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ACT EU launches two new advice pilots to improve quality of applications for clinical trials in Europe

?? Celebrating International Clinical Trial Day 2024: Our Commitment to Advancing Healthcare ?? Last week, Symbiance team proudly celebrated International Clinical Trial Day 2024, reaffirming our unwavering dedication to the healthcare industry. This day holds deep significance as it honors the pioneering work of James Lind, whose clinical trials in 1747 laid the foundation for modern medical research. During our celebration, we reflected on the essential role clinical trials play in transforming patient lives. Our team shared impactful stories and insights from our journey in clinical research, highlighting the collective impact we have made. At Symbiance, every effort is driven by a commitment to excellence and innovation. Symbiance's Contribution:?As a leading CRO, Symbiance has been at the forefront of clinical research, partnering with healthcare providers, pharmaceutical, and biotech companies to bring new therapies to market. On this special day, we created awareness about the critical importance of clinical trials and their role in advancing medical science. A Heartfelt Thank You:?We extend our deepest gratitude to our dedicated team members, partners, and, most importantly, the patients who participate in clinical trials. Your trust and collaboration are the driving forces behind our success and the advancement of global healthcare. Together, we continue to pave the way for a healthier future, transforming hope into reality, one clinical trial at a time. Few Key Points About International Clinical Trials Day Historical Significance: Commemorates the first controlled clinical trial conducted by James Lind on May 20, 1747, which laid the foundation for modern clinical research. Raising Awareness: Aims to increase public awareness about the importance of clinical trials in advancing medical knowledge and improving patient care. Highlighting Contributions: Recognizes the vital role of clinical trial participants, researchers, healthcare professionals, and organizations in the development of new treatments and therapies. Promoting Ethical Standards: Emphasizes the importance of ethical conduct, patient safety, and regulatory compliance in all clinical research activities. Fostering Collaboration: Encourages collaboration among global stakeholders, including pharmaceutical companies, research institutions, and regulatory bodies, to accelerate the development of innovative medical solutions. Ilango Ramanujam Tamilselvi Senthilkumar Balamurugan Dhayalan Pathamuthu Kumar Gajendran Ramkumar M.Rajendiran Nishath Altaf Jayapandian Nagamalaiyan Susan Gallop Mark Pittman Suresh Narayanasamy B.E., M.B.A. #InternationalClinicalTrialDay #ClinicalTrials #HealthcareInnovation #Symbiance #CommitmentToCare #AdvancingMedicine

At the Duke-Margolis Institute for Health Policy conference, the Director of CDER at FDA discussed the future of clinical trials, showcasing significant strides towards regulatory modernization and efficiency. The FDA's dedication to integrating innovative methodologies in drug evaluation and research was emphasized, with key takeaways including the integration of adaptive trial designs and digital health technologies to streamline drug approval processes. The establishment of a translational medicine team within the Office of New Drugs highlights the FDA's focus on accelerating therapy approvals, especially for rare diseases. Additionally, the FDA's modernization of inspection protocols and enhancement of cross-sector collaboration are among its strategies to align with the dynamic landscape of clinical trials. The groundbreaking approval for a drug targeting Friedreich's ataxia underlines the FDA's embrace of real-world evidence and adaptive regulatory approaches. Furthermore, future FDA strategies include enhancing collaborations with NIH and CMS to leverage real-world data for better drug monitoring post-approval. For professionals and stakeholders in the clinical trials and regulatory sectors, these developments signify a pivotal era of innovation and collaboration. Stay up-to-date with the latest in #ClinicalTrials, #FDA, #RegulatoryInnovation, #DrugApproval, #RealWorldEvidence, and #TranslationalMedicine by visiting the full article here.

At Symbiance, we celebrated this special day by reflecting on over 30 years of dedication to advancing clinical research through our premier services in #StatisticalProgramming, #Biostatistics, #DataManagement, #Pharmacovigilance, and #RealWorldData and have supported numerous clients in achieving their research goals. To all pharmaceutical, biotechnology, and medical device organizations: if you are seeking a specialized partner with expert, highly skilled professionals offering cost-effective Biometrics and PV services, we invite you to connect with us. Discover how our comprehensive services and capabilities can benefit your projects. Our team holds extensive experience working with over 50 pharmaceutical companies globally, including many top 20 sponsors, and has supported various regulatory submissions. Let's discuss how our Biometrics services can elevate your clinical trials to the next level. #InternationalClinicalTrialDay #ClinicalTrials #HealthcareInnovation #Symbiance #CommitmentToCare #AdvancingMedicine #Biometrics #DataManagement #StatisticalProgramming #Biostatistics #CDISC #RWE #RealWorldEvidence #DatabaseProgramming #ClinicalProgramming #SDTM #ADaM #AnalysisDataset #TLF"

It was a pleasure to participate in last week's World Orphan Drug Congress Europe in Barcelona. Lots of talk about #rarediseases plans, patient involvement, etc. but for me the biggest issue was the new EU HTA Regulation and the resulting joint clinical assessments; a mandatory scheme for all oncology medicines and #cellandgenetherapy as of 2025 and all #orphanmedicines as of 2028. From the various sessions these are my 10 observations: 1. JCA – a top priority for #pharmaceutical industry: The EU Joint Clinical Assessment (JCA) will have a profound impact on patient access across Europe. 2. JCA Objectives: Positioned as a "one-stop shop" for regulatory and market access decisions, aiming to streamline the process of getting medicines to patients - but the jury is still out as to whether this will be the case. 3. Complexities and Uncertainties: Several complexities and uncertainties need addressing, including skepticism about its ability to speed up patient access. 4. Patient and Industry Concerns: Concerns continue that JCA may duplicate national HTAs, causing confusion and potential delays in treatment access. 5. Patient Involvement: There is a gap between patient expectations and their actual involvement in the JCA process. 6. Conflicts of Interest: Managing conflicts of interest, especially involving patient experts, is crucial but challenging, with a need for balanced policies. 7. Standard of Care Variations: Variations in the standard of care across countries could result in different PICO schemes, impacting access. 8. Early Engagement: Early engagement with regulatory bodies through Joint Scientific Consultations (JSCs) is crucial for better preparation but there are public authority resource constraints to handle such discussions. 9. Adaptability: Mechanisms are needed to handle product label changes during the JCA process without causing delays or confusion. 10. Conclusion: Improving patient involvement, addressing national variations in decision-making, and early planning through JSCs are essential. Last but not least, thanks to EuropaBio - the European Association for Bioindustries, Adrien Samson and Claire Skentelbery, for an interesting panel discussion on the EU's #biotechlogy act. More to follow! #proudptcemployee

Healthcare (Drug) Intervention = Clinical (Drug) Trial Controversial? Why are we so afraid to define "intervention" in clinical research regulations? Kudos to France, Saudi Arabia, South Africa, and the USA for defining 'interventional' in the context of clinical trials. In Europe we have 'clinical trials', 'low intervention clinical trials', and 'non-interventional studies'. Talk about half-a-job-bob! How can you define something as 'low intervention' if you haven;t defined 'intervention'. From a scientific (and logic) perspective this makes no sense. You should start at the highest risk position = Interventional = Directly impacts a patient's healthcare with a new drug or an approved drug with an unproved indication = Clinical trial Low interventional = Directly impacts a patient's healthcare with an approved drug used as per approval conditions (i.e., SmPC, Pack Insert) Non-Interventional = Does not impact a patient's healthcare This isn't rocket science...how can we NOT agree on a defintion for 'interventional (clinical trial) research'? Until we do...(unecessary) confusion will abound...and it directly impacts real world research. Regulators it's time to step up and address the elephant in the room and define "intervention" in the context of clinical trials.

This month, FDA issued two guidance documents:?Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice (draft), and Conducting Clinical Trials With Decentralized Elements (final), that highlight the Agency’s efforts to advance innovations in clinical trial design and conduct. When?finalized,?the guidance on Randomized Controlled Trials (RCTs) would?facilitate the use of data from research carried out during routine clinical practice to support drug approvals. The most applicable studies are those testing new indications of already approved drugs, though testing of unapproved drugs may also be supported when the safety is sufficiently characterized. This guidance supports the conduct of?RCTs?with streamlined protocols and procedures that focus on essential data collection, allowing integration of research into routine clinical practice. It also outlines the role of sponsors, clinical investigators, and HCPs in RCTs integrated into clinical practice, and describes how to use a Quality by Design approach. The final guidance on Decentralized Controlled Trials (DCTs) addresses some key issues from the draft version including more info on requirements to keep a task log of HCPs, inspection requirements, and changes around data variability. By enabling remote participation, DCTs may enhance convenience for trial participants, reduce the burden on caregivers, expand access to more patient populations, improve trial efficiencies, and facilitate research on rare diseases and diseases affecting populations with limited mobility. CRC supports advancements that promote innovation in clinical trial design and execution, as well as the increasing use of Real World Evidence in drug development. We look forward to helping our clients navigate and effectively implement the Agency’s evolving recommendations toward clinical trial innovation. #FDANews #ClinicalTrials #RegulatoryInnovation #CRC #DrugDevelopment https://lnkd.in/eBWNW6f8 https://lnkd.in/e72JDuvj

The success of clinical trials is pivotal. As someone with a deep-rooted history in facilitating educational growth within this sector, I'm excited to announce an invaluable resource for professionals committed to advancing their clinical trial strategies. Introducing: Optimizing Clinical Trial Success - Strategic Site Selection, Robust Support, and Effective Management from Inception to Completion Here’s why this training is indispensable: Strategic Site Selection: Navigate the complexities of site selection to enhance patient recruitment and trial efficiency. Robust Support Mechanisms: Learn to implement support systems that ensure smooth trial progression and data integrity. Effective Trial Management: Learn the nuances of managing trials to meet objectives within timelines and budgets, overcoming common and unforeseen hurdles. Why Participate? Your expertise in clinical operations is crucial. This course equips you with cutting-edge strategies and practical tools to elevate your trials from good to great, ensuring not just success, but excellence. Course Details: When & Where: 13&14 May 9:00-13:00 CET, Online Secure Your Spot: https://lnkd.in/dswGeBPR Transform the way you approach clinical trials. Join us to make a significant impact on your career and the future of clinical research. Your journey to clinical trial excellence starts here. #ClinicalTrials #Pharmaceuticals #Biotech #ClinicalResearch #ProfessionalDevelopment #NewEraWebinars

Medical research is progressing rapidly to keep up with the increase in complex diseases and new treatment options. This has highlighted the need for innovation in clinical trials to facilitate enhanced communication and collaboration between various stakeholders (clinicians, researchers, patients, etc.). By way of open dialogue and communication, this can accelerate the development of novel therapies in order to improve patient outcomes in complex diseases while also providing means to efficiently exchange insight. Read more about the Center for Clinical Trial Innovation to know more about how the US FDA is working towards enhancing communication and collaboration & overall innovation in the space of clinical trials! https://lnkd.in/gQfyyaSh Meet us at BIO and DIA to discuss your requirements for clinical trials! ?? Meet us at BIO International: https://lnkd.in/gJt7Vxwv ?? Meet us at DIA Global: https://lnkd.in/grrwWGU6 #BIO2024 #DIA2024 #pharma #clinical #trial #innovation #regulatoryservices #USFDA #medical #research

In a recent article by Cytel, the indispensable role of Key Opinion Leaders (KOLs) in the realm of rare disease clinical trials is illuminated. Rare diseases present unique challenges in drug development, from limited patient populations to complex regulatory pathways. Here are some key takeaways: 1. Expert Guidance: KOLs, with their deep expertise and insights, play a pivotal role in guiding clinical trial design and execution in the context of rare diseases. Their involvement ensures that trials are tailored to address the specific needs and challenges of these conditions. 2. Patient Advocacy: Beyond their scientific acumen, KOLs often serve as advocates for patients with rare diseases. Their advocacy can influence trial protocols, ensure patient-centric approaches, and ultimately improve the chances of success in clinical development. 3. Navigating Regulatory Hurdles: Regulatory bodies have unique considerations for rare disease therapies. KOLs, well-versed in both scientific advancements and regulatory landscapes, can help navigate these complexities, accelerating the path to regulatory approval. 4. Collaborative Networks: Establishing collaborative networks involving KOLs, researchers, industry stakeholders, and patient communities fosters a synergistic approach to tackling rare diseases. Such partnerships facilitate knowledge exchange, resource sharing, and innovative solutions. The collaboration between pharmaceutical companies and Key Opinion Leaders is paramount in advancing rare disease therapies. Their expertise, advocacy, and collaborative efforts are instrumental in overcoming the challenges inherent in rare disease clinical trials. Read the full insightful article here: https://bit.ly/44Y1jWi #RareDisease #ClinicalTrials #KeyOpinionLeaders #PatientAdvocacy