials are typically conducted on a larger scale, involving hundreds or even thousands of patients. The primary objective is to confirm and expand on the effectiveness and safety profile of the drug. Phase 3 trials typically involve comparing the drug against existing standard treatments or a placebo. These studies collect comprehensive data on the drug’s efficacy, optimal dosage, long-term effects, and safety across a broader patient population. The data generated from Phase 3 trials is crucial for regulatory submissions and potential approval of the drug for market distribution. </p></div></div></div></div></div></div></div></div></div><div id="block_89aa388402a734bd55e1b9a4de466352" class="wp-block em-call-to-action em-mb--none alignfull"><div class="em-call-to-action--align-center has-primary-l-background-color has-background-opacity-- em-pt--lg em-pb--lg em-pl--md em-pr--md"><div class="em-call-to-action__inner"><p class=""></p><h2 class="h2">Learn More about BioAgilytix鈥檚 Australian Advantage</h2><p class=""></p><div class="wp-block-emagine-button has-text-align-left is-style-arrow-right em-mb--none"><a class="btn btn--size-md btn--style-primary has-quaternary-background-color" href="https://www.bioagilytix.com/solutions/phases/clinical-drug-development-process/australia-advantage/" target="_self" rel="noopener" aria-label=""><span>Learn <span class="btn__last-word">More</span></span></a></div></div></div></div><div id="block_683d628d7c0ba4f4c5405fe450c54117" class="wp-block em-media-content em-mt--none em-mb--xl alignfull"><div class="em-media-content__inner em-media-content__inner--media-left has-quaternary-background-color em-media-content__inner--content-has-padding"><div class="em-media-content__media em-media-content__media--left"> <noscript><img decoding="async" src="https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_128540396.jpg" alt="pipette adding fluid" class="object-fit--cover" srcset="https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_128540396.jpg 1000w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_128540396-300x200.jpg 300w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_128540396-768x512.jpg 768w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_128540396-100x67.jpg 100w" width="1000" height="667"></noscript><img decoding="async" src='data:image/svg+xml,%3Csvg%20xmlns=%22http://www.w3.org/2000/svg%22%20viewBox=%220%200%201000%20667%22%3E%3C/svg%3E' data-src="https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_128540396.jpg" alt="pipette adding fluid" class="lazyload object-fit--cover" data-srcset="https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_128540396.jpg 1000w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_128540396-300x200.jpg 300w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_128540396-768x512.jpg 768w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_128540396-100x67.jpg 100w" width="1000" height="667"></div><div class="em-media-content__content em-media-content__content--right em-media-content__content--add-padding"><h3 class="has-em-white-color has-text-color h3">How does BioAgilytix contribute to the clinical drug development process?</h3><p class="">During clinical drug development, each phase builds upon the knowledge gained in the previous phase. With our depth of experience and scientific focus, BioAgilytix is uniquely positioned to help our partners succeed in gathering robust data supporting regulatory approval and commercialization. We have a deep history of successful assay design, , data generation, and compliance with ethical and regulatory guidelines. We help drug sponsors stay on target for budget and timeline.</p></div></div></div><div class="wp-block-group alignwide em-mt--none em-mb--none is-layout-constrained wp-block-group-is-layout-constrained"><h2 class="has-text-align-left h2">Stages in the drug development process</h2><p class="has-text-align-left">The drug development process is a complex and rigorous journey that encompasses several stages, starting from the initial discovery of a potential drug candidate and progressing through preclinical testing, clinical trials, regulatory approval, and post-marketing activities. This process aims to ensure the safety, efficacy, and quality of pharmaceutical products before they reach patients.</p><p class="has-text-align-left">BioAgilytix is the partner trusted most by leading biotechnology and pharmaceutical organizations to usher candidates through all stages in the drug development process.</p><div class="wp-block-image alignwide size-full em-mt--md"><div><figure class=""><noscript><img decoding="async" width="2000" height="1031" src="https://www.bioagilytix.com/wp-content/uploads/2023/10/BioAgilytix_Drug_Development-1-1.png" alt="" class="wp-image-5946" srcset="https://www.bioagilytix.com/wp-content/uploads/2023/10/BioAgilytix_Drug_Development-1-1.png 2000w, https://www.bioagilytix.com/wp-content/uploads/2023/10/BioAgilytix_Drug_Development-1-1-300x155.png 300w, https://www.bioagilytix.com/wp-content/uploads/2023/10/BioAgilytix_Drug_Development-1-1-1024x528.png 1024w, https://www.bioagilytix.com/wp-content/uploads/2023/10/BioAgilytix_Drug_Development-1-1-768x396.png 768w, https://www.bioagilytix.com/wp-content/uploads/2023/10/BioAgilytix_Drug_Development-1-1-1536x792.png 1536w, https://www.bioagilytix.com/wp-content/uploads/2023/10/BioAgilytix_Drug_Development-1-1-100x52.png 100w" sizes="(max-width: 2000px) 100vw, 2000px" /></noscript><img decoding="async" width="2000" height="1031" src='data:image/svg+xml,%3Csvg%20xmlns=%22http://www.w3.org/2000/svg%22%20viewBox=%220%200%202000%201031%22%3E%3C/svg%3E' data-src="https://www.bioagilytix.com/wp-content/uploads/2023/10/BioAgilytix_Drug_Development-1-1.png" alt="" class="lazyload wp-image-5946" data-srcset="https://www.bioagilytix.com/wp-content/uploads/2023/10/BioAgilytix_Drug_Development-1-1.png 2000w, https://www.bioagilytix.com/wp-content/uploads/2023/10/BioAgilytix_Drug_Development-1-1-300x155.png 300w, https://www.bioagilytix.com/wp-content/uploads/2023/10/BioAgilytix_Drug_Development-1-1-1024x528.png 1024w, https://www.bioagilytix.com/wp-content/uploads/2023/10/BioAgilytix_Drug_Development-1-1-768x396.png 768w, https://www.bioagilytix.com/wp-content/uploads/2023/10/BioAgilytix_Drug_Development-1-1-1536x792.png 1536w, https://www.bioagilytix.com/wp-content/uploads/2023/10/BioAgilytix_Drug_Development-1-1-100x52.png 100w" data-sizes="(max-width: 2000px) 100vw, 2000px" /></figure></div></div></div><div class="wp-block-emagine-background alignfull has-primary-l-background-color has-background-dim em-pt--lg em-pb--lg em-mt--lg em-mb--none"><div class="wp-block-emagine-background__content"><div class="wp-block-emagine-background__content-inner"><div class="wp-block-group alignfull is-layout-constrained wp-container-core-group-is-layout-3 wp-block-group-is-layout-constrained"><h3 class="has-em-white-color has-text-color has-text-align-center h3">Learn more about how BioAgilytix is helping leading companies achieve success in other stages of the drug development process:</h3><p class=""></p></div><div class="wp-block-emagine-buttons alignwide has-text-align-center"><div class="wp-block-emagine-button has-text-align-left is-style-arrow-right"><a class="btn btn--size-md btn--style-primary has-quaternary-background-color" href="https://www.bioagilytix.com/solutions/phases/discovery-phase-drug-development/" rel="" aria-label=""><span><span class="btn__last-word">Discovery</span></span></a></div><div class="wp-block-emagine-button has-text-align-left is-style-arrow-right"><a class="btn btn--size-md btn--style-primary has-quaternary-background-color" href="https://www.bioagilytix.com/solutions/phases/preclinical-research-drug-development/" rel="" aria-label=""><span><span class="btn__last-word">preclinical</span></span></a></div><div class="wp-block-emagine-button has-text-align-left is-style-arrow-right"><a class="btn btn--size-md btn--style-primary has-quaternary-background-color" href="https://www.bioagilytix.com/solutions/bioanalytical-laboratory-services/cmc-analytical-development/" rel="" aria-label=""><span><span class="btn__last-word">post-marketing/manufacturing</span></span></a></div></div></div></div></div><div id="block_7c332962d079b806c26d845a002eef43" class="wp-block em-media-content em-mt--none em-mb--xl alignfull"><div class="em-media-content__inner em-media-content__inner--media-right has-gray-xxl-background-color em-media-content__inner--content-has-padding"><div class="em-media-content__media em-media-content__media--right"> <noscript><img decoding="async" src="https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_1544710745.jpg" alt="scientist holding pill" class="object-fit--cover" srcset="https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_1544710745.jpg 1000w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_1544710745-300x200.jpg 300w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_1544710745-768x512.jpg 768w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_1544710745-100x67.jpg 100w" width="1000" height="667"></noscript><img decoding="async" src='data:image/svg+xml,%3Csvg%20xmlns=%22http://www.w3.org/2000/svg%22%20viewBox=%220%200%201000%20667%22%3E%3C/svg%3E' data-src="https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_1544710745.jpg" alt="scientist holding pill" class="lazyload object-fit--cover" data-srcset="https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_1544710745.jpg 1000w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_1544710745-300x200.jpg 300w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_1544710745-768x512.jpg 768w, https://www.bioagilytix.com/wp-content/uploads/2023/08/shutterstock_1544710745-100x67.jpg 100w" width="1000" height="667"></div><div class="em-media-content__content em-media-content__content--left em-media-content__content--add-padding"><h2 class="h2">Gaining regulatory approval for drugs</h2><p class="">The regulatory review process involves close collaboration between a drug sponsor and regulatory authorities to ensure that a drug meets standards for safety, efficacy, and quality before approval is granted. </p><p class="">BioAgilytix provided bioanalytical support for nearly a third of all therapeutics that received BLA approvals from the FDA between 2018 and 2022. Contact us today to learn more about how BioAgilytix scientists can help your drug candidate succeed.</p><div class="wp-block-emagine-button has-text-align-left is-style-arrow-right em-mt--md"><a class="btn btn--size-md btn--style-primary has-quaternary-background-color" href="https://www.bioagilytix.com/speak-to-scientist/" rel="" aria-label=""><span>Learn <span class="btn__last-word">More</span></span></a></div></div></div></div><h2 class="h2">People also ask:</h2><div id="block_488a8ad4e8989641795d4e54ffb0a8ec" class="wp-block em-accordions aligndefault"><div id="block_45c2e07d804e711c4914ad17dfcdd922" class="wp-block em-accordion"> <button id="em-accordion-674086fe3173b-control" class="em-accordion__control" type="button" aria-expanded="false" aria-controls="em-accordion-674086fe3173b" ><h3 class="em-accordion__title">What are the stages of the drug development process?</h3></button><div id="em-accordion-674086fe3173b" class="em-accordion__content" aria-labelledby="em-accordion-674086fe3173b-control" ><div class="em-accordion__content-inner"><p class="">The stages of the drug development process include Discovery, Preclinical Testing, Clinical Trials (Phase 1, 2, 3), New Drug Application (NDA) or Biologics License Application (BLA) Submission, Regulatory Review, Approval, Post-Market Approval Surveillance, and Lifecycle Management.</p></div></div></div><div id="block_4b3b3d3696923add851654a66a075688" class="wp-block em-accordion"> <button id="em-accordion-674086fe318e1-control" class="em-accordion__control" type="button" aria-expanded="false" aria-controls="em-accordion-674086fe318e1" ><h3 class="em-accordion__title">What are the goals of clinical drug development?</h3></button><div id="em-accordion-674086fe318e1" class="em-accordion__content" aria-labelledby="em-accordion-674086fe318e1-control" ><div class="em-accordion__content-inner"><p class="">The goals of clinical drug development are to evaluate the safety and efficacy of a potential therapy, determine the appropriate dosage and administration regimens, assess its benefits and risks in specific patient populations, and gather comprehensive data to support regulatory approval for market distribution.</p></div></div></div><div id="block_4bcca4f2d2b4b13bde2df5af9bf6693b" class="wp-block em-accordion"> <button id="em-accordion-674086fe31a66-control" class="em-accordion__control" type="button" aria-expanded="false" aria-controls="em-accordion-674086fe31a66" ><h3 class="em-accordion__title">What are Phase 4 clinical trials?</h3></button><div id="em-accordion-674086fe31a66" class="em-accordion__content" aria-labelledby="em-accordion-674086fe31a66-control" ><div class="em-accordion__content-inner"><p class="">Phase 4 clinical trials, also known as post-marketing studies, occur after a drug is approved and on the market. They aim to gather additional information on the drug’s safety, long-term effectiveness, and potential benefits or risks in larger patient populations, providing real-world evidence for further evaluation and monitoring.</p></div></div></div></div></article></main><footer class="site-footer site-footer--has-logo site-footer--align-brand-left"><div class="deep-footer clearfix"><div class="alignwide"><div class="em-grid"><div class="em-col-6_md-12"><div class="deep-footer__brand"><div class="deep-footer__logo" style="max-width: 300px"> <a href="https://www.bioagilytix.com"><div class="em-image"><div class="em-image__ratio" style="padding-top:21.420572708367%;"> <svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 187.53 40.17" width="187.53px" height="40.17px" class=""><g fill="none"><g fill="#fff"><path d="M12.04 18.13v-.14c2.53-1.16 3.8-2.91 3.8-5.23 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