Oversight with less presence how to make this work, Effectively building strong working relationships remotely, Strategies to deliver training and upskill your team, Handling hard discussions with your CRO/partner when you cant meet in person, Optimizing communication channels/effectiveness with your CRO partner and team, Maintaining a positive working relationship prioritizing and building strategies from the outset, Clinical trial timelines are lengthy and on average a Phase 3 trial can take between 1-4 years. During her career she has supported Class 1-3 devices through the entire product lifecycle. Understanding Social Determinants of Health: Identifying the variables that burden trial participants how can we collect this data? Wayne resides in Miami, Florida. Why having IRT experts involved in your study is important. Phase 1 Trials: How to globalize to accelerate value inflection. Datacubed Health is a pioneering technology company making better science and healthier communities a reality. Clinical Trials Conferences | Clinical Trials Meetings | Japan | USA Partnerships in Clinical Trials Europe 2021. Our full service offering includes clinical program management, biometrics services and regulatory affairs. http://www.labconnectllc.com/. She has executed a variety of clinical trials involving therapeutic areas including autologous breast reconstruction, heart failure, hypertension, arrhythmia management and erectile dysfunction. Join thought leaders from regulatory agencies, biotech, pharma, patients, and academia to discuss the latest advances, challenges, and forward-thinking . 7 - 9 November 2022, Amsterdam . With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners most high-profile drug and device programs. Axiom Exhibiting at Outsourcing in Clinical Trials West Coast 2023 http://www.novotech-cro.com/, To learn more , please visit our website - His father was a physician who developed an interest in the disease decades ago when the family moved to Bakersfield, California, a focal area for the disease. Discover effective strategies for outsourcing clinical trial operations to ensure trials run smoothly and within budget . KPS is a global, innovative, Clinical Outsourcing Provider delivering clinical trial monitoring, management and quality oversight services to pharmaceutical, biotechnology, medical device, and related industries. Clinical Research Conferences | Meetings | Events | Symposiums Dr. Hayat is managing partner of Revive Pharm USA. In her spare time, Ndidi enjoys creative writing and interior decorating. The 2014 event will focus on how companies from the region can implement effective clinical outsourcing strategies. He also been instrumental in enhancing FDA relationship with U.S. Customs and Border Protection (CBP) and other Partnering Government Agencies. To learn more , please visit our website - www.ledgerrun.com/, To learn more , please visit our website - 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. Lead on the diversity and inclusion team, and member of DTRA, CISCRP and other industry consortiums aimed at improving access to clinical research and providing clinical research as a care option. Where do the opportunities lie for further acceleration in clinical development? Why the current state of trials makes it difficult for patients to participate in research, How and when to incorporate patient insights into your programs, How to create a business case to garner support for investing in solutions, The benefit for the study sponsor, and other stakeholders, for investing in solutions to make it easier to be a participant, Barriers to patient participation with a focus on the barrier that became the impetus of the model, Delving into benefits of Patient Navigators and challenges with consistent comprehensive support for patients, Exploring the Enhanced Patient Support Services, Cover proactive strategies to address performance risk and protocol deviations, How to apply performance data from simulation-based training to manage risk areas, Discuss how to interpret and apply learning results to optimize and de-risk your DCT, Rethinking your site management strategy to minimize overburdening sites, dependant on the phase of your study, Pinpointing how site turnover impacts the sponsor and how to help reduce it whilst keeping patient care front of mind. 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. Clinical Outcome Assessments (COAs): Applying scientific rigor and good instrument design. ICACB 2023: Applied Clinical Biostatistics Conference, Rio de Janeiro (Feb 16-17, 2023) ICAHIPHIM 2023: Advanced Healthcare Informatics and Public Health Informatics Management Conference, New York (Feb 16-17, 2023) ICCPP 2023: Clinical Psychiatry and Psychology Conference, Barcelona (Feb 16-17, 2023) ICEPNR 2023: Exercises for Pediatric . 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. OCT Europe 2022 | SGS - SGSCorp Rave RTSM is the only fully pre-validated randomization and trial supply management solution that can be configured in minutes and enables mid-study changes with minimal downtime and no change orders. 7th Decentralized & Hybrid Clinical Trials - Dynamic Global Events To learn more , please visit our website - www.eclinicalsol.com. Are Hybrid trials the more realistic and practical approach compared to full DCT agree or disagree? LabConnect provides global central laboratory services including routine and esoteric lab testing, kit building, sample management, biostorage and scientific support services for our biopharmaceutical clients. . 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. Any Disease. 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. We provide one of the broadest testing portfolios in the industry and this includes Safety & Efficacy testing, Biomarkers & Flow Cytometry, Cell based assays, Oncology/Pathology, Genomics, Virology, Immunology, Microbiology, Bioanalytical Services, early clinical development service and clinical trials supply. From 2008 to 2011, he was Senior Clinical Trial Manager at Seattle Genetics where he was responsible for the oversight of multiple oncology clinical trials, as well as support for the development of the Clinical Operations infrastructure and regulatory authority marketing approval inspection hosting. Aug 09 International Conference on Drug Development, Clinical Trial Phases and Technology (ICDDCTPT) - Lagos, Nigeria. Currently, Arvinder is VP of Clinical Development at Rani Therapeutics, where she is responsible for Clinical and Regulatory functions for all programs. His mother started a foundation in 1998 and raised some $20M for research into vaccines against Valley Fever. Over the past 30 years his focus has been in the areas of drug substance as well as drug product R&D, manufacturing and outsourcing the small molecules as well as biologics. From early phase, bioanalytical sciences, late phase, post-approval and real-world evidence,Worldwide Clinical Trialsprovides full-service drug development services for central nervous system, cardiovascular, metabolic, general medicine, oncology and rare disease therapies. GreenLight Clinical is a physician-led, boutique full-service clinical CRO with its own central clinical, bioanalytical, histopathology laboratories in Sydney, Australia. 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. As a CSO, he conducted domestic food inspection, consumer compliant investigation, recall traceback investigation, and inspection of imported FDA regulated products. 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. These conferences closely focus on the advancements in clinical research and trials. Axiom Exhibiting at Outsourcing in Clinical Trials Southeast 2022. https://www.worldwide.com, To learn more , please visit our website - Global Clinical Trials Connect 2023 2022 London United Kingdom. medtech.labcorp.com. Clinical research professional with 25 years of experience in clinical and medical affairs, most recently as Director of Clinical Affairs and Associate Director of Medical Affairs for a global medical device manufacturer focusing on endovascular and surgical repair of aortic disease. Read more . Arena International are delighted to announce that our Outsourcing Clinical Trials Europe event is returning to an in-person format in 2022. Our intense focus on the patient experience, deep therapeutic area expertise and global operational scale enable hundreds of sponsors and CROs (including all Top 20 pharma) to extend the reach of drug development, expand patient opportunities and improve data quality helping them bring life-changing therapies to our families and communities around the world. She received her MS and PhD in Microbiology from New York University and did a postdoctoral research at Merck Research Laboratories. Arvinder received her undergrad in Biophysics and doctorate in Cardiovascular Physiology from University of Manitoba, Canada. . Subsequently, Arun lead the Gastric-Immuno-Oncology Rare Disease Bispecific-T cell-Engager portfolio at Amgen on various aspects of clinical research operations. We offer Bioanalysis for small molecules and biologics for PK, immunogenicity and biomarkers utilising the platforms of LC-MS/MS (7) and Immunoassay (MesoScale, Gyrolab). Global Clinical Trials Connect 2023 2022 London United For more than 20 years, Axiom has delivered data-driven, powerful and cost-effective eClinical Solutions and Services dedicated to small-to-medium life science companies. Dr. Jankicevic is a sought-after speaker, and author of numerous articles in peer-reviewed and trade journals. Over the years, Lin has achieved success at both large corporations and startups. Jay is responsible for managing the creation and design of product features and new capabilities for Trial Interactive. Currently he is the CEO of Certum Bio in San Francisco Bay area and honors the co-appointment as the Member of the Board of Advisors, UC Berkeley Postdoc Entrepreneurs Program (BPEP). She also has a special interest in innovations that can improve the quality and efficiency of clinical trial execution. Alexis Garelli has over 15 years of diverse healthcare information and pharmaceutical software technology experience. By tapping into patients rich and varied health journeys on Inspire, researchers and health practitioners around the world are advancing treatments and making breakthrough discoveries. 8 th Pharmaceutics and Novel Drug Delivery Systems Conference. From 2 to 4 November 2021. Our specialized experts drive scale, innovation, and speed to market for visionary clients around the world. Dr. Apfel is an internationally known authority on designing, conducting, and publishing highest quality clinical trials with thousands of patients that have changed medical practice with over 100 peer-reviewed publications. http://www.kpslife.com. Mr. Chu has served as a mentor for the Federal Executive Board in Los Angeles, CA. To learn more , please visit our website - MedPoint Digital develops intuitive, ICH-GCP compliant eClinical platforms for virtual investigator meetings, trial portals, interactive modules, and virtual clinical trials. Outsourcing in Clinical Trials & Clinical Trial Supply Nordics Emmes acquired Casimir in March 2022, and the . Outsourcing in Clinical Trials Southeast 2023 - Arena International European Clinical Trials Event In Dsseldorf On 18-19 April 2023 He is a member of DIA, ARVO and CDISC. www.gobio.com/clinical-research/. http://www.rhoworld.com/. Alton Sartor completed a combined MD/MBA from Tulane University. To learn more , please visit our website - Since our inception in 2003, over 1 million patients in more than 75 countries have participated in studies powered by Viedoc. Applied Clinical Trials Online We have expanded our product line to include Medical Device Labeling through AWT Labels & Packaging. To learn more , please visit our website - 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. 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. 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. 11 th International Conference on Clinical Trials is scheduled to be held during November 09-10, 2023 at London, UK. At Strategikon Pharma, we bring a high level of precision and speed to outsourced clinical trial operations through our flagship SaaS platform, Clinical Maestro. Dan is responsible for presenting the robust data management solutions made possible with elluminate, and can customize product demonstrations to address specific customer needs. It is the go-to solution in over 1,000 sites and 40 countries enabling investigators and sponsors to simply record, review, anonymise and submit assessments to regulatory bodies. 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. Inspire is a vital health community where more than two million patients and caregivers feel comfortable sharing personal health data, experiences, and answering questions candidly. Specifically for Clinical Trials and RWE studies, Medocitys modular and flexible architecture ensures swift configuration and deployment in less than 4 weeks, through a fully interoperable and connected SaaS cloud database. We help teams bring order, trust, and predictability to protocol execution and automation. Global Player in eClinical Solutions . Partnerships in Clinical Trials Europe 2022. Evolve our technology to improve the study experience for patients, site, and sponsors with the move towards more decentralized trial models, Software will be more heavily relied upon to keep patients connected, informed, and engaged, Explore the importance of utilizing user-focused research on software design and implementation of eCOA and eConsent in clinical trials, Define the role of leadership in cultivating a Quality and Compliance culture, Establish key considerations for implementation, Explore best practices for ensuring sustainability, Operational analytics including enrollment, protocol compliance and safety, Risk-based analyses and insights with elluminate RBQM, Operational knowledge for data-driven development with elluminate CTMS, Centralized issue management across roles in operations, data and medical review, Sample tracking, data forecasting and financial performance indicators, See how Curebase can design a flexible site model to address specific study concerns, Learn about the features Curebase can incorporate based on Sponsor needs, Witness how virtual sites can be deployed to collect high-quality patient data in real-world settings, Strategies for global patient recruitment, Supplies management and shipping challenges. The main program of the conference is discussion and debate on the outsourcing of clinical research. Sun, 24 Apr 2022, 09:00 End. December 07-09, 2015 Atlanta, USA. Pharmapack is the European event focal point for the pharma packaging and drug delivery device industry. Rigorous scientific background and 9+ years of experience in driving both academic and industry clinical programs. During her career she has advocated for critical partnerships with vendors supporting integration with internal stakeholders. Dr. Apfel is also the Chair of Life Sciences at the Keiretsu Angel Investment Forum, where he invests in life-science companies that have the potential to positively impact patients with serious conditions. 1333 Bayshore Highway, Burlingame, At UCSF he co-invented suitable PEGylated lipids to make the very first PEGylated liposomes. She has a unique perspective in leading clinical programs in a dynamic startup environment. To learn more , please visit our website - May 02-03, 2016 Chicago, USA. YPrimescloud-based technology streamlines clinical trial data collection and management. 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. Examining the behaviors of clinical trial stakeholders to better understand challenges in patient participation. eClinical & Clinical Data Management Innovation Conference 2022 . Outsourcing In Clinical Trials East Coast 2022 User Dashboard. Conference series LLC Ltd Organizes 3000+ Global Events Every Year across . She was an assistant professor at Loyola University Chicago and a practicing vascular surgeon in Shanghai, China. She has a unique perspective in leading clinical programs in a dynamic startup environment. ), pharmacovigilance and safety solutions, translation and language services, and call center support. 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. https://www.nucleusnetwork.com/au/, To learn more , please visit our website - To learn more , please visit our website - CROMSOURCE operates offices across Europe and North America. 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. For over 25 years, Altasciences has been integrating into clients projects to help support educated, faster, and more complete early drug development decisions. https://www.intrinsequehealth.com/. OCT DACH Conference 2022 - Outsourcing in Clinical Trials. Meghan McKenzie works in Patient Inclusion and Health Equity in Genentechs Chief Diversity Office. 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. His thesis was on the role of the Androgen Receptor in Hormone Refractory Prostate Cancer. Outsourcing In Clinical Trials East Coast 2022 - HealthManagement.org She has actively participated in departmental preparation for the EU CTR implementation and is one of ICONs SMEs on this topic. Why expert partners and staff matter; what metrics dont tell. Be sure to stop by to visit my colleagues at booth #60. Dr. Hayat received his Ph.D. in process engineering from INP-Toulouse, France and Post-Doctoral Fellowship from Ecole Polytechnique de Montreal, Canada. 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. Axiom Exhibiting at Outsourcing in Clinical Trials New England 2022 Aditya is the Regional Director of Business Development at Novotech, the Asia Pacific specialist CRO. The Top 24 Clinical Trial Conferences of 2022 - Montrium Mr. Chu was selected to be the Director of Investigations Branch (DIB) for DWCI in June 2018. You might have known us as Myoderm as we have recently changed our name but not our high-quality services as the complete clinical trial supply partner. Our latest enhancements include patient genetic and biomarker matching to promote swift site identification and patient enrollment. Exploring the idea of adopting a medical device-like regulatory philosophy/strategy for bringing drugs forwards, with a focus on antimicrobials, Industry is on high alert for bacterial outbreak, with parallels to the covid pandemic. Conference . Lee King on LinkedIn: #octwestcoast2023 #clinicalresearch #lifesciences https://www.sdcclinical.com/. With more than30 years of experience in over 60 countries, our individualized partnership approach provides experience-driven insights and expertise to assist clients in successfully navigating the complexities of delivering novel treatments to patients. This, exclusive event brings together attendees from established pharma, large and small, alongside with biopharmaceutical companies and gives opportunity to dive into the operational challenges and innovations in clinical development found within the UK & Ireland region. In partnership with customers, we build solution-driven teams working for a healthier future. Previous roles within both CRO and Sponsor organizations which provide valuable perspective from both sides of the industry. Chemistry degree from Punjab University, Institute of Chemistry, Executive Director, Global Digital Quality Management Systems and Business Intelligence BeiGene, Executive Director, Global Medical Affairs Study Management, BioMarin Pharmaceuticals, Inc. Wendi Carroll received her Pharm D from the University of the Pacific. Deep 6 eliminates months of manual data validation, to de-risk and accelerate clinical trials, because clinical trials should be a gatekeeper (accelerator), not a bottleneck to innovation. Clinical Research Organization (CRO) & Biopharmaceutical Services - Parexel Panellists will discuss the challenges and tech barriers with DCT. Featuring solutions for automated referrals, eConsent, patient engagement, connected devices, eCOA, and eSource, ClinOne makes participating in a clinical trial a little easier, every day. ProTrials Research, Inc., is a full-service clinical research organization (CRO) and woman-owned business headquartered in San Jose, CA, with clinical operations personnel located throughout North America and across the world. Communities. Sections. Our Leukopaks are available for Research Use Only and Clinical Grade (FDA 21 CFR 1271-compliant) applications. http://www.clinicalink.com/, To learn more , please visit our website - 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. www.Clario.com, To learn more , please visit our website - His current work focuses on deep collaboration with an interdisciplinary team of engineers and scientists to successfully integrate data from multiple assessments and sensors, implement high-dimensional feature engineering, and both evaluate as well as apply scalable machine learning algorithms. Last year alongside talks from industry leaders Pfizer, Bristol Myers Squibb, [] Our Sponsor Edition includes dedicated applications for clinical study planning and budgeting, outsourcing and forecasting. 3 rd Clinical Pharmacy Conference. 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.
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