www.greenlightclinical.com, To learn more , please visit our website - To understand site-side difficulties in trial recruitment and conduct, Arun served as a Senior Clinical Research Coordinator for Cardiology Phase 4 trials at the Loma Linda VA Medical Center, and as a Lead Clinical Research Specialist for Investigator-Initiated and Phase 0 3 Gastric Neuroendocrine Rare Disease trials at Stanford Cancer Center. 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. degree in Neurobiology and is the author of several peer-reviewed papers in prostate cancer and premature ovarian failure. 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. He is an advisor to several biotech companies. The Investigations Branch handles: importer inspection, import sample collection, field examination, entry review, investigation, and inspection of imported FDA regulated products. Future Trials Conference: Decentralised, Direct To Patient And Virtual 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. Ops components of various FIH studies and global P1-P3 drug development programs and post-marketing studies in Oncology, Hematology-Oncology, Immuno-Oncology, Infectious Diseases, Immunology, Metabolic Diseases, Ophthalmology, and Critical Care conducted in North America, Europe, Africa, Central and South Americas, Asia-Pacific regions including Japan, China, So Korea, and Australia *Lead cross-functional teams and successfully contributed to several INDs, NDAs, FDA, EMEA, TGA, and NMPA regulatory filings and approvals of marketed products within HIV/Virology Therapeutic Area *Mentor, motivate, and develop clinical operations teams and direct reports *Strong, flexible, strategic team leader with extensive change management successes *Track record to develop, problem-solve, and execute creative and innovative process improvements and quality efficiencies within development operations *Motivated and driven to continue contributing to drug development in transformative medicines with a focus on unmet medical needs, CLOSING KEYNOTE: ClinOps team focus: Managing relationships, retention and hiring in the new world. His current work focuses on deep collaboration with an interdisciplinary team of engineers and scientists to successfully integrate data from multiple assessments and sensors, implement high-dimensional feature engineering, and both evaluate as well as apply scalable machine learning algorithms. TORONTO, Oct. 12, 2022 (GLOBE NEWSWIRE) -- Axiom Real-Time Metrics ("Axiom"), a premier provider of unified eClinical solutions and services focused on small-to-medium life science organizations, will be exhibiting at Outsourcing in Clinical Trials New England 2022, October 12-13 in Boston, MA. Our leading clinical show will focus on providing delegates with practical take-aways and solutions to their most current operational and outsourcing challenges in clinical trials, this is an [] 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). 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. Anca has over 15 years of experience in the biopharmaceutical industry, working both on the CRO and the Sponsor side. My training is in genetics (Ph.D.) and mechanical/biochemical engineering (M.S. Were doing more than streamlining your processes. This event is a great opportunity to get to know the online casino players who will be [] During her career she has advocated for critical partnerships with vendors supporting integration with internal stakeholders. With over 40 years experience, 600 beds and locations in NA, EU and Asia, Celerion conducts First-in-Human, clinical Proof-of-Concept and patient dose response studies, cardiovascular safety and NDA-enabling clinical pharmacology research. Meraf has over 20 years experience working in biotech, health and the pharmaceutical industry. Kunal has over 18 years of experience managing and conducting clinical trials. Actalent is a leading provider of Clinical and Laboratory services. CISCRP staff is committed to participating and presentingspeaker, chairperson, moderator, advisor rolesin relevant and engaging educational events within the clinical research industry. PANEL DISCUSSION: Decentralized/Hybrid Trials: Discussing the current challenges and debating best practises for a successful virtual study, Considerations and best practices in direct-to-patient (DTP) / decentralized clinical trials (DCT) lessons learned from past trials, PANEL DISCUSSION: Reversing the Conversation What the clinical trial industry really wants from its service providers, KEYNOTE A playbook for how to handle an undesirable CRO-Sponsor partnership & how to turn it around, A playbook for how to handle an undesirable CRO-Sponsor partnership & how to turn it around. Henry is a Vice President of Data Sciences at Medidata. I am passionate about the life sciences and the clinical and commercial potential of novel therapeutics and applications of synthetic biology. March 14 . To learn more , please visit our website - http://kpslife.com/. There, he employed a broad range of methodologies, including: visual psychophysics, neuropsychological and computer-based cognitive assessments, eye tracking, electrophysiology, and structural imaging. Commercial Services. Over the past 30 years his focus has been in the areas of drug substance as well as drug product R&D, manufacturing and outsourcing the small molecules as well as biologics. This conference will explore the latest regulatory updates, global clinical trials, advanced technologies and more. Aug 16 International Conference on Clinical Trials in Cardiovascular Medicine (ICCTCM) - Barcelona, Spain. Datacubed Health is a pioneering technology company making better science and healthier communities a reality. Reem enjoys working in startups bringing forward long-term vision and strategies. Specifically for Clinical Trials and RWE studies, Medocitys modular and flexible architecture ensures swift configuration and deployment in less than 4 weeks, through a fully interoperable and connected SaaS cloud database. Mr. Luciano earned a B.A. www.gobio.com/clinical-research/. Caroline Cooper is the Director of Clinical Operations at CymaBay Therapeutics, Inc. with over 10 years of experience in clinical research. What can small biotech ClinOps teams learn from large Pharma, and vice versa? 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. Extensive Outsourcing and Contracts experience in the area of Clinical Development primarily at small to mid-size biotech organizations. DGE invites you to return to the industry's first, most detailed, and most trusted conference on this topic - our 7th Decentralized & Hybrid Clinical Trials Summit. Cognizing & mitigating Does AI-ML offer a solution? Prior to Medable, Reem worked in the clinical space in both the industry and academia settings after making a transition from basic science research. Sections. As Vice President, Business Development at Curebase, Wayne leverages more than a decade of experience in clinical research across both clinical operations and strategic sales to identify new areas for growth within the company. The Association of Clinical Research Professionals (ACRP) supports clinical research professionals through membership, training and development, and certification. European Union Clinical Trial Regulation: Strategic Considerations, Hyatt Regency San Francisco Airport Hotel NikZ shows promise against other important fungal diseases. Artificial intelligence in medicine & clinical trials. February 27, 2023. Clinical Technologies. Francis is an expert in clinical system regulatory compliance with over 20 years pharma experience spanning R&D, manufacturing and clinical research. The Global Clinical Trials Connect 2022 will focus on futuristic advancements in the clinical research industry and clinical trials. http://www.datacubed.com/. Axiom Exhibiting at Outsourcing in Clinical Trials Southeast 2022. CA; X-Mine, CA; Delphian Pharma, CA and Certum LLC, CA). Rave RTSM streamlines your operations and provides real-time visibility for your study teams. https://www.nucleusnetwork.com/au/, To learn more , please visit our website - Wayne holds an MBA and B.S. We're here at the Outsourcing in Clinical Trials & Clinical Trial Supply East Asia conference. Jowita Marszewska, Ph.D. is a Scientific Advisor at Clario, a global data and technology company that helps minimize risk in clinical trials. Amsterdam RAI. Subsequently, Arun lead the Gastric-Immuno-Oncology Rare Disease Bispecific-T cell-Engager portfolio at Amgen on various aspects of clinical research operations. Outsourcing In Clinical Trials East Coast 2022 User Dashboard. She has 20+ years of diverse global experience in the biotechnology industry including roles within Clinical Development, Medical Affairs, and Risk Management. As a service company, our mission is the pursuit of health equity, a focus on diversity and excellence in clinical trial conduct. She currently serves as Vice President of Clinical Affairs at Endogenex, a medical device company developing innovative solutions for the treatment of Type 2 diabetes. https://www.trilogywriting.com/. 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. From 7 to 9 November 2022. www.orbisclinical.com. Advarra advances the way clinical trials is conducted to make them safer, smarter, and faster. To learn more , please visit our website - Dan is responsible for presenting the robust data management solutions made possible with elluminate, and can customize product demonstrations to address specific customer needs. Medocitys platform captures valuable real-time clinical insights & real-world data, while engaging patients, sites, and sponsors. 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. Since 2000, Anne has held supervisory and branch director positions. Dan Solis is a recognized expert in FDA import operations and is the Assistant Commissioner for ORAs Office of Import Operations. He enjoys connecting like-minded people, introducing new ideas, and immersing himself in an environment of continuous learning.