The FDA-cleared KardiaMobile device is the most clinically-validated personal ECG solution in the world. The Patient Engagement track will be chaired byEstela Mata-Carcamo(Healthcare Advocate) and will delve into topics such as,outreach to minority groups,social determinants of health, and best practices forengaging the patient community. CROMSOURCE operates offices across Europe and North America. 1333 Bayshore Highway, Burlingame, API Services & Chemical Development. Wayne resides in Miami, Florida. 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. Arena International are delighted to announce the Outsourcing in Clinical Trials Southern California Event will be returning to California's La Jolla on September 26th & 27th 2023! The Investigations Branch handles: importer inspection, import sample collection, field examination, entry review, investigation, and inspection of imported FDA regulated products. Today she serves as the Chief Strategic Officer for Potrero Medical, a Hayward, California-based predictive health company developing the next generation of medical devices with smart sensors and artificial intelligence. To learn more , please visit our website - To learn more , please visit our website - Deep 6 AI is the leader in precision research software, connecting all research stakeholders in an AI-powered, real-time, data-driven, collaborative ecosystem. www.td2inc.com. Our digital solutions enable sites to be more productive, with online study training, study eBinders (eISF), digital study alerts and SUSARs, patient visit guides, and a wide range of study tools, available via web portals and mobile apps. Join Premier Research at Outsourcing in Clinical Trials Southern California 2022 as it returns for its 9 th annual event. Stop by to see us at Outsourcing in Clinical Trials New England 2021 conference. https://www.propharmagroup.com/. We go beyond traditional events and offer, The main program of the conference is discussion and debate on the outsourcing of clinical research. OMDRHO's Key Initiatives, inspectional and compliance activities, Define RWE and real-world data sources/needs, Making progress during pandemic for a first-in-human device study, Designing a hybrid trial for a novel interventional device, Navigating the complexities of multi-specialty study, Determining the technologies to move studies off site in order to move forward with the new norm, Investigating technology to save costs and improve accuracy of pharmacokinetic and pharmacodynamic data, Learning how to improve study drug adherences so only the study participant has access and, can only take the drug as per study protocol, Case Study looking at Digitization for objective data and cost saving, Defining the reimbursement strategy to prove medical benefit and value, Understanding codes for medical device technologies, Working with the FDA to secure your reimbursement, Programming for efficient data management, Generating metrics for data tracking and study progress, Overview of how we interface with our organization, Discussing the technologies accessible for the smaller biotechs, Assessing how to make access to innovations affordable for companies on a smaller budget and how to best allocate limited resources, How to work with a vendor partner as a smaller biotech to get access to new technologies, Removing the barriers: what still needs to be done to improve access to innovation for all, Key drivers for trial enrolment and in time completion, Population and high prevalence of disease in developing countries, Barriers and hurdles to access vast pool of patients, Strategies/solutions to penetrate through barriers and pass hurdles, Common operational, security and regulatory issues around the collection, management, and reporting of essential clinical trial documents, How eTMF solutions can help to address these issues, and ensure inspection-ready and regulatory compliant storage of trial content, How eTMF solutions reduce business risk, improve team collaboration and productivity, reduce auditing and reporting costs, and ensure enhanced artifact quality, Major capabilities that current eTMF solutions should provide. 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. 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. https://www.sdcclinical.com/. Mr. Chu began his FDA career in 2002 as a Consumer Safety Officer (CSO). http://www.protrials.com/. The Global Clinical Trials Connect 2022 will focus on futuristic advancements in the clinical research industry and clinical trials. In 2019, THREAD was acquired by strategic health care investors Water Street Healthcare Partners and JLL Partners. Francis is an expert in clinical system regulatory compliance with over 20 years pharma experience spanning R&D, manufacturing and clinical research. Since our inception in 2003, over 1 million patients in more than 75 countries have participated in studies powered by Viedoc. He held senior level positions with Relypsa (acquired by Galenica for 1.52B US$), Anacor (acquired by Pfizer for 5.2B US$) and Transcept Pharmaceuticals (revers merger with Paratek). There, he employed a broad range of methodologies, including: visual psychophysics, neuropsychological and computer-based cognitive assessments, eye tracking, electrophysiology, and structural imaging. Clinical Trials 2022 will discuss various disciplines involved in the pre-clinical research, conduct of clinical trials; it will educate health care researchers about design, operation, organizing, research computing . Clinical Trials Conferences | Clinical Trials Meetings | Japan | USA 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. Industrial Pharmacy Conference. My training is in genetics (Ph.D.) and mechanical/biochemical engineering (M.S. Decentralized Clinical Trials 2022 was a really good opportunity to . 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. Global Clinical Trials Connect 2023 2022 London United Kingdom. Outsourcing In Clinical Trials East Coast 2022 - HealthManagement.org Our mission is to eliminate the barriers to clinical trials by bringing access to people where they live, work and are willing to engage. He has been actively involved on both sides of the business in managing CDMOs and CROs. Henry earned his B.S. Read more . Our Ergomed team is looking forward to exhibiting at Outsourcing Clinical Trials - Texas 2022, December 7th & 8th . For over 35 years Parexel has been a trusted global clinical research organization (CRO) and biopharmaceutical services company. The Association of Clinical Research Professionals (ACRP) supports clinical research professionals through membership, training and development, and certification. OCT DACH Conference 2022 - Outsourcing in Clinical Trials www.bsi-lifesciences.com. IRT Interactive Response Technologies - Informa Connect http://www.spauldingclinical.com/, To learn more , please visit our website - She advises on eCOA best practices, diary and instrument design and training for participants, caregivers and raters. 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. 8th Edition of Global Conference on Pharmaceutics and Novel Drug Delivery Systems (PHARMA 2023) Mon, 13 . As the IPM, he is the District liaison to FDA Headquarter handling import related issues and concerns. AWT Healthcare is solely focused on providing the clinical pharmaceutical and custom labels & packaging industry with state-of-the-art solutions at a fair price and competitive timing. Visit our website to learn more about how we deliver a Better Clinical Experience. We're here at the Outsourcing in Clinical Trials & Clinical Trial Supply East Asia conference. Clinical Trial Supply New England . 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. 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. I look forward to being in the Bay Area in early Lee King on LinkedIn: #octwestcoast2023 #clinicalresearch #lifesciences #outsourcing In this position, she focuses on initiatives for employee development or training and topics to advance health literacy for underserved communities as it relates to clinical trial access. Clinical Trials Innovation Programme 2023 is the only platform to . Wednesday, 28th Sep 2022 - Thursday, 29th Sep 2022 . Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve live. 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. 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. Zigzag aims to provide straightforward, reliable and flexible Quality Assurance and auditing services on a local or global basis. An opportunity at Gilead Sciences sparked her move to the West Coast, and she is now settled in the San Francisco Bay Area. The therapeutic areas include: Cancer, CV, CNS and infectious diseases. Emmes is a full service contract research organization collaborating with our clients to produce valued, trusted scientific research. Dr Jankicevic holds Doctor of Medicine degree, Master of Medical Sciences degree, and Board-certification in Dermatology and Venereology from the University of Belgrade, Serbia. www.viroclinics.com. For more information, please contact us at 262-334-6020, or via email at Daniel.Selness@spauldingclinical.com. We proactively plan, coordinate and write clinical documents to meet timelines, with a readability that reduces the time for review and approval. www.careaccess.com. We are a certified Minority Business and always do the right thing. We work With HeartTMevery day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. We are now in the position now to share our practical experiences with Decentralized & Hybrid Clinical Trials; The bedrock of a successful trial is a well-designed protocol with reliable measurements of biomedical and health-related outcomes to satisfy regulatory standards. To learn more , please visit our website - Lee King on LinkedIn: #octwestcoast2023 #clinicalresearch #lifesciences Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionalscollaborateswith biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. 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. www.emvenio.com, To learn more , please visit our website - Francis has lead supplier oversight responsibilities for sponsors, CROs and clinical system vendors. Erin has over 20 years of clinical trial and pharmaceutical software technology experience . The conference is tailor-made to address the concerns of trial sponsors based in Texas who are conducting . Over 20 years in clinical research, including patient innovation, feasibility, strategy, patient recruitment, retention, site engagement. Exploring new science and a futuristic perspective on AB/AM drug development, Exciting growth of artificial intelligence in medicine, A framework on development of artificial intelligence in medicine, The power of public attention and funding, Business opportunity of artificial intelligence in medicine, What they like to see in an outsourced partner organization, What they would like a partner to know about them / how they work. Key changes for the implementation of the EU CTR, Preparation for the EU CTR implementation, Submission efficiencies when using a CRO in the EU, Exploring how to introduce a new digital quality compliance management system. To learn more , please visit our website - Discover effective strategies for outsourcing clinical trial operations to ensure trials run smoothly and within budget . Subsequently completed a Neurology Residency at Columbia University with additional Fellowship training in Neuro-Oncology at the Mass General Brigham program. 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. He is also a co-founder of U&D Pharma and working on Replyte Gel, a treatment for anogenital warts. www.saama.com. She has led clinical development in dermatology and medical aesthetics for pharma/biotech, CROs, medical device and cosmetic companies including RAPT, Innovaderm, Premier Research, Allergan, Leo Pharma, and Murad. 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. To learn more , please visit our website - www.Clario.com. 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! Passionate about novel tech-enabled medical devices that advance the understanding and treatment of diseases. Explore online site training as a less time/labour intensive way to educate site. Partnerships in Clinical Trials Europe 2020. CHI's Clinical Trial Innovation Summit To learn more , please visit our website - 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. 85356 Mnchen-Flughafen , Join NAMSA 5-6 April in Munich, Germany for Outsourcing in Clinical Trials: Medical Devices Europe. Optimizing cell-based Gene Therapy Programs through the continued evolution. Pro-ficiency ensures that everyone in your study is compliant with all training requirements. August, 2023. Outsourcing In Clinical Trials East Coast 2022 User Dashboard. Our Provider Edition offers a CRO costing module and bid benchmarking. Medocitys platform is the only solution that provides a fully interactive clinical trial ecosystem enabling early decision making and safety monitoring in real time. In another exclusive data-led investigation, Andrew and Reynald Castaeda investigate which diseases are set to have an increase in clinical trial activity this year. She develops strategies to drive greater inclusion of racial and ethnically representative patient populations in clinical research and to advance health equity Gaining patient, clinician and community insights early in program development is integral to developing what is important to patients and improving access to medicines and treatments for all patients, regardless of race, ethnicity, sexual orientation, gender identity, age, socioeconomic status and ability/disability. Clinical Services. 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. Ellen Weiss is the Vice President, In-Home Solutions, Decentralized Clinical Trials at PCM Trials. Our standard products and services include patient recruitment, eConsent, ePRO/eCOA, interactive digital support and symptom monitoring with the capability to provide an end to end clinical to commercial solution. 28 - 29. Advice for the ClinOps team to avoid unnecessary patient visits, how does your protocol affect the site? 11 clinical trials that will shape medicine in 2022 - Nature Other companies he has founded or co-founded include: 1) IMTH, a real estate investment trust with properties through the state of California; 2) iPill Dispenser, a medical device that uses a mobile app to control a secure, stand-alone pill dispenser to prevent opioid sharing, diversion, and drug overdoses; and 3) NAOMI systems, a practice management software company that integrates digital X-rays devices in PACS, EMR and RCM billing modules. Mr. Chu was also the Import Program Manager (IPM) for the FDA Los Angeles District. 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. With offices in over 100 cities worldwide, TransPerfect is the ideal partner to ensure that your global launch makes a global impact by driving quality, mitigating compliance risk, and enhancing patient engagement. AliveCor is a privately-held company headquartered in Mountain View, Calif. Consumer or Personal ECGs are ECG devices available for direct sale to consumers. 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. Our experts are ready to discuss how our solutions can best support your live studies. The Technology track will seeKimberley Ferguson(Commercial Head of Personalized Healthcare Partnerships, Genentech) discussing all thingsWearables. RadMD, a Medica Group Company, is your full service imaging core lab solution. https://www.nucleusnetwork.com/au/, To learn more , please visit our website - Headquartered in Sydney since 1996, Novotech has come to be recognised as the CRO of choice for many US and European biotechnology firms in the Asia Pacific. Mr. Luciano earned a B.A. May 02-03, 2016 Chicago, USA. During her career she has advocated for critical partnerships with vendors supporting integration with internal stakeholders. http://www.labconnectllc.com/. To learn more , please visit our website - The DPO Centre has assisted over 600 clients globally, including a broad range of bioscience, genomics, therapeutics, healthcare and pharma companies to comply with EU data protection laws such as the GDPR, the EU Clinical Trials Regulation and specific member state requirements. Sandy Mohan is the VP of Quality at Iovance Biotherapeutics. www.flexdatabases.com. Dont miss out; join us in Burlingame on March 1st& 2nd2023! Global Clinical Trials Connect 2023 2022 London United 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. Catalyst Clinical Research is a new generation Clinical Research Organization, serving the unique needs of small-to-medium sized biopharmaceutical companies. Her experience in a multitude of therapeutic indications has led to an acute knowledge of study conduct and execution with a keen focus on protocol dynamics. 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 assisTek has been paving the way for integrating technology and data collection in clinical trials for over 25 years. Future Trials Conference: Decentralised, Direct To Patient And Virtual Project Leader, Health Equity And Population Sciences, Hoffman La Roche. www.tprausa.com. Since our establishment in 2004, we have conducted over 700 phase I clinical trials, with 80% of our clients consisting of US based biotech and pharmaceutical companies. Conferences > Medicine & Healthcare > Translational Medicine, Clinical Meghan McKenzie works in Patient Inclusion and Health Equity in Genentechs Chief Diversity Office. http://www.axiommetrics.com/. Study sponsors and contract research organizations have used Medrio extensively in clinical trials across a wide array of therapeutic areas, with notable success in oncology, infectious disease, and more. Whether you require ad hoc support or a team to partner with on audit programs, we have the people, the expertise and the experience to provide the assistance you need. Our scientific knowledge base, technical expertise and reputation for high quality services have been integral to our ability to turn our services into your solutions. To learn more , please visit our website - http://kpslife.com/. Tickets. November 13-14, 2023 Dubai, UAE. Trial enrollment accounts for 60% of the total time of the trial and for 80% of trial failures. She facilitates policy and procedure development within OMDRHO and collaborates with medical product partners in the Office of Medical Product and Tobacco Operations, and with peers throughout CDRH during daily operations and on special projects. Extensive Outsourcing and Contracts experience in the area of Clinical Development primarily at small to mid-size biotech organizations. I went into industry for post-doctoral studies at the biotechnology research center at Ciba-Geigy Corp. (Novartis) and have over three decades of academic and industrial research and senior management experience in protein and metabolic engineering, bio-based manufacturing, and drug discovery / development. 21 October 2022 Outsourcing In Clinical Trials - Texas 2022. To learn more , please visit our website - http://www.clinicalink.com/. What things do they need a partner to do and what they dont need! Founded in 1996, ProTrials has been successfully supporting clinical research for over 25 years. Cultural consideration - translations, typical distance from site, etc. Kardia is the first AI-enabled platform to aid patients and clinicians in the efficient detection of atrial fibrillation, the most common arrhythmia and one associated with a highly-elevated risk of stroke. 2023 edition of Outsourcing in Clinical Trials East Coast will be held at King of Prussia starting on 23rd May. He has worked for CROs as well as small and large biotechnology companies. Wayne holds an MBA and B.S. With the most trusted review solutions, innovative technologies, experienced consultants, and deep-seated connections across the industry, Advarra optimizes research performance, empowers clinical sites, and ensures compliance. She is a career FDA federal service veteran with vast experience in technical and managerial positions across multiple commodities. Presently, Ndidi is the Associate Director, Clinical Quality Assurance & GxP Compliance at Ultragenyx Pharmaceutical Inc. where she has worked for over 6 years. Genentechwill give a case study session onpiloting health inequities and gender identity data why collecting this data now will aide you with your clinical trial. Conference . http://www.novotech-cro.com/, To learn more , please visit our website - Cliniacal Trials 2023 | 13th International Conference on Clinical 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. 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 . To learn more , please visit our website - www.frontagelab.com. She has extensive experience in managing complex projects, with a strong focus on building and maintaining relationships at both company and industry level from an operational role within the organization. Are Hybrid trials the more realistic and practical approach compared to full DCT agree or disagree? He also served on multiple FDA Headquarter working group and committee related to Food Safety Modernization Act (FSMA), import process improvement, strategic framework, rapid screening technology, and partnership agreements. Rhonda has more than 30 years of experience in FDA, starting as an ORA Investigator in Portland, OR before becoming a manager located in FDA's Minneapolis office. Long term solutions: could reducing the site certification process be a realistic solution? www.curebase.com, To learn more , please visit our website - http://www.endpointclinical.com/. www.viedoc.com, To learn more , please visit our website - Subsequently, Arun lead the Gastric-Immuno-Oncology Rare Disease Bispecific-T cell-Engager portfolio at Amgen on various aspects of clinical research operations. 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.