The Medicine Maker’s Post

Increasingly Sponsors and CRO's are choosing #Zelta by #Merative for their clinical studies. Zelta supports studies across all phases. If you are planning to run a clinical study, then you should consider #Zelta

Curious about the driving force behind successful clinical trials? Explore our latest blog, "What is the role of a CRO in a clinical trial?" for a deep dive into how Contract Research Organizations navigate challenges, accelerate innovation, and help bring new therapies to market. Uncover the CRO impact: https://lnkd.in/gh2dQFW8

Celebrate #ClinicalTrialsDay today by checking out the newly released Toward a National Action Plan for Achieving Diversity in Clinical Trial, which includes eight domains and action steps intended to drive system-wide collective action. The need to improve diversity in clinical trials has been evident for many years, but a multi-sector action plan for system-wide, sustainable change was lacking. This foundational document is a call to collective action that has been (and continues to be) informed by the shared wisdom of hundreds of leaders in health equity and representation involved in a series of convenings over the last year. These include meetings held by the Clinical Trials Transformation Initiative (CTTI) in June 2023, the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center) in September 2023, Milken Institute’s FasterCures in November 2023, and the meeting today May 20, 2024, hosted by the National Academies Forum on Drug Discovery, Development, and Translation Forum on Drug Discovery, Development, and Translation. We call on each of us from across the clinical research enterprise to step forward and commit to working together to implement this National Action Plan and achieve representative clinical trials.  https://bit.ly/3UXTsVs

Celebrate #ClinicalTrialsDay today by checking out the newly released Toward a National Action Plan for Achieving Diversity in Clinical Trial, which includes eight domains and action steps intended to drive system-wide collective action. The need to improve diversity in clinical trials has been evident for many years, but a multi-sector action plan for system-wide, sustainable change was lacking. This foundational document is a call to collective action that has been (and continues to be) informed by the shared wisdom of hundreds of leaders in health equity and representation involved in a series of convenings over the last year. These include meetings held by the Clinical Trials Transformation Initiative (CTTI) in June 2023, the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center) in September 2023, Milken Institute’s FasterCures in November 2023, and the meeting today May 20, 2024, hosted by the National Academies Forum on Drug Discovery, Development, and Translation Forum on Drug Discovery, Development, and Translation. We call on each of us from across the clinical research enterprise to step forward and commit to working together to implement this National Action Plan and achieve representative clinical trials.  https://bit.ly/3wjll0y

Delve into adaptive protocol design with our experts, and learn how you can propel your clinical trial forward from the start. » https://bit.ly/3NeqYCw #drugdevelopment #clinicaltrial #clinicalresearch #earlyclinicaldevelopment

Is clinical trial contracting a bottleneck in the journey from lab innovation to market-ready products? Biotechs active in pre-clinical or clinical research often lack sufficient in-house resource capacity and expertise to anticipate, design, and prepare for multi-jurisdictional clinical trial agreements. In an industry that has innovation in its DNA, the leap to more advanced contracting strategies is a logical progression. In a new article for Applied Clinical Trials Magazine, Factor’s Ann Heidger Pequeño outlines how biotechs can innovate their approach to clinical trial agreements to streamline research, reduce delays, and bring vital therapies to market faster. Read it here: https://ow.ly/hLc050RZV1s

The industry is reliant on data ✅ Technology, collaboration & awareness are all key for improvement ✅ There’s a greater need for harmonization across markets ✅

More positive momentum around community-oriented research from Eli Lilly and Company's Rob Metcalf in Fierce Biotech. The push towards community-centered trials took off with Covid, but the real opportunity lies in moving research into a new phase entirely. For community physicians and patients, this means: significant and dedicated operational support (think “lean ops”), a reduced upfront financial burden for providers; efficient staffing and staff retention; legal and compliance infrastructure; and an overall new understanding of clinical research as a meaningful care line for systems and practices. https://lnkd.in/gF9iS55q

OrphoMed Inc., a clinical-stage biopharmaceutical company developing first-in-class dimer therapeutics, today announced positive results from the recent Phase 2 study of ORP-101 for treatment of irritable bowel syndrome with diarrhea (IBS-D). The double-blind, placebo-controlled, 12-week response adaptive randomization study investigated once-daily doses of 100 mg and 50 mg of ORP-101 vs. placebo. The 100 mg dose was more effective than placebo, whereas the 50 mg dose did not achieve statistical separation. Overall, ORP-101 was safe and well tolerated in all patients. Importantly, ORP-101 was also effective and safe in post-cholecystectomy IBS-D patients at the 100 mg dose throughout the treatment period. https://lnkd.in/dagFrEjm

🔍 Mastering Master Protocols in Clinical Trials 🔍 We're excited to share insights from the #DIA2024 conference, where industry leaders discussed the transformative potential of master protocols. At SDC Clinical, we specialize in leveraging these innovative trial designs to enhance efficiency and effectiveness in drug development. Our latest blog explores how master protocols can streamline your clinical trials and bring therapies to market faster. 👉 Read the full blog: https://bit.ly/3VMwh0D Discover how SDC Clinical can guide your innovations and help you navigate the complexities of modern clinical trials. Let's drive change together! #ClinicalTrials #MasterProtocols #InnovationInResearch #SDCClinical