INTERACTIVE SESSION Data matters in health outcomes and equity: Collecting and understanding Social Determinants of Health (SDOH) data in clinical trials and beyond. Alexis Garelli has over 15 years of diverse healthcare information and pharmaceutical software technology experience. We provide a comprehensive digital solution for Ph 1-4 studies with enterprise-level capability that is configurable to be fit for purpose to support biopharmaceutical companies, CROs and research sites. 8 th Pharmaceutics and Novel Drug Delivery Systems Conference. 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. http://www.protrials.com/. Our Australian phase I facilities are in Melbourne and Brisbane, and our US phase I facility is located in Minneapolis. vial.com. Clinical Technologies. KPS Life (www.kpslife.com) is a stand-alone, global functional service provider (FSP) that offers a clinical outsourcing solution across all phases of clinical drug development. Jay is responsible for managing the creation and design of product features and new capabilities for Trial Interactive. She has a unique perspective in leading clinical programs in a dynamic startup environment. Mobile in Clinical Trials is the first conference, founded in 2013 to convene R&D operations and digital leaders to get the best access, deploy and scale strategies for applying mobile/digital tools to connect and empower patients, and obtain better outcomes in drug development/clinical research. Formed through the merger of IMS Health and Quintiles, IQVIA has more than 58,000 employees worldwide. To learn more , please visit our website - Previously, Arvinder has worked at CV Therapeutics and Gilead Sciences where she led various projects from early discovery to clinical development. To learn more , please visit our website - http://www.yprime.com/, Curebase leads decentralized clinical research using a sophisticated eClinical software platform that manages all site/patient data capture, along with a fully virtual site that acts much like a traditional site, but with greater flexibility and reach. We work With HeartTMevery day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, please contact us at 262-334-6020, or via email at Daniel.Selness@spauldingclinical.com. Signant Health provides solutions that simplify every step of the patient journey to make it easier for people to participate in, and for sites and study teams to run, clinical trials. Exceptional quantitative and analytical skills with a passion for high quality outcomes and business profit. 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. 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. 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. Partnerships in Clinical Trials Europe 2020. What are global biotech executives asking/concerned about when evaluating Phase I study plans? The company has a wealth of experience in the execution of global, regional and local clinical development programs with a special focus on addressing unmet needs in areas such as analgesia, CNS, oncology, pediatric, and rare disease. Vial is a next-generation CRO that leverages the nationwide Vial site network to ensure faster, higher-quality trial outcomes for sponsors. Currently, Arvinder is VP of Clinical Development at Rani Therapeutics, where she is responsible for Clinical and Regulatory functions for all programs. 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. We do this by combining our 25 years of proven quality and results with expertise in 30+ therapeutic areas, a flexible approach, and dedicated teams who enable rapid startups and fast timelines. Since 2003, Conversis has supported our life sciences clients to successfully and effectively communicate with patients and medical professionals worldwide. A significant portion of the cost in a clinical trial can be attributed to operational conduct of the trial such as site monitoring related activities, data management and site oversight. AliveCor is a privately-held company headquartered in Mountain View, Calif. Consumer or Personal ECGs are ECG devices available for direct sale to consumers. Prior to joining Iovance she served as the VP of Quality at Immune Design which was acquired by Merck. She is currently managing a Ph3 program in rare liver disease. 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. Stop by to see us at Outsourcing in Clinical Trials New England 2021 conference. www.emvenio.com, To learn more , please visit our website - ICON plc is a world-leading healthcare intelligence and clinical research organisation. www.frontagelab.com. This talk will provide an overview of the application of Artificial Intelligence methods in clinical operations. To learn more , please visit our website - Login; Register now; Toggle navigation. Optimizing cell-based Gene Therapy Programs through the continued evolution. 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. Slope makes clinical trials boring by using real-time data to orchestrate operational complexity. medtech.labcorp.com. As a community leader and healthcare advocate she partners, collaborates with initiatives including the U.S. Department of Health and Human Services Office of Minority Health and the U.S. Food and Drug Administrations Office of Minority Health and Health to increase awareness on the need for diversity in lupus clinical trials, All Of US Research, Scripps Digital Trials Center and Congresswoman Grace Napolitanos Mental Health Consortium. Dr. Karl McEvoy has over a decade of industry experience in both the vendor and sponsor sides. 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. Strategy/Planning: How do you make the decision to run a DCT; what are the considerations? To learn more , please visit our website - http://www.pcmtrials.com/. To learn more , please visit our website - We have conducted clinical trials contributing to the market approval of nearly 100 new drugs to date. She is a Nurse Practitioner by training and spent over 10 years caring for patients before coming to industry. Specialized in clinical strategy and projects within digital health, with experience spanning from product ideation to commercialization. To learn more , please visit our website - Following its virtual success over the COVID lockdowns, we are pleased to forecast the 2022 live edition will attract even more, with a great speaker line up and up to date content. Add the event to your calendar. Amsterdam RAI. Proven ability to organize and manage late-stage development cross-functional teams completing projects on time with meticulous attention to detail. She is also a Certified Clinical Research Professional, and a trained journalist. Wayne resides in Miami, Florida. UPCOMING EVENT. 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. Advantages of working alongside grass root organisations and PAGs what groups are out there? To learn more , please visit our website - Earlier as a bench chemist, he was the first to make Iotrolan, a CT X-ray contrast agent, generic for decades, replaced in about 2005 by newer agents. GreenLight Clinical is a physician-led, boutique full-service clinical CRO with its own central clinical, bioanalytical, histopathology laboratories in Sydney, Australia. KEYNOTE: Seeing your site as a partner and identifying best practices for reducing site-burden, Seeing your site as a partner and identifying best practices for reducing site-burden, Clinical Operations leader with extensive bio-pharmaceutical and CRO industry experiences (20+years) *Develop and implement strategic Clin. Drivers of failures, Flawed clinical study design leading to failures, Diagnostic indicators and early Go/No-Go decisions in proceeding further during clinical study phases. Also within Genentech, she is a core member of the Advancing Inclusive Research Site Alliance and leads the company's LGBTQ+ Health equity strategies. Are you attending Outsourcing in Clinical Trials West 2023 conference? Imaging endpoints are often used to support go/no-go decision-making in early phase trials. Mr. Luciano earned a B.A. 7 - 9 November 2022, Amsterdam . Extensive Outsourcing and Contracts experience in the area of Clinical Development primarily at small to mid-size biotech organizations. FIRESIDE CHAT: Addressing the growing challenge of staff shortages and site delays to develop a seamless contracting and start-up phase. http://www.conversis.com/, To learn more , please visit our website - The main program of the conference is discussion and debate on the outsourcing of clinical research. Swiss Biotech Day 24th April 2023 to 25th April 2023 Basel, Switzerland. In that role, she built and led the commercial organization that developed go-to-market strategies for Potrero's Accuryn Monitoring System. Henry is a Vice President of Data Sciences at Medidata. Our Leukopaks are available for Research Use Only and Clinical Grade (FDA 21 CFR 1271-compliant) applications. Best practices and tools for managing supplier governance and ascertaining who is accountable, Identifying the criteria to determine level of oversight needed for a vendor. I am very excited to be attending Clinical Outsourcing Group UK this year in London! RT1 Conducting a study when there is minimal education, Hang Nguyen, Sr. Director, Clinical Affairs, Materna Medical, RT2 Navigating the complex spiderweb of multiple vendor relationships, Sarah Mullen, Vice President of Clinical, HeartFlow, RT3 Training Strategies for a Novel Therapeutic Medical Device, Ann Louise Armstrong, Senior Manager of Clinical Affairs and Field Operations, Ancora Heart, - How the process started and steps taken, - Assessment of eligibility and submission, - Lessons learnt - how it helped and what we did, what we companies can learn and do better, Discussion focusing on Real World Data; an overview of opportunities and challenges in working with RWD/RWE, Ted Chun, Director, Global Clinical Shared Services, Stryker Neurovascular, RT2- Navigating the complex spiderweb of multiple vendor relationships, RT3- Training Strategies for a Novel Therapeutic Medical Device, Ann Louise Armstrong, RN, MSN, CCRC, CCRA, Senior Manager of Clinical Affairs and Field Operations, Ancora Heart. To enquire about sponsorship opportunities for the conference, please contact: To enquire about speaking opportunities for the conference, please contact: Arena International is a global B2B events company for online casino players. To learn more , please visit our website - To learn more , please visit our website - 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. Learn how elluminate delivers: Empowering excellence in supply through digital quality management systems, In this session our guest speaker will address the challenges with these drugs in development and looking at parallels in a medical device regulatory strategy. 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. Conference series LLC Ltd Organizes 3000+ Global Events Every Year across . Rho, a contract research organization (CRO) located in Chapel Hill, NC, provides a full range of services across the entire drug development process. She has actively participated in departmental preparation for the EU CTR implementation and is one of ICONs SMEs on this topic. UPCOMING EVENT. We contribute to a safer and better world by helping our sponsor clients accelerate drug and device approvals to market. Using modern payment, transportation, and communication solutions we help drive retention, compliance, and data quality. 3 rd Clinical Pharmacy Conference. We provide personalized patient logistics management, reimbursement, and convenience services to support clinical trial participants. Topics include feasibility & site selection, clinical data & technology, patient engagement & enrollment, risk-based monitoring, and budeting & clinical outsourcing. At Trilogy, medical writing is our passion. 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. Online event and networking. Zigzag aims to provide straightforward, reliable and flexible Quality Assurance and auditing services on a local or global basis. 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. To learn more , please visit our website - www.eclinicalsol.com. Altasciences full-service solutions include preclinical safety testing, clinical pharmacology, bioanalysis, program management, medical writing, biostatistics, data management and more, all of which can be tailored to specific sponsor requirements. With presentations and panel discussions on all the hottest industry trends and outsourcing challenges. 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. 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. For the past 10 years, Estela has co-facilitated support groups, led, and participated in educational symposiums, advocated locally and nationally. Ops components of various FIH studies and global P1-P3 drug development programs and post-marketing studies in Oncology, Hematology-Oncology, Immuno-Oncology, Infectious Diseases, Immunology, Metabolic Diseases, Ophthalmology, and Critical Care conducted in North America, Europe, Africa, Central and South Americas, Asia-Pacific regions including Japan, China, So Korea, and Australia *Lead cross-functional teams and successfully contributed to several INDs, NDAs, FDA, EMEA, TGA, and NMPA regulatory filings and approvals of marketed products within HIV/Virology Therapeutic Area *Mentor, motivate, and develop clinical operations teams and direct reports *Strong, flexible, strategic team leader with extensive change management successes *Track record to develop, problem-solve, and execute creative and innovative process improvements and quality efficiencies within development operations *Motivated and driven to continue contributing to drug development in transformative medicines with a focus on unmet medical needs, CLOSING KEYNOTE: ClinOps team focus: Managing relationships, retention and hiring in the new world. 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. To learn more , please visit our website - https://lnkd.in/gEJj4yXX Please come and visit us at stand Visit our website to learn more about how we deliver a Better Clinical Experience. DGE invites you to return to the industry's first, most detailed, and most trusted conference on this topic - our 7th Decentralized & Hybrid Clinical Trials Summit. Conduct of clinical trials are increasingly becoming expensive. 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. Fusion eClinical Suite is the most adaptable, unified platform that serves as the Connected Hub for all your Clinical Trial and operational data and reporting. She is acknowledged for her expertise and passion in Data Integrity and Vendor Oversight, and has been recognized as a thought leader in process optimization and standardization as they relate to Inspection Readiness. Looking forward to another great conference! Tactical clinical operations in digital health studies, First-hand learnings, breakthrough device system, a case study. 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. https://www.medidata.com/, To learn more , please visit our website - THREAD provides key platform features such as eConsent, eCOA/ePRO, sensors, reminders, and telehealth Virtual Visits to support remote data capture, hybrid virtual studies, and fully decentralized studies in key therapeutic areas. Were a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. Driven by a unique combination of deep domain expertise and technical capabilities, our ClinRun application suite rethinks trial administration through active engagement, smart design, and breakthrough technology.

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