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

🌍 Emerging Powerhouse: Latin America’s Impact on FDA-Regulated Clinical Research 🌎 We’re excited to share the Second Edition of our newsletter, where we explore the dynamic and evolving landscape of global clinical trials. This issue dives into Latin America’s Growing Role in FDA-Regulated Clinical Trials, highlighting the region’s emergence as a key player in life sciences. Did you know that nearly 80% of FDA-regulated clinical trials are now conducted outside the U.S.? Latin America has become a preferred destination, offering: ✅ Cost-efficiency and operational flexibility ✅ Access to diverse patient populations ✅ Talented investigators trained to global standards At @ESTERN Medical, we’ve been at the forefront of this shift, investing early in the region to build a robust clinical research infrastructure. Latin America is deeply embedded in our DNA, and this edition underscores how we’re empowering sponsors to thrive in this vibrant, fast-growing market. 📍 Highlights include: • Key opportunities in Mexico, Colombia, Chile, Argentina, and Brazil • The unique advantages of conducting clinical trials in the region • Strategic recommendations for navigating challenges, from regulatory frameworks to cultural sensitivities Discover how our tailored Functional Service Model (FSM) supports life sciences companies in delivering high-quality, efficient clinical trials. 🌟 Let’s unlock the potential of Latin America together! 📖 Read the full newsletter here: [Link] 💡 We’d love your feedback—let us know your thoughts on this edition! #ClinicalResearch #LatinAmerica #LifeSciences #CRO #GlobalHealth #FDA #Innovation

Introducing Our First Company Newsletter: COVID-19 & Long COVID Vaccine Development. #AfroDescendantHealth #Biotech #BiotechInnovation #bigcro #Boston #California #Canada #ClinicalDevelopment #ClinicalRegulatory #ClinicalResearch #ClinicalResearchOrganization #ClinicalResearchTrials #ClinicalStudies #ClinicalTrialManagement #ClinicalTrials2024 #Compliance #COVID19 #COVIDComparativeAnalysis #CRO #CROLatinAmerica #CROLifeSciences #CROServices #CulturalCompetency #DEI #DiversePopulations #DiversityInResearch #DrugDevelopment #EmergingMarkets #ESTERNMedical #Europe #FDA #FDAStandards #France #Genetown #GeneticDiversity #Germany #GlobalHealth #GlobalHealthcare #GlobalTrials #GTM #HealthInnovation #Healthcare #HealthcareAccess #HealthcareEquity #HealthcareIndustry #HealthcareInsights #HealthcareTech #HealthcareTransformation #InclusiveResearch #IndigenousHealth #Innovation #InternationalCRO #Japan #LATAM #LATAMCRO #LatinAmericaClinicalTrials #LatinxHealth #LatinxRepresentation #largecros #LifeSciences #LifeSciencesInnovation #LongCOVID #LongCOVIDResearch #Massachusetts #MedicalAdvancements #MedicalDevices #MedicalResearch #MedicalSciences #Medicine #MedTechs #mRNA #Netherlands #NewEngland #NewJersey #NorthCarolina #NorthernCalifornia #PandemicResponse #PatientDiversity #PatientEngagement #Pharma #PharmaResearch #PharmaTechSolutions #PharmaceuticalIndustry #Pharmaceuticals #PharmaUpdates #PopulationHealth #ProteinSubunit #PublicHealth #RegulatoryCompliance #ResearchAndDevelopment #ResearchInnovation #RTP #SanDiegoCA #SanFrancisco #ScientificResearch #smallcro #SouthAmerica #SouthernCalifornia #Spain #Sweden #Switzerland #Texas #TrialDiversity #UK #USA #USFDACompliance #VaccineDevelopment #VaccineDiversity #ViralVecto

The FDA's Diversity, Equity, & Inclusion (DEI) Mandate: Strategies to Accelerate R&D Diversity Initiatives, Achieve Enrollment Goals, and Enhance Data Collection in Clinical Trials across Latin America and the U.S. 🌎   Unlocking the Future of Clinical Trials: Diversity, Efficiency, and Inclusion Pharma, Biotech, and Medical Device companies: Are your clinical trials reflecting the real-world diversity that drives meaningful healthcare outcomes? With nearly 20% of the U.S. population identifying as Latinx, bridging gaps in Latin American representation is more essential than ever. Conducting trials in Latin America, where diversity is embedded in the population, enables companies to meet U.S. FDA standards while streamlining costs and reducing dropout rates. With populations of European, Mixed (Mestizo), Indigenous, Asian, and Afro-descendant backgrounds, Latin America provides a comprehensive representation of genetic and environmental factors. Latin America Snapshot as of 2024: *Population: 670 million Diverse Composition: *Mestizo (mixed ancestry with White European and Indigenous): 60% *European descent: 20% *Indigenous: 10% *Afro-descendant: 7% *Asian and other groups: 3% Let’s create impactful, inclusive research that drives real-world change. Ready to enhance your clinical trials? Let’s discuss how we can partner to achieve your goals and ensure your success! Learn More: https://lnkd.in/drEYHabf AfroDescendantHealth #Biotech #BiotechInnovation #bigcro #Boston #California #Canada #ClinicalDevelopment #ClinicalRegulatory #ClinicalResearch #ClinicalResearchOrganization #ClinicalResearchTrials #ClinicalStudies #ClinicalTrialManagement #ClinicalTrials #ClinicalTrials2024 #Compliance #CRO #CROLatinAmerica #CROServices #CulturalCompetency #DiversePopulations #DiversityInResearch #DrugDevelopment #EmergingMarkets #ESTERNMedical #EsternCRO #Europe #FDAStandards #France #Genetown #GeneticDiversity #Germany #GlobalHealth #GlobalHealthcare #GlobalTrials #GTM #Healthcare #HealthcareAccess #HealthcareIndustry #HealthcareTech #HealthcareTransformation #InclusiveResearch #IndigenousHealth #Innovation #InternationalCRO #Japan #LATAM #LATAMCRO #LatinAmericaClinicalTrials #LatinxHealth #LatinxRepresentation #largecros #LifeSciences #LifeSciencesInnovation #Massachusetts #MedicalDevices #MedicalResearch #MedicalSciences #Medicine #MedTechs #Netherlands #NewEngland #NewJersey #NorthCarolina #NorthernCalifornia #PatientDiversity #PatientEngagement #Pharma #PharmaResearch #PharmaceuticalIndustry #Pharmaceuticals #PharmaTechSolutions #PopulationHealth #RegulatoryCompliance #ResearchAndDevelopment #ResearchInnovation #RTP #SanDiegoCA #SanFrancisco #ScientificResearch #smallcro #SouthAmerica #SouthernCalifornia #Spain #Sweden #Switzerland #Texas #TrialDiversity #UK #USA #USFDACompliance #denmark #DEI #FDA

Experience the Future of Healthcare Life Sciences Go-to-Market (GTM) for Pharma, Biotech’s & Medical Devices. Revolutionize Healthcare with Advanced Life Sciences “GTM” Commercialization Solutions. In today’s fast-paced and competitive pharmaceutical, biotech, medical device R&D, and life sciences industry, strategic partnerships are critical to staying ahead. Navigating the complexities of regulatory compliance can be overwhelming, but innovative CRO expertise gives you the competitive edge. Discover how purpose-built solutions are transforming the way life sciences companies interact with healthcare providers: - Leverage ESTERN Medical's Life Sciences CRO expertise to streamline third-party compliance and cut down “GTM” operational costs. - Identify key features of a powerful life sciences CRO with a proven track record for managing healthcare interactions efficiently “global or international GTM”. - Manage and monitor interactions for biotech, pharmaceutical, or medical device “GTM products”—all in one place Take control of your international healthcare provider relationships with smarter, faster, and more efficient GTM solutions. - "Learn More": https://lnkd.in/dV7pFeyN #Biotech, #bigcro, #Boston, #California, #Canada, #ClinicalDevelopment, #ClinicalRegulatory, #ClinicalResearch, #ClinicalResearchOrganization, #ClinicalResearchTrials, #ClinicalStudies, #ClinicalTrials, #Compliance, #CRO, #CROLatinAmerica, #CROServices, #DrugDevelopment, #EmergingMarkets, #ESTERNMedical, #EsternCRO, #Europe, #France, #Genetown, #Germany, #GlobalHealthcare, #GTM, #Healthcare, #HealthcareIndustry, #HealthcareInnovation, #HealthcareTech, #HealthcareTransformation, #Innovation, #InternationalCRO, #Japan, #LATAM, #LATAMCRO, #LatinAmerica, #LifeSciences, #LifeSciencesInnovation, #Massachusetts, #MedicalDevices, #MedicalResearch, #MedicalSciences, #Medicine, #MedTechs, #Netherlands, #NewEngland, #NewJersey, #NorthCarolina, #NorthernCalifornia, #Pharma, #PharmaceuticalIndustry, #Pharmaceuticals, #PharmaTechSolutions, #RegulatoryCompliance, #ResearchAndDevelopment, #RTP, #SanDiegoCA, #SanFrancisco, #ScientificResearch, #smallcro, #SouthAmerica, #SouthernCalifornia, #Spain, #Sweden, #Switzerland, #Texas, #UK, #USA

ESTERN Medical CRO Life Sciences Welcomes Carmen Serfezi to the Executive Advisory Board We are pleased to announce that Carmen Serfezi, a senior executive with 35+ years of experience in healthcare GTM sales, marketing, and operations, has joined our Executive Advisory Board at ESTERN Medical CRO Life Sciences. Carmen’s global expertise, entrepreneurial drive, & proven track record will help advance our healthcare initiatives. Carmen has built a reputation for visionary leadership, strategic planning, & tactical execution. With an MBA & extensive experience across the US, EU, & China, she has led senior teams & business expansion in regions including The Netherlands, Germany, France, the UK, Scandinavia, China, the Middle East, & Latin America. Fluent in English, German, & Romanian, her intercultural skills have been instrumental in forming global partnerships. Her career includes a role on the Senior Executive Team at Medrad Inc. (Pittsburgh), where she contributed to the company’s international growth. Medrad, a leader in Radiology MRI/MRA, CT, & Angio medical devices, later merged with Bayer Pharmaceuticals Radiology & Interventional, expanding its global reach. Carmen also founded S&C Enterprises Ltd. (Cyprus), providing healthcare product solutions, & co-founded The Mikan Group LLC (Pittsburgh), where she supported emerging medical device companies in bringing innovative technologies to market. At ESTERN Medical CRO Life Sciences, Carmen will be key to driving global expansion & fostering business partnerships. “We are excited to welcome Carmen to our Executive Advisory Board,” said Dr. Jorge Estrella, MD, President & CMO of ESTERN Medical. “Her global experience will be essential as we expand in the international CRO market. We look forward to her insights.” Carmen’s appointment reinforces ESTERN Medical’s commitment to innovation, excellence, & global growth. We are confident her leadership will shape the future of our Life Sciences organization. #bayer #biotech #biotechs #boston #businessdevelopment #california #clinicaldevelopment #clinicalresearch #clinicalresearchorganization #clinicaltrials #cro #cros #croindustry #drugdevelopment #emergingmarkets #esternmedical #europe #executiveboard #france #germany #globalexpansion #globalhealth #globalhealthcare #globalmarkets #globalstrategy #healthcare #healthcareadvisoryboard #healthcaregrowth #healthcareindustry #healthcareinnovation #healthcareleadership #healthcarestrategy #innovationinhealthcare #internationalcro #japan #latinamerica #latam #latamcro #lifesciences #lifesciencesinnovation #lifesciencesleadership #massachusetts #meddevice #medicaldevices #medicalleadership #medicalresearch #medicalsciences #medicine #medrad #medtechs #mikangroup #netherlands #newengland #newjersey #northamerica #northcarolina #pharmaceuticalindustry #researchanddevelopment #rtp #sanfrancisco #sandiegoca #scientificresearch #spain #strategicleadership #sweden #switzerland #texas #uk #pa #pittsburgh

ESTERN Medical CRO Life Sciences New Web Page Digital Edition  As we are Building a Better Life Sciences CRO Across The "USA. & Latin America" Not Just a Bigger One. We are excited to announce the launch of the newly redesigned online edition of the ESTERN Medical CRO Life Sciences Connection, now available for your viewing pleasure. Optimized for an exceptional reading experience across desktop monitors, tablets, and smartphones, our updated website at www.esternmedical.com  features our enhanced clinical trial research services across the US & Latin America Emerging Markets, the latest "Corporate Presentation, and Therapeutic expertise Brochures". We also highlight our strengthened "Life Sciences GTM" (Go-To-Market) expertise, showcasing our expanded Portfolio of R&D Services. Additionally, we welcome "new management team members and executive board advisory members" who have recently joined ESTERN Medical. Explore our latest company News, notable Clinical R&D Publications, inspiring stories, and much more that you've come to know and love. We would love to hear your thoughts! Please feel free to send us your feedback. #GTM #HealthcareIndustry #LifeSciencesLeadership #MedicalInnovation #ResearchAndDevelopment #TherapeuticExpertise #CorporateGrowth #HealthcareStrategy #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

🧬 Embracing Diversity in Clinical Trials: A Tale of Two Americas 🌎 At ESTERN Medical CRO Life Sciences, enhancing the safety and 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 and 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 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

Dr. Jorge Estrella, M.D., CMO/President, alongside Dr. Charles Schmidt, M.D., Head of the Scientific Clinical Medical Advisory Board at ESTERN Medical CRO Life Sciences, recently convened at the prestigious World Orphan Drug Congress USA 2024 in Boston, Massachusetts. This key event in the international calendar brought together major stakeholders in the field of Life Sciences to focus on rare diseases and innovative treatments.   The Congress served as a critical platform for dialogue among pharmaceutical leaders, research bodies, healthcare providers, patient advocacy groups, and regulatory agencies. Such interactions are pivotal to advancing clinical trials and research and development efforts.   This year’s conference successfully bridged gaps within the rare disease community, enhancing cooperative efforts that are essential for the progression of clinical trials and for improving patient access to crucial therapies. Key industry players, including leading pharmaceutical and biotech firms, regulatory bodies, and investors, engaged extensively to propel forward the development of orphan drugs.   As the need for clinical trial development surges, smaller and mid-sized biotech and pharmaceutical companies in the USA and Europe are encountering notable challenges due to limited operational capacities at all stages of their INDs and NDAs—from Phase I, II, III through IV.   At ESTERN Medical, we are poised to mitigate these challenges. We provide comprehensive, customized solutions and in-depth expertise to support your R&D across the entire lifecycle of product development. Our services are tailored to address the specific needs of your projects in North America and the burgeoning markets of Latin America and South America.   Together, let’s champion innovation in Life Sciences, transform the landscape of clinical trials and R&D, and ultimately revolutionize global healthcare. Join us in shaping a future where advanced therapies become accessible to those in dire need. #biotech #biotechs #boston #california #canada #clinicaldevelopment #clinicalregulatory #clinicalresearch #clinicalresearchorganization #clinicalresearchtrials #clinicalstudies #clinicaltrials #cro #cros #crolatinamerica #croservices #drugdevelopment #emergingmarkets #estenmedical #europe #france #genetown #germany #globalhealthcare #healthcare #healthcareIndustry #healthcareinnovation #internationalcro #japan #latinamerica #latam #latamcro #lifesciences #massachusetts #medicaldevices #ESTERNMedicalCRO #medicalresearch #medicalsciences #medicine #medtechs #netherlands #newengland #newjersey #northcarolina #northerncalifornia #pharmaceuticalindustry #pharmaceuticals #regulatorycompliance #researchanddevelopment #rtp #sanfrancisco #sandiegoca #scientificresearch #southamerica #southerncalifornia #spain #sweden #switzerland #texas #uk #usa #inds #ndas #WorldOrphanDrugCongressUSA #rarediseases #innovation #DrCharlesSchmidtMD #DrJorgeEstrellaMD #WorldOrphanUSA #RnD

Maximizing Time to Modernize: Clinical Trials & Navigating Healthcare Regulatory Commercialization: At ESTERN Medical CRO Life Sciences, we fully understand the pivotal importance of choosing the optimal delivery model for outsourcing your clinical trial work. Understanding your requirements empowers you to select a model that is effective now and adaptable for the future. Here's how we assist our Life Sciences Partners & Sponsors, including Biotech’s, Pharmaceuticals, Medical Device Companies, and CROs across the US, North America, and Latin America/South America regions: - Conducting an in-depth analysis of your company's R&D project pipeline and needs to identify the most suitable model for your clinical trials. - Taking a consultative approach to determine the optimal model or combination of clinical and regulatory frameworks. - Assessing your current clinical phase stage and geographical capabilities to ensure the delivery of present and future Clinical Trials R&D requirements. - Evaluating your potential healthcare product's strategy, regulatory registration, and commercialization partners' distribution capabilities to meet the current and future needs of your company across diverse geographic regions. Introducing ESTERN Medical's Comprehensive Clinical Development Solutions: Unlock the full potential of your clinical trials with our expert guidance. We meticulously assess your options for delivery models, going beyond mere selection to craft a tailored solution. Whether you're considering a full-service CRO, a Functional Service Provider (FSP), or a hybrid CRO model, ESTERN Medical is your trusted partner. We not only address your current needs but also ensure adaptability to align with the evolving landscape of your Life Science organization and clinical outsourcing requirements. Moreover, we assist in navigating regulatory registration and commercialization challenges across diverse geographic regions. Let's elevate your clinical development journey together. #biotech #biotechs #boston #california #canada #clinicaldevelopment #clinicalregulatory #clinicalresearch #clinicalresearchorganization #clinicalresearchtrials #clinicalstudies #clinicaltrials #cro #cros #crolatinamerica #croservices #drugdevelopment #emergingmarkets #estenmedical #esterncro #europe #france #genetown #germany #globalhealthcare #healthcare #healthcareIndustry #healthcareinnovation #internationalcro #japan #latinamerica #latam #latamcro #lifesciences #lifesciencesinnovation #massachusetts #medicaldevices #medicalresearch #medicalsciences #medicine #medtechs #netherlands #newengland #newjersey #northcarolina #northerncalifornia #pharmaceuticalindustry #pharmaceuticals #pharmatechsolutions #regulatorycompliance #researchanddevelopment #rtp #sanfrancisco #sandiegoca #scientificresearch #southamerica #southerncalifornia #spain #sweden #switzerland #texas #uk #usa

It was an absolute delight reconnecting with familiar faces and esteemed colleagues during my recent dynamic meeting in Boston, MA. I had the distinct honor of meeting with my former CEO, Mike Webb, the visionary leader who formerly helmed EPIX Pharmaceuticals, INC. Mike now stands as the CEO and Board Member of Epion Therapeutics and is at the helm of ESTERN Medical CRO, steering the Life Sciences Corporate Board. Our conversations were nothing short of exhilarating, revolving around strategic innovations and potential collaborations that aim to propel unprecedented growth within the clinical development sector of the Biotech, Pharmaceutical, and Medical Device life sciences industry. This was not just a meeting; it was a boundless exploration of ideas, a synergistic dance of possibilities, and a visionary quest into future endeavors. The prospect of harnessing our collective expertise to drive positive change and make impactful contributions to the field has ignited a genuine sense of enthusiasm within me. The journey ahead promises not only excitement but also the opportunity to shape the future of our industry. As the President and Chief Medical Officer of ESTERN Medical, I am eagerly anticipating the thrilling possibilities that lie ahead. My commitment to building meaningful connections within the vibrant life sciences community of New England and Boston extends beyond geographical boundaries, reaching internationally. Together, let's chart a course toward innovation, collaboration, and transformative impact in the world of clinical development. The future is bright, and I am energized by the prospect of leading ESTERN Medical into this exciting new chapter. #biotechcollaboration #boston #bostonbiotech #bostonnetworking #biotech #california #canada #clinicaldevelopment #clinicalresearch #clinicalresearchorganization #clinicalresearchTrials #clinicalregulatory #clinicalstudies #clinicaltrials #cro #croservices #crolatinamerica #drugdevelopment #emergingmarkets #epixpharmaceuticals #epiontherapeutics #esternmedicalcro #esternmedical #esterncro #europeanunion #france #futureofhealthcare #genetown #germany #globalbiotech #healthcare #healthcareinnovation #innovatetogether #Internationalcro #japanlifesciences #leadershipInbiopharma #lifesciences #lifesciencesgrowth #lifesciencesInnovation #massachusetts #medicaldevices #medicalresearch #medicalsciences #medicine #medtechs #newengland #newjersey #netherlands #northcarolina #northerncalifornia #pharmatechsolutions #pharmaceuticalindustry #researchanddevelopment #rtp #sandiegocalifornia #sanfrancisco #sciencecommunityImpact #scientificresearch #southamerica #southerncalifornia #spain #sweden #switzerland #texas #uk #usa