{"id":3802,"date":"2018-02-23T17:42:51","date_gmt":"2018-02-23T22:42:51","guid":{"rendered":"http:\/\/www.imperialcrs.com\/blog\/?p=3802"},"modified":"2023-12-12T17:30:16","modified_gmt":"2023-12-12T17:30:16","slug":"outsmartbigdogs","status":"publish","type":"post","link":"https:\/\/www.imperialcrs.com\/blog\/business-insights\/outsmartbigdogs\/","title":{"rendered":"3 Ways to Outsmart the Big Dogs as You Move into the Clinic"},"content":{"rendered":"<p>You\u2019ve done all the background work. You\u2019ve navigated the complex U.S. regulatory environment and achieved investigational new drug approval. You\u2019ve secured investors and assembled your core team. You are now preparing for the next big milestone for your burgeoning biopharmaceutical company \u2013 entering the clinic. It\u2019s an exciting step, filled with potential, excitement and a lot of peril. Many companies don\u2019t make it past phase 1, let alone into proof of concept and pivotal studies. You\u2019re going to be different.<\/p>\n<p>Hey, the fact is that you\u2019re small and you\u2019re now swimming in a large ocean of big-time companies, all vying to enroll their studies\u2014possibly competing directly with yours, or at least creating a lot of waves to navigate. Your size can be a tremendous advantage, especially when it relates to overcoming one of the largest pitfalls of ANY size company running clinical trials; enrolling study subjects on time. Delayed enrollment represents one of the biggest risks in the successful completion of a trial. The good news is there are things you can do.<\/p>\n<p>If you\u2019re in the greater Toronto area on March 20, you can learn more by joining us at JLABS @ Toronto for a special session. Click <a href=\"https:\/\/www.eventbrite.com\/e\/surviving-the-transition-to-clinical-trials-tickets-42234302937\">here<\/a> for information about this event.<\/p>\n<p>Until then, here are three key considerations to keep in mind when taking your drug to trial:<\/p>\n<p><strong>Proactive Planning:<\/strong> In a 2017 survey of 400 clinical operations executives from mostly large biopharmaceutical companies, it was revealed that 45 percent of those companies didn\u2019t develop their own proactive recruitment plans. Yet more than 85 percent of trials are delayed due to slow or no enrollment. By putting a proactive plan in place, you are immediately taking a critical step that others have missed because of a variety of reasons; not one of them being that it\u2019s not smart. In fact, if you attend the event in Toronto, you\u2019ll see a case study demonstrating the significant cost savings that can be achieved by developing a proactive recruitment plan vs. waiting and facing a rescue situation. It\u2019s tens of thousands of dollars.<\/p>\n<p><strong>Treat Sites Like Your Best Clients:<\/strong> Your study sites are on the very front lines of clinical research and patient enrollment. There is no recruitment program in existence that can overcome sites that don\u2019t enroll patients. Study sites are filled with hard working <em>people<\/em>. Guess what? People like attention, support and to feel like they are heard and respected. Many large trial sponsors have lost sight of this fact and their studies suffer for it. You can immediately differentiate your study by engaging your sites and getting their feedback and opinions before, during and after the trial. Regular communication, on-time payments and low\/no-cost acts of recognition all go a long way towards keeping sites focused on your study and enthusiastically enrolling subjects into YOUR study.<\/p>\n<p><strong>Treat Study Volunteers Like a Critical Partner in the Trial:<\/strong> Quite simply, without individuals consenting to participate in your trial and remaining engaged and compliant with study requirements, you\u2019re dead in the water. Like sites, study volunteers are a critical partner in the success of your study. Treat them as such. There are a lot of things you can do to make sure that they are educated properly about your study, consented correctly, communicated with frequently and supported consistently.<\/p>\n<p>We hope you can join us at the JLABS @ Toronto event on March 20, where we will present more specifics on keeping study subjects engaged.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>You\u2019ve done all the background work. You\u2019ve navigated the complex U.S. regulatory environment and achieved investigational new drug approval. You\u2019ve secured investors and assembled your core team. You are now preparing for the next big milestone for your burgeoning biopharmaceutical company \u2013 entering the clinic.&hellip;<\/p>\n","protected":false},"author":7,"featured_media":69595,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[22,43],"tags":[1529,1533,1528,1532,575,458,1534,1527,1531,1530],"class_list":["post-3802","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-business-insights","category-events","tag-biopharmaceutical-innovation","tag-biotech-industry-strategies","tag-clinical-research-advancements","tag-clinical-research-tactics","tag-clinical-trial-planning","tag-clinical-trial-strategies","tag-drug-development-challenges","tag-drug-development-tactics","tag-drug-development-trends","tag-pharma-industry-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>3 Ways Your Company can Outsmart the Big Dogs as You Move into the Clinic\u2026. and Enroll Your Study On Time!<\/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:\/\/www.imperialcrs.com\/blog\/business-insights\/outsmartbigdogs\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"3 Ways Your Company can Outsmart the Big Dogs as You Move into the Clinic\u2026. and Enroll Your Study On Time!\" \/>\n<meta property=\"og:description\" content=\"You\u2019ve done all the background work. 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You are now preparing for the next big milestone for your burgeoning biopharmaceutical company \u2013 entering the clinic.&hellip;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.imperialcrs.com\/blog\/business-insights\/outsmartbigdogs\/\" \/>\n<meta property=\"og:site_name\" content=\"Imperial Clinical Research Services Blog\" \/>\n<meta property=\"article:published_time\" content=\"2018-02-23T22:42:51+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-12-12T17:30:16+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.imperialcrs.com\/blog\/wp-content\/uploads\/2018\/02\/Three-key-considerations-to-keep-in-mind-when-taking-drug-to-trial.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"800\" \/>\n\t<meta property=\"og:image:height\" content=\"495\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Dan McDonald\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta 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