ESTERN Medical CRO Life Sciences a Clinical Contract Research Organization | USA & Latin America |’s Post

🧬 Embracing Diversity in Clinical Trials: A Tale of Two Americas 🌎 We at ESTERN Medical CRO Life Sciences, enhancing the safety & effectiveness of Pharmaceutical & Medical Device treatments is our priority. The diversity in clinical trials is key to this mission, with distinct differences between the landscapes in "US North America & Latin America." Understanding these distinctions is crucial for inclusive healthcare solutions. "US North America: Inclusion and Representation": In the United States and Canada, there's a strong focus on diversity in clinical trials. Regulatory agencies like the FDA emphasize including participants from various racial, ethnic, and socioeconomic backgrounds to: *Ensure Treatments Work for Everyone: Different populations may react differently to treatments. *Address Health Disparities: Including underrepresented groups helps tackle health disparities. *Enhance Scientific Validity: A diverse population leads to more accurate clinical trial outcomes. "Latin America: A Unique Opportunity": Latin America is becoming a significant hub for global clinical trials, offering diverse patient populations and a growing research infrastructure. Key aspects include: *Diverse Genetic Background: The region's population provides valuable genetic variability. *Rapid Enrollment: High population density often leads to faster patient enrollment. *Economic Considerations: While cost-efficient, economic disparities and healthcare access challenges can impact trial participation and follow-up. "Why It Matters: The Power of Diversity" Diversity in clinical trials isn't just a regulatory requirement; it's essential for developing safe and effective therapies for all. As we expand across both US North America and Latin America, we must tailor our approaches to each region’s unique characteristics, ensuring comprehensive and inclusive studies. Let's champion diversity in clinical trials, breaking barriers and building a healthier, inclusive future for everyone. "Join Our Conversation!" What are your thoughts on the importance of diversity in clinical trials? How can ESTERN Medical CRO Life Sciences improve representation in US North America and Latin America? Share your experiences and insights below! 👇 #DiversityInResearch #Inclusion #NorthAmerica #GlobalHealth #biotech #biotechs #boston #california #clinicaldevelopment #clinicalresearch #clinicalresearchorganization #clinicalstudies #clinicaltrials #cro #cros #drugdevelopment #emergingmarkets #estenmedical #europe #france #germany #globalhealthcare #healthcare #healthcareIndustry #healthcareinnovation #internationalcro #japan #latinamerica #latam #latamcro #lifesciences #lifesciencesinnovation #massachusetts #medicaldevices #medicalresearch #medicalsciences #medicine #medtechs #netherlands #newengland #newjersey #northcarolina #northerncalifornia #pharmaceuticalindustry #researchanddevelopment #rtp #sanfrancisco #sandiegoca #scientificresearch #spain #sweden #switzerland #texas #uk

Brazil's diverse population is a significant asset for medical device trials, offering a rich tapestry of genetic profiles that enhance the relevance and inclusivity of clinical data. With over 215 million people from various ethnic backgrounds, Brazil is a prime location for rare disease studies and personalized medicine. The country’s advanced healthcare infrastructure and strategic regulatory improvements, like the New Brazilian Clinical Research Law, streamline the trial process, making it appealing for global manufacturers. Bioaccess® is uniquely positioned as the only Medtech CRO in Latin America specializing in early feasibility clinical trials in Brazil, helping startups navigate this promising landscape. 🌎💡 #Medtech #ClinicalTrials

Clinical Trialist - Physicians: Exciting Opportunity for a Clinical Research Career at a Well-Established Center in the Indianapolis Area. Even though I have been a principal investigator for >35 years for 550 trials in the cardio-metabolic area (more planned this year), I am mystified that this career choice has been ignored by the medical community in general. This has been significantly hampered by being employed by one of the different hospital systems in town. As a private business: (Remember when physicians were independent and had their own practice!!) 1.    One does not have a non-compete contract. 2.    One gets to pick and choose the appropriate trials in which to participate. 3.    One is not forced to see 20-30 patients a day to keep the bean counters happy. 4.    One has access to the new medications that one hopes will have a positive impact for people’s lives. Here are a couple of examples which have been exciting for me: Regarding every new cholesterol lowering drug on the market, I have been in one or more of the trials prior to drug approval (230 lipid trials). Regarding the new obesity medications (the GLP-1 and GLP-1 combinations), I have been in 12 trials so far and will participate in several more new ones, still this year. So, if physician/independent medical group might want to get involved, I would love to discuss opportunities that would be available.

Latin America offers a promising landscape for medical device clinical trials, presenting significant economic opportunities for researchers and companies alike. With a projected market growth from USD 521.2 million in 2023 to USD 950.0 million by 2030, the region is evolving rapidly. Key advantages include cost efficiencies of up to 75% compared to US rates and a diverse population base exceeding 650 million. Patient retention rates are notably higher, three times better than in the US and EU, making it a compelling choice for trials. However, navigating the regulatory landscape can be complex. bioaccess® provides robust solutions, simplifying early feasibility studies and first-in-human trials. Their strategic framework helps in overcoming regulatory hurdles, leveraging local partnerships, and ensuring quality management. For medical device startups looking to explore these opportunities, bioaccess® stands ready to guide you through the process, making Latin America a viable option for clinical advancements. #Medtech #ClinicalTrials https://lnkd.in/eATXg4EH

Ensuring diversity in clinical trials is more than just a goal—it's a necessity for accurate and equitable healthcare outcomes. Why patient diversity in clinical trials matters, who should be concerned, and what can be done to enhance inclusivity? Why It Matters: Diverse patient representation leads to more accurate and generalizable data, ensuring treatments are effective for all populations. Who Should Be Concerned: Everyone involved in clinical research, from pharmaceutical companies to regulatory bodies, must prioritize diversity. What Can Be Done: Implementing culturally sensitive recruitment strategies and engaging with diverse communities are essential steps forward. At CSOFT Health Sciences, we recognize the critical role that language and culture play in this process. Our expert clinical trial translation services ensure that all patients, regardless of their background, can participate fully and understand every aspect of their involvement. By breaking down language barriers, we help make clinical trials truly inclusive. Discover more about how we can drive diversity in clinical trials together ⬇️⬇️ https://ow.ly/5XNx50RPgM2 #ClinicalTrials #Diversity #HealthEquity #PatientInclusion #ClinicalTrialTranslations #MedicalResearch #CSOFTHS

🧬 Embracing Diversity in Clinical Trials: A Tale of Two Americas 🌎 At ESTERN Medical CRO Life Sciences, we believe that diversity in clinical trials is not just a value; it's a necessity. As we navigate the distinct landscapes of clinical research in both US North America and Latin America, our commitment to inclusivity remains unwavering. *US North America: Inclusion and Representation In the “United States”, we strive to include participants from diverse racial, ethnic, and socioeconomic backgrounds. This not only ensures that treatments work effectively for everyone but also addresses critical health disparities. The rich diversity of our participant pool enhances the scientific validity of our research, leading to more accurate and reliable outcomes. *Latin America: A Unique Opportunity In “Latin America”, we recognize the region's growing significance in the global clinical trials arena. The diverse genetic background and rapid patient enrollment potential offer invaluable insights. However, we are also mindful of the unique challenges, such as economic disparities and healthcare access, that can affect trial participation and follow-up. Our approach is simple: tailor our strategies to each region's unique characteristics to ensure comprehensive and inclusive studies. We are committed to breaking down barriers and building a future where every patient has a voice in shaping healthcare solutions. Let's continue to champion diversity in clinical trials together. Your experiences and insights are vital as we work towards a healthier, more inclusive future for all. *Join the Conversation! What are your thoughts on the importance of diversity in clinical trials? How can ESTERN Medical CRO Life Sciences improve representation in US North America and Latin America? Share your experiences and insights below! 👇 #DiversityInResearch #Inclusion #NorthAmerica #GlobalHealth #biotech #biotechs #boston #california #clinicaldevelopment #clinicalresearch #clinicalresearchorganization #clinicalstudies #clinicaltrials #cro #cros #drugdevelopment #emergingmarkets #estenmedical #europe #france #germany #globalhealthcare #healthcare #healthcareIndustry #healthcareinnovation #internationalcro #japan #latinamerica #latam #latamcro #lifesciences #lifesciencesinnovation #massachusetts #medicaldevices #medicalresearch #medicalsciences #medicine #medtechs #netherlands #newengland #newjersey #northcarolina #northerncalifornia #pharmaceuticalindustry #researchanddevelopment #rtp #sanfrancisco #sandiegoca #scientificresearch #spain #sweden #switzerland #texas #uk #usa

In an op-ed published in BioCentury Inc. May 14, Gigi Hirsch of NEWDIGS Initiative at Tufts Medical Center and Jane F. Barlow, MD, MPH, MBA of Real Endpoints make the case that the only way to have our cake (medical innovation) and to be able to eat it (afford the innovation) is to increase health efficiency – that is, capturing the full value of medical products. And that means consistently doing the following: using the innovations where they’re needed; not using them where they’re not needed; innovating in the use of cheaper medicines and investing in systems changes to support their use. Reducing drug costs alone, with blunt instruments like the IRA, isn’t going to create the investment incentives that result in therapies that will make people healthier. Similarly, pursuing innovative science without also investing in innovations in health efficiency creates a vicious circle where cost containment becomes the primary rallying cry. Hirsch and Barlow suggest, as a start, three ways to begin to break this vicious circle: 1. Recommit to precision medicine (in particular, make diagnostic-driven drug therapy routine medical practice); 2. Build infrastructure to scale value-based payments; 3. Where applicable, repurpose generic drugs to save lives and lower costs. By catalyzing multi-stakeholder collaborations, drug companies have an opportunity to play a leading role accelerating healthcare efficiency in these three areas. As the authors rightly point out, drug companies also have much to gain by helping the overall system catch up with science. After all, what’s the point of a breakthrough that doesn’t reach ALL the patients who need it? #healthcare #value #innovation #efficiency #drugpricing #newmodels #healthcaredelivery #affordability #BioCentury #editorial cc Roger Longman Jeff Berkowitz Michael Sherman Brian Reid Gigi Hirsch Jane F. Barlow, MD, MPH, MBA Mark Trusheim https://lnkd.in/g2naerXA  

Diversity in clinical trials is crucial for accurate healthcare outcomes. CSOFT Health Sciences is committed to promoting inclusivity through clinical trial translations. Learn more about the importance of patient diversity and our role ⬇ https://ow.ly/M20U50RPhSf

💰 Drug and Medical Device Companies Paid U.S. Physicians $12.1 Billion Over Last 10 Years A new report also shows that Big Pharma is targeting social media users with subtle promotional activities, such as sponsored patient influencers and “help-seeking” treatment ads that often contain misleading and poor-quality health information. The International Federation of Medical Students’ Associations has also demanded that universities implement conflict of interest policies and restrict industry marketing and the presence of industry representatives in learning environments. Still, more action is needed to mitigate health harms due to industry influence and protect patients and the integrity of healthcare in the U.S. and globally, the researchers say. Their recommendations include: Explicit institutional policies that promote and sustain independent decision-making (such as eliminating gifts and industry-sponsored meals). Making individual training on conflicts of interest arising from industry payments a mandatory part of curriculums in medical schools and residency programs. Educational interventions teach students and fellows how to critically assess drug industry-provided information and seek independent sources. Robust, enforceable processes to prevent or manage conflicts of interest arising from financial and gift relationships with industry. Healthcare institutions, they conclude, “must acknowledge the extent of commercial influence in healthcare and the risk of patient harm and prioritize building health systems and practice environments that preserve the integrity and independence of all clinical decision making.” Read more from U.S. Right to Know ⬇️ https://lnkd.in/eY9eeiHr