Henry is a Vice President of Data Sciences at Medidata. Rigorous scientific background and 9+ years of experience in driving both academic and industry clinical programs. Through innovative eClinical and Regulatory solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market reliably. www.eclinicalsol.com. CHI's 9th Annual Clinical Trial Innovation Summit, November 10-11, 2020, Boston, MA, is multi-track event on best practices needed to optimize clinical trial innovation, planning and management. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancements, drive the industry standard for data precision and usher in a new generation of clinical trials. Currently a Medical Director/Patient Safety Physician Digital & Devices at Astrazeneca. We have earned a solid reputation around the globe by delivering customized solutions used in over 500 clinical research trials, across 90 different languages in 80 different countries. http://www.spauldingclinical.com/, To learn more , please visit our website - INTERACTIVE SESSION: Establishing and maintaining strong CRO/sponsor relationships and building trust in a more virtual landscapeWhat have we learned and what should we focus on? Examining the behaviors of clinical trial stakeholders to better understand challenges in patient participation. www.flexdatabases.com. She has 20+ years of diverse global experience in the biotechnology industry including roles within Clinical Development, Medical Affairs, and Risk Management. Harbor Clinical, a WBENC-certified, women-owned company, provides a hybrid of services which ensure all aspects of clinical trials meet quality assurance and regulatory standards from study documentation, vendor oversight, and flexible resourcing throughout operations. The company has a wealth of experience in the execution of global, regional and local clinical development programs with a special focus on addressing unmet needs in areas such as analgesia, CNS, oncology, pediatric, and rare disease. She is a Nurse Practitioner by training and spent over 10 years caring for patients before coming to industry. https://www.discoverinternational.com/. Quickly upscaling digital technologies. Prior to working at Genentech, she graduated from the Johns Hopkins Bloomberg School of Public Health with a Master of Bioethics. She has held key national leadership roles including advisor within the Obama/Biden administrations global HIV response team, advisor to United Nations leadership and instructor at the CDC and USAID. The 2014 event will focus on how companies from the region can implement effective clinical outsourcing strategies. Amsterdam RAI. Are you attending Outsourcing in Clinical Trials West 2023 conference? To learn more , please visit our website - https://lifesciences.transperfect.com/. 85356 Mnchen-Flughafen , Join NAMSA 5-6 April in Munich, Germany for Outsourcing in Clinical Trials: Medical Devices Europe. December 07-09, 2015 Atlanta, USA. medtech.labcorp.com. Swiss Biotech Day 24th April 2023 to 25th April 2023 Basel, Switzerland. Regional Director, Business Development, Novotech, Executive Vice President Business Development, Nucleus Network, VP of Clinical Development, Rani Therapeutics, VP of Clinical Operations, CymaBay Therapeutics, Inc, Associate Director, Clinical Operations, Santen, Senior Lead, Global Compliance and Strategy, Medidata, Therapeutic Strategy Lead, Gene Therapy Think Tank, Worldwide Clinical Trials, Vice President, Quality Iovance Biotherapeutics, Vice President, Program Management, Iovance Biotherapeutics, Head of Product, Trial Interactive, TransPerfect, M.A. The DPO Centre has assisted over 600 clients globally, including a broad range of bioscience, genomics, therapeutics, healthcare and pharma companies to comply with EU data protection laws such as the GDPR, the EU Clinical Trials Regulation and specific member state requirements. WCG measurably improves the quality and efficiency of clinical trials, helping biopharmaceutical companies, CROs, and institutions facilitate the development of new treatments and therapies for patients. It is a 2 day event organised by Arena International Events Group and will conclude on 30-Nov-2022. To learn more , please visit our website - She is acknowledged for her expertise and passion in Data Integrity and Vendor Oversight, and has been recognized as a thought leader in process optimization and standardization as they relate to Inspection Readiness. We offer customizable specimen collection kits, specialty testing capabilities, dedicated project management and trial site support, biostorage, and real-time data management and reporting. Decentralized Clinical Trials 2022 was a really good opportunity to . 2023. She intentionally injects laughter and authenticity into everything she does, and is an advocate for kindness, diversity and inclusion, as well as issues impacting women and children. The DPO Centre isEuropes leading life science experts, providing Data Protection Officer (DPO) and Data Protection Representative (DPR) services. To learn more , please visit our website - http://www.pcmtrials.com/. See Our Products. Are you planning to attend the upcoming Outsourcing in Clinical Trials New England, November 9-10th, 2021? PANEL DISCUSSION THE PATIENT IMPACT: Patient recruitment, patient centricity & virtual trials Navigating the New Normal, QUICK FIRE ROUNDS: The Patient Perspective, Keynote Not just ticking a box: Outreach to minority groups is improving but the focus now is on establishing trust and relationships. The "Global Clinical Trial Outsourcing Market by Clinical Trial Phase, Therapeutic Area, End-user and Region: Competition Forecast and Opportunities to 2027" report has been added to . Executive Director, Program Strategy, Rare Disease and Pediatrics, Premier Research, https://www.medidata.com/en/clinical-trial-products/clinical-data-management/rtsm/, https://www.linkedin.com/in/ndidi-rickert-she-her-47197371/, https://eurofinscentrallaboratory.com/biopharma-services/, eurofinscentrallaboratory.com/biopharma-services, Hyatt San Francisco Airport, Burlingame, San Francisco, Best practices for engaging the patient community and growing that relationship using real life case studies. Ndidi also leads the X2 Women in Biotech Group speaker series and is one of the founding members of the UltraMosaic Employee Resource Group. Headquartered in Uppsala, Sweden, Viedoc also has offi ces in America, France, Japan, Vietnam, and China. She has extensive experience in managing complex projects, with a strong focus on building and maintaining relationships at both company and industry level from an operational role within the organization. This talk will provide an overview of the application of Artificial Intelligence methods in clinical operations. Myonexis a global complete clinical trial solutions provider. Best practices and tools for managing supplier governance and ascertaining who is accountable, Identifying the criteria to determine level of oversight needed for a vendor. Reem holds a PhD in genetics from the Hebrew University of Jerusalem. To learn more , please visit our website - The Technology track will seeKimberley Ferguson(Commercial Head of Personalized Healthcare Partnerships, Genentech) discussing all thingsWearables. in Psychology and Biology from the University of California at Santa Cruz. Optimizing cell-based Gene Therapy Programs through the continued evolution. Phase 1 Trials: How to globalize to accelerate value inflection. To learn more , please visit our website - ACM is certified by the College of American Pathologists (CAP) and the Substance Abuse and Mental Health Services Administration (SAMHSA). The Digital Transformation of Clinical Trials the Importance of Data Accuracy. Previously she served as Head of Clinical Outsourcing and Analytics for BioMarin Pharmaceuticals, where she was responsible for vendor contractual, relationship and financial management. Worldwide is changing how the world experiences CROs in the best possible way. Are you choosing best in class or a bundle? Tranquil Clinical Research is an early phase CRO with a fully accredited Hospital Phase I unit. Karl has collaborated with the world's top 20 pharmaceutical companies and has extensive experience in patient-centered outcomes research, eCOA strategy, and drug development. Pro-ficiency converts training from a cost center to a powerful quality improvement system. Debashish has over 18 years of experience in the life sciences / clinical trials industry, including several leadership roles in Product Management. As a CSO, he conducted domestic food inspection, consumer compliant investigation, recall traceback investigation, and inspection of imported FDA regulated products. After completing her education in England, Ndidi began her career working for Parexel followed by Merck Sharp & Dohme. www.versiticlinicaltrials.org, Viedoc designs engaging software for the life science industry. Dr. Yunis is a scientist with multidisciplinary training and experience in the mechanism of diseases. Our Australian phase I facilities are in Melbourne and Brisbane, and our US phase I facility is located in Minneapolis. I am passionate about the life sciences and the clinical and commercial potential of novel therapeutics and applications of synthetic biology. Francis is an expert in clinical system regulatory compliance with over 20 years pharma experience spanning R&D, manufacturing and clinical research. Dr. Raymond completed her doctoral training in molecular biology at University of California San Diego and post-doctoral training in molecular biology at Memorial Sloan-Kettering in New York City, New York, USA. In partnership with customers, we build solution-driven teams working for a healthier future. Diagnostic Services. http://greenphire.com/. . These conferences closely focus on the advancements in clinical research and trials. Meghan received her Masters Degree in Human Biology at San Francisco State University and her Bachelors Degree in Economics at University of North Carolina, Chapel Hill. The event is a must-attend for people from the clinical trials . 12 years at Parexel. This conference will explore the latest regulatory updates, global clinical trials, advanced technologies and more. To learn more , please visit our website - April 28-29, 2016 Dubai, UAE. Prior to TransPerfect, Jay directed teams on moving several enterprise product platforms to the cloud at Medidata and Sparta Systems. What should we be doing now to anticipate, prepare, prevent and respond? www.curebase.com, To learn more , please visit our website - Advarra integrated solutions connects life sciences companies, CROs, research sites, investigators, and academia at the intersection of safety, technology, and collaboration. Global Player in eClinical Solutions . To learn more , please visit our website - Amy has been a drug discovery and development professional for 25+ years, including progressive roles in clinical operations and clinical strategy. Through Inspire you will access a unique blend of data longitudinally across patients health journey to draw insights that accelerate medical progress and improve healthcare. She is mastering the logistics of dosing and testing clinical trial participants where they live, work, and study. Discuss a pathway to extend biotech cash burn runway while still meeting Phase I objectives and meeting investor expectations! She facilitates policy and procedure development within OMDRHO and collaborates with medical product partners in the Office of Medical Product and Tobacco Operations, and with peers throughout CDRH during daily operations and on special projects. Deep 6 AI is the leader in precision research software, connecting all research stakeholders in an AI-powered, real-time, data-driven, collaborative ecosystem. She received her MS and PhD in Microbiology from New York University and did a postdoctoral research at Merck Research Laboratories. Our latest enhancements include patient genetic and biomarker matching to promote swift site identification and patient enrollment. With her unique blend of business acumen and technical expertise, Rebecca Lin is a dynamic leader with many years of success in the healthcare industry. A significant portion of the cost in a clinical trial can be attributed to operational conduct of the trial such as site monitoring related activities, data management and site oversight. Wendi is currently the Executive Director, Global Medical Affairs Evidence Generation COE at BioMarin Inc. where she oversees global operational strategy and execution for programs in the post-approval setting. info@caidya.com. Hang Nguyen brings over 20 years of medical device clinical research and is currently the Sr. Director of Clinical Affairs at Materna Medical, a novel OBGYN platform company defining a $6B market in the most common pelvic conditions women face. Our experienced team has been in this niche of clinical research with deep domain experience for decades and client solutions has been our passion for over two decades. Medocitys platform is the only solution that provides a fully interactive clinical trial ecosystem enabling early decision making and safety monitoring in real time. She currently serves as Vice President of Clinical Affairs at Endogenex, a medical device company developing innovative solutions for the treatment of Type 2 diabetes. https://www.medidata.com/, To learn more , please visit our website - www.viedoc.com. www.kardia.com. Dont miss out; join us in Burlingame on March 1st& 2nd2023! Aug 09 International Conference on Drug Development, Clinical Trial Phases and Technology (ICDDCTPT) - Lagos, Nigeria. Clinical ink is the global life science company that brings data, technology, and patient science together. During her career she has supported Class 1-3 devices through the entire product lifecycle. Why drugs fail in clinical trials? As the IPM, he is the District liaison to FDA Headquarter handling import related issues and concerns. Interactive Response Technologies (IRT) 2022 brings the clinical community together to discuss cutting-edge updates in technology and dives into strategies to help the clinical industry excel in their trials and data management. KPS Life (www.kpslife.com) is a stand-alone, global functional service provider (FSP) that offers a clinical outsourcing solution across all phases of clinical drug development. We offer both single modules and a unified solution to maintain all processes you can cover all existing software needs with only one vendor. Spaulding Clinical operates a 200-bed Clinical Pharmacology Unit, a Full Service Biometrics Group and Cardiac Core Laboratory. Our digital solutions enable sites to be more productive, with online study training, study eBinders (eISF), digital study alerts and SUSARs, patient visit guides, and a wide range of study tools, available via web portals and mobile apps. Improving the patient experience through user-focused design. Our high-caliber project management, clinical monitoring, medical safety, data management, biostatistics, regulatory affairs and quality assurance capabilities make us a valued partner. In her spare time, Ndidi enjoys creative writing and interior decorating. The company has a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients. Basel, Switzerland. Prior to Medable, Reem worked in the clinical space in both the industry and academia settings after making a transition from basic science research. Online event and networking. She has authored or co-authored 10 publications and has been an advocate for STEM education throughout her career. To learn more , please visit our website - We're here at the Outsourcing in Clinical Trials & Clinical Trial Supply East Asia conference. Prior to her work at Potrero, she was the VP of Business Development at Theranova and led marketing initiatives for C. R. Bard (now owned by Becton Dickinson), in both Shanghai and the U.S. She has also worked as a Board Fellow at the American Red Cross Bay Area, currently serves as a guest lecturer at the University of California, San Francisco and Berkeley, and spent several years in sales and training at Johnson & Johnson. Medables completely modular approach allows pharmaceutical companies and clinical research organizations (CROs) to use only what they want, while scaling capabilities to better suit their unique studies. ESMO TAT, known as "The Home of Phase I in Oncology", is the leading congress focusing on promising new anticancer targets and agents, with a particular emphasis on those in early phase clinical development. The award-winning platform gives unprecedented real-time visibility into clinical data, enabling sponsors to file New Drug Applications (NDAs) more efficiently to bring drugs to market faster and at lower costs. To learn more , please visit our website - Rhonda Mecl recently became the Deputy Program Director after serving as the Program's Operations Staff Director for the previous five years. She was an assistant professor at Loyola University Chicago and a practicing vascular surgeon in Shanghai, China. Dr Jasmina Jankicevic is globally recognized as an expert in dermatology drug/device development. We are known for our superior statistical leadership and data management expertise and proud to have supported thousands of studies across a diverse range of diseases. OCT DACH Conference 2022 - Outsourcing in Clinical Trials. Dublin, March 01, 2023 (GLOBE NEWSWIRE) -- The "Clinical Trials Outsourcing Market Share, Size, Trends, Industry Analysis Report, By End-Use, By Therapeutics Area, By Workflow, By Region, Segment . Bioethics, regulations, patient recruitment, site selection, real-world data, data integration & Strategy, outsourcing, vendor management, quality (QbD) in Trial Conduct, risk-based . Helping you take advantage of the speed of study start-up and R&D tax incentives in Australia and allow for smooth trial transition in the US. Vice President, Clinical Operations, Corvus Pharmaceuticals Inc. Assistant Commissioner for Import Operations, U.S. Food and Drug Administration, Director, Global Patient Engagement and Advocacy, Acceleron Pharma, Associate Director, Site Contracts & Budgets Deciphera Pharmaceuticals, LLC, Program Director, Office Of Medical Device And Radiological Health Operations, FDA. Communities. 4G Clinical, a leader in randomization and trial supply management (RTSM) for the global life sciences industry, is sponsoring the 2022 Outsourcing Clinical Trials DACH. Agilex Biolabs is the leading Australian Bioanalytical CRO providing regulated Bioanalysis to support clinical trials. She also has a special interest in innovations that can improve the quality and efficiency of clinical trial execution. Trial enrollment accounts for 60% of the total time of the trial and for 80% of trial failures. She has extensive experience in building quality organizations, overseeing Phase 3 global clinical trials, supporting marketing authorization applications in the US and EU, and managing pre-approval inspections leading to multiple product approvals and launches. http://www.rhoworld.com/. Practical use cases to improve clinical site efficiency with technology. Advarra advances the way clinical trials is conducted to make them safer, smarter, and faster. Our specialized experts drive scale, innovation, and speed to market for visionary clients around the world. Chief Executive Officer, Agility Pharmaceuticals, Dr Mishra (Ex Genentech, Ex NCI, Ex NIH) is the founding president and CEO of the American Association for Precision Medicine ( and chair of ACT AAPMs Coronavirus Taskforce He is leading research efforts focused on preventing curing chronic diseases not only treating the sick but also providing knowledge/tools to individuals to live longer, healthier lives He is also the founder and CEO of Agility Pharmaceuticals, a pharmaceutical company committed to revolutionizing drug discovery development through technology, big data, robotics, and artificial intelligence He is a serial entrepreneur who founded his first company after graduating high school, and his second company during his Ph D Since then, he has accumulated a wealth of experience by building, investing, and advising numerous other companies He is an investor, co founder/ board member of a few corporations, focused on accelerating drug discovery/ development, data analytics, robotics, mental health, and digital health He is also the founder of AAPM Angels and Investors AAi an investment group focused on investing in drug discovery, diagnostics, precision medicine, technology healthcare companies He is also the founding investor and advisor to Barcelona Ventures and serves as an advisor to a 100 M private equity fund Widely recognized as a thought leader in the field of technology and healthcare, Dr Mishra has keynoted, chaired, curated, and organized numerous successful international conferences He served as a Scientist and Principal Investigator at the pharma giant Genentech, Roche Where he participated in several drug discovery project teams Moreover, his passion for drug development and precision medicine has led to the identification of new drug targets, biomarkers, companion diagnostics, and several drugs/ combinations in the clinic His research work has been recognized globally by over 40 prestigious awards and honors Due to his unique perspective selfless service, he is a highly respected sought after mentor to many The companies that he has advised have raised multimillion dollars Notably, he serves as a mentor and advisor to several VC funds and startup accelerators, including IndieBio HIMSS/Health 2 0 s Project Zygote, MedLabs ZGC Capital, J&J JLabs UCSF Innovation Venture, UCSF Invent Fund, and California Life Sciencess FAST program, to help grow Californias life sciences innovation ecosystem, Chief Executive Officer, Strategikon Pharma. http://www.protrials.com/. We have expanded our product line to include Medical Device Labeling through AWT Labels & Packaging. Dan Solisfrom TheFDAwill give the closing keynote. Frontageis a CRO providing integrated, scientifically-driven research, analytical and product development services throughout the drug discovery and development process to enable biopharmaceutical companies to achieve their drug development goals. By harnessing digital data, we power sponsors, CROs, researchers, and patients to recenter decentralized trials and rewrite the clinical development experience. BDO Releases 2022/2023 CRO Insights Report. Current topics in the Medical Device Regulatory Landscape, Presented by the FDA. Nucleus Network is Australias largest Phase 1 clinical research organisation and the only Phase 1 specialist globally with phase I facilities in the US and Australia. She is driven by listening and incorporating the patient voice and by finding innovative ways to improve the patient experience. www.deeplink-medical.com. For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. The DIA's Digital Technology in Clinical Trials Conference discovers how digital technology is transforming the drug, device, and diagnostics development process in clinical trials. Dr. Marszewska has experience with electronic data capture and data management in clinical research. Contact: Amy Apostoleris, aapostoleris@medocity.com, To learn more , please visit our website - Additionally, Funwie collaborates with colleagues to co-create educational resources as a part of the core team of the Advancing Inclusive Research Site Alliance, which focuses on addressing disparities in clinical research. Dr. Cunningham came from academic background. Based outside Philadelphia, Pennsylvania, we pride ourselves on being boutique by design and always customer focused. Genentechwill give a case study session onpiloting health inequities and gender identity data why collecting this data now will aide you with your clinical trial. He worked as a Research Associate to improve recruitment metrics in the Million Veterans Program genomic biobanking initiative for Loma Linda VA Medical Center where he developed a novel Point of Care recruitment solution in outpatient clinics. Agilex Biolabs operate a fully quality-assured, FDA-inspected laboratory (ISO/IEC17025 and OECD GLP). Wed, 25 May 2022, 18:00 WebSite. Q2 Solutions is a leading global clinical trials laboratory services organization that helps biopharmaceutical, medical device and diagnostics customers improve human health through innovation that transforms science and data into actionable medical insights. http://citlabels.com/. Enhance site negotiations and pay with ease, with the industrys first Procure-to-Pay solution designed specifically for clinical trials. Founded in 1985, Promedica International, a woman-owned corporation, is headquartered in Orange County, California. She then ventured across the pond to the United States where she worked for Novartis, Pfizer, Johnson & Johnson and Aeras (one of the Bill Gates Foundation companies specializing in TB and Malaria). We leverage our proprietary payments platform and workflow automation to help clients improve operational efficiency, reduce costs, mitigate regulatory risks, improve the patient and site experience and produce quantifiable results that improve clinical operations and strategic planning. Data-driven operations and oversight with elluminate. Each nurse is trained, tested, and certified as a Certified Mobile on an annual basis in the principles of clinical trial research, GCP, Nurse Guidelines and IATA. Jay holds an MBA from Villanova University and a degree in Computer Science and Physics from Gettysburg College. 5 th Clinical Nutrition Conference. I will be there with my colleague Georgi Govedarov, come visit us at booth Isidora Teodorovi on LinkedIn: I am very excited to be attending Clinical Outsourcing Group UK this year

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