We will synthesize the scientific practices underpinning good instrument design and COA data collection methods and recommend next steps for addressing data collection challenges. Joined industry with a goal of developing digital and devices to improve patient care. Rated 4.5 by 2 people. Deep 6 AI is the leader in precision research software, connecting all research stakeholders in an AI-powered, real-time, data-driven, collaborative ecosystem. At Strategikon Pharma, we bring a high level of precision and speed to outsourced clinical trial operations through our flagship SaaS platform, Clinical Maestro. Whether you require ad hoc support or a team to partner with on audit programs, we have the people, the expertise and the experience to provide the assistance you need. I look forward to being in the Bay Area in early Lee King on LinkedIn: #octwestcoast2023 #clinicalresearch #lifesciences #outsourcing 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. Acceleration of clinical development in the worlds fastest growing region, Biotech Market Performance and the impact on Clinical Trials and Operations. The Outsourcing in Clinical Trials Texas event aims to be a solution-driven conference that allows Clinical Operations professionals to network with innovative vendors, hear cutting-edge content, and participate in interactive discussions. Topics: http://www.dsg-us.com/. This is because many conference attendees are likely to be active online casino, President, Healthcare Advocate, Looms For Lupus, Executive Director, Program Strategy, Rare Disease And Pediatrics, Premier Research, Inclusive Research and Health Equity - gRED ECD Clinical Operations,Genentech, Director Patient Innovation Center, Patient Insights, Parexel. 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). Ms. Lea is the Director of Global Patient Engagement and Advocacy for Acceleron, a wholly-owned Subsidiary of Merck. www.frontagelab.com. In that role, she built and led the commercial organization that developed go-to-market strategies for Potrero's Accuryn Monitoring System. Explore and learn more about Conference Series : World's leading Event Organizer. To learn more , please visit our website - I am passionate about the life sciences and the clinical and commercial potential of novel therapeutics and applications of synthetic biology. Tactical clinical operations in digital health studies, First-hand learnings, breakthrough device system, a case study. To enquire about sponsorship opportunities for the conference, please contact: To enquire about speaking opportunities for the conference, please contact: Arena International is a global B2B events company for online casino players. To learn more , please visit our website - OMDRHO is one of five programs in the Office of Medical Products Operations within FDAs Office of Regulatory Affairs. 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. Alton Sartor completed a combined MD/MBA from Tulane University. To learn more , please visit our website - http://www.pcmtrials.com/, To learn more , please visit our website - Drivers of failures, Flawed clinical study design leading to failures, Diagnostic indicators and early Go/No-Go decisions in proceeding further during clinical study phases. Her background in Biotechnology and proficiency in Data Management solidified her proven ability to identify data integrity risks, and problem solve the most complaint path to drug submissions and approvals. https://lifesciences.transperfect.com/, To learn more , please visit our website - Medrio has extensive experience in all study phases and leads the market in early-phase trials. Start. Pharmaceutical Development. Henry earned his B.S. By harnessing digital data, we power sponsors, CROs, researchers, and patients to recenter decentralized trials and rewrite the clinical development experience. Anju is a portfolio company of Abry Partners serving the worldwide pharmaceutical, biotech and contract research Life Sciences markets. Local vendor oversight vs global provider oversight how would you manage this differently? She is a Registered Respiratory Therapist, holds the CPPS (Certified Professional in Patient Safety) credential from IHI and has a Masters degree from Johns Hopkins in Patient Safety and Healthcare Quality. Communities. 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). The last decade of this time has been solely focused on the investigator grant administration domain driving strategy and leading teams implementing payment technology in both BPO and enablement models. Subsequently, Arun lead the Gastric-Immuno-Oncology Rare Disease Bispecific-T cell-Engager portfolio at Amgen on various aspects of clinical research operations. To learn more , please visit our website - To learn more , please visit our website - She also had several leadership positions with PharmaNet Development Group (now Syneos Health), ICON Clinical Research and eMetagen Corporation. Our biotech recruiters, pharmaceutical recruiters and scientific recruiters provide multiple solutions spanning temporary and permanent placement to clients ranging from venture-backed start-ups to Fortune 500 firms. Home / Events /. Helping you take advantage of the speed of study start-up and R&D tax incentives in Australia and allow for smooth trial transition in the US. This conference will focus on topics such as bioethics, regulations, patient recruitment, site selection, data integration & strategy, and many more. Amsterdam RAI. Dr. Marszewska earned her MSc and PhD degrees in the field of chemistry. 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). Amy has been a drug discovery and development professional for 25+ years, including progressive roles in clinical operations and clinical strategy. http://www.altasciences.com/, To support the acceleration of drug development, over the last 12 years, ARENSIA Exploratory Medicine GmbH (www.arensia-em.com) has built up its own research clinics, with full Phase I infrastructure, entirely dedicated to the performance of sophisticated FIRST-in-PATIENT Phase IB, IIA and PROOF OF CONCEPT clinical trials with novel compounds. This conference intends to focus on the global health and clinical trials around the world. Minimize site activity- could decentralization and Direct-to-Patient trials be the answer to staff shortages? Driven by a unique combination of deep domain expertise and technical capabilities, our ClinRun application suite rethinks trial administration through active engagement, smart design, and breakthrough technology. She received her MS and PhD in Microbiology from New York University and did a postdoctoral research at Merck Research Laboratories. 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. KPS Life (www.kpslife.com) is a stand-alone, global functional service provider (FSP) that offers a clinical outsourcing solution across all phases of clinical drug development. 7 - 9 November 2022, Amsterdam . Partnerships in Clinical Trials Europe 2022. Since 1996, ARA has supported 700+ clinical trials worldwide across all therapeutic areas. Premier Research is a leading clinical development service provider that helps highly innovative biotech and specialty pharma companies transform breakthrough ideasinto reality. www.Clario.com, To learn more , please visit our website - To learn more , please visit our website - https://www.calyx.ai. Proven ability to organize and manage late-stage development cross-functional teams completing projects on time with meticulous attention to detail. Passionate about novel tech-enabled medical devices that advance the understanding and treatment of diseases. She has held key national leadership roles including advisor within the Obama/Biden administrations global HIV response team, advisor to United Nations leadership and instructor at the CDC and USAID. Versiti Clinical Trials Services support biopharma and cell therapy companies through central laboratory, logistics, biomaterials provision, and IRB services. NikZ shows promise against other important fungal diseases. . http://www.augustresearch.com/. To learn more , please visit our website - Optimizing cell-based Gene Therapy Programs through the continued evolution. Panellists will address the advantages of DCT; from taking the trial to the patient to boosting recruitment. We have access to a population of over 10.5 million people across all 3 sites, and the ability to offer a multi-site solution in recruiting participants and patients to our clients. Sections. Decentralized Clinical Trials 2022 was a really good opportunity to . To learn more , please visit our website - https://www.worldwide.com. 10th International Conference on Clinical Trials is scheduled to be held during August 04-05, 2022 at Vancouver, Canada. Emvenio Research is transforming how patients and care-givers engage in and experience clinical research, To learn more , please visit our website - Precision medicine is in our blood, our cells, our genes, and our name. United States, 94010, To learn more , please visit our website - 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. Learn more atwww.clinone.com. Her passion for ensuring that clinical trials are reflective of our society drove her to her most recent work in Health Equity, where she works with a group of committed and passionate individuals to successfully develop and implement scalable and sustainable strategic interventions for the recruitment of underrepresented patient populations. Funwie strives to do meaningful work that combines and applies her bioethics background while prioritizing and addressing health equity in the context of clinical studies, patient experience, and policy. To learn more , please visit our website - San Diego Marriott La Jolla. Arena International are delighted to announce Outsourcing in Clinical Trials West Coast will be returning to Burlingame for the annual event on March 1st & 2nd 2023! Focusing on life sciences, Datacubed offers software and services driven by behavioral science to improve patient retention and compliance, resulting in better data and positive health outcomes. Our collaborative approach helps maximize efficiency and agility by acting as an experienced member of your team. Since our establishment in 2004, we have conducted over 700 phase I clinical trials, with 80% of our clients consisting of US based biotech and pharmaceutical companies. 21 October 2022 Outsourcing In Clinical Trials - Texas 2022. Dont miss out; join us in Burlingame on March 1st& 2nd2023! Diagnostic Services. www.saama.com. 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. Clinical Trial Supply New England . Based outside Philadelphia, Pennsylvania, we pride ourselves on being boutique by design and always customer focused. The 2022 program boasts two full streams including: Presently, Ndidi is the Associate Director, Clinical Quality Assurance & GxP Compliance at Ultragenyx Pharmaceutical Inc. where she has worked for over 6 years. To learn more , please visit our website - Meraf Eyassu is a Executive Director of Clinical Operations at Terns Pharmaceuticals. 2022 looks to be a bumper year too, so Nature Medicine asks leaders in their field what they think . dpocentre.com. info@caidya.com. Wayne resides in Miami, Florida. Infectious disease clinical trials; Biometrics functional outsourcing; We also provide: Drug development consultancy and services to assist the development plan of molecules in early clinical phases; Clinical pharmacology units, bioanalytical laboratories and trial management offices across Europe and North America to perform your clinical . https://www.medidata.com/en/clinical-trial-products/clinical-data-management/rtsm/, To learn more , please visit our website - https://www.medidata.com/. Our innovative model brings a global network of sites, decentralized trials, Sites On Demand, Virtual PIs, and Mobile Sites to previously-unreachable patient populations to expand the impact of clinical research. Anca has over 15 years of experience in the biopharmaceutical industry, working both on the CRO and the Sponsor side. http://www.celerion.com. It seamlessly integrates with EMR, lab, genetic mapping and APCD data, as well as EDC, CTMS and iRT systems to support site and patient identification. Improving communication, relationships and work-life balance with your internal team as well as partners. TFS HealthScience is a global Contract Research Organization (CRO) that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey. Previous roles within both CRO and Sponsor organizations which provide valuable perspective from both sides of the industry. 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. At Trilogy, medical writing is our passion. OCT DACH Conference 2022 - Outsourcing in Clinical Trials. With an agenda covering the future of Clinical trials, patient centricity, digitalization and drug development post COVID, Clinical Trials Innovation Programme 2023 will feature tailored sessions presented by the leading experts and service providers from across the globe. About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . Outsourcing Clinical Trials New England 2022. www.greenlightclinical.com, To learn more , please visit our website - Caroline is experienced in the planning and execution of global clinical drug trials in the European, North American, Latin American, and Asia Pacific regions. Last year alongside talks from industry leaders Pfizer, Bristol Myers Squibb, [] Clinical Chemistry & Laboratory Medicine Conference. Currently, Arvinder is VP of Clinical Development at Rani Therapeutics, where she is responsible for Clinical and Regulatory functions for all programs. He is also a co-founder of U&D Pharma and working on Replyte Gel, a treatment for anogenital warts. 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. To learn more , please visit our website - We are focused on helping our clients to address their most significant and complex drug discovery and development challenges. We are known for our superior statistical leadership and data management expertise and proud to have supported thousands of studies across a diverse range of diseases. This Clinical Trials Conference includes a wide range of Keynote presentations, Plenary talks, Symposia, Workshops, Exhibitions, Poster presentations and Career development programs. https://www.parexel.com/, To learn more , please visit our website - ACM performs more than 20 million laboratory tests each yearspanning all medical disciplines including pathology, microbiology, molecular diagnostics, toxicology and more. Signant Health provides solutions that simplify every step of the patient journey to make it easier for people to participate in, and for sites and study teams to run, clinical trials. He has been actively involved on both sides of the business in managing CDMOs and CROs. AWT Healthcare manufacturers clinical trial labels. He was Senior Director of Clinical Operations at Pharmacyclics from 2012 to 2017 where he was responsible for the development, implementation and maintenance of the Clinical Operations infrastructure, as well as the GCP inspection hosting platform and processes, and regulatory authority marketing approval inspection hosting. 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. Dr Jasmina Jankicevic is globally recognized as an expert in dermatology drug/device development. After years of watching the opioid crisis develop, John has developed an innovative drug and dispenser to safely treat pain and deter abuse. To learn more , please visit our website - 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. AI-ML, a Hype or Hope. 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. This conference is always a great opportunity to share and learn with our colleagues across the industry. She has actively participated in departmental preparation for the EU CTR implementation and is one of ICONs SMEs on this topic. Scalable clinical analytics platforms built within core engineering frameworks are the only way to ensure the integrity, repeatability, and value of data standards and insights. He brings over 25 years of product management, consulting, and engineering experience across verticals such as life sciences, enterprise software, healthcare, government, entertainment and manufacturing. An Introduction to Simulation-Based Training in Clinical Research: De-Risking your Studies in 3 Steps. Meghan joined a CNS-focused start up in RTP and has spent the last 15+ years working in the life science technology industry. To learn more , please visit our website - September 28-29, 2022. In his role as BD lead, he is responsible for many aspects of the companys planning and operations. Discuss a pathway to extend biotech cash burn runway while still meeting Phase I objectives and meeting investor expectations! deep6.ai, To learn more , please visit our website - Rhonda Mecl recently became the Deputy Program Director after serving as the Program's Operations Staff Director for the previous five years. Find out about the events you can meet the Caidya team at and stay updated about the latest conferences and clinical research events. This conference will explore the latest regulatory updates, global clinical trials, advanced technologies and more. Dr. Debashish Niyogi is currently Vice President, Product Management at Anju Software, where he is responsible for the vision, strategy, and roadmap for the companys eTMF and CTMS solutions. 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. To learn more , please visit our website - The DPO Centre has assisted over 600 clients globally, including a broad range of bioscience, genomics, therapeutics, healthcare and pharma companies to comply with EU data protection laws such as the GDPR, the EU Clinical Trials Regulation and specific member state requirements. Join Premier Research at Outsourcing in Clinical Trials Southern California 2022 as it returns for its 9 th annual event. The Decentralized Clinical Trials hybrid event, April 18th - 20th in Boston, will provide leading insights and practical guidance on how to decentralize your clinical trials for greater diversity, accessibility and efficiency, with guidance a world-class speaker line up. Founded in 1976, ACRP is a Washington, DC-based non-profit organization with more than 13,000 members who work in clinical research in more than 70 countries. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve live. Anju Software is a customer-first organization providing adaptable life science solutions for clinical research, medical affairs, and data science. 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. www.deeplink-medical.com. Rigorous scientific background and 9+ years of experience in driving both academic and industry clinical programs. A NEW paradigm of engineering-forward analytics solutions powering digital biomarkers. Many biopharmaceutical trial sponsors rely on or scientific leaders to help design and optimize their protocols and statistical analysis plans. https://www.chillipharm.com/. Dr. Marszewska has experience with electronic data capture and data management in clinical research. Collaterally with her Regional Food and Drug Director duties, Anne served as the acting program director for both the Biologics and Tobacco programs during significant planning phases for program alignment. 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. 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. Analytical & Solid State Services. https://www.propharmagroup.com/. In this position, she focuses on initiatives for employee development or training and topics to advance health literacy for underserved communities as it relates to clinical trial access. 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. Contact: Amy Apostoleris, aapostoleris@medocity.com, To learn more , please visit our website - 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. 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). Mr. Luciano earned a B.A. 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. She leads the scientific development of digital clinical measures and the modernization of clinical development models under the banner Technology As Methodology. 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. 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. He received his medical degree (MD) and his doctoral degree (PhD equivalent) from Justus-Liebig-Universitt Giessen, Germany, and his Master of Business Administration (MBA) from the Wharton School of Business, University of Pennsylvania, PA. Kunal Sampat is the founder of the Clinical Trial Podcast, a podcast and blog platform for clinical research professionals. Network with 600+ clinical peers. With the most trusted review solutions, innovative technologies, experienced consultants, and deep-seated connections across the industry, Advarra optimizes research performance, empowers clinical sites, and ensures compliance. As an international key opinion leader in dermatology clinical development, Dr. Jankicevic has served as advisor to multiple companies on their path to global regulatory and commercial success. This event is a great opportunity to get to know the online casino players who will be [] 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. She has a unique perspective in leading clinical programs in a dynamic startup environment. She also has a special interest in innovations that can improve the quality and efficiency of clinical trial execution. As a Solutions Consultant with eClinical Solutions, Dan serves as a subject matter expert for the elluminate Clinical Data Cloud, the foundation of digital trials. Finding patients is a challenge. Prior to working at Genentech, she graduated from the Johns Hopkins Bloomberg School of Public Health with a Master of Bioethics. Taking a Data Science approach to gain financial oversight of clinical trials. RT1 Conducting a study when there is minimal education, Hang Nguyen, Sr. Director, Clinical Affairs, Materna Medical, RT2 Navigating the complex spiderweb of multiple vendor relationships, Sarah Mullen, Vice President of Clinical, HeartFlow, RT3 Training Strategies for a Novel Therapeutic Medical Device, Ann Louise Armstrong, Senior Manager of Clinical Affairs and Field Operations, Ancora Heart, - How the process started and steps taken, - Assessment of eligibility and submission, - Lessons learnt - how it helped and what we did, what we companies can learn and do better, Discussion focusing on Real World Data; an overview of opportunities and challenges in working with RWD/RWE, Ted Chun, Director, Global Clinical Shared Services, Stryker Neurovascular, RT2- Navigating the complex spiderweb of multiple vendor relationships, RT3- Training Strategies for a Novel Therapeutic Medical Device, Ann Louise Armstrong, RN, MSN, CCRC, CCRA, Senior Manager of Clinical Affairs and Field Operations, Ancora Heart. Dr. Arvinder Dhalla has more than twenty years of experience in pharmaceutical R&D, project management, regulatory affairs and clinical development across several therapeutic areas. Amsterdam RAI. https://www.muralhealth.com/. Dr. Cunningham has over 15 years experience in clinical leadership position in medical device industry, overseeing a full spectrum of clinical development programs ranging from FIM to pivotal to post-market phases. www.rad-md.net. www.careaccess.com. With more than30 years of experience in over 60 countries, our individualized partnership approach provides experience-driven insights and expertise to assist clients in successfully navigating the complexities of delivering novel treatments to patients. In addition to her deep understanding of the unique dynamics of developing novel treatments for rare and complex diseases, Dr. Raymond also leverages her combination of training and experience leading the Gene Therapy Think Tank at Worldwide Clinical Trials. He is also President of SBS Medical Management, a healthcare economic consulting firm for investment banks and Expert Medical Reviews, including the California Medical Board.