{"id":17649,"date":"2025-10-20T15:03:20","date_gmt":"2025-10-20T15:03:20","guid":{"rendered":"https:\/\/ubc.com\/?post_type=insights&#038;p=17649"},"modified":"2025-10-20T15:03:30","modified_gmt":"2025-10-20T15:03:30","slug":"to-rescue-or-not-to-rescue-your-study-how-to-spot-trigger-points-in-strategic-partnerships","status":"publish","type":"insights","link":"https:\/\/ubc.com\/insights\/to-rescue-or-not-to-rescue-your-study-how-to-spot-trigger-points-in-strategic-partnerships\/","title":{"rendered":"To Rescue or Not to Rescue Your Study: How to Spot Trigger Points in Strategic Partnerships"},"content":{"rendered":"\n<p>Instability is woven into our industry\u2019s DNA. We operate daily in a high-stakes, high-risk environment where financial pressures, regulatory changes, and patient lives hang in the balance. The CRO selection process reflects this tension, few other sectors require competitors to both challenge and collaborate with one another, often for the same client. Our ecosystem is built on expertise, trust, and long memories, and everyone remembers how a company handles pressure.<\/p>\n\n\n\n<p>Which makes it even more complicated when you realize a mid-study change might be necessary. Switching service providers in the middle of a clinical trial is never simple.&nbsp; Patient safety, accountability, personal relationships, and significant financial investment are all on the line. With RFP-to-contract cycles stretching from three to 12 months, the sunk costs in time and effort can feel overwhelming.<\/p>\n\n\n\n<p>Even with these pressures, a moment comes when the risks to data, timelines, and delivery are too great, and the same conclusion is drawn: it\u2019s time to move on.\u00a0Some signals are obvious, while others are much quieter. \u00a0At UBC, our rescue experts have seen them all.\u00a0Here are a few of the most common \u2014 and what to do about them.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-trigger-point-1-communication-worries\"><strong>Trigger Point 1: Communication Worries<\/strong><\/h2>\n\n\n\n<p>You\u2019re nearing a study first: site activated, patient screened, IP delivery, but responsiveness on the CRO side has stalled. &nbsp;Your repeated outreaches go unanswered, and it\u2019s unclear who owns communication and accountability. &nbsp;Every email gets forwarded to a new name in the reply chain. Every meeting has a new project management person.&nbsp; You\u2019re spending twice the time you budgeted just to get answers to basic questions about your study.<\/p>\n\n\n\n<p>This is one of the most frequent pain points Sponsors cite, particularly with large CROs. They highlight shifting teams, the breakdown of communication, spotty governance, and lack of personalized attention as their biggest frustrations. &nbsp;Yet even though these communication breakdowns are painful, they are often reversible. The right CRO will respond when feedback is delivered clearly, when additional transparency is requested, and when expectations are tied to measurable outcomes.<\/p>\n\n\n\n<p>\u201cWe promise good communication\u201d is not a tagline; it\u2019s a mandate. It demands a competent team, a well-established structure, and an organization devoted to study ownership and strong training.<\/p>\n\n\n\n<p><strong>Our Approach:<\/strong><br>At UBC, communication isn\u2019t left to chance. We apply a centralized model, assigning a single point of contact who serves as the fulcrum for study management. In a rescue, that focus becomes even sharper, aligning our expert Rescue Team with specialized staff that can anticipate bottlenecks, communicate effectively, and neutralize transition risk.<br><br>\u201cWe think in terms of creating a tailored clinical support team. This isn\u2019t a call center or an inbox\u2014these are real people dedicated to the transition, one single point of contact,\u201d Rahul Malhotra, Program Director explains. \u201cSometimes the sponsor is just overwhelmed, and it\u2019s our job to show up consistently and provide that stability.\u201d<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-trigger-point-2-the-bait-and-switch\"><strong>Trigger Point 2: The Bait and Switch<\/strong><\/h2>\n\n\n\n<p>This one is infamous. \u201cIt feels like every conference I\u2019ve been to this year,\u201d notes JB Flinders, Executive Director of Strategic Client Engagement, \u201cSponsors commiserate about how their CRO\u2019s \u2018A team\u2019 was replaced by the \u2018C team\u2019, rarely with an explanation why.\u201d&nbsp;It\u2019s a pain many sponsors feel.&nbsp; You sign with a CRO expecting a specific team, a defined price, and a clear delivery path. Then post-award, things start to shift. &nbsp;The team changes, timelines extend, and your inbox is suddenly full of change order requests. The CRO you thought you hired no longer resembles the one now running your trial.<\/p>\n\n\n\n<p>In the highly competitive environment of drug development, this can be disastrous. &nbsp;While the most evident costs are budgetary, more subtle costs in credibility, potential market share, and stakeholder relationships begin to emerge. &nbsp;Your \u201cstrategic partner\u201d suddenly feels less integrated and more transactional. &nbsp;The essence of partnership may still be there, but the real test is what happens when things go wrong.<\/p>\n\n\n\n<p><strong>Our Approach:<\/strong><br>No two rescues are alike, but one truth remains constant: recovery depends on readiness. Our experienced Rescue Team brings decades of experience managing complex, at-risk trials across numerous therapeutic areas. We have encountered every rescue challenge imaginable and have solutions ready from Day 1.&nbsp;<\/p>\n\n\n\n<p>We know that rescue work is as much about rebuilding trust and stabilizing the relationship &#8211; with you, your sites, and your patients &#8211; as it is about operational turnaround. That process begins long before contract signature, building proposals grounded in realism with an eye toward sustainable, measurable, and dependable results.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-counter-point-radical-accountability\"><strong>Counter Point: Radical Accountability<\/strong><\/h2>\n\n\n\n<p>A successful partnership isn\u2019t about hitting the mark 100% of the time, it\u2019s about trust and accountability. In clinical development, failure often teaches faster than success, and your most valuable partners are those who own their mistakes, improve processes, and move forward without any loss in momentum.&nbsp;<\/p>\n\n\n\n<p>For the studies you have, it may be worth asking: Do you enjoy working with your project team? Is senior leadership actively engaged or CC\u2019d occasionally in a long chain of emails? &nbsp;Do you have transparency into budgets, study team decisions, and milestones? These answers may be strong indicators of long-term compatibility with your CRO partner.<\/p>\n\n\n\n<figure class=\"wp-block-pullquote\"><blockquote><p> Do you enjoy working with your project team? Is senior leadership actively engaged or CC\u2019d occasionally in a long chain of emails? \u00a0Do you have transparency into budgets, study team decisions, and milestones?<\/p><\/blockquote><\/figure>\n\n\n\n<p>Ultimately, while our endpoints are data-focused, we are an industry of relationships.&nbsp; Each of us is a steward, working towards a singular goal of better outcomes for patients. Success isn\u2019t one-size-fits-all, but strong communication, meaningful connections, and collaborative and transparent processes ensure that positive outcomes are more likely to be met.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-final-thought-what-the-data-says\"><strong>Final Thought: What the Data Says<\/strong><\/h2>\n\n\n\n<p>A recent <strong><a href=\"https:\/\/www.appliedclinicaltrialsonline.com\/view\/assessing-investigative-site-outlook-and-operating-experience-post-pandemic\">Tufts Center for the Study of Drug Development<\/a><\/strong> analysis confirms growing sponsor concern about the operational stability of large CROs. It notes performance volatility and turnover as primary risks, which reinforces the need for true partnership models rather than traditional transactional outsourcing. In an era defined by volatility, UBC is here to support our Sponsors by pairing operational excellence, data-driven strategies, dedicated oversight, and an environment of trust and transparency<strong>.<\/strong><\/p>\n\n\n\n<p><a href=\"https:\/\/ubc.com\/insights\/beyond-enrollment-woes-why-sponsors-seek-rescue-in-tumultuous-times\/\">Read part one of our series here.<\/a><\/p>\n\n\n\n<p><strong>About UBC<\/strong><br>United BioSource LLC (UBC) is the leading provider of evidence development solutions with expertise in uniting evidence and access. UBC helps biopharma mitigate risk, address product hurdles, and demonstrate safety, efficacy, and value under real-world conditions. UBC leads the market in providing integrated, comprehensive clinical, safety, and commercialization services and is uniquely positioned to seamlessly integrate best-in-class services throughout the lifecycle of a product.<\/p>\n\n\n\n<figure class=\"wp-block-image alignleft size-thumbnail is-resized\"><img decoding=\"async\" width=\"150\" height=\"150\" src=\"https:\/\/ubc.com\/wp-content\/uploads\/2025\/09\/Headshot-2-150x150.png\" alt=\"\" class=\"wp-image-17417\" style=\"width:128px;height:auto\"\/><\/figure>\n\n\n\n<p><strong>About the Author<\/strong><\/p>\n\n\n\n<p><em>JB Flinders<\/em>, <em>Executive Director, Strategic Client Engagement<\/em><\/p>\n\n\n\n<p>With over 16 years of clinical and academic research experience, JB Flinders has an extensive track record of driving successful operational, feasibility, and analytic strategy across the full scope of therapeutic areas and trials including multiple rescue studies.<\/p>\n\n\n\n<figure class=\"wp-block-image alignleft size-thumbnail is-resized\"><img decoding=\"async\" width=\"150\" height=\"150\" src=\"https:\/\/ubc.com\/wp-content\/uploads\/2025\/09\/Rahul-Headshot-150x150.jpg\" alt=\"\" class=\"wp-image-17418\" style=\"width:128px;height:auto\"\/><\/figure>\n\n\n\n<p><\/p>\n\n\n\n<p><em>Rahul Malhotra<\/em>, <em>Project Director,&nbsp;Global Project Delivery<\/em><\/p>\n\n\n\n<p>Rahul Malhotra is an experienced clinical research Director with more than 17 years in global project delivery. He is recognized for his strategic oversight, strong client partnerships, and successful delivery of studies Globally, spanning Real-World Evidence and interventional research across a wide range of therapeutic areas.<\/p>\n\n\n\n<figure class=\"wp-block-image alignleft size-thumbnail is-resized\"><img decoding=\"async\" width=\"150\" height=\"150\" src=\"https:\/\/ubc.com\/wp-content\/uploads\/2025\/09\/Natania-headshot-150x150.png\" alt=\"\" class=\"wp-image-17416\" style=\"width:128px;height:auto\" srcset=\"https:\/\/ubc.com\/wp-content\/uploads\/2025\/09\/Natania-headshot-150x150.png 150w, https:\/\/ubc.com\/wp-content\/uploads\/2025\/09\/Natania-headshot-300x300.png 300w, https:\/\/ubc.com\/wp-content\/uploads\/2025\/09\/Natania-headshot-768x768.png 768w, https:\/\/ubc.com\/wp-content\/uploads\/2025\/09\/Natania-headshot.png 960w\" sizes=\"(max-width: 150px) 100vw, 150px\" \/><\/figure>\n\n\n\n<p><\/p>\n\n\n\n<p><em>Natania Barron<\/em>, <em>Sr. Director, Marketing<\/em><\/p>\n\n\n\n<p>Natania Barron is a life sciences marketing professional with over 20 years of experience. Her passion is storytelling at the intersection of data and narrative.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Instability is woven into our industry\u2019s DNA. We operate daily in a high-stakes, high-risk environment where financial pressures, regulatory changes, and patient lives hang in the balance. The CRO selection process reflects this tension, few other sectors require competitors to both challenge and collaborate with one another, often for the same client. Our ecosystem is [&hellip;]<\/p>\n","protected":false},"featured_media":17650,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"open","template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"insights_category":[33],"insights_tags":[202],"class_list":["post-17649","insights","type-insights","status-publish","format-standard","has-post-thumbnail","hentry","insights_category-blog","insights_tags-rescue-studies"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.7 (Yoast SEO v26.1.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>To Rescue or Not to Rescue Your Study: How to Spot Trigger Points in Strategic Partnerships - UBC<\/title>\n<meta name=\"description\" content=\"Clinical trials are often in need of rescue, but how do you know when it&#039;s time? 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