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. She has driven program strategy and planning, including implementation of 300+ clinical study protocols in 25+ indications, by leading global cross-functional teams towards successful regulatory submissions, product launches, and innovative lifecycle management. He played a pivotal role in the development and commercialization of Veltassa (USA and EU), a treatment for hyperkalemia, Intermezzo for MOTN insomnia, Kerydin for onychomycosis, and Eucrisa for atopic dermatitis. Estela is an exceptional community engagement liaison for both English and Spanish speakers. It offers its clients a global reach through a network of 38 processing laboratories. http://www.arensia-em.com/. September 28-29, 2022. Online event and networking. Dan is responsible for presenting the robust data management solutions made possible with elluminate, and can customize product demonstrations to address specific customer needs. ), pharmacovigilance and safety solutions, translation and language services, and call center support. What should we be doing now to anticipate, prepare, prevent and respond? Any Where. Partnerships in Clinical Trials Europe 2022. CHI's 9th Annual Clinical Trial Innovation Summit, November 10-11, 2020, Boston, MA, is multi-track event on best practices needed to optimize clinical trial innovation, planning and management. She advises on eCOA best practices, diary and instrument design and training for participants, caregivers and raters. 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. Join us in April 2023 to learn from the best in the drug development industry and have an opportunity to learn from their experiences. Finding patients is a challenge. With her unique blend of business acumen and technical expertise, Rebecca Lin is a dynamic leader with many years of success in the healthcare industry. Stop by to see us at Outsourcing in Clinical Trials New England 2021 conference. May 3 - May 4 @ Barcelona, Spain. Each nurse is trained, tested, and certified as a Certified Mobile on an annual basis in the principles of clinical trial research, GCP, Nurse Guidelines and IATA. Anju Software is a customer-first organization providing adaptable life science solutions for clinical research, medical affairs, and data science. 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. With over 15 years experience in the industry, Esther has predominantly worked in clinical trial management and data management roles across Europe, North America and South Africa. To learn more , please visit our website - www.promedica-intl.com. Sandy Mohan is the VP of Quality at Iovance Biotherapeutics. Panellists will address the advantages of DCT; from taking the trial to the patient to boosting recruitment. Proven track record of coordinating teams in order to meet tight deadlines, set and communicate expectations, and manage deliverables. Presently, Ndidi is the Associate Director, Clinical Quality Assurance & GxP Compliance at Ultragenyx Pharmaceutical Inc. where she has worked for over 6 years. An Introduction to Simulation-Based Training in Clinical Research: De-Risking your Studies in 3 Steps. Theyre more likely to finish on time and on budget. In her spare time, Ndidi enjoys creative writing and interior decorating. OCT DACH Conference 2022 - Outsourcing in Clinical Trials. Jowita Marszewska, Ph.D. is a Scientific Advisor at Clario, a global data and technology company that helps minimize risk in clinical trials. deep6.ai, To learn more , please visit our website - In 2010, he became a Supervisor Consumer Safety Officer (SCSO). https://www.muralhealth.com/. Post doctoral research studies in Human Behavior. Meghan McKenzie works in Patient Inclusion and Health Equity in Genentechs Chief Diversity Office. Emmes acquired Casimir in March 2022, and the . http://catalystcr.com/. I look forward to being in the Bay Area in early Lee King on LinkedIn: #octwestcoast2023 #clinicalresearch #lifesciences #outsourcing Any Disease. Basel, Switzerland. Join Premier Research at Outsourcing in Clinical Trials Southern California 2022 as it returns for its 9 th annual event. Through innovative eClinical and Regulatory solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market reliably. His last company, TheraSim, trained over 1 million physicians worldwide and was sold to WebMD in 2013. Outsourcing in Clinical Trials New England 2023 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. To learn more , please visit our website - www.careaccess.com. The company serves over 600 customers globally, with headquarters in San Francisco and offices in numerous domestic and international locations. Improving communication, relationships and work-life balance with your internal team as well as partners. OUTSOURCING IN CLINICAL TRIALS EUROPE 2022 - HealthManagement.org Learn how elluminate delivers: Empowering excellence in supply through digital quality management systems, In this session our guest speaker will address the challenges with these drugs in development and looking at parallels in a medical device regulatory strategy. Pharmapack is the European event focal point for the pharma packaging and drug delivery device industry. To learn more , please visit our website - By tapping into patients rich and varied health journeys on Inspire, researchers and health practitioners around the world are advancing treatments and making breakthrough discoveries. 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. www.flexdatabases.com. Clinical Research Conferences | Meetings | Events | Symposiums To learn more , please visit our website - ACM is certified by the College of American Pathologists (CAP) and the Substance Abuse and Mental Health Services Administration (SAMHSA). Compare and contrast the FDA, MHRA and TGA regulatory requirements for Phase I clinical entry. 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. LabConnects unique combination of state-of-the-art technology, world-class laboratories, easy access to emerging markets and extensive specialized testing expertise means the drug development industry can rely on a single provider for all of their central lab needs. We offer customizable specimen collection kits, specialty testing capabilities, dedicated project management and trial site support, biostorage, and real-time data management and reporting. Parexel Introduces Expert SeriesNew Medicines, Novel Insights. We look forward to welcoming you In-Person to Amsterdam for Clinical Trials Europe 2022 to celebrate our 21st birthday. To learn more , please visit our website - ProTrials works with sponsors in the pharmaceutical, biotechnology and medical device industries to deliver high-quality clinical development services in a wide range of therapeutic areas. Find out about the events you can meet the Caidya team at and stay updated about the latest conferences and clinical research events. Reem enjoys working in startups bringing forward long-term vision and strategies. How applying behavioral science insights can better inform the way we do patient engagement. For more information, please contact us at 262-334-6020, or via email at [email protected]. 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. At Trilogy, medical writing is our passion. To learn more , please visit our website - http://www.iconplc.com/. Day 1 will kick off with a talk on designinga playbook for how to handle an undesirable CRO-Sponsor partnership, followed by a Keynote Panel allowing attendees to debate how to optimize theiroversight & governance, led byAbby Kennedy(VP of Clinical Operations, CymaBay Therapeutics). https://www.rad-md.net/, To learn more , please visit our website - Axiom Exhibiting at Outsourcing in Clinical Trials New England 2022 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. To learn more , please visit our website - http://www.premier-research.com/. www.tprausa.com. Clinical Research Organization (CRO) & Biopharmaceutical Services - Parexel To learn more , please visit our website - His teams mission is to build scalable data science and engineering software services that are integrated into Medidata platform to accelerate the generation of actionable insights across the clinical development lifecycle. 11 th International Conference on Clinical Trials is scheduled to be held during November 09-10, 2023 at London, UK. To learn more , please visit our website - Clinical Trials Conferences | Meetings 2023 | World BI Our comprehensive solutions include clinical trial management technology and services (TMF services, eTMF, CTMS, regulated content management, etc. http://www.clinicalink.com/, To learn more , please visit our website - Novotech is an Australia based clinical CRO operating across Asia and South Africa. 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. To learn more , please visit our website - For over 35 years Parexel has been a trusted global clinical research organization (CRO) and biopharmaceutical services company. To learn more , please visit our website - Exceptional quantitative and analytical skills with a passion for high quality outcomes and business profit. https://medrio.com/, To learn more , please visit our website - To learn more , please visit our website - In addition to several peer reviewed publications and patents he published two volumes on, Process Chemistry in the Pharmaceutical Industry and currently is working on the third volume entitled, Bioprocessing, Bioengineering and Process Chemistry in the Biopharmaceutical Industry jointly with the bio-process leaders at Pfizer. degree in Neurobiology and is the author of several peer-reviewed papers in prostate cancer and premature ovarian failure. 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. 6 th Clinical & Forensic Pathology Conference. http://www.dsg-us.com/. 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. Gordon Chu is the Director of Investigations Branch at the Food and Drug Administration (FDA) Division of West Coast Imports (DWCI) within the Office of Enforcement and Import Operations (OEIO). Aditya is the Regional Director of Business Development at Novotech, the Asia Pacific specialist CRO. 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.
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