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ProPharma is the premier Research Consulting Organization (RCO), delivering fully customizable consulting solutions to empower biotech, med device, and pharmaceutical organizations of all sizes to advance scientific breakthroughs confidently and introduce new therapies. With over 20 years of expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma partners with clients across the complete product lifecycle through an advise-build-operate model. Our end-to-end suite of consulting solutions de-risk and accelerate high-profile drug and device programs, ultimately improving patient health and safety. Discover how ProPharma can help you inspire the future of science!
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Tap into this week's #ProPharmaPoll! Learn more about our RDIT services: https://lnkd.in/gVn7YVtg. #PharmaInsights
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Did you know that patient experience is now as critical to clinical trial success as achieving commercial outcomes? We understand the delicate balance between advancing groundbreaking treatments and ensuring patients feel supported every step of the way. Our latest blog explores how Clinical Trial Concierge Services are transforming the landscape of clinical trials by: - Elevating patient retention and engagement - Minimizing trial disruptions - Enhancing data quality for better commercial outcomes By focusing on tailored solutions, we’re helping sponsors create trials prioritizing human connection, the cornerstone of successful outcomes for patients and sponsors alike. Read the blog to see how these services are reshaping the clinical trial experience.: https://lnkd.in/dkQH9q5X How do you see patient-centric approaches influencing the future of clinical trials? We’d love to hear your thoughts!
The European pharmaceutical landscape is evolving rapidly, with 2025 bringing new regulations, challenges, and opportunities for the industry. Staying informed is critical for navigating these changes effectively. Check out our latest thought leadership piece, where our experts dive into the key regulatory trends to watch this year and what they mean for pharmaceutical and biotech companies operating in the EU. Read the full article here: https://lnkd.in/e9UEH4fZ.
Our data strategy consultants can help you turn your data into actionable insights with well-defined data use cases. Identifying and developing data use cases is crucial for maximizing the value of your data. A proven methodology and extensive industry experience will help you pinpoint high-impact use cases, design tailored data solutions, and implement them effectively. Our Approach: - Identify business challenges - Develop tailored data solutions - Measure and optimize outcomes Let’s create data-driven solutions that drive business results! Learn More: https://lnkd.in/eksSnr-i.
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Risk Evaluation and Mitigation Strategies (REMS) are vital for ensuring the safe use of medications with serious risks. Implementing these programs effectively requires expertise, precision, and a patient-centered approach. We specialize in designing and managing REMS programs that align with FDA requirements while keeping patients’ safety and healthcare provider compliance at the forefront. From development to ongoing support, we ensure your strategy is robust, efficient, and impactful. Our REMS Services Include: - Program design and development - FDA submission and approval support - Healthcare provider training and education - Ongoing program management Partner with us to enhance compliance, reduce risks, and create safer pathways for patients to access life-saving medications. Learn more about how we can help your team navigate REMS challenges https://lnkd.in/eJEhSNeZ.
What Is a Clinical Evaluation Report (CER)? A CER is essential for achieving CE Marking under the EU MDR, emphasizing safety, performance, and compliance. Key updates include stricter equivalence standards, integration of clinical data, and alignment with State of the Art (SOTA). Thorough planning and tailored strategies are critical to regulatory success. Let ProPharma guide your path to compliance.
What is a Clinical Evaluation Report (CER), and how does it play a role in achieving and maintaining CE Marking under the European Union’s Medical Device Regulation (EU MDR)? https://lnkd.in/e5wc2HuV By Jennifer Daudelin, MSJ, Director, MedTech Regulatory / Quality, ProPharma
Join Us at SCOPE Summit 2025! Now in its 16th year of driving collaboration and innovation, the SCOPE Summit is where the brightest minds in clinical trials, digital health, and clinical research come together to shape the future of medicine. When: February 3–6, 2025 Where: Rosen Shingle Creek, Orlando, FL We are proud to participate in this stimulating event, dedicated to advancing medical knowledge, improving patient care, and developing life-changing treatments. Visit us at Booth #838 to connect with our team and learn more about how we’re making a difference in clinical research. Don’t Miss This Highlight: - Moderating Session: Feasibility & Study Start-up by Stacey Burghdoff on Thursday, February 6, 8:20 a.m. Meet Our Team: - Tony Crone - Allison Billups - Brittany Strubbe - Nikki (Cooper) Costantino Costantino - Shannon Hutchinson - Liz Sachnoff, MBA, PMP, LSSGB, DTM Let’s connect, collaborate, and innovate at SCOPE Summit 2025: https://lnkd.in/e8WqAcJd!
We are excited to see our experts at ProPharma leading the way in compliance workshops, focusing on the vital rules and regulations governing interactions between healthcare professionals and the pharmaceutical industry. It’s always inspiring to see how we’re reinforcing adherence to industry standards and sharing valuable knowledge. #WeAreProPharma
Dynamic and Innovative Regulatory Affairs Professional with a Proven Track Record in Solution-Driven Strategies.
Today I had the fortunate opportunity to attend a compliance workshop led by two of our promotional material experts at ProPharma . The session focused on the rules and regulations governing interactions between healthcare professionals and pharmaceutical industries. It was an enlightening experience, reinforcing the importance of adherence to industry standards. Grateful for the insights and knowledge shared!
Founded in 1995 by Matthew Weinberg President of Regulatory Sciences at ProPharma, Building STEPS is a 501(c)(3) nonprofit profoundly impacting Baltimore. The organization is dedicated to helping underserved youth achieve college success and beyond, focusing on increasing underrepresented participation in STEM and healthcare fields. What began as an internship program has evolved into a comprehensive, multi-year initiative serving over 175 Baltimore City public high school juniors and seniors and 300 college students and alumni annually. Nearly all participants are the first in their families to attend college. Matthew created Building STEPS with a vision of equal opportunity for all students. Reflecting on its origins, he shared, "I thought that if everybody had the same economic opportunities, we could cut down on many social issues that cause unrest and wealth disparity. Exposing students to careers in math and science creates a bigger pool of talented, diverse professionals.” The impact speaks for itself: high graduation rates, successful STEM careers, and a new generation of community leaders. After serving as Chair of the Board for 18 years, Matthew now proudly holds the title of Chair Emeritus, continuing to support the life-changing work of Building STEPS. Read more in Baltimore magazine's article: https://lnkd.in/euiJCn_B.