Our Australian phase I facilities are in Melbourne and Brisbane, and our US phase I facility is located in Minneapolis. Dr Frances Rubenstein has worked in clinical data management for more than 20 years in both medical device and pharmaceutical companies. With presentations and panel discussions on all the hottest industry trends and outsourcing challenges. Many biopharmaceutical trial sponsors rely on or scientific leaders to help design and optimize their protocols and statistical analysis plans. To learn more , please visit our website - September 28-29, 2022. Mr. Chu has served as a mentor for the Federal Executive Board in Los Angeles, CA. We offer both single modules and a unified solution to maintain all processes you can cover all existing software needs with only one vendor. In the life sciences vertical, we help pharmaceutical and medical device companies with clinical trial management, data management, biometrics, medical affairs, regulatory affairs, and quality and compliance initiatives. BS in Human and Organizational Behavior, and Communication Studies and authored numerous trade articles and frequently present on behalf of Parexel at trade conferences. Arena International are delighted to announce that our Outsourcing Clinical Trials Europe event is returning to an in-person format in 2022. Despite the ongoing disruptions from COVID-19, 2021 saw some major results from clinical trials. The Decentralized Clinical Trials hybrid event, April 18th - 20th in Boston, will provide leading insights and practical guidance on how to decentralize your clinical trials for greater diversity, accessibility and efficiency, with guidance a world-class speaker line up. 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. To learn more , please visit our website - 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. 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. Dr. Marszewska has experience with electronic data capture and data management in clinical research. I am the CEO at OrPro Therapeutics, a biotechnology company in San Diego, CA developing biologic drug solutions to unmet needs in serious epithelial diseases including cystic fibrosis. Deep 6 AI is the leader in precision research software, connecting all research stakeholders in an AI-powered, real-time, data-driven, collaborative ecosystem. Orbis Clinical is a leading global life science recruitment partner. https://www.intrinsequehealth.com/. She advises on eCOA best practices, diary and instrument design and training for participants, caregivers and raters. Frances has an undergraduate degree in Physiology and a PhD in medical science from the University of Sydney. We are an embedded partner dedicated to the success of your study, offering managed services such as: Data Management, On-Demand Data Analytics, Biostatistics, Clinical Management, eTMF Management and Pharmacovigilance. Actalent is a leading provider of Clinical and Laboratory services. To learn more , please visit our website - With an agenda covering the future of Clinical trials and drug development post COVID, Clinical Trials Innovation Programme 2023 will feature tailored sessions presented by the leading experts from across the . She has over 25 years of clinical development experience working at sites and in industry, and spanning multiple diseases, including oncology, ophthalmology, immunology, neurology, infectious and rare diseases. To learn more , please visit our website - . To learn more , please visit our website - The 2023 programme will offer a fresh insight into the latest regulatory updates, global clinical trials, advanced technologies such as digital health and connected devices space, and more. To learn more , please visit our website - https://lifesciences.transperfect.com/. Rated 4.5 by 2 people. MedPoint Digital develops intuitive, ICH-GCP compliant eClinical platforms for virtual investigator meetings, trial portals, interactive modules, and virtual clinical trials. 2023 will see the return of the Clinical Trial Supply Europe conference to Milan where pharma, large and small, alongside biotechs will have the opportunity to discuss, debate and consider new technologies and processes to streamline supply chain operations. Anju is a portfolio company of Abry Partners serving the worldwide pharmaceutical, biotech and contract research Life Sciences markets. Passionate about novel tech-enabled medical devices that advance the understanding and treatment of diseases. 85356 Mnchen-Flughafen , Join NAMSA 5-6 April in Munich, Germany for Outsourcing in Clinical Trials: Medical Devices Europe. 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. Chris has dedicated his 16-year career to the services side of the Phase I clinical drug development industry, including both operational and business development roles. Wednesday, 28th Sep 2022 - Thursday, 29th Sep 2022 . To learn more , please visit our website - She has been with Calyx for 17 years as a key strategic leader, with a specific focus on IRT solutions. https://www.discoverinternational.com/. To learn more , please visit our website - Clinical Technologies. For the 13 th Annual event, our flagship European clinical show will provide delegates with practical take-aways and solutions to their most current operational and outsourcing challenges in clinical trials . She is a career FDA federal service veteran with vast experience in technical and managerial positions across multiple commodities. Combining medical expertise and deep industry knowledge, we develop bespoke solutions to accelerate your innovative treatment development for patients with unmet needs, one trial at a time. He is a key member of the leadership team responsible for defining the company's go to market strategy and value proposition across the many segments of the pharmaceuticals and device research industry. Amy has been a drug discovery and development professional for 25+ years, including progressive roles in clinical operations and clinical strategy. AliveCor is a privately-held company headquartered in Mountain View, Calif. Consumer or Personal ECGs are ECG devices available for direct sale to consumers. From 2 to 4 November 2021. Improving the patient experience through user-focused design. Mr. Larwood co-invented his first two commercial molecules before age 30. Jowita Marszewska, Ph.D. is a Scientific Advisor at Clario, a global data and technology company that helps minimize risk in clinical trials. Dr. David Anderson is a Senior Scientist at Clinical Ink, where he focuses on the development of digital biomarkers in decentralized and remotely-monitored clinical research. 28 - 29. Includes management of the RFP process for outsourced services as well as contract/proposal and budget negotiations, vendor selection, and vendor oversight/relationship management. Due to increased utility of digital data collection tools and compute infrastructure, ability to generate real-time insights are now possible. Importance of teams meeting face-to-face so that human touch and team cohesion isnt lost, Setting up rules and expectations creating space for communication, Strategies for prioritising work and tracking milestones with remote teams, Assessing the impact on the trial of remote vs in-person working; how to find a happy medium, How to best leverage remote trial management platforms, How to best utilize critical and non-critical data validation plans, What trial management services are best provided by the sponsor vs. CRO, How to best manage SOW/budget throughout the course of the trial. www.td2inc.com. This is the unmissable event that the pharmaceutical, biotechnology, and medical device communities need to come together and discuss strategies for operational success in clinical trials. 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. The Budget Conundrum. OMDRHO is one of five programs in the Office of Medical Products Operations within FDAs Office of Regulatory Affairs. Check out who is attending exhibiting speaking schedule & agenda reviews timing entry ticket fees. Start. Going the last millimeter: What you may not know about home visits. 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 . Improving communication, relationships and work-life balance with your internal team as well as partners. Ellen brings decentralized clinical trial visits to patients with PCM Trials experienced Certified Mobile Research Nurses. www.tprausa.com. Dr. Hsu is anesthesiologist and pain management physician, but also a serial entrepreneur. Ndidi also leads the X2 Women in Biotech Group speaker series and is one of the founding members of the UltraMosaic Employee Resource Group. 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. Conversis is built on one goal: To provide you with the highest-quality clinical trials translations. 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. Weve all had to sit through several pitches from vendor companies telling us what they can do for us, but now its time to reverse the conversation! To learn more , please visit our website - Scout Clinical, part of the Meeting Protocol Family, provides stress-free, confidential and personalized travel, expense and compensation management services to clinical trial participants on a global scale. 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. GreenLight Clinical is a physician-led, boutique full-service clinical CRO with its own central clinical, bioanalytical, histopathology laboratories in Sydney, Australia. Amsterdam RAI. Partnerships in Clinical Trials Europe 2022. David Larwood is a founder, the CEO, and chief chemist for Valley Fever Solutions, running the manufacturing process for a novel antifungal headed for Phase 2a trials in 2022. ACM provides a powerful combination of operational excellence, scientific expertise and unsurpassed global service to customers in more than 65 countries. European Union Clinical Trial Regulation: Strategic Considerations, Hyatt Regency San Francisco Airport Hotel
To learn more , please visit our website - https://www.worldwide.com. as a Microbiologist, HQ position within the Division of Import Operations in Rockville, MD, working as an Import Compliance Officer and working in the FDA Los Angeles District Office as a Director of Import Operations Branch. Dr. Lindsay Hughes, Director of eCOA Clinical Science and Consulting at Clario, is a scientist and leader with over 15 years of experience in behavioral and life sciences. Medrio is the leading provider of eClinical technology for pharma, biotech, device, diagnostics, and animal health clinical trials. Chris deep knowledge of the global early phase drug development industry strengthens the tradition of success of Nucleus Network, our customers and partners in Advancing Medicines, Improving Lives. As the worlds largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. Meghan McKenzie works in Patient Inclusion and Health Equity in Genentechs Chief Diversity Office. Join us in Philadelphia, May 10th-11th, to shape best practice on: Refining patient recruitment strategy. 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. Diagnostic Services. What things do they need a partner to do and what they dont need! About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . Anca has over 15 years of experience in the biopharmaceutical industry, working both on the CRO and the Sponsor side. Why expert partners and staff matter; what metrics dont tell. From 2 to 4 November 2020. 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. Practical use cases to improve clinical site efficiency with technology. We develop new innovations, drive emerging therapies forward and improve patient lives. We offer customized solutions to fit the needs of each study, patient and site, making it easier for your patients to stick with it. Having worked within all major biopharma markets including USA, Japan, China, EU and Australia has enabled him to become a trusted advisor to many customers and help them achieve their clinical drug development objectives. Emvenio Research is transforming how patients and care-givers engage in and experience clinical research, To learn more , please visit our website - In her role at Nevro, Frances is responsible for leading the data management team, driving the adoption of new technologies and innovative data management processes to bring new treatments to patients. Kristina leads the Patient Insights team at Parexel and is dedicated to bringing a thorough understanding of the patient journey, and the patient voice to the entire spectrum of research services. How best to go about educating the patient community? Technology as a methodology: Accelerating Clinical Development timelines. A NEW paradigm of engineering-forward analytics solutions powering digital biomarkers. To learn more , please visit our website - http://greenphire.com/. With over 15 years experience in the industry, Esther has predominantly worked in clinical trial management and data management roles across Europe, North America and South Africa. Parexel Introduces Expert SeriesNew Medicines, Novel Insights. Curebase is also pioneering the Bring Your Own Physician (BYOP) model, allowing patients the comfort to make decisions with support from their trusted physician, To learn more , please visit our website - www.curebase.com. To learn more , please visit our website - http://www.premier-research.com/. Altasciencesis a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies of all sizes a proven, flexible approach to preclinical and early phase clinical studies, from lead candidate selection to proof of concept. 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. 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. www.versiticlinicaltrials.org, Viedoc designs engaging software for the life science industry. Subsequently, Arun lead the Gastric-Immuno-Oncology Rare Disease Bispecific-T cell-Engager portfolio at Amgen on various aspects of clinical research operations. Kumar earned his Ph.D. from the University of Vermont and was a post-doctoral fellow at the University of Virginia. Mr. Luciano joined Corvus Pharmaceuticals in 2018 and has served as Vice President of Clinical Operations since 2021. Combining OCT, CTS and Medical Devices events, this is the perfect platform for professionals from . Dr. Karl McEvoy has over a decade of industry experience in both the vendor and sponsor sides. https://www.rad-md.net/, To learn more , please visit our website - March 14 . The must attend clinical outsourcing event in the Southeast region where industry professional can encounter a platform to explore new solutions to common issues within their clinical trial. To learn more , please visit our website - Clinical ink is the global life science company that brings data, technology, and patient science together. Read more . Francis is an expert in clinical system regulatory compliance with over 20 years pharma experience spanning R&D, manufacturing and clinical research. Choose from over 15 fully integrated modules on a single platform: EDC, DM, RTSM/IWRS, CTMS, Inventory Management, ePRO, eConsent, Patient Portal, AE/SAE Tracking, Safety Database, Central/Local Lab, Imaging Management, eTMF, and 24/7 Project and Clinical Data Reporting. More recently, Arun headed to Santen, with a focus on driving operational excellence in Ophthalmology clinical research as Associate Director Global Clinical Development and Operations, where he oversees Phase 1 4 clinical trial conduct. 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. Understanding Digital and Device Safety Across a Large Organization, a Perspective of a Center of Excellence. To learn more , please visit our website - He is also a co-founder of U&D Pharma and working on Replyte Gel, a treatment for anogenital warts. Session Reserved for Worldwide Clinical Trials, Data Management: Programming and metrics in medical device studies, Vast experience of over 20 years in Quality, Regulatory, Processes Improvements and leading cross organization projects, VP Quality Assurance, Regulatory Affairs and Clinical at IceCure Medical, since September 2020, leading the company compliance and clinical affairs, Prior to joining IceCure Medical, held a position of Director of Quality, Regulatory and Customer Support at Applied Spectral Imaging (ASI) and Several positions at Carestream Health (formerly Orex Computed Radiography). He is also President of SBS Medical Management, a healthcare economic consulting firm for investment banks and Expert Medical Reviews, including the California Medical Board. 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. She also had several leadership positions with PharmaNet Development Group (now Syneos Health), ICON Clinical Research and eMetagen Corporation. Bringing together nearly 700 professionals, TFS delivers tailored clinical research services in more than 40 countries. She holds medical license issued by Serbian Medical Chamber. . Our performance is built on years of experience staffing the competitive biopharma job recruitment landscape, leveraging our deep networks to source the most highly sought-after candidates in the industry. Collaterally with her Regional Food and Drug Director duties, Anne served as the acting program director for both the Biologics and Tobacco programs during significant planning phases for program alignment. Frances has been working at Nevro Corp, a medical device company for the past 10 years as Director, Database Management. Advarra advances the way clinical trials is conducted to make them safer, smarter, and faster. www.assistek.com, To learn more , please visit our website - 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. To learn more , please visit our website - To learn more , please visit our website - http://www.novotech-cro.com/. pril 28-29, 2016 Dubai, UAE. This is a great opportunity to network and share knowledge with regions leading pharmaceutical firms, biotechs and med device companies, discuss operationally efficient, specifically targeted clinical trials. Their experienced research team comprises key opinion leaders, board-certified cardiologists and radiologists, sub-specialty scientists, and highly trained technicians who acquire, evaluate, and report high-quality data through an efficient, cloud-based infrastructure. Practiced Neuro-Oncology and General Neurology at the VA and Boston Medical Center. She is currently managing a Ph3 program in rare liver disease. She has a unique perspective in leading clinical programs in a dynamic startup environment. Wayne resides in Miami, Florida. For over 30 years, we have been the leading global clinical trial supply company and we have expanded our service portfolio to offer complete solutions around clinical trials for our partners. She leads the scientific development of digital clinical measures and the modernization of clinical development models under the banner Technology As Methodology. With nearly a decade of home visits learnings, Ellen has a unique perspective on how decentralized clinical trials have changed over the years and what the future looks like. Anju Software is a customer-first organization providing adaptable life science solutions for clinical research, medical affairs, and data science. 2022 looks to be a bumper year too, so Nature Medicine asks leaders in their field what they think . 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. United States, 94010, To learn more , please visit our website - Supported by top pharmaceutical and biotech partners across 20 different therapeutic areas, Care Access is scaling and globalizing its new model for clinical trial delivery, where more physicians and patients can engage in life-saving research to develop new therapies faster. From 1990 to 2008 he held various Clinical Operations positions at Abgenix, Pharmacyclics, Quintiles, Covance and Syntex. Dont miss out; join us in Burlingame on March 1st& 2nd2023! YPrimescloud-based technology streamlines clinical trial data collection and management. Focusing on life sciences, Datacubed offers software and services driven by behavioral science to improve patient retention and compliance, resulting in better data and positive health outcomes. UPCOMING EVENT. We go beyond traditional events and offer, The main program of the conference is discussion and debate on the outsourcing of clinical research. Dr. Jankicevic is a sought-after speaker, and author of numerous articles in peer-reviewed and trade journals. Our high-caliber project management, clinical monitoring, medical safety, data management, biostatistics, regulatory affairs and quality assurance capabilities make us a valued partner. The Technology track will seeKimberley Ferguson(Commercial Head of Personalized Healthcare Partnerships, Genentech) discussing all thingsWearables. Digital health technologies and biomarkers in clinical trials requires the highest standards of data collection, transmission, security, quality, and analysis. Advarra integrated solutions connects life sciences companies, CROs, research sites, investigators, and academia at the intersection of safety, technology, and collaboration. Meghan started her career as a Masters level psychologist working within a medical care team treating patients with ALS and traumatic brain injury. Quickly upscaling digital technologies. Due to increased utility of digital data collection tools and compute infrastructure, ability to generate real-time insights are now possible. Clinical Trials Innovation Programme 2023 is the only platform to . Catalyst Clinical Research is a new generation Clinical Research Organization, serving the unique needs of small-to-medium sized biopharmaceutical companies. ), both from Duke University where I was also an undergraduate. http://www.clindatrix.com/. www.clinone.com, To learn more , please visit our website - Prior to joining Iovance she served as the VP of Quality at Immune Design which was acquired by Merck.
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