Mr. Luciano earned a B.A. Quickly upscaling digital technologies. https://www.advancedclinical.com/. She became the Deputy Program Director for OMDRHO in 2017 and ultimately became OMDRHO Program Director in February 2022. Debashish has previously managed successful eTMF products at Veeva and Medidata, as well as clinical trial imaging tools at Synarc (now part of Clario). Exploring the need for a dedicated regulatory pathway for antibacterial/antimicrobial drugs. Alexis Garelli has over 15 years of diverse healthcare information and pharmaceutical software technology experience. We are a patient-centric tool utilized to decrease the burden of clinical trial participation. Network with 600+ clinical peers. She received her MS and PhD in Microbiology from New York University and did a postdoctoral research at Merck Research Laboratories. 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. To learn more , please visit our website - Their services include clinical monitoring, clinical monitoring oversight, clinical trial management, data management, biometrics, and medical writing. To learn more , please visit our website - Stop by to see us at Outsourcing in Clinical Trials New England 2021 conference. Of the several programs he worked at Pharma and Biotech companies, three culminated in making to the market [PaclitaxelTM Bristol-Myers Squibb; SensiparTM Amgen and DuexisTM - Horizon Therapeutics). Parexel Introduces Expert SeriesNew Medicines, Novel Insights. THREADs platform and supporting services are helping customers to shorten study launch timelines, reduce study budgets with Virtual Visits, and bring studies from the clinic to patients homes. ARENSIA is trusted by Leading Pharmaceutical and Biotechnology organizations worldwide. An international speaker, Dr. Hughes is responsible for a team of scientific experts who provide guidance and analysis services related to the creation of electronic data collection systems for clinical trials. 5 th Global Pharmacovigilance Summit. 200+. This event is a great opportunity to get to know the online casino players who will be [] 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. 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. Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture. Executive Director, Clinical Outsourcing and Alliance Management, BridgeBio Pharma, Inc. VP Digital Transformation Strategy, Medable, Sr. Director, Clinical Operations NGM Bio, Vice President, Drug Development, Alto Neuroscience, VP Clinical Trial Financial Management, Medidata, Product Director, Decentralised Trial Technology at YPrime, Health Technology - Clinical Research, Meta, Director, eCOA Science & Consulting, Clario, Associate Director, Quality Culture Excellence, Ultragenyx Pharmaceutical, Solutions Consultant, eClinical Solutions, Associate Director of Clinical Operations, CymaBay Therapeutics, Associate Director, Global Regulatory Clinical Services, Global Outsourcing Director, Development Operations, Ascendis Pharma, Sr. Clinical Operations Professional, Imago BioSciences, Senior Director Of Clinical Affairs , Materna Medical, RN, MSN, CCRC, CCRA, Senior Manager of Clinical Affairs and Field Operations Ancora Heart, Deputy Program Director, Office of Medical Devices and Radiological Health Operations (OMDRHO), ORA, FDA, Director, Global Clinical Shared Services at Stryker Neurovascular, Vice President Of Clinical Affairs, Endogenex, Director, Clinical Programs, Clinical Affairs, ReCor Medical, Director, Database Management, Nevro Corporation, Director Global Patient Safety- Device And Digital Health, AstraZeneca, Medical Director, Patient Safety Physician Digital & Devices, AstraZeneca, VP Quality Assurance, Regulatory Affairs And Clinical, IceCure Medical, Vice President, Product Management, Anju Software. Medocitys platform captures valuable real-time clinical insights & real-world data, while engaging patients, sites, and sponsors. This experience includes in vivo viral- vectored gene therapies, ex-vivo viral vectored and gene edited treatments for oncology and non-oncology patient communities, and RNA medicine modalities. TFS demonstrates scientific and medical competence across populations and therapeutics, with industry-leading capabilities in: -Dermatology, Immunology and Inflammatory Diseases, -Internal Medicine including Neurology & Respiratory, -Pediatrics, Rare Diseases and Orphan Drugs, Detailed information about TFS, and its business offerings can be obtained through. To learn more , please visit our website - 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. Post doctoral research studies in Human Behavior. Our experts are ready to discuss how our solutions can best support your live studies. This event is a great opportunity to get to know the online casino players who will be performing at this meeting. His goal is to help you accelerate your clinical research career and be a more effective leader. Philips BioTel Research offers global operational support for cardiovascular monitoring in all therapeutic areas, and advances imaging services in oncology, cardiovascular, metabolic, musculoskeletal, neurologic, and medical device studies. 21 October 2022 Outsourcing In Clinical Trials - Texas 2022. Visit our website to learn more about how we deliver a Better Clinical Experience. Long term solutions: could reducing the site certification process be a realistic solution? To learn more , please visit our website - To learn more , please visit our website - In 2010, he became a Supervisor Consumer Safety Officer (SCSO). Since 2003, Conversis has supported our life sciences clients to successfully and effectively communicate with patients and medical professionals worldwide. The global clinical trials outsourcing market size is expected to reach USD 67.62 billion by 2030, according to a new study. As the IPM, he is the District liaison to FDA Headquarter handling import related issues and concerns. Swiss Biotech Day 24th April 2023 to 25th April 2023 Basel, Switzerland. This conference intends to focus on the global health and clinical trials around the world. Sandy Mohan is the VP of Quality at Iovance Biotherapeutics. What things do they need a partner to do and what they dont need! She has driven program strategy and planning, including implementation of 300+ clinical study protocols in 25+ indications, by leading global cross-functional teams towards successful regulatory submissions, product launches, and innovative lifecycle management. To learn more , please visit our website - http://www.pcmtrials.com/. www.pro-ficiency.com, To learn more , please visit our website - To learn more , please visit our website - She has a unique perspective in leading clinical programs in a dynamic startup environment. We are focused on helping our clients to address their most significant and complex drug discovery and development challenges. Advantages of working alongside grass root organisations and PAGs what groups are out there? Partnerships in Clinical Trials Europe 2020. Were streamlining your research, helping you get to your next milestone faster. Wayne holds an MBA and B.S. Complimentary. Dan Solisfrom TheFDAwill give the closing keynote. Study sponsors and contract research organizations have used Medrio extensively in clinical trials across a wide array of therapeutic areas, with notable success in oncology, infectious disease, and more. AWT Healthcare manufacturers clinical trial labels. Learn more at www.iqvia.com. The two day programme will take a holistic approach to the latest challenges and innovations in clinical operations, such as, the [] Why should we collect Sexual Orientation and Gender Identity in Clinical Research Studies? He is also a co-founder of U&D Pharma and working on Replyte Gel, a treatment for anogenital warts. Reem holds a PhD in genetics from the Hebrew University of Jerusalem. TORONTO, March 23, 2022 (GLOBE NEWSWIRE) -- Axiom Real-Time Metrics ("Axiom"), a premier provider of unified eClinical solutions . The two day, in person conference, Outsourcing in Clinical Trials will deliver top-quality content from industry experts covering all aspects of operational . Learn more about and Labcorp at www.Labcorp.com or follow us on LinkedIn and Twitter @Labcorp. Founded and operated as a more customer centric and nimblealternative to traditional CROs, KPS offers a full range of services leveraging the latest clinical technologies. To learn more , please visit our website - 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. Examining the behaviors of clinical trial stakeholders to better understand challenges in patient participation. www.precisionformedicine.com. Greenphire is the industry leader of clinical payment technology, designed to improve the way research professionals work. Dr. Cunningham has over 15 years experience in clinical leadership position in medical device industry, overseeing a full spectrum of clinical development programs ranging from FIM to pivotal to post-market phases. Her experience in a multitude of therapeutic indications has led to an acute knowledge of study conduct and execution with a keen focus on protocol dynamics. RadMD, a Medica Group Company, is your full service imaging core lab solution. Dr. Jankicevic is a sought-after speaker, and author of numerous articles in peer-reviewed and trade journals. This holistic self-service platform provides faster data access and intelligent analytics, empowering clinical trial teams to think innovatively. www.allucent.com. Our leading clinical show will focus on providing delegates with practical take-aways and solutions to their most current operational and outsourcing challenges in clinical trials, this is an [] Ms. OBrien has been conducting clinical research for more than 35 years and has covered multiple functions during that time. Why expert partners and staff matter; what metrics dont tell. Dr. Debashish Niyogi is currently Vice President, Product Management at Anju Software, where he is responsible for the vision, strategy, and roadmap for the companys eTMF and CTMS solutions. Vial is a next-generation CRO that leverages the nationwide Vial site network to ensure faster, higher-quality trial outcomes for sponsors. Commercial Services. What are global biotech executives asking/concerned about when evaluating Phase I study plans? March 1 - March 2,2023 Outsourcing in Clinical Trials West Coast. She also has a special interest in innovations that can improve the quality and efficiency of clinical trial execution. After 3 years as a patent lawyer at Apple Computer, he took a VP role at startup FormFactor, staying in an IP role, then became the first General Counsel for startup Verisity Design, taking them public in 2001, then ultimately through successful acquisition in 2005. Partnerships in Clinical Trials Europe 2021. PANEL DISCUSSION: The concept of DCT, is it the future? TD2 offers fully integrated precision oncology clinical development solutions that combine the highest standards in clinical trials management, disruptive imaging, biomarker strategies, and unparalleled access to real-time patient data. 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. Passionate about novel tech-enabled medical devices that advance the understanding and treatment of diseases. Mr. Chu was also the Import Program Manager (IPM) for the FDA Los Angeles District. http://www.augustresearch.com/. OMDRHO is one of five programs in the Office of Medical Products Operations within FDAs Office of Regulatory Affairs. Presently, Ndidi is the Associate Director, Clinical Quality Assurance & GxP Compliance at Ultragenyx Pharmaceutical Inc. where she has worked for over 6 years. Optimizing CRO Success: Relationship, contribution and oversight, PANEL DISCUSSION Defining your outsourcing strategy to contain costs and accelerate drug development time-to-market: what should you consider in the new COVID-19 era, Executing clinical trials on a shoestring: Optimizing the CRO Functional Service Provider model. The news service . Online event and networking. Premier Research is a leading clinical development service provider that helps highly innovative biotech and specialty pharma companies transform breakthrough ideasinto reality. Additionally, our tech-enabled trial management system, streamlined study startup processes, centralized pre-screening call center, and unparalleled approach to patient recruitment will successfully deliver a superior CRO experience. Arvinder received her undergrad in Biophysics and doctorate in Cardiovascular Physiology from University of Manitoba, Canada. Dr. Richard Abelson, President & CEO of Statistics & Data Corporation (SDC), founded the company in November of 2005. Prior to joining Iovance she served as the VP of Quality at Immune Design which was acquired by Merck. Debashish has over 18 years of experience in the life sciences / clinical trials industry, including several leadership roles in Product Management. Subsequently completed a Neurology Residency at Columbia University with additional Fellowship training in Neuro-Oncology at the Mass General Brigham program. http://greenphire.com/. How best to go about educating the patient community? All three clinics are strategically co-located within leading medical, research and biotech precincts offering unique access to ancillary services including bioanalytical laboratories, MRI, lumbar punctures, chest X-rays, ophthalmology assessments and others. TransPerfect Life Sciences specializes in supporting the global development and commercialization of drugs, treatments, and devices designed to improve and save lives. Sections. He has extensive experience helping sponsor companies make their trials a reality across a range of projects from first in human to phase iv. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionalscollaborateswith biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Medidata is leading the digital transformation of life science, with the worlds most used platform for clinical development, commercial, and real-world data. www.frontagelab.com. I look forward to being in the Bay Area in early Lee King on LinkedIn: #octwestcoast2023 #clinicalresearch #lifesciences #outsourcing Cultural consideration - translations, typical distance from site, etc. We have conducted clinical trials contributing to the market approval of nearly 100 new drugs to date. Powered by the IQVIA CORE, IQVIA delivers unique and actionable insights at the intersection of large-scale analytics, transformative technology and extensive domain expertise, as well as execution capabilities. ClinDatrix, Inc., a CRO, helps pharmaceutical, biotechnology and medical device innovators with clinical projects ranging from Phase I studies to multinational pivotal Phase III trials and post-marketing studies. Our latest enhancements include patient genetic and biomarker matching to promote swift site identification and patient enrollment. Medable offers the most flexible decentralized clinical trial platform streamlining trials for patients, sites, and clinicians whether in-clinic or at home. Care Access is a global research site that accelerates the availability of new treatments and therapies through our unique site infrastructure and ability to cultivate research-empowered communities. SCOPE 2022 attracted more than 2,300 leaders in clinical operations and research and all conference tracks will feature best practice case studies relevant to clinical operations experts and those new to the field. 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. Solution-oriented professional, with strong problem solving capabilities. Anju Software is a customer-first organization providing adaptable life science solutions for clinical research, medical affairs, and data science. Technology as a methodology: Accelerating Clinical Development timelines. The groundbreaking WATCH-PD study exemplifies how high-dimensional data sources allowing more precise, objective, and higher frequency patient monitoring enable digital biomarker development. Since our inception in 2003, over 1 million patients in more than 75 countries have participated in studies powered by Viedoc. As Vice President, Business Development at Curebase, Wayne leverages more than a decade of experience in clinical research across both clinical operations and strategic sales to identify new areas for growth within the company. RTSM is built on Rave EDC, so there is no double data entry and minimal reconciliation expediting study start-up and study-close out. Francis is an expert in clinical system regulatory compliance with over 20 years pharma experience spanning R&D, manufacturing and clinical research. Dr. Arvinder Dhalla has more than twenty years of experience in pharmaceutical R&D, project management, regulatory affairs and clinical development across several therapeutic areas. AWT Healthcare is solely focused on providing the clinical pharmaceutical and custom labels & packaging industry with state-of-the-art solutions at a fair price and competitive timing. His PhD research at UC San Francisco established the foundation for PEGylated drugs widely used today. Arun Sivanandam has more than 12 years of experience in clinical research at site and sponsor side. Her experiences in academia, biotech, and CROs confirm that meeting the needs of all stakeholders payers, regulators, patients, families, and sites is a critical success factor for efficient development programs. Mr. Luciano joined Corvus Pharmaceuticals in 2018 and has served as Vice President of Clinical Operations since 2021. To learn more , please visit our website - Jay has also created and managed products for eCTD submission publishing and review, enterprise quality management, document management, computer validation, as well as mobile apps for physicians, sales reps, and music and sports fans. theactigraph.com. eClinical & Clinical Data Management Innovation Conference 2022 . To learn more , please visit our website - Europe's leading clinical trials conference focusing on partnerships, outsourcing, operations and technology is now In-person event. Clinical Services. To learn more , please visit our website - https://www.anjusoftware.com/. Explore and learn more about Conference Series : World's leading Event Organizer. This presentation will discuss: With increasing site staff/physician burnout and sites taking on less projects, we are still feeling the ripple effect of this on trials. http://www.conversis.com/, To learn more , please visit our website - It offers its clients a global reach through a network of 38 processing laboratories. Intrinseque Health is an EN ISO 13485 certified Global Clinical Supply Chain organisation, building & executing complex Clinical Supply Plans for Ancillary, Medicinal products, Clinical Supplies, Equipment and Services required by Pharmaceutical & Biotech companies and CROs for their Clinical Trials. Actalent is a leading provider of Clinical and Laboratory services. Before joining Curebase, Wayne served as Vice President at mid-sized Florida based CRO Biorasi, where he helped to lead that company to a successful acquisition by a private equity partner in 2018. These conferences closely focus on the advancements in clinical research and trials. For more than 30 years, Rho has been a trusted partner to leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations. A visual cognitive neuroscientist by training, Dr. Anderson has over a decade of experience developing both hardware and software to evaluate behavioral and neural mechanisms of attention, working memory, and visual perception. As a service company, our mission is the pursuit of health equity, a focus on diversity and excellence in clinical trial conduct. www.eclinicalsol.com. PANEL DISCUSSION: Decentralized/Hybrid Trials: Discussing the current challenges and debating best practises for a successful virtual study, Considerations and best practices in direct-to-patient (DTP) / decentralized clinical trials (DCT) lessons learned from past trials, PANEL DISCUSSION: Reversing the Conversation What the clinical trial industry really wants from its service providers, KEYNOTE A playbook for how to handle an undesirable CRO-Sponsor partnership & how to turn it around, A playbook for how to handle an undesirable CRO-Sponsor partnership & how to turn it around. http://www.kpslife.com. Henry earned his B.S. His most recent activity is as CEO and Founder of QuiVivePharma, a company he took from inception to a FDA face-to-face PreIND meeting in just 1 year. Signant unites eCOA, eConsent, Patient Engagement, IRT, Clinical Supplies and Endpoint Quality into the industrys most comprehensive patient-centric suite an evolution built on more than 20 years of proven clinical research technology. Outsourcing In Clinical Trials . She was an assistant professor at Loyola University Chicago and a practicing vascular surgeon in Shanghai, China. AliveCor protects its customers with stringent data security and compliance practices, achieving ISO 27001 Certification, SOC 2 Type 2 Certification and HIPAA compliance attestation. https://www.muralhealth.com/. To learn more , please visit our website -
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