Oncospire Consultants LLC

Attending ASCO? Let's meet up!

Our CEO is challenging the LinkedIn Clinical Drug Development community to identify the 50 top pain points of running Clinical Trials. We are looking forward to great participation! ??

Final day of the Head & Neck Cancer Alliance Move-a-thon As the sun sets on the last day of the Head and Neck Alliance move-a-thon, I'm at the finish line, full of thanks and with sneakers covered in dust from my hard work. ?? Today isn't just about finishing a journey; it's about what we can do when we join forces for something bigger than ourselves. I started aiming to cover 150 miles by walking, cycling, and hiking. With each step and pedal, I felt stronger and went past my goal, reaching 223 miles yesterday. ??♂??? I'm so grateful for all the support this past week. A kind donor helped me raise \$125, almost hitting my $150 target. This generosity doesn't just help me—it also supports the amazing work of the Head and Neck Cancer Alliance. You can still donate today as I aim for 230 miles! Just click this link https://lnkd.in/eAaqtN74 Thinking about how our efforts will help the Gas Card program, which lets patients travel for treatment; the Screening program, catching cancer early; the Peer to Peer and Ambassador programs, offering support and friendship; and patient education and research to fight head and neck cancer—this is the real win of our shared effort. ??? Thank you so much for donating, cheering, and believing. Let's keep going together, step by step, because together, #WeCanMakeADifference. ?? #HeadAndNeckCancerAlliance #Moveathon #CancerAwareness #FundraisingSuccess #CommunitySupport #TogetherWeAchieveMore

Countdown to Impact: 5 Days Left in the April Head and Neck Cancer Alliance Move-a-thon ??♀??? As the sun sets on this pivotal month, our shared journey of compassion and support takes on a more urgent pace. There are just 5 days left to contribute to a cause that’s much more than a statistic; it's a lifeline for those battling head and neck cancer. I set out with an ambition – a concise, yet significant goal of raising $150 through the Move-a-thon. This sum symbolizes hope – the equivalent of a night at a hotel for a travelling patient or easing the burden covering some essentials on treatment day. Each donation is a beacon of comfort, providing essentials like a gas card, parking, lunch, and sometimes the priceless gift of child care. While the road ahead is paved with possibility, the present moment reflects a challenging truth. I currently stand at 83% of my fundraising target. "The distance between where we are and where we aspire to be is measured not in miles but in moments of generosity." I humbly ask you to consider the value of your daily coffee – could it instead fund a gesture of immense value? A few dollars could mean the world to someone enduring the most challenging fight of their life. Together, we can fill these last few days with action and purpose. Let's rally to offer more than just relief; let’s provide a sanctuary of support for at least one patient in need. To donate, simply click on the link https://lnkd.in/e_d95i2c Your contribution, no matter the size, will weave into the tapestry of someone’s survival story. Let's make these remaining days count! Thank you for standing with me, for them. #HeadAndNeckCancer #HNCA #Moveathon #Support #Donate #CancerCare #MakeADifference

?? Pedaling with Purpose: My Palm Springs Experience on "Coral" the bike! ?? Amid the sun-kissed vistas of Palm Springs, I found a friend in Coral, my trusty rented bicycle. Together, we embarked on a journey that was not just about reveling in the beauty around us but also about contributing to a cause much bigger than ourselves. Over the course of 5 days, Coral ?? and I traversed an impressive 42 miles! That's an average of 8 miles per day, weaving through bustling cityscapes, a desert oasis and the iconic neighborhoods once strolled by Old Hollywood legends. In this oasis of tranquility, we didn't just ride – we celebrated life, honored battles fought, and propelled forward the message of hope with each pedal stroke. This getaway turned into a moving testament to what we can achieve when we marry our passions to purpose. Let's keep the wheels moving and the support flowing! I invite you all to join me in this journey by supporting my cause. Any donation you make through the link below will go a long way in aiding those affected by Head and Neck cancer. ???? https://lnkd.in/e_d95i2c Together, we can make a difference ??? #Moveathon #CyclingForACause #HeadAndNeckCancerAwareness #PalmSprings #BicycleAdventures #StayActive

Our Founder is in "Just Do It" mode!

?? Understanding the Blueprint of Success in Clinical Trials: Clinical Development Plan vs. Single Study Operational Plan ?? Wednesday Clinical Operation Wisdom #5 In the quest for medical breakthroughs, understanding the strategic underpinnings of clinical trials is key. Let's delve into the essence of two critical components: ? Clinical Development Plan (CDP) ? A CDP is your holistic roadmap, encompassing the entire journey of a drug from preclinical phases to post-marketing. It weaves together scientific rigor, regulatory strategies, and a vision for commercialization. ?? Key elements include (see prior post for details): - Long-term goals and milestones - Risk assessment and mitigation strategies - Regulatory pathways across different regions - Integrated analysis of target patient populations - Preclinical summaries and Pharmacology - Dosage & pharmaceutical forms - Safety profile (class or molecule specific) The CDP encapsulates the 'big picture', ensuring that every clinical trial not only serves its immediate purpose but also contributes cohesively to the ultimate goal of bringing a therapy to market. It is a document that evolve with the information of each trial, informs decisions and long-term plans to be confirmed. ? Single Study Operational Plan (OP) ? Zoom into the magnifying glass of clinical research and you find the OP. This is your tactical execution guide for individual studies. ?? It covers specifics such as: -Timelines and budget allocation for a specific trial -Recruitment strategies for participants -Special testing such as PK/PD/ Biomarker strategies -Data collection methods and management processes -Monitoring and clinical trial supply estimates -Risk identification and mitigation -Site and vendor selection An OP functions as a highly detailed instruction manual that ensures day-to-day operations align with the broader objectives outlined in the CDP. ?? Are Both Necessary When Resources Are Tight? In times of limited resources, prioritizing becomes imperative. However, sacrificing either plan isn't an option. The CDP ensures long-term success while the OP guarantees the integrity and quality of immediate results. Skimping on one can compromise the whole development process, leading to increased costs down the line or even failure to bring a much-needed drug to patients. ?? Think of the CDP as the architect's master blueprint and the OP as the contractor's daily schedule. Both are crucial; the former sets the vision while the latter realizes it, brick by brick. Let's navigate resource constraints with wisdom, ensuring that every step we take is measured, meaningful, and meticulously planned. After all, in the world of clinical development, precision and foresight spell the difference between a groundbreaking therapy and a missed opportunity. ?? Remember, greatness often stems from the strength of one's foundation! #ClinicalDevelopment #OperationalExcellence #PharmaIndustry #StrategicPlanning #ResourceManagement

Wednesday Clin Ops Wisdom #4 In the ever-evolving landscape of clinical trials, we've witnessed firsthand the challenges brought on by resource constraints, both in headcount and budget. These limitations invariably impact the planning process of clinical trials, restricting the time and effort we can allocate to this crucial activity. Fortunately, platforms like LinkedIn offer a glimmer of hope, providing preliminary guidance and support to kick-start clinical development and tactical plans. Through some research, I've discovered valuable resources that could serve as an initial framework for your team: ? One resource that stands out, notably for its clear visual roadmap, is offered by the team at Cytel: How to Create and Optimize a Clinical Development Plan – Cytel, August 2023 ?? https://lnkd.in/en2mtSJv Navigating the Clinical Development Journey: From Planning to Approval https://lnkd.in/e5M3_V34 For Medical devices from an EU perspective, uncovering the relationship between the Clinical Development Plan (CDP) and Clinical Evaluation Plan (CEP): https://www.emwa.org/ EMWA - Medical Writing, June 2022, Vol 31, Number 2, page 32-33 For Medical devices - Useful tips for devising Clinical Development Plan: https://lnkd.in/dFc8m4CN ? Tactical plans essentials: 1. Statistical Analysis plan (SAP) [GR1]?- From development to execution: Statistical Analysis Plan (SAP): Development to Execution[GR2]?: 2. Essentials of a Clinical Monitoring plan – LinkedIn post by Alec Spinelli https://lnkd.in/eSEF_dAM]? ? To further bolster your Clinical Development plan, do not overlook: The pivotal importance of Key Opinion Leaders (KOL's) in Clinical Development: <iframe src="https://lnkd.in/e2YRCaS2" height="869" width="504" frameborder="0" allowfullscreen="" title="Embedded post"></iframe>[GR4] These are just starters ?? but can significantly influence the effectiveness and efficiency of your clinical trial planning. Let's continue to share and grow our knowledge base for better outcomes in clinical development. #ClinicalOperations #ClinicalDevelopmentPlan #ClinicalTrials #ResourceManagement

Now that we have determined that having a clinical development plan sets teams up for success and that we can develop it using 8-10 major categories, let’s pause and take a poll:

I always love to get feedback, I am looking forward to hearing from you!