As a CSO, he conducted domestic food inspection, consumer compliant investigation, recall traceback investigation, and inspection of imported FDA regulated products. This holistic self-service platform provides faster data access and intelligent analytics, empowering clinical trial teams to think innovatively. May 3 - May 4 @ Barcelona, Spain. We have been driving the success of our clients, consultants, and employees in staffing and consulting services since 2004. 2022 looks to be a bumper year too, so Nature Medicine asks leaders in their field what they think . Debashish has previously managed successful eTMF products at Veeva and Medidata, as well as clinical trial imaging tools at Synarc (now part of Clario). Dr. Debashish Niyogi is currently Vice President, Product Management at Anju Software, where he is responsible for the vision, strategy, and roadmap for the companys eTMF and CTMS solutions. 4240 La Jolla Village Drive. www.promedica-intl.com. 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. www.advarra.com. Join us in April 2023 to learn from the best in the drug development industry and have an opportunity to learn from their experiences. https://www.parexel.com/, To learn more , please visit our website - To learn more , please visit our website - www.Clario.com. Were your solution. With this expertise, global scale and the broadest endpoint technology platform, Clario will continue to lead the way in clinical trial technology that will transform patients lives. 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. www.tprausa.com. 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. 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. www.medocity.com, To learn more , please visit our website - 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. With locations in the US and EU, Catalyst offers highly flexible and customized, customer-centric solutions from Global Resourcing and FSP, to Full Service Managed Solutions, with a focus on oncology product development. Tickets. Prior to SDCs inception, Richard served on the Board of Directors of Ora, Inc. (www.oraclinical.com) for over 10 years. Emmes acquired Casimir in March 2022, and the . http://www.peachtreebrs.com. We work With HeartTMevery day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. 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. CROMSOURCE operates offices across Europe and North America. An Introduction to Simulation-Based Training in Clinical Research: De-Risking your Studies in 3 Steps. http://www.axiommetrics.com/. Communities. Our simulation-based protocol training prevents study errors, guarantees timely SIV, and frees up thousands of hours for your study team and site-staff. Amy has been a drug discovery and development professional for 25+ years, including progressive roles in clinical operations and clinical strategy. Electronic clinical outcome assessments (eCOA)and interactive response technology (IRT) platforms introduce greater speed, precision and data quality to clinical trials. https://lnkd.in/gEJj4yXX Please come and visit us at stand The 15th annual conference will provide experts in the life science industry to connect and explore solutions to current operational and outsourcing challenges associated with clinical trials . 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. Slope makes clinical trials boring by using real-time data to orchestrate operational complexity. 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. Her experiences in academia, biotech, and CROs confirm that meeting the needs of all stakeholders payers, regulators, patients, families, and sites is a critical success factor for efficient development programs. Conversis is built on one goal: To provide you with the highest-quality clinical trials translations. He has been a visiting professor at Catholic U., Louvain, Belgium and U. Pittsburgh, Pittsburgh, PA and visiting speaker at Humboldt U. in Berlin, Germany. 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. Nucleus Network is Australias largest Phase 1 clinical research organisation and the only Phase 1 specialist globally with phase I facilities in the US and Australia. After 3 years as a patent lawyer at Apple Computer, he took a VP role at startup FormFactor, staying in an IP role, then became the first General Counsel for startup Verisity Design, taking them public in 2001, then ultimately through successful acquisition in 2005. The must attend clinical outsourcing event in the Southeast region where industry professional can encounter a platform to explore new solutions to common issues within their clinical trial. 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. Vice President, CMC and Supply Chain, Union Therapeutics, Umar Hayat, Ph.D. is VP of CMC and Supply Chain at Union Therapeutics and has more than two decades of experience in pharmaceutical development, manufacturing and supply chain. Where do the opportunities lie for further acceleration in clinical development? He received a Certificate for Graduate Biostatistics at Harvard University Extension. theactigraph.com. She has extensive experience in building quality organizations, overseeing Phase 3 global clinical trials, supporting marketing authorization applications in the US and EU, and managing pre-approval inspections leading to multiple product approvals and launches. Anca has over 15 years of experience in the biopharmaceutical industry, working both on the CRO and the Sponsor side. As a Solutions Consultant with eClinical Solutions, Dan serves as a subject matter expert for the elluminate Clinical Data Cloud, the foundation of digital trials. Partnerships in Clinical Trials Europe 2020. 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. https://www.threadresearch.com/, To learn more , please visit our website - . www.frontagelab.com. 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. Her background in Biotechnology and proficiency in Data Management solidified her proven ability to identify data integrity risks, and problem solve the most complaint path to drug submissions and approvals. 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. The FDA-cleared KardiaMobile device is the most clinically-validated personal ECG solution in the world. www.emmes.com, Emvenio Research is a leading decentralized research organization (DRO) providing scalable and hybrid decentralized trial solutions improving clinical trial access to underserved and high-risk populations. https://www.anjusoftware.com/, To learn more , please visit our website - April 18-20, 2016 Dubai, UAE. Estela has supported her sister and her passion to help others has evolved to iLOOMinating, Engaging, Empowering and Supporting the community as a whole to take control of their healthcare. Medocitys platform captures valuable real-time clinical insights & real-world data, while engaging patients, sites, and sponsors. TORONTO, March 23, 2022 (GLOBE NEWSWIRE) -- Axiom Real-Time Metrics ("Axiom"), a premier provider of unified eClinical solutions . 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. Rigorous scientific background and 9+ years of experience in driving both academic and industry clinical programs. Topics: Developing and supporting your quality initiatives from Day 1, the Harbor team is committed to quality through each functional service we provide. 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. She became the Deputy Program Director for OMDRHO in 2017 and ultimately became OMDRHO Program Director in February 2022. She also has a special interest in innovations that can improve the quality and efficiency of clinical trial execution. Novotech is an Australia based clinical CRO operating across Asia and South Africa. 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. This experience has allowed her to understand the nuances that set rare and pediatric studies apart from routine clinical studies and develop proper strategies for clients to execute their studies in real world settings. www.gobio.com/clinical-research/. http://www.altasciences.com/, To support the acceleration of drug development, over the last 12 years, ARENSIA Exploratory Medicine GmbH (www.arensia-em.com) has built up its own research clinics, with full Phase I infrastructure, entirely dedicated to the performance of sophisticated FIRST-in-PATIENT Phase IB, IIA and PROOF OF CONCEPT clinical trials with novel compounds. Mr. Chu was also the Import Program Manager (IPM) for the FDA Los Angeles District. She holds medical license issued by Serbian Medical Chamber. https://www.medidata.com/en/clinical-trial-products/clinical-data-management/rtsm/, To learn more , please visit our website - https://www.medidata.com/. An opportunity at Gilead Sciences sparked her move to the West Coast, and she is now settled in the San Francisco Bay Area. 2022 edition of Outsourcing in Clinical Trials & Clinical Trial Supply East Asia Conference will be held at InterContinental Seoul Coex, Seoul starting on 29th November. Amsterdam RAI. Pro-ficiency ensures that everyone in your study is compliant with all training requirements. The 2014 event will focus on how companies from the region can implement effective clinical outsourcing strategies. Reem holds a PhD in genetics from the Hebrew University of Jerusalem. To learn more , please visit our website - Are you planning to attend the upcoming Outsourcing in Clinical Trials New England, November 9-10th, 2021? Embedding fit-for-purpose technology solutions enhances access, accelerates enrollment, improves representation, and increases compliance and retention, Strategies for successfully hiring and growing a ClinOps team in this day and age, Discussing how training improvements can increase retention, WFH vs in office: Pros and cons of managing a more remote ClinOps team in the US. Our specialized experts drive scale, innovation, and speed to market for visionary clients around the world. UPCOMING EVENT. Meghan joined a CNS-focused start up in RTP and has spent the last 15+ years working in the life science technology industry. AliveCors enterprise platform allows third-party providers to manage their patients and customers heart conditions simply using state-of-the-art tools that provide easy front-end and back-end integration to AliveCor technologies. 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. www.deeplink-medical.com. 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. We offer global DCT participant-centric approaches that provide flexibility, meet the most challenging clinical trial demands and provide convenience for patients/caregivers in a compliant manner. With presentations and panel discussions on all the hottest industry trends and outsourcing challenges. In addition to her deep understanding of the unique dynamics of developing novel treatments for rare and complex diseases, Dr. Raymond also leverages her combination of training and experience leading the Gene Therapy Think Tank at Worldwide Clinical Trials. Consulting Dermatologist, Clinical Development & Medical Affairs RAPT Therapeutics, Inc. Caroline Cooper is the Director of Clinical Operations at CymaBay Therapeutics, Inc. with over 10 years of experience in clinical research. Outsourcing In Clinical Trials East Coast 2022 User Dashboard. http://catalystcr.com/. Industrial Pharmacy Conference. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancements, drive the industry standard for data precision and usher in a new generation of clinical trials. Presently, Ndidi is the Associate Director, Clinical Quality Assurance & GxP Compliance at Ultragenyx Pharmaceutical Inc. where she has worked for over 6 years. Our biotech recruiters, pharmaceutical recruiters and scientific recruiters provide multiple solutions spanning temporary and permanent placement to clients ranging from venture-backed start-ups to Fortune 500 firms. Read more. Discuss a pathway to extend biotech cash burn runway while still meeting Phase I objectives and meeting investor expectations! AWT Healthcare manufacturers clinical trial labels. To learn more , please visit our website - Over the years, Lin has achieved success at both large corporations and startups. 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). Are you choosing best in class or a bundle? 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. https://www.advancedclinical.com/. Our company is committed to improving all lives touched by clinical research and we address the hopes of patients and healthcare professionals with industry-leading services and technology in life sciences. http://www.medable.com/, To learn more , please visit our website - April 28-29, 2016 Dubai, UAE. 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. He started his career with FDA in 1998. www.prevailinfoworks.com. He has extensive experience helping sponsor companies make their trials a reality across a range of projects from first in human to phase iv. 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. www.td2inc.com. YPrimescloud-based technology streamlines clinical trial data collection and management. . Local vendor oversight vs global provider oversight how would you manage this differently? Mr. Chu was selected to be the Director of Investigations Branch (DIB) for DWCI in June 2018. http://www.clindatrix.com/. His clinical trial experience spans from set-up to delivery across all phases in a wide variety of disease and therapeutic areas. To learn more , please visit our website - Spaulding Clinical Research is a global CRO providing Phase I IV drug development services to pharmaceutical and biotechnology companies. FIRESIDE CHAT: Addressing the growing challenge of staff shortages and site delays to develop a seamless contracting and start-up phase. In 2021, ERT and Bioclinica merged to become Clario creating the broadest endpoint technology platform in the industry and enhancing our scientific expertise. To learn more , please visit our website - Kris OBrien is an Executive Director in Program Strategy, specializing in Rare Disease and Pediatrics, at Premier Research. Zigzag aims to provide straightforward, reliable and flexible Quality Assurance and auditing services on a local or global basis. Dr. Hsu is anesthesiologist and pain management physician, but also a serial entrepreneur. 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. dpocentre.com. Frances has been working at Nevro Corp, a medical device company for the past 10 years as Director, Database Management. Philips BioTel Research is an industry leader in medical imaging and cardiovascular safety testing for clinical trials. His most recent activity is as CEO and Founder of QuiVivePharma, a company he took from inception to a FDA face-to-face PreIND meeting in just 1 year. 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.
West Midlands Football Trials, Rite Aid New Uniforms, How Do I Check My Cpap Recall Status, Police Incident Falkirk Today, Island Lava Java Happy Hour Menu, Articles O