Day 1 will kick off with a talk on designinga playbook for how to handle an undesirable CRO-Sponsor partnership, followed by a Keynote Panel allowing attendees to debate how to optimize theiroversight & governance, led byAbby Kennedy(VP of Clinical Operations, CymaBay Therapeutics). 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. Arun Sivanandam has more than 12 years of experience in clinical research at site and sponsor side. 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. The Budget Conundrum. 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. www.orbisclinical.com. UPCOMING EVENT. Wayne resides in Miami, Florida. Dr Morimoto has over 25 years of industry experience in leading project teams in the development of innovative medicines, providing guidance in the design and execution of preclinical, clinical and regulatory strategies with a therapeutic focus in Parkinsons, Alzheimers and frontotemporal dementias. Genentech Chief Diversity Office, Patient Inclusion And Health Equity. Spaulding Clinical operates a 200-bed Clinical Pharmacology Unit, a Full Service Biometrics Group and Cardiac Core Laboratory. Our specialized experts drive scale, innovation, and speed to market for visionary clients around the world. Over the years, Lin has achieved success at both large corporations and startups. 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. Dan Solis is a recognized expert in FDA import operations and is the Assistant Commissioner for ORAs Office of Import Operations. Meet Inspiring Speakers and Experts at our 3000+ Global Events with over 1000+ Conferences, 1000+ Symposiums and 1000+ Workshops on Medical, Pharma, Engineering, Science, Technology and Business. 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. Reimbursement for medical devices in trials, and, understanding the process. 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. 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. What can small biotech ClinOps teams learn from large Pharma, and vice versa? Exceptional quantitative and analytical skills with a passion for high quality outcomes and business profit. Read more . Medical Writing and Healthcare Communications Conference. Are you planning to attend the upcoming Outsourcing in Clinical Trials New England, November 9-10th, 2021? www.frontagelab.com. 11 th International Conference on Clinical Trials is scheduled to be held during November 09-10, 2023 at London, UK. Mr. Larwood is the third of his family to be involved in Valley Fever. GlobalPlus Diagnostics on LinkedIn: Outsourcing in Clinical Trials As a supervisor, he had the opportunity to manage an Import Field Operation Team, an FDA team in the Centralized Examination Stations (CES), and the Los Angeles International Mail Facility. Phase 1 Trials: How to globalize to accelerate value inflection. Our goal each day, every day is to make sure our partners have whatever they need when and where they need it to execute a successful clinical trial, while also minimizing delays, unnecessary costs, and surprises. The DPO Centre isEuropes leading life science experts, providing Data Protection Officer (DPO) and Data Protection Representative (DPR) services. Theyll ensure your translations will be of the highest quality, on time, and within budget. . Estela is an exceptional community engagement liaison for both English and Spanish speakers. By harnessing digital data, we power sponsors, CROs, researchers, and patients to recenter decentralized trials and rewrite the clinical development experience. What is critical to get right to make a digital QM System work? Clinical Trials 2023. Clinical Services. To learn more , please visit our website - Since 1996, ARA has supported 700+ clinical trials worldwide across all therapeutic areas. Project Leader, Health Equity And Population Sciences, Hoffman La Roche. www.viroclinics.com. ClinOne, a leader in virtual clinical trial management, provides a single platform technology experience to accelerate clinical trial enrollment and remote patient care, compliance and retention. 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. Five gene therapy trial readouts to watch in the first half of 2023 New Omicron variant could threaten vulnerable people this winter Inclusive drugs: designing clinical trials for the pregnant population www.precisionformedicine.com. Join thought leaders from regulatory agencies, biotech, pharma, patients, and academia to discuss the latest advances, challenges, and forward-thinking . Working closely with the CRO and giving your site the freedom to breathe, Communication is key- how can the sponsor/CRO help and support as a partner, Trends in clinical development across the globe over the last 5 years, Pre and post covid impact on the clinical trial global economy, Patterns in investment and clinical trial equity. Our Precision Matching software mines millions of patient records, including unstructured physician notes, to pin-point eligible study patients in real-time. OCT Europe 2022 | SGS - SGSCorp To learn more , please visit our website - 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. 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. Stop by to see us at Outsourcing in Clinical Trials New England 2021 conference. To learn more , please visit our website - https://www.advancedclinical.com/. Conference series LLC Ltd Organizes 3000+ Global Events Every Year across . Advice for the ClinOps team to avoid unnecessary patient visits, how does your protocol affect the site? Parexel Introduces Expert SeriesNew Medicines, Novel Insights. 4240 La Jolla Village Drive. Our Australian phase I facilities are in Melbourne and Brisbane, and our US phase I facility is located in Minneapolis. This conference will focus on topics such as bioethics, regulations, patient recruitment, site selection, data integration & strategy, and many more. Heather Kellerman on LinkedIn: Are you attending Outsourcing in Network with 600+ clinical peers. 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 Their services include clinical monitoring, clinical monitoring oversight, clinical trial management, data management, biometrics, and medical writing. The company serves over 600 customers globally, with headquarters in San Francisco and offices in numerous domestic and international locations. September 28-29, 2022. We have successfully been providing exceptional value to our clients for over 30 years. After years of watching the opioid crisis develop, John has developed an innovative drug and dispenser to safely treat pain and deter abuse. Global Player in eClinical Solutions . At Pro-ficiency, Dave has transformed clinical research training into a powerful study resource and analytics tool, and Pro-ficiency has become the leader in the proactive, metric-driven approach to training that contradicts the traditional, check-it-off-the-list approach. Exploring incentives for the community if not financial what else can you offer? Arena International are delighted to announce Outsourcing in Clinical Trials Europe will be returning to Barcelona on the 3rd-4th May 2023! Mr. Larwood co-invented his first two commercial molecules before age 30. 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. Clinical Trials Conferences | Meetings 2023 | World BI Outsourcing in Clinical Trials East Coast - 10times With 2,000 annual trials and projects, around 200 active clients and global access to source drugs in over 60 countries,Myonex is your complete partner around clinical trials around the globe reliable, trusted and by your side. Founded in 1976, ACRP is a Washington, DC-based non-profit organization with more than 13,000 members who work in clinical research in more than 70 countries. ACM performs more than 20 million laboratory tests each yearspanning all medical disciplines including pathology, microbiology, molecular diagnostics, toxicology and more. Anne came to FDA in 1990 with an undergraduate degree in Biochemistry and a masters degree in Food Science and segued into FDAs laboratory science regulatory operations. Mr. Solis has held many positions within FDA that includes working at the FDA lab in Irvine, Ca. We have five years of clinical trial experience and capabilities around the globe in over 90 countries and across any therapeutic area whether for decentralized, hybrid or fully virtual studies. Her passion for ensuring that clinical trials are reflective of our society drove her to her most recent work in Health Equity, where she works with a group of committed and passionate individuals to successfully develop and implement scalable and sustainable strategic interventions for the recruitment of underrepresented patient populations. Global Clinical Trials Connect 2023 2022 London United Elon Musk's Neuralink sought FDA permission in early 2022 for human clinical trials of its brain-computer interface and received an application rejection, Reuters reports. www.advanceresearch.com. Why drugs fail in clinical trials? He was Senior Director of Clinical Operations at Pharmacyclics from 2012 to 2017 where he was responsible for the development, implementation and maintenance of the Clinical Operations infrastructure, as well as the GCP inspection hosting platform and processes, and regulatory authority marketing approval inspection hosting. March 14 . eClinical Solutions is a leading global provider of cloud-based enterprise software and software-driven clinical data services. At Strategikon Pharma, we bring a high level of precision and speed to outsourced clinical trial operations through our flagship SaaS platform, Clinical Maestro. Operating in 49 countries across the globe, KPS Life is committed to working together with its clients through a hands-on operating model rooted in a partnership approach. 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. CROMSOURCE operates offices across Europe and North America. Basel, Switzerland. Previous roles within both CRO and Sponsor organizations which provide valuable perspective from both sides of the industry. She has a wealth of knowledge and experience having served more than 24 years in ORA managing staff and operations focused on medical devices, radiological health, and MQSA. ICON plc is a world-leading healthcare intelligence and clinical research organisation. Ndidi Rickert is an experienced Quality Assurance leader with over 20 years of experience in the Pharmaceutical/Biotechnology industry. 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. http://www.cromsource.com/. EVENT - DIA Global Pharmacovigilance and Risk Management Strategies Conference. To learn more , please visit our website - 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. 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. About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . Increasing inclusion in future trials for vulnerable populations with health disparities some success stories, Home visits have evolved since their inception in 2003, Services possible in 2023 an overview of what is possible today, Sourcing the right professionals for visits is essential to success, Addressing the reduced site pool challenge and focussing on sites you know can deliver, Overcoming hurdles with imaging centres with reduced staff when trying to qualify patients in a timely manner. Subsequently completed a Neurology Residency at Columbia University with additional Fellowship training in Neuro-Oncology at the Mass General Brigham program. atreo.io, To learn more , please visit our website - in Psychology and Biology from the University of California at Santa Cruz. 21 October 2022 Outsourcing In Clinical Trials - Texas 2022. Medocitys platform captures valuable real-time clinical insights & real-world data, while engaging patients, sites, and sponsors. 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. His thesis was on the role of the Androgen Receptor in Hormone Refractory Prostate Cancer. Fun fact: Ndidi was born and raised in Sierra Leone, and is a descendant of the Krio people who were freed slaves that returned to Freetown from Africa, America and The West Indies. His mother started a foundation in 1998 and raised some $20M for research into vaccines against Valley Fever. Rigorous scientific background and 9+ years of experience in driving both academic and industry clinical programs. Dr. Marszewska has experience with electronic data capture and data management in clinical research. assisTek has been paving the way for integrating technology and data collection in clinical trials for over 25 years. Dr. Hsu is anesthesiologist and pain management physician, but also a serial entrepreneur. Joined industry with a goal of developing digital and devices to improve patient care. www.signanthealth. 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 . www.tranquilclinicalresearch.com. Our Leukopaks are available for Research Use Only and Clinical Grade (FDA 21 CFR 1271-compliant) applications. Debashish has over 18 years of experience in the life sciences / clinical trials industry, including several leadership roles in Product Management. Booth #4. Dr. Cunningham came from academic background. Read more. in Electrical Engineering & Computer Science from UC Berkeley and Ph.D. in Biological & Medical Informatics from UCSF. Our experts are ready to discuss how our solutions can best support your live studies. The global clinical trials outsourcing market size is expected to reach USD 67.62 billion by 2030, according to a new study. www.agilexbiolabs.com. To learn more , please visit our website - Review and assess the selection criteria sponsors face when selecting Phase I jurisdiction. 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. www.allucent.com. Flex Databases platform is a secure, unified and compliant system for clinical trials. 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. With a dual clinical appointment in Robotic-Surgery at the Institute, Arun focused on post-surgical outcomes of Da-Vinci Robotic Prostatectomy for Hormone Refractory Patients. To learn more , please visit our website - Since 2000, Anne has held supervisory and branch director positions. 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. Pharmapack is the European event focal point for the pharma packaging and drug delivery device industry. In 2011 she co-founded Looms for Lupus when her sister almost lost her life to Immune thrombocytopenia and Lupus; she is alive today because she advocated for herself. www.kardia.com. Swiss Biotech Day 24th April 2023 to 25th April 2023 Basel, Switzerland. Patient Inclusion and Health Equity, Chief Diversity Office, Genentech, Vice President, In-Home Solutions, Decentralized Clinical Trials, PCM Trials, Executive Director, Clinical Operations, Terns Pharmaceuticals. . Stream B: Clinical Innovation & Technology, A Fireside Chat on. 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. CA; X-Mine, CA; Delphian Pharma, CA and Certum LLC, CA). Brandi Coffin has been in the medical device industry for over 15 years with various roles in post market surveillance, quality, compliance and patient safety. Bringing together nearly 700 professionals, TFS delivers tailored clinical research services in more than 40 countries. 1333 Bayshore Highway, Burlingame, www.advarra.com. www.promedica-intl.com. Bioethics, regulations, patient recruitment, site selection, real-world data, data integration & Strategy, outsourcing, vendor management, quality (QbD) in Trial Conduct, risk-based . Clinical Trial Conferences 2023 - mcdougallscientific.com Dr. Kumar Gadamasetti is an experienced pharmaceutical and biopharmaceutical executive. 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. Anju is a portfolio company of Abry Partners serving the worldwide pharmaceutical, biotech and contract research Life Sciences markets. Datacubed applies innovative solutions for the capture of active and passive data for engagement with patients in in-person, hybrid, or fully virtual clinical studies. To learn more , please visit our website - Aug 16 International Conference on Clinical Trials in Cardiovascular Medicine (ICCTCM) - Barcelona, Spain. About Mobile Technologies in Clinical Trials. Arena International are delighted to announce that our Outsourcing Clinical Trials Europe event is returning to an in-person format in 2022. Partnerships in Clinical Trials Europe 2021. Complimentary. From 2 to 4 November 2021. Topics include feasibility & site selection, clinical data & technology, patient engagement & enrollment, risk-based monitoring, and budeting & clinical outsourcing. Local vendor oversight vs global provider oversight how would you manage this differently? Clinical Trials Innovation Programme 2023 is the only platform to . 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. Rave RTSM streamlines your operations and provides real-time visibility for your study teams. Outsourcing In Clinical Trials East Coast 2022 User Dashboard. 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. April 28-29, 2016 Dubai, UAE. 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 . As an international key opinion leader in dermatology clinical development, Dr. Jankicevic has served as advisor to multiple companies on their path to global regulatory and commercial success. Visit our website to learn more about how we deliver a Better Clinical Experience. Anne Reid is the Program Director of the Office of Medical Device and Radiological Health Operations (OMDRHO). Arvinder received her undergrad in Biophysics and doctorate in Cardiovascular Physiology from University of Manitoba, Canada. https://www.medidata.com/en/clinical-trial-products/clinical-data-management/rtsm/, To learn more , please visit our website - https://www.medidata.com/. Prior to Medable, Reem worked in the clinical space in both the industry and academia settings after making a transition from basic science research. Add the event to your calendar. YPrimescloud-based technology streamlines clinical trial data collection and management. Outsourcing Clinical Trials New England 2022 - Almac http://www.axiommetrics.com/. http://www.celerion.com. Developing and supporting your quality initiatives from Day 1, the Harbor team is committed to quality through each functional service we provide. Imaging endpoints are often used to support go/no-go decision-making in early phase trials. 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. The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. We contribute to a safer and better world by helping our sponsor clients accelerate drug and device approvals to market. We will synthesize the scientific practices underpinning good instrument design and COA data collection methods and recommend next steps for addressing data collection challenges.