Future Trials Conference: Decentralised, Direct To Patient And Virtual To learn more , please visit our website - Chemistry degree from Punjab University, Institute of Chemistry, Executive Director, Global Digital Quality Management Systems and Business Intelligence BeiGene, Executive Director, Global Medical Affairs Study Management, BioMarin Pharmaceuticals, Inc. Wendi Carroll received her Pharm D from the University of the Pacific. SDC delivers top-tier clinical trial services to pharmaceutical, biologic and device/diagnostic companies. Meghan serves as the VP, Clinical Trial Financial Management at Medidata driving roadmap and strategy across our Grants Manager and Site Payments products. 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. Program and Alliance Management professional with 15+ years of product development, project management and operations experience within the biotechnology and biopharmaceutical sectors. How do we move forward from here? View Event. For more information, please contact us at 262-334-6020, or via email at Daniel.Selness@spauldingclinical.com. 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. To learn more , please visit our website - www.pro-ficiency.com. 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. She also has a special interest in innovations that can improve the quality and efficiency of clinical trial execution. The event is a must-attend for people from the clinical trials . How do you arrange with and clean the large amounts of data generated? Ndidi Rickert is an experienced Quality Assurance leader with over 20 years of experience in the Pharmaceutical/Biotechnology industry. Outsourcing in Clinical Trials: Medical Devices Europe 2023 He has been actively involved on both sides of the business in managing CDMOs and CROs. Partnerships in Clinical Trials Europe 2022 - ntradeshows.com Outsourcing Clinical Trials New England 2022. His mother started a foundation in 1998 and raised some $20M for research into vaccines against Valley Fever. 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. 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. April 25-27, 2016 Dubai, UAE. Partnerships in Clinical Trials Europe 2022. Catalyst Clinical Research is a new generation Clinical Research Organization, serving the unique needs of small-to-medium sized biopharmaceutical companies. 5 th Global Pharmacovigilance Summit. To learn more , please visit our website - http://www.pcmtrials.com/. ACM Global Laboratories is one of the largest global independent central labs in the industry. The company specializes in end-to-end services supporting drug discovery, precision medicine and clinical development for smarter clinical studies. In this presentation we will discuss the following: Clinical development has shifted from a scientifically driven journey to a patient-focused one. https://www.medidata.com/, To learn more , please visit our website - Hear from the trial industry as they discuss the services they would like to see from their solution providers, including: Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Online event and networking. Review and assess the selection criteria sponsors face when selecting Phase I jurisdiction. Read more . IRT Interactive Response Technologies - Informa Connect He is also a co-founder of U&D Pharma and working on Replyte Gel, a treatment for anogenital warts. 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. During her career she has supported Class 1-3 devices through the entire product lifecycle. Scalable, Reliable. DSG, Inc. celebrates over 25 years as a leading global eClinical provider with a fully integrated suite of innovative technology solutions and data management services: Award-winning eCaseLink EDC & DSG Designer for Enterprise licensing with CDISC standards; Risk-Based Monitoring, eSource, IWRS Randomization and Clinical Supply, Drug Safety, Patient Profiles, ePRO, CTMS, Site Payment, Protocol Violations, ad-hoc reporting, CDM services, and digital on-demand Clinical Printing services. We offer customized solutions to fit the needs of each study, patient and site, making it easier for your patients to stick with it. Arena International are delighted to announce that our Outsourcing Clinical Trials Europe event is returning to an in-person format in 2022. www.greenlightclinical.com, To learn more , please visit our website - MedPoint Digital develops intuitive, ICH-GCP compliant eClinical platforms for virtual investigator meetings, trial portals, interactive modules, and virtual clinical trials. PCM TRIALSscreens, hires, trains and manages all of our own Certified Mobile Research Nurses who conduct clinical trial visits in the subjects homes. To learn more , please visit our website - FDAs role in maintaining a secure and resilient supply chain. What can we do to take advantage of high prevalence of disease in populous countries but systems are either rudimentary or non-existent? About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . http://www.endpointclinical.com/. Making the patient stories the centre of your study with a focus on feedback, Important topics to address with patients, Best timing and approach to successfully engage patients. Through innovative eClinical and Regulatory solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market reliably. Our Provider Edition offers a CRO costing module and bid benchmarking. The main program of the conference is discussion and debate on the outsourcing of clinical research. Optimizing cell-based Gene Therapy Programs through the continued evolution. Triomics is a technology company offering an enterprise-grade platform for clinical trial sites to automate data collection practices. Dr. David Anderson is a Senior Scientist at Clinical Ink, where he focuses on the development of digital biomarkers in decentralized and remotely-monitored clinical research. We develop new innovations, drive emerging therapies forward and improve patient lives. Meraf has over 20 years experience working in biotech, health and the pharmaceutical industry. Understanding Social Determinants of Health: Identifying the variables that burden trial participants how can we collect this data? Events Archive - Pharmaceutical Technology 11 th International Conference on Clinical Trials is scheduled to be held during November 09-10, 2023 at London, UK. 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 . This conference is always a great opportunity to share and learn with our colleagues across the industry. 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. She also has a special interest in innovations that can improve the quality and efficiency of clinical trial execution. 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. Isabel Brown (she/her) currently works on the Inclusive Research and Health Equity team for Genentech's Research and Early Development, Clinical Operations group. She also has worked within the clinical department at several reputable companies like Axogen, Medtronic, Coloplast and CR Bard. Emmes acquired Casimir in March 2022, and the . IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. atreo.io, To learn more , please visit our website - She is definitely not afraid of being the least popular girl in the room in order to support patient safety! To learn more , please visit our website - https://www.threadresearch.com/. http://www.protrials.com/. Mr. Larwood co-invented his first two commercial molecules before age 30. Despite the ongoing disruptions from COVID-19, 2021 saw some major results from clinical trials. Karl has collaborated with the world's top 20 pharmaceutical companies and has extensive experience in patient-centered outcomes research, eCOA strategy, and drug development. Or has the noise around DCT quietened? She has worked with Calyx for over 7 years as a key strategic leader and director in IRT solutions and services. Clinical Chemistry & Laboratory Medicine Conference. ), pharmacovigilance and safety solutions, translation and language services, and call center support. European Union Clinical Trial Regulation: Strategic Considerations, Hyatt Regency San Francisco Airport Hotel These conferences closely focus on the advancements in clinical research and trials. 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. Mr. Chu holds a Bachelor of Science in Applied Ecology from the University California of Irvine. He has supervised the management of a clinical portal, eTMF, CTMS, RTSM, EDC, Coding and Grants solutions. Anca has over 15 years of experience in the biopharmaceutical industry, working both on the CRO and the Sponsor side. Ndidi also leads the X2 Women in Biotech Group speaker series and is one of the founding members of the UltraMosaic Employee Resource Group. Last year alongside talks from industry leaders Pfizer, Bristol Myers Squibb, [] Any Disease. Examining the behaviors of clinical trial stakeholders to better understand challenges in patient participation. She also had several leadership positions with PharmaNet Development Group (now Syneos Health), ICON Clinical Research and eMetagen Corporation. Read more. Altasciencesis a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies of all sizes a proven, flexible approach to preclinical and early phase clinical studies, from lead candidate selection to proof of concept. Founded in 2005, the companys cloud-based EDC, Direct Data Capture, eConsent, and ePRO solutions deliver fast, flexible, and easy-to-use tools for the collection and management of clinical data and patient reported outcome responses. This talk will provide an overview of the application of Artificial Intelligence methods in clinical operations. Caroline Cooper is the Director of Clinical Operations at CymaBay Therapeutics, Inc. with over 10 years of experience in clinical research. Medables completely modular approach allows pharmaceutical companies and clinical research organizations (CROs) to use only what they want, while scaling capabilities to better suit their unique studies.