Dr. Apfel is also the Chair of Life Sciences at the Keiretsu Angel Investment Forum, where he invests in life-science companies that have the potential to positively impact patients with serious conditions. She then ventured across the pond to the United States where she worked for Novartis, Pfizer, Johnson & Johnson and Aeras (one of the Bill Gates Foundation companies specializing in TB and Malaria). www.curebase.com, To learn more , please visit our website - Global Player in eClinical Solutions . actalentservices.com, To learn more , please visit our website - 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). We have conducted clinical trials contributing to the market approval of nearly 100 new drugs to date. INTERACTIVE SESSION Data matters in health outcomes and equity: Collecting and understanding Social Determinants of Health (SDOH) data in clinical trials and beyond. ClinChoice is a leading full-service clinical CRO offering high-quality solutions to pharmaceutical, biotechnology, medical device and consumer products clients. Medocitys platform is the only solution that provides a fully interactive clinical trial ecosystem enabling early decision making and safety monitoring in real time. Passionate about novel tech-enabled medical devices that advance the understanding and treatment of diseases. Anca has over 15 years of experience in the biopharmaceutical industry, working both on the CRO and the Sponsor side. To learn more , please visit our website - https://www.worldwide.com. Check out who is attending exhibiting speaking schedule & agenda reviews timing entry ticket fees. Should our biggest concern post-covid be remote working? Our experienced team has been in this niche of clinical research with deep domain experience for decades and client solutions has been our passion for over two decades. 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. We have expanded our product line to include Medical Device Labeling through AWT Labels & Packaging. https://www.worldwide.com, To learn more , please visit our website - 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 . 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. To learn more , please visit our website - Due to increased utility of digital data collection tools and compute infrastructure, ability to generate real-time insights are now possible. Alton Sartor completed a combined MD/MBA from Tulane University. Taking place in Boston, 17 - 19 October 2022. 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. To learn more , please visit our website - www.eclinicalsol.com. ), pharmacovigilance and safety solutions, translation and language services, and call center support. Join us in Philadelphia, May 10th-11th, to shape best practice on: Refining patient recruitment strategy. This event is a great opportunity to get to know the online casino players who will be performing at this meeting. Versiti Clinical Trials Services support biopharma and cell therapy companies through central laboratory, logistics, biomaterials provision, and IRB services. https://lnkd.in/gEJj4yXX Please come and visit us at stand 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. To learn more , please visit our website - Executive Director, Program Strategy, Rare Disease and Pediatrics, Premier Research, https://www.medidata.com/en/clinical-trial-products/clinical-data-management/rtsm/, https://www.linkedin.com/in/ndidi-rickert-she-her-47197371/, https://eurofinscentrallaboratory.com/biopharma-services/, eurofinscentrallaboratory.com/biopharma-services, Hyatt San Francisco Airport, Burlingame, San Francisco, Best practices for engaging the patient community and growing that relationship using real life case studies. 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. To learn more , please visit our website - CISCRP staff is committed to participating and presentingspeaker, chairperson, moderator, advisor rolesin relevant and engaging educational events within the clinical research industry. To learn more , please visit our website - Medable offers the most flexible decentralized clinical trial platform streamlining trials for patients, sites, and clinicians whether in-clinic or at home. Our latest enhancements include patient genetic and biomarker matching to promote swift site identification and patient enrollment. www.careaccess.com. http://www.cromsource.com/. 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. Understanding Digital and Device Safety Across a Large Organization, a Perspective of a Center of Excellence. Trial enrollment accounts for 60% of the total time of the trial and for 80% of trial failures. For more than 40 years, Emmes has been dedicated to research for a healthier world. To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit almacgroup.com. Prior to starting SageMedic, he was an Associate Professor at UCSF. 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. Dont miss out; join us in Burlingame on March 1st& 2nd2023! AI-ML, a Hype or Hope. Choose from over 15 fully integrated modules on a single platform: EDC, DM, RTSM/IWRS, CTMS, Inventory Management, ePRO, eConsent, Patient Portal, AE/SAE Tracking, Safety Database, Central/Local Lab, Imaging Management, eTMF, and 24/7 Project and Clinical Data Reporting. Clinical Trials conferences 2023 are large-scale multidisciplinary events well attended by clinical researchers, media partners, renowned speakers, sponsors, scientists, exhibitors, and other attendees. 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. http://www.premier-research.com/, To learn more , please visit our website - She is a Nurse Practitioner by training and spent over 10 years caring for patients before coming to industry. To learn more , please visit our website - https://lifesciences.transperfect.com/. Optimizing cell-based Gene Therapy Programs through the continued evolution. With presentations and panel discussions on the top industry trends and outsourcing challenges, and . Making progress of a complex Interventional device study during covid. We contribute to a safer and better world by helping our sponsor clients accelerate drug and device approvals to market. In 2010, he became a Supervisor Consumer Safety Officer (SCSO). 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. 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. Advarra advances the way clinical trials is conducted to make them safer, smarter, and faster. Frontageis a CRO providing integrated, scientifically-driven research, analytical and product development services throughout the drug discovery and development process to enable biopharmaceutical companies to achieve their drug development goals. We help teams bring order, trust, and predictability to protocol execution and automation. 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. Kumar earned his Ph.D. from the University of Vermont and was a post-doctoral fellow at the University of Virginia. In 2021, ERT and Bioclinica merged to become Clario creating the broadest endpoint technology platform in the industry and enhancing our scientific expertise. https://www.propharmagroup.com/. Reem holds a PhD in genetics from the Hebrew University of Jerusalem. Jay holds an MBA from Villanova University and a degree in Computer Science and Physics from Gettysburg College. Interactive Response Technologies (IRT) 2022 brings the clinical community together to discuss cutting-edge updates in technology and dives into strategies to help the clinical industry excel in their trials and data management. Datacubed Health is a pioneering technology company making better science and healthier communities a reality. 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. deep6.ai, To learn more , please visit our website - http://www.endpointclinical.com/. Optimizing CRO Success: Relationship, contribution and oversight, PANEL DISCUSSION Defining your outsourcing strategy to contain costs and accelerate drug development time-to-market: what should you consider in the new COVID-19 era, Executing clinical trials on a shoestring: Optimizing the CRO Functional Service Provider model. Tickets. We have successfully been providing exceptional value to our clients for over 30 years. 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. 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. 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. We are a patient-centric tool utilized to decrease the burden of clinical trial participation. Can you share some of your workflow procedures? 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. degree in Neurobiology and is the author of several peer-reviewed papers in prostate cancer and premature ovarian failure. To learn more , please visit our website - https://www.medidata.com/, To learn more , please visit our website - Discover effective strategies for outsourcing clinical trial operations to ensure trials run smoothly and within budget Join us for a two day event filled with case studies, panel discussion and face to face networking opportunities around clinical operations, technology and innovation, and data management. In her spare time, Ndidi enjoys creative writing and interior decorating. FDAs role in maintaining a secure and resilient supply chain. Rho, a contract research organization (CRO) located in Chapel Hill, NC, provides a full range of services across the entire drug development process. Our experienced project managers and global network of linguists are supported by proven processes and cutting-edge technology. Where do the opportunities lie for further acceleration in clinical development? Altasciences helping sponsors get better drugs to the people who need them, faster. www.orbisclinical.com. www.ACMGlobalLab.com. He worked in fortune 500 companies (Bristol-Myers Squibb Co, NJ-USA and Amgen, CA-USA), mid-size and startups/CROs (Discovery Partners Intl. 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. Conferences. The event is a must-attend for people from the clinical trials . Dr Jasmina Jankicevic is globally recognized as an expert in dermatology drug/device development. Arun received a Bachelors degree in Biological Sciences from University of California-Riverside, a Masters degree in Biomedical Sciences from Wayne State University and completed Doctoral degree coursework from Michigan State University College of Human Medicine. March 14 . Subsequently completed a Neurology Residency at Columbia University with additional Fellowship training in Neuro-Oncology at the Mass General Brigham program. During her career she has supported Class 1-3 devices through the entire product lifecycle. https://www.q2labsolutions.com/, You need an Imaging Strategy thats designed and customized for your oncology clinical trial. We are an embedded partner dedicated to the success of your study, offering managed services such as: Data Management, On-Demand Data Analytics, Biostatistics, Clinical Management, eTMF Management and Pharmacovigilance. Emmes is a full service contract research organization collaborating with our clients to produce valued, trusted scientific research. http://www.medable.com/, To learn more , please visit our website - Peachtree BioResearch Solutions is an Atlanta-based Clinical Research Organization that provides clinical development support services and innovative resourcing solutions to medical device, pharmaceutical, and biotech companies. Isabel Brown (she/her) currently works on the Inclusive Research and Health Equity team for Genentech's Research and Early Development, Clinical Operations group. Previous roles within both CRO and Sponsor organizations which provide valuable perspective from both sides of the industry. Triomics is a technology company offering an enterprise-grade platform for clinical trial sites to automate data collection practices. Aug 05 International Conference on Clinical Trials in Endocrinology (ICCTE) - Montreal, Canada. 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. Best practices for managing CRO governance for small/start-up companies with limited resources or large companies with competing priorities, Driving success in either unexplored settings or in saturated market settings, Maintaining Chain of Identity/Chain of Custody, Evolving Technologies & Regulatory Guidance documents, Roel of Project Management in helping to drive and streamline cross functional communication, Key considerations for communicating timelines and milestones, Maintaining focus on Quality centric culture, Using machine learning to increase efficiency, Leveraging interoperability to streamline operations. Flex Databases platform is a secure, unified and compliant system for clinical trials. www.versiticlinicaltrials.org, Viedoc designs engaging software for the life science industry. Examining the behaviors of clinical trial stakeholders to better understand challenges in patient participation. eClinical Solutions is a leading global provider of cloud-based enterprise software and software-driven clinical data services. Lead on the diversity and inclusion team, and member of DTRA, CISCRP and other industry consortiums aimed at improving access to clinical research and providing clinical research as a care option. To learn more , please visit our website - Spaulding Clinical operates a 200-bed Clinical Pharmacology Unit, a Full Service Biometrics Group and Cardiac Core Laboratory. Through innovative eClinical and Regulatory solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market reliably. 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. Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. Combined, our clinics offer over 200 beds. 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. To learn more , please visit our website -

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