{"id":26355,"date":"2026-02-25T08:00:48","date_gmt":"2026-02-25T13:00:48","guid":{"rendered":"https:\/\/inderocro.com\/?post_type=podcast&#038;p=26355"},"modified":"2026-02-23T09:57:35","modified_gmt":"2026-02-23T14:57:35","slug":"episode-39-building-a-robust-startup-unit-in-clinical-trials","status":"publish","type":"podcast","link":"https:\/\/inderocro.com\/fr\/podcast\/episode-39-building-a-robust-startup-unit-in-clinical-trials\/","title":{"rendered":"Episode 39: Esther Sanchez &#8211; Building a Robust Startup Unit in Clinical Trials"},"content":{"rendered":"<p><iframe src=\"https:\/\/w.soundcloud.com\/player\/?url=https%3A\/\/api.soundcloud.com\/tracks\/soundcloud%3Atracks%3A2268843374%3Fsecret_token%3Ds-7h9YvDUnVK6&amp;color=%23ff5500&amp;auto_play=false&amp;hide_related=false&amp;show_comments=true&amp;show_user=true&amp;show_reposts=false&amp;show_teaser=true\" width=\"100%\" height=\"166\" frameborder=\"no\" scrolling=\"no\"><span data-mce-type=\"bookmark\" style=\"display: inline-block; width: 0px; overflow: hidden; line-height: 0;\" class=\"mce_SELRES_start\">\ufeff<\/span><\/iframe><\/p>\n<p><img fetchpriority=\"high\" decoding=\"async\" class=\"size-large wp-image-26382 aligncenter\" src=\"https:\/\/inderocro.com\/wp-content\/uploads\/2026\/02\/Episode-39-Esther-1-1024x1024.webp\" alt=\"\" width=\"800\" height=\"800\" srcset=\"https:\/\/inderocro.com\/wp-content\/uploads\/2026\/02\/Episode-39-Esther-1-1024x1024.webp 1024w, https:\/\/inderocro.com\/wp-content\/uploads\/2026\/02\/Episode-39-Esther-1-300x300.webp 300w, https:\/\/inderocro.com\/wp-content\/uploads\/2026\/02\/Episode-39-Esther-1-150x150.webp 150w, https:\/\/inderocro.com\/wp-content\/uploads\/2026\/02\/Episode-39-Esther-1-768x768.webp 768w, https:\/\/inderocro.com\/wp-content\/uploads\/2026\/02\/Episode-39-Esther-1.webp 1200w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><\/p>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">In this episode, <a href=\"https:\/\/www.linkedin.com\/in\/esthersanchezperez-spain\/\" target=\"_blank\" rel=\"noopener\">Esther S\u00e1nchez<\/a>, Associate Director of the Global Start-Up Unit at Indero, brings more than 24 years of experience in clinical research to our discussion. Esther provides\u00a0expert\u00a0perspective on the vital role of a strong startup team in clinical trials, shares the key factors that contribute to team effectiveness, and highlights strategies for avoiding common pitfalls in the startup process. Listen for actionable insights to elevate your clinical trial outcomes.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h2><span data-contrast=\"auto\">The Essential Role of a Robust Startup Unit in Clinical Trials<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/h2>\n<p><span data-contrast=\"auto\">Establishing a robust startup unit is fundamental to clinical trial success. The startup phase\u00a0determines\u00a0whether timelines are protected or\u00a0lost,\u00a0risks are\u00a0anticipated\u00a0or overlooked, and critical relationships with sites and sponsors are\u00a0properly managed. A strong startup team ensures efficient execution of essential activities such as regulatory submission, site activation, and contract execution.\u00a0Clear\u00a0understanding of local requirements and strategic oversight\u00a0are\u00a0necessary to address country-specific challenges and flag feasibility concerns early. Close alignment with clinical operations, regulatory functions, and sponsors reduces delays, minimizes amendments, and supports confident enrollment progression. Excellence in startup operations accelerates site activation, enables earlier first patient\u00a0in, improves enrollment projections, and enhances data quality throughout the trial.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h2><span data-contrast=\"auto\">Startup Teams: Warriors on the Front Lines<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/h2>\n<p><span data-contrast=\"auto\">The startup phase in clinical trials serves as the operational front line, distinguished by its complexity and intense pressure. During this stage, multiple stakeholders, demanding timelines, regulatory requirements, and competing priorities all converge, creating a challenging environment that demands exceptional coordination. Achieving success in this phase hinges on the team&rsquo;s resilience, adaptability, and proactive, solution-oriented mindset.\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Teams must skillfully navigate regulatory hurdles, negotiate budgets and contracts, address site-specific challenges, and manage unexpected last-minute changes.\u00a0To keep study timelines on track, it is essential to anticipate potential obstacles and resolve problems swiftly as they arise.\u00a0Ultimately, effective\u00a0performance in this critical phase requires a sense of ownership and advocacy for the goals of the study, sites, and sponsors\u00a0while\u00a0maintaining\u00a0a careful balance between company needs, a sense of urgency, and unwavering commitment to quality.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h2><span data-contrast=\"auto\">Essential Startup Process Checks for Every Company<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/h2>\n<p><span data-contrast=\"auto\">Cross-functional collaboration is essential for clinical trial startup success. This collaboration must\u00a0include\u00a0both internal teams and sponsors, functioning as a unified group. By integrating feasibility, site identification, regulatory, contract, and clinical functions within a shared framework, teams can\u00a0leverage\u00a0collective\u00a0expertise\u00a0to efficiently navigate complex regulatory environments. Optimal activation strategies depend on genuine partnership with sponsors and internal stakeholders, which\u00a0fosters\u00a0active listening, adaptability, and the co-creation of solutions.\u00a0Each startup brings its own unique challenges, making it essential to develop tailored strategies and\u00a0maintain\u00a0clear alignment with client priorities.<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Effective cross-functional collaboration hinges on treating sponsors as true partners, ensuring consistent communication and shared goals.\u00a0Building on\u00a0this foundation, proactive risk management is crucial; early identification and mitigation of risks help prevent delays and reduce rework or missed milestones in contracts, regulatory documents, and submissions. Accountability and ownership are key, requiring team members to recognize their responsibilities and\u00a0maintain\u00a0clarity\u00a0regarding\u00a0roles, especially when communicating with sponsors. Equally important are strong relationships with sites, which serve as critical partners in clinical trial success. Establishing robust collaboration with sites moves interactions beyond mere transactions, fostering genuine partnerships that drive successful startup outcomes.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h2><span data-contrast=\"auto\">Key Challenges Companies Face During Startup<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/h2>\n<p><span data-contrast=\"auto\">The clinical trial startup phase presents significant complexity and independence, particularly in global environments where regulatory requirements, ethics committee approvals, and contract negotiations differ across countries and regions.\u00a0Clear\u00a0understanding of startup timelines and local regulatory landscapes is essential to\u00a0maintain\u00a0efficiency and mitigate delays.\u00a0Clear alignment among sponsors,\u00a0CROs, and internal groups such as regulatory, legal, clinical operations, and feasibility is essential.\u00a0<\/span><span data-contrast=\"auto\">When\u00a0expectations,\u00a0responsibilities, and\u00a0priorities\u00a0are not\u00a0well\u00a0defined, trial\u00a0delays\u00a0tend to\u00a0increase.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Site readiness and engagement require careful assessment beyond feasibility on paper.\u00a0Real-world constraints such as staffing shortages, competing studies, and slow contract execution must be\u00a0identified\u00a0early. Effective contingency planning, including backup site identification and robust site activation timelines,\u00a0ensures\u00a0baseline activation rates are\u00a0maintained\u00a0throughout the trial.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Proactive risk management forms the foundation of successful startup operations.\u00a0Early anticipation of challenges, informed by comprehensive knowledge of local regulatory requirements, prevents reactive approaches and minimizes cost impact.\u00a0Strategic startup units must foster innovation, collaboration, and value creation, transforming the risk-heavy startup phase into a controlled, predictive, and proactive process.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">As we conclude another illuminating episode of Phase Forward, we find ourselves at the crossroads of science and progress. Remember that behind the jargon and\u00a0statistics,\u00a0lies stories of unwavering commitment, meticulous observation, and the pursuit of evidence that shapes our understanding of health and disease. Stay at the forefront of knowledge and innovation and follow Phase Forward on your preferred platform. My name is Valerie Coveney. Thank you for joining us. Until next time.<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\ufeff &nbsp; In this episode, Esther S\u00e1nchez, Associate Director of the Global Start-Up Unit at Indero, brings more than 24 years of experience in clinical research to our discussion. Esther provides\u00a0expert\u00a0perspective on the vital role of a strong startup team in clinical trials, shares the key factors that contribute to team effectiveness, and highlights strategies [&hellip;]<\/p>\n","protected":false},"featured_media":16950,"parent":0,"template":"","meta":{"_acf_changed":false,"inline_featured_image":false},"podcast-category":[344],"class_list":["post-26355","podcast","type-podcast","status-publish","has-post-thumbnail","hentry","podcast-category-season-5"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Episode 39: Esther Sanchez - Building a Robust Startup Unit in Clinical Trials | Indero<\/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:\/\/inderocro.com\/fr\/podcast\/episode-39-building-a-robust-startup-unit-in-clinical-trials\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Episode 39: Esther Sanchez - Building a Robust Startup Unit in Clinical Trials | Indero\" \/>\n<meta property=\"og:description\" content=\"\ufeff &nbsp; In this episode, Esther S\u00e1nchez, Associate Director of the Global Start-Up Unit at Indero, brings more than 24 years of experience in clinical research to our discussion. 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