{"id":42,"date":"2025-10-13T21:57:36","date_gmt":"2025-10-13T21:57:36","guid":{"rendered":"https:\/\/kpncresearch.wpenginepowered.com\/clinical-trials\/?page_id=42"},"modified":"2026-06-17T21:53:22","modified_gmt":"2026-06-17T21:53:22","slug":"information-for-sponsors","status":"publish","type":"page","link":"https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/information-for-sponsors\/","title":{"rendered":"Information for Sponsors"},"content":{"rendered":"<div class=\"wpb-content-wrapper\">[vc_row full_width=&#8221;stretch_row&#8221; el_class=&#8221;block-hero&#8221; css=&#8221;.vc_custom_1760571006004{background-image: url(https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/10\/hero-sponsors.webp?id=37) !important;}&#8221;][vc_column][\/vc_column][\/vc_row][vc_row remove_bottom_col_margin=&#8221;true&#8221;][vc_column offset=&#8221;vc_col-lg-10&#8243;]<h1 class=\"vcex-heading vcex-heading-plain vcex-module wpex-heading wpex-text-2xl\"><span class=\"vcex-heading-inner wpex-inline-block\">Information for Sponsors<\/span><\/h1>[vc_column_text css=&#8221;&#8221;]The Clinical Trials Program (CTP) at Kaiser Permanente Northern California (KPNC) offers sponsors a powerful platform for conducting high-impact clinical trials. As an integrated healthcare system serving over 4.5 million members, we provide seamless coordination across care delivery, research, and data collection. Our strategically located trial units enable efficient study execution across diverse populations.<\/p>\n<p>Sponsors benefit from access to a broad and representative patient base, robust participant recruitment, and comprehensive trial support services including expert coordination, compliance oversight, advanced analytics, and investigator training.<\/p>\n<p>With a strong track record in research and a commitment to innovation, our program is designed to accelerate discovery, improve lives, and bring transformative therapies to market.[\/vc_column_text][\/vc_column][\/vc_row][vc_row content_placement=&#8221;middle&#8221; gap=&#8221;20&#8243; wpex_padding_top=&#8221;sm&#8221; equal_height=&#8221;yes&#8221;][vc_column width=&#8221;1\/2&#8243; offset=&#8221;vc_col-md-7&#8243;]<figure class=\"vcex-image vcex-module\"><div class=\"vcex-image-inner wpex-relative wpex-inline-block\"><img width=\"1920\" height=\"1280\" src=\"https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/11\/p-integrated-health-care.webp\" class=\"vcex-image-img wpex-align-middle\" alt=\"Nurses and Doctor walking in hospital hall\" loading=\"lazy\" decoding=\"async\" srcset=\"https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/11\/p-integrated-health-care.webp 1920w, https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/11\/p-integrated-health-care-300x200.webp 300w, https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/11\/p-integrated-health-care-1024x683.webp 1024w, https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/11\/p-integrated-health-care-768x512.webp 768w, https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/11\/p-integrated-health-care-1536x1024.webp 1536w\" sizes=\"auto, (max-width: 1920px) 100vw, 1920px\" \/><\/div><\/figure>[\/vc_column][vc_column width=&#8221;1\/2&#8243; offset=&#8221;vc_col-md-5&#8243;]<h2 class=\"vcex-heading vcex-heading-plain vcex-module wpex-heading wpex-text-2xl\"><span class=\"vcex-heading-inner wpex-inline-block\">Integrated Healthcare System<\/span><\/h2>[vc_column_text css=&#8221;&#8221;]KPNC\u2019s unique structure as an integrated healthcare system allows for seamless coordination across care delivery, research, and data collection.[\/vc_column_text][\/vc_column][\/vc_row][vc_row content_placement=&#8221;middle&#8221; gap=&#8221;20&#8243; wpex_padding_top=&#8221;sm&#8221; equal_height=&#8221;yes&#8221; columns_right=&#8221;yes&#8221;][vc_column width=&#8221;1\/2&#8243; offset=&#8221;vc_col-md-7&#8243;]<figure class=\"vcex-image vcex-module\"><div class=\"vcex-image-inner wpex-relative wpex-inline-block\"><img width=\"1920\" height=\"1280\" src=\"https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/11\/p-diverse-population.webp\" class=\"vcex-image-img wpex-align-middle\" alt=\"Group therapy session\" loading=\"lazy\" decoding=\"async\" srcset=\"https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/11\/p-diverse-population.webp 1920w, https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/11\/p-diverse-population-300x200.webp 300w, https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/11\/p-diverse-population-1024x683.webp 1024w, https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/11\/p-diverse-population-768x512.webp 768w, https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/11\/p-diverse-population-1536x1024.webp 1536w\" sizes=\"auto, (max-width: 1920px) 100vw, 1920px\" \/><\/div><\/figure>[\/vc_column][vc_column width=&#8221;1\/2&#8243; offset=&#8221;vc_col-md-5&#8243;]<h2 class=\"vcex-heading vcex-heading-plain vcex-module wpex-heading wpex-text-2xl\"><span class=\"vcex-heading-inner wpex-inline-block\">Diverse Patient Population<br \/>\nin the Bay Area<\/span><\/h2>[vc_column_text css=&#8221;&#8221;]Located in one of the most ethnically and socioeconomically diverse regions in the U.S., KPNC offers access to a broad and representative patient base.[\/vc_column_text][\/vc_column][\/vc_row][vc_row content_placement=&#8221;middle&#8221; gap=&#8221;20&#8243; wpex_padding_top=&#8221;sm&#8221; equal_height=&#8221;yes&#8221;][vc_column width=&#8221;1\/2&#8243; offset=&#8221;vc_col-md-7&#8243;]<figure class=\"vcex-image vcex-module\"><div class=\"vcex-image-inner wpex-relative wpex-inline-block\"><img width=\"1920\" height=\"1280\" src=\"https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/11\/p-membership-base.webp\" class=\"vcex-image-img wpex-align-middle\" alt=\"Husband and wife with child in woods\" loading=\"lazy\" decoding=\"async\" srcset=\"https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/11\/p-membership-base.webp 1920w, https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/11\/p-membership-base-300x200.webp 300w, https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/11\/p-membership-base-1024x683.webp 1024w, https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/11\/p-membership-base-768x512.webp 768w, https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/11\/p-membership-base-1536x1024.webp 1536w\" sizes=\"auto, (max-width: 1920px) 100vw, 1920px\" \/><\/div><\/figure>[\/vc_column][vc_column width=&#8221;1\/2&#8243; offset=&#8221;vc_col-md-5&#8243;]<h2 class=\"vcex-heading vcex-heading-plain vcex-module wpex-heading wpex-text-2xl\"><span class=\"vcex-heading-inner wpex-inline-block\">Large, Stable Membership Base<\/span><\/h2>[vc_column_text css=&#8221;&#8221;]With 4.5 million members across Northern California, KPNC provides a robust pool for participant recruitment.[\/vc_column_text][\/vc_column][\/vc_row][vc_row content_placement=&#8221;middle&#8221; gap=&#8221;20&#8243; wpex_padding_top=&#8221;sm&#8221; equal_height=&#8221;yes&#8221; columns_right=&#8221;yes&#8221;][vc_column width=&#8221;1\/2&#8243; offset=&#8221;vc_col-md-7&#8243;]<figure class=\"vcex-image vcex-module\"><div class=\"vcex-image-inner wpex-relative wpex-inline-block\"><img width=\"1920\" height=\"1280\" src=\"https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/10\/p-services.webp\" class=\"vcex-image-img wpex-align-middle\" alt=\"Technicians working in lab\" loading=\"lazy\" decoding=\"async\" srcset=\"https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/10\/p-services.webp 1920w, https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/10\/p-services-300x200.webp 300w, https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/10\/p-services-1024x683.webp 1024w, https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/10\/p-services-768x512.webp 768w, https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/10\/p-services-1536x1024.webp 1536w\" sizes=\"auto, (max-width: 1920px) 100vw, 1920px\" \/><\/div><\/figure>[\/vc_column][vc_column width=&#8221;1\/2&#8243; offset=&#8221;vc_col-md-5&#8243;]<h2 class=\"vcex-heading vcex-heading-plain vcex-module wpex-heading wpex-text-2xl\"><span class=\"vcex-heading-inner wpex-inline-block\">Commitment to<br \/>\nResearch and Innovation<\/span><\/h2>[vc_column_text css=&#8221;&#8221;]KPNC has a strong track record in clinical research, supported by dedicated research centers and infrastructure, and experienced investigators and multidisciplinary teams.[\/vc_column_text][\/vc_column][\/vc_row][vc_row content_placement=&#8221;middle&#8221; gap=&#8221;20&#8243; wpex_padding_top=&#8221;sm&#8221; wpex_padding_bottom=&#8221;sm&#8221; equal_height=&#8221;yes&#8221;][vc_column width=&#8221;1\/2&#8243; offset=&#8221;vc_col-md-7&#8243;]<figure class=\"vcex-image vcex-module\"><div class=\"vcex-image-inner wpex-relative wpex-inline-block\"><img width=\"1920\" height=\"1280\" src=\"https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/10\/p-about.webp\" class=\"vcex-image-img wpex-align-middle\" alt=\"Physician meeting with patient\" loading=\"lazy\" decoding=\"async\" srcset=\"https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/10\/p-about.webp 1920w, https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/10\/p-about-300x200.webp 300w, https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/10\/p-about-1024x683.webp 1024w, https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/10\/p-about-768x512.webp 768w, https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/10\/p-about-1536x1024.webp 1536w\" sizes=\"auto, (max-width: 1920px) 100vw, 1920px\" \/><\/div><\/figure>[\/vc_column][vc_column width=&#8221;1\/2&#8243; offset=&#8221;vc_col-md-5&#8243;]<h2 class=\"vcex-heading vcex-heading-plain vcex-module wpex-heading wpex-text-2xl\"><span class=\"vcex-heading-inner wpex-inline-block\">Focus on Translational Impact<\/span><\/h2>[vc_column_text css=&#8221;&#8221;]Research at KPNC is closely tied to clinical practice, enabling rapid translation of findings into care improvements.[\/vc_column_text][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; remove_bottom_col_margin=&#8221;true&#8221; el_class=&#8221;block-section bg-lte-blue-grey&#8221;][vc_column]<h2 class=\"vcex-heading vcex-heading-plain vcex-module wpex-heading wpex-text-2xl wpex-text-center no-before\"><span class=\"vcex-heading-inner wpex-inline-block\">How to Collaborate With Us<\/span><\/h2>[vc_row_inner gap=&#8221;20&#8243;][vc_column_inner el_class=&#8221;b-drk-drk-blue&#8221; width=&#8221;1\/5&#8243; css=&#8221;.vc_custom_1762924047252{border-top-width: 10px !important;border-top-style: solid !important;}&#8221;][vc_column_text css=&#8221;&#8221;]\n<h3>Step 1:<\/h3>\n<p>Contact us[\/vc_column_text][\/vc_column_inner][vc_column_inner el_class=&#8221;b-drk-blue&#8221; width=&#8221;1\/5&#8243; css=&#8221;.vc_custom_1760738128861{border-top-width: 10px !important;border-top-style: solid !important;}&#8221;][vc_column_text css=&#8221;&#8221;]\n<h3>Step 2:<\/h3>\n<p>Sign confidentiality agreement[\/vc_column_text][\/vc_column_inner][vc_column_inner el_class=&#8221;b-blue&#8221; width=&#8221;1\/5&#8243; css=&#8221;.vc_custom_1760738135893{border-top-width: 10px !important;border-top-style: solid !important;}&#8221;][vc_column_text css=&#8221;&#8221;]\n<h3>Step 3:<\/h3>\n<p>Share protocol for<br \/>\nsite feasibility assessment<br \/>\nand pre-site visit[\/vc_column_text][\/vc_column_inner][vc_column_inner el_class=&#8221;b-lte-blue&#8221; width=&#8221;1\/5&#8243; css=&#8221;.vc_custom_1760738141630{border-top-width: 10px !important;border-top-style: solid !important;}&#8221;][vc_column_text css=&#8221;&#8221;]\n<h3>Step 4:<\/h3>\n<p>Negotiate budget\/contract and submit protocol<br \/>\nto IRB[\/vc_column_text][\/vc_column_inner][vc_column_inner el_class=&#8221;b-drk-drk-blue&#8221; width=&#8221;1\/5&#8243; css=&#8221;.vc_custom_1760738147903{border-top-width: 10px !important;border-top-style: solid !important;}&#8221;][vc_column_text css=&#8221;&#8221;]\n<h3>Step 5:<\/h3>\n<p>Initiate trial[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row disable_element=&#8221;yes&#8221;][vc_column][vc_column_text css=&#8221;&#8221;]\n<h2>Operational Support<\/h2>\n<ul>\n<li>Integrated care across 21 medical centers throughout Northern California<\/li>\n<li>Connected care and electronic health records<\/li>\n<li>Experienced clinical trials investigators<\/li>\n<li>Dedicated clinical trials staff<\/li>\n<\/ul>\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row el_class=&#8221;block-section&#8221;][vc_column]<h2 class=\"vcex-heading vcex-heading-plain vcex-module wpex-heading wpex-text-2xl\"><span class=\"vcex-heading-inner wpex-inline-block\">Frequently Asked Questions<\/span><\/h2><style>.vcex-toggle-group.vcex_6aa03277ea02c{--vcex-spacing:20px;}.vcex-toggle-group.vcex_6aa03277ea02c .vcex-toggle__heading{font-weight:700;}<\/style><div class=\"vcex-toggle-group vcex-toggle-group--w-borders vcex-module wpex-mx-auto vcex_6aa03277ea02c\" data-vcex-accordion=\"1\"><div class=\"vcex-toggle vcex-module\" data-animate=\"true\" data-duration=\"300\"><div class=\"vcex-toggle__heading\"><a href=\"#how-would-a-sponsor-proceed-with-collaborating-with-kaiser-permanente-northern-california-for-a-clinical-trial\" class=\"vcex-toggle__trigger wpex-transition-colors wpex-flex wpex-items-center wpex-gap-10\" aria-expanded=\"false\" aria-controls=\"how-would-a-sponsor-proceed-with-collaborating-with-kaiser-permanente-northern-california-for-a-clinical-trial\"><div class=\"vcex-toggle__icon wpex-flex wpex-items-center wpex-justify-center\" aria-hidden=\"true\"><div class=\"vcex-toggle__icon-open wpex-flex wpex-flex-col wpex-items-center\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" height=\"1.5em\" viewBox=\"0 0 24 24\" width=\"1.5em\" fill=\"currentColor\" class=\"vcex-toggle__icon-open\"><path d=\"M0 0h24v24H0V0z\" fill=\"none\"\/><path d=\"M19 13h-6v6h-2v-6H5v-2h6V5h2v6h6v2z\"\/><\/svg><\/div><div class=\"vcex-toggle__icon-close wpex-flex wpex-flex-col wpex-items-center\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" height=\"1.5em\" viewBox=\"0 0 24 24\" width=\"1.5em\" fill=\"currentColor\" class=\"vcex-toggle__icon-close\"><path d=\"M0 0h24v24H0V0z\" fill=\"none\"\/><path d=\"M19 13H5v-2h14v2z\"\/><\/svg><\/div><\/div><div class=\"vcex-toggle__title\">How would a Sponsor proceed with collaborating with Kaiser Permanente Northern California for a clinical trial?<\/div><\/a><\/div><div id=\"how-would-a-sponsor-proceed-with-collaborating-with-kaiser-permanente-northern-california-for-a-clinical-trial\" class=\"vcex-toggle__content wpex-clr wpex-last-mb-0 wpex-my-10\"><p>Sponsors interested in collaborating with the Kaiser Permanente Northern California Clinical Trials Program (KPNC CTP) should submit a request through the <a href=\"https:\/\/researchcollaboration.kaiserpermanente.org\/\" target=\"_blank\" rel=\"noopener\">Research Collaboration Portal<\/a>. This portal serves as the primary entry point for initiating partnerships, allowing sponsors to connect with KP researchers, share study proposals, and begin the process of collaboration.<\/p>\n<\/div><\/div> <div class=\"vcex-toggle vcex-module\" data-animate=\"true\" data-duration=\"300\"><div class=\"vcex-toggle__heading\"><a href=\"#who-negotiates-contracts-for-clinical-trials\" class=\"vcex-toggle__trigger wpex-transition-colors wpex-flex wpex-items-center wpex-gap-10\" aria-expanded=\"false\" aria-controls=\"who-negotiates-contracts-for-clinical-trials\"><div class=\"vcex-toggle__icon wpex-flex wpex-items-center wpex-justify-center\" aria-hidden=\"true\"><div class=\"vcex-toggle__icon-open wpex-flex wpex-flex-col wpex-items-center\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" height=\"1.5em\" viewBox=\"0 0 24 24\" width=\"1.5em\" fill=\"currentColor\" class=\"vcex-toggle__icon-open\"><path d=\"M0 0h24v24H0V0z\" fill=\"none\"\/><path d=\"M19 13h-6v6h-2v-6H5v-2h6V5h2v6h6v2z\"\/><\/svg><\/div><div class=\"vcex-toggle__icon-close wpex-flex wpex-flex-col wpex-items-center\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" height=\"1.5em\" viewBox=\"0 0 24 24\" width=\"1.5em\" fill=\"currentColor\" class=\"vcex-toggle__icon-close\"><path d=\"M0 0h24v24H0V0z\" fill=\"none\"\/><path d=\"M19 13H5v-2h14v2z\"\/><\/svg><\/div><\/div><div class=\"vcex-toggle__title\">Who negotiates contracts for clinical trials?<\/div><\/a><\/div><div id=\"who-negotiates-contracts-for-clinical-trials\" class=\"vcex-toggle__content wpex-clr wpex-last-mb-0 wpex-my-10\"><p>The KPNC CTP team will review submissions and coordinate with the appropriate legal, administrative, and clinical teams to support contract negotiation, protocol evaluation, and study setup. <\/p>\n<\/div><\/div> <div class=\"vcex-toggle vcex-module\" data-animate=\"true\" data-duration=\"300\"><div class=\"vcex-toggle__heading\"><a href=\"#how-long-does-it-typically-take-to-negotiate-a-budgetcontract\" class=\"vcex-toggle__trigger wpex-transition-colors wpex-flex wpex-items-center wpex-gap-10\" aria-expanded=\"false\" aria-controls=\"how-long-does-it-typically-take-to-negotiate-a-budgetcontract\"><div class=\"vcex-toggle__icon wpex-flex wpex-items-center wpex-justify-center\" aria-hidden=\"true\"><div class=\"vcex-toggle__icon-open wpex-flex wpex-flex-col wpex-items-center\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" height=\"1.5em\" viewBox=\"0 0 24 24\" width=\"1.5em\" fill=\"currentColor\" class=\"vcex-toggle__icon-open\"><path d=\"M0 0h24v24H0V0z\" fill=\"none\"\/><path d=\"M19 13h-6v6h-2v-6H5v-2h6V5h2v6h6v2z\"\/><\/svg><\/div><div class=\"vcex-toggle__icon-close wpex-flex wpex-flex-col wpex-items-center\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" height=\"1.5em\" viewBox=\"0 0 24 24\" width=\"1.5em\" fill=\"currentColor\" class=\"vcex-toggle__icon-close\"><path d=\"M0 0h24v24H0V0z\" fill=\"none\"\/><path d=\"M19 13H5v-2h14v2z\"\/><\/svg><\/div><\/div><div class=\"vcex-toggle__title\">How long does it typically take to negotiate a budget\/contract?<\/div><\/a><\/div><div id=\"how-long-does-it-typically-take-to-negotiate-a-budgetcontract\" class=\"vcex-toggle__content wpex-clr wpex-last-mb-0 wpex-my-10\"><p>The time it takes to negotiate a budget or contract can vary widely depending on several factors. While CTP aims to align with industry standards and drive toward our \u201cDrive to 90\u201d goals, negotiation timelines are influenced by a range of considerations such as fair market value assessments, sponsor budget constraints, non-negotiable terms, the complexity of study requirements, internal review processes, legal review turnaround times, and the level of alignment between both parties.<\/p>\n<p>If the sponsor is responsive and amenable to our site fees and other non-negotiables, this can significantly expedite the process. Additionally, CTP is working toward implementing standardized sponsor-specific rate cards and contract language to streamline and further accelerate budget and contract negotiations. <\/p>\n<\/div><\/div> <div class=\"vcex-toggle vcex-module\" data-animate=\"true\" data-duration=\"300\"><div class=\"vcex-toggle__heading\"><a href=\"#do-you-have-an-internal-quality-and-compliance-program\" class=\"vcex-toggle__trigger wpex-transition-colors wpex-flex wpex-items-center wpex-gap-10\" aria-expanded=\"false\" aria-controls=\"do-you-have-an-internal-quality-and-compliance-program\"><div class=\"vcex-toggle__icon wpex-flex wpex-items-center wpex-justify-center\" aria-hidden=\"true\"><div class=\"vcex-toggle__icon-open wpex-flex wpex-flex-col wpex-items-center\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" height=\"1.5em\" viewBox=\"0 0 24 24\" width=\"1.5em\" fill=\"currentColor\" class=\"vcex-toggle__icon-open\"><path d=\"M0 0h24v24H0V0z\" fill=\"none\"\/><path d=\"M19 13h-6v6h-2v-6H5v-2h6V5h2v6h6v2z\"\/><\/svg><\/div><div class=\"vcex-toggle__icon-close wpex-flex wpex-flex-col wpex-items-center\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" height=\"1.5em\" viewBox=\"0 0 24 24\" width=\"1.5em\" fill=\"currentColor\" class=\"vcex-toggle__icon-close\"><path d=\"M0 0h24v24H0V0z\" fill=\"none\"\/><path d=\"M19 13H5v-2h14v2z\"\/><\/svg><\/div><\/div><div class=\"vcex-toggle__title\">Do you have an internal quality and compliance program?<\/div><\/a><\/div><div id=\"do-you-have-an-internal-quality-and-compliance-program\" class=\"vcex-toggle__content wpex-clr wpex-last-mb-0 wpex-my-10\"><p>We maintain an internal quality monitoring program that reviews active clinical trial protocols and oversees compassionate use studies to ensure compliance and best practices. <\/p>\n<\/div><\/div> <div class=\"vcex-toggle vcex-module\" data-animate=\"true\" data-duration=\"300\"><div class=\"vcex-toggle__heading\"><a href=\"#do-you-have-a-central-institutional-review-board-irb\" class=\"vcex-toggle__trigger wpex-transition-colors wpex-flex wpex-items-center wpex-gap-10\" aria-expanded=\"false\" aria-controls=\"do-you-have-a-central-institutional-review-board-irb\"><div class=\"vcex-toggle__icon wpex-flex wpex-items-center wpex-justify-center\" aria-hidden=\"true\"><div class=\"vcex-toggle__icon-open wpex-flex wpex-flex-col wpex-items-center\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" height=\"1.5em\" viewBox=\"0 0 24 24\" width=\"1.5em\" fill=\"currentColor\" class=\"vcex-toggle__icon-open\"><path d=\"M0 0h24v24H0V0z\" fill=\"none\"\/><path d=\"M19 13h-6v6h-2v-6H5v-2h6V5h2v6h6v2z\"\/><\/svg><\/div><div class=\"vcex-toggle__icon-close wpex-flex wpex-flex-col wpex-items-center\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" height=\"1.5em\" viewBox=\"0 0 24 24\" width=\"1.5em\" fill=\"currentColor\" class=\"vcex-toggle__icon-close\"><path d=\"M0 0h24v24H0V0z\" fill=\"none\"\/><path d=\"M19 13H5v-2h14v2z\"\/><\/svg><\/div><\/div><div class=\"vcex-toggle__title\">Do you have a central Institutional Review Board (IRB)?<\/div><\/a><\/div><div id=\"do-you-have-a-central-institutional-review-board-irb\" class=\"vcex-toggle__content wpex-clr wpex-last-mb-0 wpex-my-10\"><p>Yes. The KPNC Clinical Trials Program utilizes the WCG IRB to ensure ethical oversight and regulatory compliance for all studies conducted. KPNC IRB handles submissions for minimal risk studies (including those involving vulnerable populations) while WCG IRB is used for clinical trials involving more than minimal risk. These IRBs play a critical role in maintaining the integrity and safety of clinical research conducted through the program.<\/p>\n<\/div><\/div> <div class=\"vcex-toggle vcex-module\" data-animate=\"true\" data-duration=\"300\"><div class=\"vcex-toggle__heading\"><a href=\"#what-kind-of-training-do-principal-investigators-and-staff-receive\" class=\"vcex-toggle__trigger wpex-transition-colors wpex-flex wpex-items-center wpex-gap-10\" aria-expanded=\"false\" aria-controls=\"what-kind-of-training-do-principal-investigators-and-staff-receive\"><div class=\"vcex-toggle__icon wpex-flex wpex-items-center wpex-justify-center\" aria-hidden=\"true\"><div class=\"vcex-toggle__icon-open wpex-flex wpex-flex-col wpex-items-center\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" height=\"1.5em\" viewBox=\"0 0 24 24\" width=\"1.5em\" fill=\"currentColor\" class=\"vcex-toggle__icon-open\"><path d=\"M0 0h24v24H0V0z\" fill=\"none\"\/><path d=\"M19 13h-6v6h-2v-6H5v-2h6V5h2v6h6v2z\"\/><\/svg><\/div><div class=\"vcex-toggle__icon-close wpex-flex wpex-flex-col wpex-items-center\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" height=\"1.5em\" viewBox=\"0 0 24 24\" width=\"1.5em\" fill=\"currentColor\" class=\"vcex-toggle__icon-close\"><path d=\"M0 0h24v24H0V0z\" fill=\"none\"\/><path d=\"M19 13H5v-2h14v2z\"\/><\/svg><\/div><\/div><div class=\"vcex-toggle__title\">What kind of training do principal investigators and staff receive?<\/div><\/a><\/div><div id=\"what-kind-of-training-do-principal-investigators-and-staff-receive\" class=\"vcex-toggle__content wpex-clr wpex-last-mb-0 wpex-my-10\"><p>Principal investigators and staff receive comprehensive training designed to ensure ethical, compliant, and high-quality research. This includes core certifications such as Human Subjects Research (HSR), Good Clinical Practice (GCP), and Responsible Conduct of Research (RCR). General trainings cover topics like informed consent procedures, HIPAA compliance, and standard operating procedures. Additionally, protocol-specific training includes site initiation visits (SIV), protocol amendment updates, electronic data capture systems, Salesforce &amp; SMA training, and device handling. These educational pathways are supported by <a href=\"https:\/\/sp-cloud.kp.org\/sites\/TheAcademyofClinicalTrialists\/SitePages\/Academy-of-Clinical-Trialists-(ACT).aspx\" target=\"_blank\" rel=\"noopener\">The Academy of Clinical Trialists (ACT)<\/a> to build expertise among TPMG physicians and research staff.<\/p>\n<\/div><\/div> <div class=\"vcex-toggle vcex-module\" data-animate=\"true\" data-duration=\"300\"><div class=\"vcex-toggle__heading\"><a href=\"#how-do-you-support-source-documentation-and-study-data-management\" class=\"vcex-toggle__trigger wpex-transition-colors wpex-flex wpex-items-center wpex-gap-10\" aria-expanded=\"false\" aria-controls=\"how-do-you-support-source-documentation-and-study-data-management\"><div class=\"vcex-toggle__icon wpex-flex wpex-items-center wpex-justify-center\" aria-hidden=\"true\"><div class=\"vcex-toggle__icon-open wpex-flex wpex-flex-col wpex-items-center\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" height=\"1.5em\" viewBox=\"0 0 24 24\" width=\"1.5em\" fill=\"currentColor\" class=\"vcex-toggle__icon-open\"><path d=\"M0 0h24v24H0V0z\" fill=\"none\"\/><path d=\"M19 13h-6v6h-2v-6H5v-2h6V5h2v6h6v2z\"\/><\/svg><\/div><div class=\"vcex-toggle__icon-close wpex-flex wpex-flex-col wpex-items-center\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" height=\"1.5em\" viewBox=\"0 0 24 24\" width=\"1.5em\" fill=\"currentColor\" class=\"vcex-toggle__icon-close\"><path d=\"M0 0h24v24H0V0z\" fill=\"none\"\/><path d=\"M19 13H5v-2h14v2z\"\/><\/svg><\/div><\/div><div class=\"vcex-toggle__title\">How do you support source documentation and study data management?<\/div><\/a><\/div><div id=\"how-do-you-support-source-documentation-and-study-data-management\" class=\"vcex-toggle__content wpex-clr wpex-last-mb-0 wpex-my-10\"><p>The KPNC CTP supports source documentation and study data management through two integrated platforms: Florence HealthCare, which serves as the regulatory binder and subject binder system, and Verily, used as the Clinical Trial Management System (CTMS). Florence enables secure, remote access to study files, electronic signatures compliant with 21 CFR Part 11, HIPAA-compliant workflows, and centralized document control with real-time monitoring and audit trails. Verily enhances operational efficiency by digitizing study protocols into automated workflows, offering real-time performance and financial metrics, and facilitating collaboration between sites and sponsors. Together, these systems ensure accurate documentation, regulatory compliance, and streamlined data management throughout the lifecycle of a clinical trial.<\/p>\n<\/div><\/div> <div class=\"vcex-toggle vcex-module\" data-animate=\"true\" data-duration=\"300\"><div class=\"vcex-toggle__heading\"><a href=\"#what-support-is-available-to-monitor-and-audit-studies\" class=\"vcex-toggle__trigger wpex-transition-colors wpex-flex wpex-items-center wpex-gap-10\" aria-expanded=\"false\" aria-controls=\"what-support-is-available-to-monitor-and-audit-studies\"><div class=\"vcex-toggle__icon wpex-flex wpex-items-center wpex-justify-center\" aria-hidden=\"true\"><div class=\"vcex-toggle__icon-open wpex-flex wpex-flex-col wpex-items-center\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" height=\"1.5em\" viewBox=\"0 0 24 24\" width=\"1.5em\" fill=\"currentColor\" class=\"vcex-toggle__icon-open\"><path d=\"M0 0h24v24H0V0z\" fill=\"none\"\/><path d=\"M19 13h-6v6h-2v-6H5v-2h6V5h2v6h6v2z\"\/><\/svg><\/div><div class=\"vcex-toggle__icon-close wpex-flex wpex-flex-col wpex-items-center\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" height=\"1.5em\" viewBox=\"0 0 24 24\" width=\"1.5em\" fill=\"currentColor\" class=\"vcex-toggle__icon-close\"><path d=\"M0 0h24v24H0V0z\" fill=\"none\"\/><path d=\"M19 13H5v-2h14v2z\"\/><\/svg><\/div><\/div><div class=\"vcex-toggle__title\">What support is available to monitor and audit studies?<\/div><\/a><\/div><div id=\"what-support-is-available-to-monitor-and-audit-studies\" class=\"vcex-toggle__content wpex-clr wpex-last-mb-0 wpex-my-10\"><p>The CTP offers study quality monitoring, a risk-based internal monitoring approach that focuses oversight on areas with the greatest potential impact to participant safety, data integrity, and compliance.<\/p>\n<\/div><\/div> <div class=\"vcex-toggle vcex-module\" data-animate=\"true\" data-duration=\"300\"><div class=\"vcex-toggle__heading\"><a href=\"#do-you-coordinate-investigational-drug-and-pharmacy-services\" class=\"vcex-toggle__trigger wpex-transition-colors wpex-flex wpex-items-center wpex-gap-10\" aria-expanded=\"false\" aria-controls=\"do-you-coordinate-investigational-drug-and-pharmacy-services\"><div class=\"vcex-toggle__icon wpex-flex wpex-items-center wpex-justify-center\" aria-hidden=\"true\"><div class=\"vcex-toggle__icon-open wpex-flex wpex-flex-col wpex-items-center\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" height=\"1.5em\" viewBox=\"0 0 24 24\" width=\"1.5em\" fill=\"currentColor\" class=\"vcex-toggle__icon-open\"><path d=\"M0 0h24v24H0V0z\" fill=\"none\"\/><path d=\"M19 13h-6v6h-2v-6H5v-2h6V5h2v6h6v2z\"\/><\/svg><\/div><div class=\"vcex-toggle__icon-close wpex-flex wpex-flex-col wpex-items-center\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" height=\"1.5em\" viewBox=\"0 0 24 24\" width=\"1.5em\" fill=\"currentColor\" class=\"vcex-toggle__icon-close\"><path d=\"M0 0h24v24H0V0z\" fill=\"none\"\/><path d=\"M19 13H5v-2h14v2z\"\/><\/svg><\/div><\/div><div class=\"vcex-toggle__title\">Do you coordinate investigational drug and pharmacy services?<\/div><\/a><\/div><div id=\"do-you-coordinate-investigational-drug-and-pharmacy-services\" class=\"vcex-toggle__content wpex-clr wpex-last-mb-0 wpex-my-10\"><p>Yes. The Clinical Trials Program (CTP) oversees and coordinates all investigational drug and pharmacy services in partnership with our Regional Pharmacy team. We have a dedicated regional pharmacy lead who serves as our primary liaison to ensure alignment and support across study sites.<\/p>\n<p>CTP and the Regional Pharmacy Lead ensure that all Investigational Products (IP) are:<\/p>\n<ul>\n<li>Stored, handled, and dispensed in accordance with sponsor requirements, FDA regulations, Good Clinical Practice (GCP), and Kaiser Permanente standard operating procedures.<\/li>\n<li>Fully documented with complete accountability, including temperature logs, chain of custody, and reconciliation.<\/li>\n<li>Monitored regularly for compliance, stability, and expiration dating.<\/li>\n<li>Supported with ongoing communication across study teams, providers, and pharmacy staff to ensure safe and compliant use in patient care.<\/li>\n<\/ul>\n<p>We also coordinate pharmacy feasibility assessments, site training, new study startups, and ensure all necessary delegation, documentation, and workflows are in place before activation.<\/p>\n<\/div><\/div> <div class=\"vcex-toggle vcex-module\" data-animate=\"true\" data-duration=\"300\"><div class=\"vcex-toggle__heading\"><a href=\"#can-you-support-specimen-collection-and-shipping\" class=\"vcex-toggle__trigger wpex-transition-colors wpex-flex wpex-items-center wpex-gap-10\" aria-expanded=\"false\" aria-controls=\"can-you-support-specimen-collection-and-shipping\"><div class=\"vcex-toggle__icon wpex-flex wpex-items-center wpex-justify-center\" aria-hidden=\"true\"><div class=\"vcex-toggle__icon-open wpex-flex wpex-flex-col wpex-items-center\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" height=\"1.5em\" viewBox=\"0 0 24 24\" width=\"1.5em\" fill=\"currentColor\" class=\"vcex-toggle__icon-open\"><path d=\"M0 0h24v24H0V0z\" fill=\"none\"\/><path d=\"M19 13h-6v6h-2v-6H5v-2h6V5h2v6h6v2z\"\/><\/svg><\/div><div class=\"vcex-toggle__icon-close wpex-flex wpex-flex-col wpex-items-center\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" height=\"1.5em\" viewBox=\"0 0 24 24\" width=\"1.5em\" fill=\"currentColor\" class=\"vcex-toggle__icon-close\"><path d=\"M0 0h24v24H0V0z\" fill=\"none\"\/><path d=\"M19 13H5v-2h14v2z\"\/><\/svg><\/div><\/div><div class=\"vcex-toggle__title\">Can you support specimen collection and shipping?<\/div><\/a><\/div><div id=\"can-you-support-specimen-collection-and-shipping\" class=\"vcex-toggle__content wpex-clr wpex-last-mb-0 wpex-my-10\"><p>Yes. Our Clinical Trials Program (CTP) provides full coordination and oversight of specimen collection, processing, and shipping in accordance with study protocols, GCP, and FDA\/ICH guidelines.<\/p>\n<p>Our capabilities include:<\/p>\n<ul>\n<li>Coordinating phlebotomy, biopsy, and other protocol-specific specimen collection procedures.<\/li>\n<li>Ensuring proper labeling, documentation, and chain of custody.<\/li>\n<li>Processing specimens according to protocol requirements (e.g., centrifugation, aliquoting, freezing, room temperature storage).<\/li>\n<li>Preparing and packaging specimens using International Air Transport Association (IATA)-compliant shipping standards for biological materials.<\/li>\n<li>Managing courier scheduling and tracking to central or specialty labs.<\/li>\n<li>Maintaining specimen logs and reconciliation records for audit readiness.<\/li>\n<li>Training study staff on protocol-specific handling and shipping procedures.<\/li>\n<\/ul>\n<p>CTP and labs work together to ensure specimens are collected, processed, and shipped accurately and on schedule, maintaining specimen integrity and regulatory compliance at all stages.<\/p>\n<\/div><\/div> <div class=\"vcex-toggle vcex-module\" data-animate=\"true\" data-duration=\"300\"><div class=\"vcex-toggle__heading\"><a href=\"#what-are-your-record-retention-practices\" class=\"vcex-toggle__trigger wpex-transition-colors wpex-flex wpex-items-center wpex-gap-10\" aria-expanded=\"false\" aria-controls=\"what-are-your-record-retention-practices\"><div class=\"vcex-toggle__icon wpex-flex wpex-items-center wpex-justify-center\" aria-hidden=\"true\"><div class=\"vcex-toggle__icon-open wpex-flex wpex-flex-col wpex-items-center\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" height=\"1.5em\" viewBox=\"0 0 24 24\" width=\"1.5em\" fill=\"currentColor\" class=\"vcex-toggle__icon-open\"><path d=\"M0 0h24v24H0V0z\" fill=\"none\"\/><path d=\"M19 13h-6v6h-2v-6H5v-2h6V5h2v6h6v2z\"\/><\/svg><\/div><div class=\"vcex-toggle__icon-close wpex-flex wpex-flex-col wpex-items-center\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" height=\"1.5em\" viewBox=\"0 0 24 24\" width=\"1.5em\" fill=\"currentColor\" class=\"vcex-toggle__icon-close\"><path d=\"M0 0h24v24H0V0z\" fill=\"none\"\/><path d=\"M19 13H5v-2h14v2z\"\/><\/svg><\/div><\/div><div class=\"vcex-toggle__title\">What are your record retention practices?<\/div><\/a><\/div><div id=\"what-are-your-record-retention-practices\" class=\"vcex-toggle__content wpex-clr wpex-last-mb-0 wpex-my-10\"><p>The KPNC CTP adheres to federal regulations and ICH Good Clinical Practice (GCP) guidelines. These typically require retention of essential documents (e.g., consent forms, source data, regulatory files) for at least 2 years after the last approval of a marketing application or as long as required by local regulations or sponsors.<\/p>\n<\/div><\/div> <div class=\"vcex-toggle vcex-module\" data-animate=\"true\" data-duration=\"300\"><div class=\"vcex-toggle__heading\"><a href=\"#how-will-patient-stipends-be-managed\" class=\"vcex-toggle__trigger wpex-transition-colors wpex-flex wpex-items-center wpex-gap-10\" aria-expanded=\"false\" aria-controls=\"how-will-patient-stipends-be-managed\"><div class=\"vcex-toggle__icon wpex-flex wpex-items-center wpex-justify-center\" aria-hidden=\"true\"><div class=\"vcex-toggle__icon-open wpex-flex wpex-flex-col wpex-items-center\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" height=\"1.5em\" viewBox=\"0 0 24 24\" width=\"1.5em\" fill=\"currentColor\" class=\"vcex-toggle__icon-open\"><path d=\"M0 0h24v24H0V0z\" fill=\"none\"\/><path d=\"M19 13h-6v6h-2v-6H5v-2h6V5h2v6h6v2z\"\/><\/svg><\/div><div class=\"vcex-toggle__icon-close wpex-flex wpex-flex-col wpex-items-center\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" height=\"1.5em\" viewBox=\"0 0 24 24\" width=\"1.5em\" fill=\"currentColor\" class=\"vcex-toggle__icon-close\"><path d=\"M0 0h24v24H0V0z\" fill=\"none\"\/><path d=\"M19 13H5v-2h14v2z\"\/><\/svg><\/div><\/div><div class=\"vcex-toggle__title\">How will patient stipends be managed?<\/div><\/a><\/div><div id=\"how-will-patient-stipends-be-managed\" class=\"vcex-toggle__content wpex-clr wpex-last-mb-0 wpex-my-10\"><p>If patient stipends are to be distributed by Kaiser Permanente, they will be processed using the Mural Link application (Mural Health for Sites &amp; Sponsors &#8211; The Mural Link Platform).<\/p>\n<\/div><\/div> <div class=\"vcex-toggle vcex-module\" data-animate=\"true\" data-duration=\"300\"><div class=\"vcex-toggle__heading\"><a href=\"#how-will-participants-be-consented\" class=\"vcex-toggle__trigger wpex-transition-colors wpex-flex wpex-items-center wpex-gap-10\" aria-expanded=\"false\" aria-controls=\"how-will-participants-be-consented\"><div class=\"vcex-toggle__icon wpex-flex wpex-items-center wpex-justify-center\" aria-hidden=\"true\"><div class=\"vcex-toggle__icon-open wpex-flex wpex-flex-col wpex-items-center\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" height=\"1.5em\" viewBox=\"0 0 24 24\" width=\"1.5em\" fill=\"currentColor\" class=\"vcex-toggle__icon-open\"><path d=\"M0 0h24v24H0V0z\" fill=\"none\"\/><path d=\"M19 13h-6v6h-2v-6H5v-2h6V5h2v6h6v2z\"\/><\/svg><\/div><div class=\"vcex-toggle__icon-close wpex-flex wpex-flex-col wpex-items-center\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" height=\"1.5em\" viewBox=\"0 0 24 24\" width=\"1.5em\" fill=\"currentColor\" class=\"vcex-toggle__icon-close\"><path d=\"M0 0h24v24H0V0z\" fill=\"none\"\/><path d=\"M19 13H5v-2h14v2z\"\/><\/svg><\/div><\/div><div class=\"vcex-toggle__title\">How will participants be consented?<\/div><\/a><\/div><div id=\"how-will-participants-be-consented\" class=\"vcex-toggle__content wpex-clr wpex-last-mb-0 wpex-my-10\"><p>Participants will be consented either in person using paper consent forms or Docusign.<\/p>\n<\/div><\/div> <div class=\"vcex-toggle vcex-module\" data-animate=\"true\" data-duration=\"300\"><div class=\"vcex-toggle__heading\"><a href=\"#how-does-kaiser-permanente-northern-california-evaluate-feasibility-for-a-new-clinical-trial\" class=\"vcex-toggle__trigger wpex-transition-colors wpex-flex wpex-items-center wpex-gap-10\" aria-expanded=\"false\" aria-controls=\"how-does-kaiser-permanente-northern-california-evaluate-feasibility-for-a-new-clinical-trial\"><div class=\"vcex-toggle__icon wpex-flex wpex-items-center wpex-justify-center\" aria-hidden=\"true\"><div class=\"vcex-toggle__icon-open wpex-flex wpex-flex-col wpex-items-center\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" height=\"1.5em\" viewBox=\"0 0 24 24\" width=\"1.5em\" fill=\"currentColor\" class=\"vcex-toggle__icon-open\"><path d=\"M0 0h24v24H0V0z\" fill=\"none\"\/><path d=\"M19 13h-6v6h-2v-6H5v-2h6V5h2v6h6v2z\"\/><\/svg><\/div><div class=\"vcex-toggle__icon-close wpex-flex wpex-flex-col wpex-items-center\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" height=\"1.5em\" viewBox=\"0 0 24 24\" width=\"1.5em\" fill=\"currentColor\" class=\"vcex-toggle__icon-close\"><path d=\"M0 0h24v24H0V0z\" fill=\"none\"\/><path d=\"M19 13H5v-2h14v2z\"\/><\/svg><\/div><\/div><div class=\"vcex-toggle__title\">How does Kaiser Permanente Northern California evaluate feasibility for a new clinical trial?<\/div><\/a><\/div><div id=\"how-does-kaiser-permanente-northern-california-evaluate-feasibility-for-a-new-clinical-trial\" class=\"vcex-toggle__content wpex-clr wpex-last-mb-0 wpex-my-10\"><p>Clinical trial protocols undergo a structured feasibility review process that includes:<\/p>\n<ul>\n<li>Patient population and eligibility assessment using EHR and clinical data<\/li>\n<li>Confirmation of PI and care team interest and capacity<\/li>\n<li>Pharmacy, laboratory, and procedural service availability<\/li>\n<li>Site resource and staffing assessment<\/li>\n<\/ul>\n<p>We view clinical trials as an extension of enhanced clinical care. If the study addresses a meaningful clinical need, fills a gap in treatment options, or benefits a population with unmet needs, we prioritize participation when operationally feasible. This includes intentional consideration of how research can improve access and outcomes for underserved or high-need patient groups.<\/p>\n<p>We provide sponsors with feasibility feedback and operational considerations prior to site selection.<\/p>\n<\/div><\/div><\/div>[\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; el_class=&#8221;block-section bg-lte-grey&#8221;][vc_column][vc_column_text css=&#8221;&#8221;]\n<h2>KP Study Search<\/h2>\n<p>KP Study Search was created to inform patients, caregivers and investigators about the ongoing clinical trials and research studies conducted at Kaiser Permanente.<\/p>\n<p><a class=\"button\" href=\"https:\/\/kpstudysearch.kaiser.org\/\" target=\"_blank\" rel=\"noopener\">Find a study<\/a>[\/vc_column_text][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row_content_no_spaces&#8221; remove_bottom_col_margin=&#8221;true&#8221; local_scroll_id=&#8221;tools-for-collaborators&#8221;][vc_column][vc_column_text css=&#8221;&#8221;]\n<div class=\"block-callout content-right\">\n<div class=\"block-callout-image\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-36 size-full\" src=\"https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/10\/banner-collaborate.webp\" alt=\"\" width=\"1920\" height=\"720\" srcset=\"https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/10\/banner-collaborate.webp 1920w, https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/10\/banner-collaborate-300x113.webp 300w, https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/10\/banner-collaborate-1024x384.webp 1024w, https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/10\/banner-collaborate-768x288.webp 768w, https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/10\/banner-collaborate-1536x576.webp 1536w\" sizes=\"auto, (max-width: 1920px) 100vw, 1920px\" \/><\/div>\n<div class=\"block-callout-content\">\n<h2>Collaborate with Us<\/h2>\n<p>Please submit a request through the Research Collaboration Portal if you are a clinical trial researcher or sponsor interested in collaborating with us.<\/p>\n<p><a class=\"button\" href=\"https:\/\/researchcollaboration.kaiserpermanente.org\/\" target=\"_blank\" rel=\"noopener\">Visit the Research Collaboration Portal<\/a><\/p>\n<\/div>\n<\/div>\n[\/vc_column_text][\/vc_column][\/vc_row]\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row full_width=&#8221;stretch_row&#8221; el_class=&#8221;block-hero&#8221; css=&#8221;.vc_custom_1760571006004{background-image: url(https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/10\/hero-sponsors.webp?id=37) !important;}&#8221;][vc_column][\/vc_column][\/vc_row][vc_row remove_bottom_col_margin=&#8221;true&#8221;][vc_column offset=&#8221;vc_col-lg-10&#8243;][vc_column_text css=&#8221;&#8221;]The Clinical Trials Program (CTP) at Kaiser Permanente Northern California (KPNC) offers sponsors a powerful platform for conducting high-impact clinical trials. As an integrated healthcare system serving over 4.5 million members, we provide seamless coordination across care delivery, research, and data collection. Our strategically located trial units&hellip;<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-42","page","type-page","status-publish","hentry","entry","no-media"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Information for Sponsors - Kaiser Permanente Northern California Clinical Trials<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/information-for-sponsors\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Information for Sponsors - Kaiser Permanente Northern California Clinical Trials\" \/>\n<meta property=\"og:description\" content=\"[vc_row full_width=&#8221;stretch_row&#8221; el_class=&#8221;block-hero&#8221; css=&#8221;.vc_custom_1760571006004{background-image: url(https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/10\/hero-sponsors.webp?id=37) !important;}&#8221;][vc_column][\/vc_column][\/vc_row][vc_row remove_bottom_col_margin=&#8221;true&#8221;][vc_column offset=&#8221;vc_col-lg-10&#8243;][vc_column_text css=&#8221;&#8221;]The Clinical Trials Program (CTP) at Kaiser Permanente Northern California (KPNC) offers sponsors a powerful platform for conducting high-impact clinical trials. As an integrated healthcare system serving over 4.5 million members, we provide seamless coordination across care delivery, research, and data collection. Our strategically located trial units&hellip;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/information-for-sponsors\/\" \/>\n<meta property=\"og:site_name\" content=\"Kaiser Permanente Northern California Clinical Trials\" \/>\n<meta property=\"article:modified_time\" content=\"2026-06-17T21:53:22+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/research-ncal.kaiserpermanente.org\/clinical-trials\/wp-content\/uploads\/sites\/2\/2025\/10\/banner-collaborate.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1920\" \/>\n\t<meta property=\"og:image:height\" content=\"720\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"9 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/research-ncal.kaiserpermanente.org\\\/clinical-trials\\\/information-for-sponsors\\\/\",\"url\":\"https:\\\/\\\/research-ncal.kaiserpermanente.org\\\/clinical-trials\\\/information-for-sponsors\\\/\",\"name\":\"Information for Sponsors - 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