Were streamlining your research, helping you get to your next milestone faster. All three clinics are strategically co-located within leading medical, research and biotech precincts offering unique access to ancillary services including bioanalytical laboratories, MRI, lumbar punctures, chest X-rays, ophthalmology assessments and others. 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. Proven ability to organize and manage late-stage development cross-functional teams completing projects on time with meticulous attention to detail. Kris OBrien is an Executive Director in Program Strategy, specializing in Rare Disease and Pediatrics, at Premier Research. www.deeplink-medical.com. 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. Meghan McKenzie works in Patient Inclusion and Health Equity in Genentechs Chief Diversity Office. We have been driving the success of our clients, consultants, and employees in staffing and consulting services since 2004. 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. Valley Fever Solutions is a small startup working first on a new and improved treatment for Valley Fever (coccidioidomycosis), for which NikZ will transform the standard of care. Outsourcing in Clinical Trials New England 2023 As the worlds largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. GreenLight Clinical is a physician-led, boutique full-service clinical CRO with its own central clinical, bioanalytical, histopathology laboratories in Sydney, Australia. http://www.conversis.com/, To learn more , please visit our website - Increasing inclusion in future trials for vulnerable populations with health disparities some success stories, Home visits have evolved since their inception in 2003, Services possible in 2023 an overview of what is possible today, Sourcing the right professionals for visits is essential to success, Addressing the reduced site pool challenge and focussing on sites you know can deliver, Overcoming hurdles with imaging centres with reduced staff when trying to qualify patients in a timely manner. To learn more , please visit our website - CA; X-Mine, CA; Delphian Pharma, CA and Certum LLC, CA). Rated 4.5 by 2 people. Mr. Larwood is the third of his family to be involved in Valley Fever. 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. Mr. Chu was selected to be the Director of Investigations Branch (DIB) for DWCI in June 2018. The 2022 program boasts two full streams including: www.harborclinical.com/. 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. Learn more about and Labcorp at www.Labcorp.com or follow us on LinkedIn and Twitter @Labcorp. 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. Rigorous scientific background and 9+ years of experience in driving both academic and industry clinical programs. We develop new innovations, drive emerging therapies forward and improve patient lives. She has executed a variety of clinical trials involving therapeutic areas including autologous breast reconstruction, heart failure, hypertension, arrhythmia management and erectile dysfunction. https://www.intrinsequehealth.com/. Over the years, Lin has achieved success at both large corporations and startups. We help teams bring order, trust, and predictability to protocol execution and automation. Panellists will discuss the challenges and tech barriers with DCT. OMDRHO is one of five programs in the Office of Medical Products Operations within FDAs Office of Regulatory Affairs. She has managed and overseen large global clinical trials in various therapeutic areas and multiple phases of development. 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. 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. www.ACMGlobalLab.com. theactigraph.com. www.zigzagassociates.com. His expertise is in regulated content management, and he is a member of the TMF Reference Model Project Team. Compare and contrast the FDA, MHRA and TGA regulatory requirements for Phase I clinical entry. TFS HealthScience is a global Contract Research Organization (CRO) that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey. 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. http://www.spauldingclinical.com/, To learn more , please visit our website - Meghan serves as the VP, Clinical Trial Financial Management at Medidata driving roadmap and strategy across our Grants Manager and Site Payments products. 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. www.ledgerrun.com/, To learn more , please visit our website - DCT was previously done out of necessity but are we seeing it as a new world order? In addition, 30% of trial participants drop out of the study, Innovation should strive to maximize the synergy of all three variables: safety, efficacy, and speed. Any Disease. Wed, 25 May 2022, 18:00 WebSite. At Medable, she works cross-functionally with engineering, product development, regulatory, AI/ML, and data science to develop first-in-class DCT solutions. www.saama.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. The Association of Clinical Research Professionals (ACRP) supports clinical research professionals through membership, training and development, and certification. Our mission is to eliminate the barriers to clinical trials by bringing access to people where they live, work and are willing to engage. 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. For the past 10 years, Estela has co-facilitated support groups, led, and participated in educational symposiums, advocated locally and nationally. Mr. Chu holds a Bachelor of Science in Applied Ecology from the University California of Irvine. 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. Many biopharmaceutical trial sponsors rely on or scientific leaders to help design and optimize their protocols and statistical analysis plans. To learn more , please visit our website - Their services include clinical monitoring, clinical monitoring oversight, clinical trial management, data management, biometrics, and medical writing. Local vendor oversight vs global provider oversight how would you manage this differently? Effective management of essential clinical trial documents using eTMF solutions. 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. Electronic clinical outcome assessments (eCOA)and interactive response technology (IRT) platforms introduce greater speed, precision and data quality to clinical trials. Scout Clinical, part of the Meeting Protocol Family, provides stress-free, confidential and personalized travel, expense and compensation management services to clinical trial participants on a global scale. She has authored or co-authored 10 publications and has been an advocate for STEM education throughout her career. The elluminate Clinical Data Cloud provides life sciences companies with greater control of their clinical trial data with one platform for all data sources, from aggregation through to standardization, visualization, and preparation for submission. An Introduction to Simulation-Based Training in Clinical Research: De-Risking your Studies in 3 Steps. Read more. deep6.ai, To learn more , please visit our website - 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. Our experts are ready to discuss how our solutions can best support your live studies. 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. TD2 offers fully integrated precision oncology clinical development solutions that combine the highest standards in clinical trials management, disruptive imaging, biomarker strategies, and unparalleled access to real-time patient data. Eurofins BioPharma Services, Laboratory Testing is a group of Eurofins companies with dedicated testing facilities for global Central Laboratory Services, Bioanalytical Services, and Specialty Virology and Oncology Services. To learn more , please visit our website - Moving to law, in leading law firms he advised major companies on patent matters. Clinical Trials Conferences | Meetings 2023 | World BI For more information please contact Graig Daley Business Development Manager and Jackson Young Business Development Associate atsales@citlabels.com. Aditya is the Regional Director of Business Development at Novotech, the Asia Pacific specialist CRO. To learn more , please visit our website - Bruce started his career on the faculty in the Chemistry Department at Purdue University where his independent research focused on neuronal signal transduction. We offer Bioanalysis for small molecules and biologics for PK, immunogenicity and biomarkers utilising the platforms of LC-MS/MS (7) and Immunoassay (MesoScale, Gyrolab). This conference intends to focus on the global health and clinical trials around the world. She has worked at several companies in positions of increasing responsibility including VP of Quality at InterMune (acquired by Roche) and Director of Quality at CV Therapeutics (acquired by Gilead). November 28-30, 2016 San Antonio, USA. Advarra integrated solutions connects life sciences companies, CROs, research sites, investigators, and academia at the intersection of safety, technology, and collaboration. http://www.arensia-em.com/. 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. She is mastering the logistics of dosing and testing clinical trial participants where they live, work, and study. Clinical Trials Conferences | Clinical Trials Meetings | Japan | USA His clinical trial experience spans from set-up to delivery across all phases in a wide variety of disease and therapeutic areas. Estela is an exceptional community engagement liaison for both English and Spanish speakers. Digital health technologies and biomarkers in clinical trials requires the highest standards of data collection, transmission, security, quality, and analysis. Precision for Medicine (PFM), the full-service global CRO, is purpose-built to accelerate clinical research and development processes to bring life-changing therapeutics to those who need them most. Greenphire is the industry leader of clinical payment technology, designed to improve the way research professionals work. 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. Join us in Philadelphia, May 10th-11th, to shape best practice on: Refining patient recruitment strategy. Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture. His father was a physician who developed an interest in the disease decades ago when the family moved to Bakersfield, California, a focal area for the disease. http://www.augustresearch.com/. TransPerfect Life Sciences specializes in supporting the global development and commercialization of drugs, treatments, and devices designed to improve and save lives. Medocitys platform is the only solution that provides a fully interactive clinical trial ecosystem enabling early decision making and safety monitoring in real time. Pro-ficiency converts training from a cost center to a powerful quality improvement system. Outsourcing in Clinical Trials Southern California 2022 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. 11 th International Conference on Clinical Trials is scheduled to be held during November 09-10, 2023 at London, UK. Our specialized experts drive scale, innovation, and speed to market for visionary clients around the world. 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. 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. To learn more , please visit our website - He received a Certificate for Graduate Biostatistics at Harvard University Extension. Caidya Events | Caidya Conferences | Clinical Research Events Deep 6 eliminates months of manual data validation, to de-risk and accelerate clinical trials, because clinical trials should be a gatekeeper (accelerator), not a bottleneck to innovation. Visit our website to learn more about how we deliver a Better Clinical Experience. Check out who is attending exhibiting speaking schedule & agenda reviews timing entry ticket fees. www.versiticlinicaltrials.org, Viedoc designs engaging software for the life science industry. info@caidya.com. Mr. Luciano joined Corvus Pharmaceuticals in 2018 and has served as Vice President of Clinical Operations since 2021. Dr Morimoto has over 25 years of industry experience in leading project teams in the development of innovative medicines, providing guidance in the design and execution of preclinical, clinical and regulatory strategies with a therapeutic focus in Parkinsons, Alzheimers and frontotemporal dementias. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. We proactively plan, coordinate and write clinical documents to meet timelines, with a readability that reduces the time for review and approval. May 02-03, 2016 Chicago, USA. www.flexdatabases.com. Arun Sivanandam has more than 12 years of experience in clinical research at site and sponsor side. Our Australian phase I facilities are in Melbourne and Brisbane, and our US phase I facility is located in Minneapolis. Debashish has previously managed successful eTMF products at Veeva and Medidata, as well as clinical trial imaging tools at Synarc (now part of Clario). 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. It is the go-to solution in over 1,000 sites and 40 countries enabling investigators and sponsors to simply record, review, anonymise and submit assessments to regulatory bodies. Dr. Cunningham came from academic background. Strategy/Planning: How do you make the decision to run a DCT; what are the considerations? Sandy Mohan is the VP of Quality at Iovance Biotherapeutics. Of the several programs he worked at Pharma and Biotech companies, three culminated in making to the market [PaclitaxelTM Bristol-Myers Squibb; SensiparTM Amgen and DuexisTM - Horizon Therapeutics). AWT Healthcare manufacturers clinical trial labels. 200+. ICON plc is a world-leading healthcare intelligence and clinical research organisation. Rave RTSM streamlines your operations and provides real-time visibility for your study teams. 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. Supported by top pharmaceutical and biotech partners across 20 different therapeutic areas, Care Access is scaling and globalizing its new model for clinical trial delivery, where more physicians and patients can engage in life-saving research to develop new therapies faster.