medtech.labcorp.com. as a Microbiologist, HQ position within the Division of Import Operations in Rockville, MD, working as an Import Compliance Officer and working in the FDA Los Angeles District Office as a Director of Import Operations Branch. Arena International are delighted to announceOutsourcing in Clinical Trials West Coastwill be returning to Burlingame for the annual event onMarch 1st& 2nd2023! UPCOMING EVENT. To learn more , please visit our website - http://www.clinicalink.com/. Kunal has over 18 years of experience managing and conducting clinical trials. DCT was previously done out of necessity but are we seeing it as a new world order? 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. CISCRP staff is committed to participating and presentingspeaker, chairperson, moderator, advisor rolesin relevant and engaging educational events within the clinical research industry. She has extensive experience in leading data management activities for multiregional clinical trials in all phases and several therapeutic areas. To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit almacgroup.com. 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. To learn more , please visit our website - http://kpslife.com/. Contact: ESMO Registration Office; Phone: [+41 (0) 91 973 19 13]; Email: registration@esmo.org. Q2 Solutions is a leading global clinical trials laboratory services organization that helps biopharmaceutical, medical device and diagnostics customers improve human health through innovation that transforms science and data into actionable medical insights. From 2008 to 2011, he was Senior Clinical Trial Manager at Seattle Genetics where he was responsible for the oversight of multiple oncology clinical trials, as well as support for the development of the Clinical Operations infrastructure and regulatory authority marketing approval inspection hosting. www.tranquilclinicalresearch.com. Deep 6 AI is the leader in precision research software, connecting all research stakeholders in an AI-powered, real-time, data-driven, collaborative ecosystem. ), pharmacovigilance and safety solutions, translation and language services, and call center support. https://www.trilogywriting.com/. 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. Global Clinical Trials Connect 2023 2022 London United Kingdom. YPrimescloud-based technology streamlines clinical trial data collection and management. Aditya is the Regional Director of Business Development at Novotech, the Asia Pacific specialist CRO. I went into industry for post-doctoral studies at the biotechnology research center at Ciba-Geigy Corp. (Novartis) and have over three decades of academic and industrial research and senior management experience in protein and metabolic engineering, bio-based manufacturing, and drug discovery / development. We go beyond traditional events and offer, The main program of the conference is discussion and debate on the outsourcing of clinical research. In a separate article, Manasi Vaidya discovers that, fuelled by the successful use of mRNA vaccines in Covid-19, RNA therapeutics are expected to make larger strides in 2022.. Based on available data, there are emerging trends . Rigorous scientific background and 9+ years of experience in driving both academic and industry clinical programs. https://medrio.com/, To learn more , please visit our website - 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. Amsterdam RAI. TFS HealthScience is a global Contract Research Organization (CRO) that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey. 21 October 2022 Outsourcing In Clinical Trials - Texas 2022. Her clinical development experience spans all therapeutic areas and all stages of the clinical development lifecycle, from natural history studies through registrational global trials, and Long-Term Follow Up and Post Marketing surveillances. eurofinscentrallaboratory.com/biopharma-services. For the 13 th Annual event, our flagship European clinical show will provide delegates with practical take-aways and solutions to their most current operational and outsourcing challenges in clinical trials . To learn more , please visit our website - 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. 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. For over 30 years, we have been the leading global clinical trial supply company and we have expanded our service portfolio to offer complete solutions around clinical trials for our partners. 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). www.maxisit.com/ctos/. As the IPM, he is the District liaison to FDA Headquarter handling import related issues and concerns. www.orbisclinical.com. Care Access is a global research site that accelerates the availability of new treatments and therapies through our unique site infrastructure and ability to cultivate research-empowered communities. 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. March 14 . She intentionally injects laughter and authenticity into everything she does, and is an advocate for kindness, diversity and inclusion, as well as issues impacting women and children. Partnerships in Clinical Trials Europe 2021. 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. https://lifesciences.transperfect.com/, To learn more , please visit our website - The Budget Conundrum. Includes management of the RFP process for outsourced services as well as contract/proposal and budget negotiations, vendor selection, and vendor oversight/relationship management. Panellists will discuss the challenges and tech barriers with DCT. Formed through the merger of IMS Health and Quintiles, IQVIA has more than 58,000 employees worldwide. Understanding Social Determinants of Health: Identifying the variables that burden trial participants how can we collect this data? Held annually in Paris and online, this event unites 5,000 attendees and 360 exhibitors centered around innovation, networking, and education. Commercial Services. 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. To learn more , please visit our website - Who we are; We offer both single modules and a unified solution to maintain all processes you can cover all existing software needs with only one vendor. http://www.spauldingclinical.com/, To learn more , please visit our website - in Psychology and Biology from the University of California at Santa Cruz. He is a key member of the leadership team responsible for defining the company's go to market strategy and value proposition across the many segments of the pharmaceuticals and device research industry. Aug 09 International Conference on Drug Development, Clinical Trial Phases and Technology (ICDDCTPT) - Lagos, Nigeria. To learn more , please visit our website - Why drugs fail in clinical trials? Our Leukopaks are available for Research Use Only and Clinical Grade (FDA 21 CFR 1271-compliant) applications. Mr. Chu has served as a mentor for the Federal Executive Board in Los Angeles, CA. Login; Register now; Toggle navigation. She is definitely not afraid of being the least popular girl in the room in order to support patient safety! She has led clinical development in dermatology and medical aesthetics for pharma/biotech, CROs, medical device and cosmetic companies including RAPT, Innovaderm, Premier Research, Allergan, Leo Pharma, and Murad. Arena International are delighted to announce that our Outsourcing Clinical Trials Europe event is returning to an in-person format in 2022. Pro-ficiency converts training from a cost center to a powerful quality improvement system. I look forward to being in the Bay Area in early Lee King on LinkedIn: #octwestcoast2023 #clinicalresearch #lifesciences #outsourcing ), both from Duke University where I was also an undergraduate. PANEL DISCUSSION: The concept of DCT, is it the future? Swiss Biotech Day 24th April 2023 to 25th April 2023 Basel, Switzerland. She also has a special interest in innovations that can improve the quality and efficiency of clinical trial execution. 7 - 9 November 2022, Amsterdam . I am the CEO at OrPro Therapeutics, a biotechnology company in San Diego, CA developing biologic drug solutions to unmet needs in serious epithelial diseases including cystic fibrosis. View Event. Each roundtable session lasts for 30 minutes, and delegates may attend up to 2 roundtables. She has extensive experience in managing complex projects, with a strong focus on building and maintaining relationships at both company and industry level from an operational role within the organization. Tranquil Clinical Research is an early phase CRO with a fully accredited Hospital Phase I unit. He works cooperatively and collaborates with Federal, State, and local agencies to ensure appropriate consumer protection. Making progress of a complex Interventional device study during covid. The Association of Clinical Research Professionals (ACRP) supports clinical research professionals through membership, training and development, and certification. Chris has dedicated his 16-year career to the services side of the Phase I clinical drug development industry, including both operational and business development roles. Our platform consists of 13 modules that cover every aspect of clinical trials, from project startup to pharmacovigilance. 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. Embassy Suites Raleigh-Durham Research Triangle, Cary, NC. Michaels background spans contract and proposal development; contract negotiations in multiple languages; set up and management of vendor oversight and governance programs; and related change management. TrialMaster, IRMS MAX, and TA Scan, the companys flagship products, lead the way in reducing complexities in the drug and device discovery and commercialization process. Exploring the need for a dedicated regulatory pathway for antibacterial/antimicrobial drugs. 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. 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. 2023. Francis is an expert in clinical system regulatory compliance with over 20 years pharma experience spanning R&D, manufacturing and clinical research. He is an advisor to several biotech companies. 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. eCOA is our core focus but not our only service. Dan Solisfrom TheFDAwill give the closing keynote. Our simulation-based protocol training prevents study errors, guarantees timely SIV, and frees up thousands of hours for your study team and site-staff. Lin holds a Master of Science in management from the Stanford University Graduate School of Business and a master's in marine biology from Sun Yat-sen University in Guangdong, China. Are you choosing best in class or a bundle? Our goal each day, every day is to make sure our partners have whatever they need when and where they need it to execute a successful clinical trial, while also minimizing delays, unnecessary costs, and surprises. 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. https://www.almacgroup.com. Our experts are ready to discuss how our solutions can best support your live studies. Dr. Yunis is a scientist with multidisciplinary training and experience in the mechanism of diseases. Clinical Trials Innovation Programme 2023 is the only platform to . Arena International are delighted to announce Outsourcing in Clinical Trials Europe will be returning to Barcelona on the 3rd-4th May 2023! http://www.cromsource.com/. Clinical Outcome Assessments (COAs): Applying scientific rigor and good instrument design. Exploring incentives for the community if not financial what else can you offer? www.zigzagassociates.com. Jay is responsible for managing the creation and design of product features and new capabilities for Trial Interactive. Ellen Weiss is the Vice President, In-Home Solutions, Decentralized Clinical Trials at PCM Trials. Mr. Luciano earned a B.A. To learn more , please visit our website - Exploring new science and a futuristic perspective on AB/AM drug development, Exciting growth of artificial intelligence in medicine, A framework on development of artificial intelligence in medicine, The power of public attention and funding, Business opportunity of artificial intelligence in medicine, What they like to see in an outsourced partner organization, What they would like a partner to know about them / how they work. 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. Our Ergomed team is looking forward to exhibiting at Outsourcing Clinical Trials - Texas 2022, December 7th & 8th . AliveCor protects its customers with stringent data security and compliance practices, achieving ISO 27001 Certification, SOC 2 Type 2 Certification and HIPAA compliance attestation. 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). Why should we collect Sexual Orientation and Gender Identity in Clinical Research Studies? Exploring the idea of adopting a medical device-like regulatory philosophy/strategy for bringing drugs forwards, with a focus on antimicrobials, Industry is on high alert for bacterial outbreak, with parallels to the covid pandemic. 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. AI-ML, a Hype or Hope. 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. Clinical ink is the global life science company that brings data, technology, and patient science together. Prior to Medable, Reem worked in the clinical space in both the industry and academia settings after making a transition from basic science research. With 2,000 annual trials and projects, around 200 active clients and global access to source drugs in over 60 countries,Myonex is your complete partner around clinical trials around the globe reliable, trusted and by your side. Online event and networking. Founded in 1985, Promedica International, a woman-owned corporation, is headquartered in Orange County, California. In 2019, THREAD was acquired by strategic health care investors Water Street Healthcare Partners and JLL Partners. Arun Sivanandam has more than 12 years of experience in clinical research at site and sponsor side. 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. Register. Spaulding Clinical Research is a global CRO providing Phase I IV drug development services to pharmaceutical and biotechnology companies. ClinChoice is a leading full-service clinical CRO offering high-quality solutions to pharmaceutical, biotechnology, medical device and consumer products clients. Effective management of essential clinical trial documents using eTMF solutions. Wednesday, 28th Sep 2022 - Thursday, 29th Sep 2022 . Francis has lead supplier oversight responsibilities for sponsors, CROs and clinical system vendors. To learn more , please visit our website - An Introduction to Simulation-Based Training in Clinical Research: De-Risking your Studies in 3 Steps. KardiaMobile 6L provides instant detection of Atrial Fibrillation, Bradycardia, Tachycardia, Sinus Rhythm with Supraventricular Ectopy, Sinus Rhythm with Premature Ventricular Contractions, Sinus Rhythm with Wide QRS, and Normal Sinus Rhythm in an ECG. 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. Combining patient-reported health data, personal medical records, and conversations in the Inspire community uncovers critical insights unattainable with traditional research methodologies. We offer customizable specimen collection kits, specialty testing capabilities, dedicated project management and trial site support, biostorage, and real-time data management and reporting. To learn more , please visit our website - Our high-caliber project management, clinical monitoring, medical safety, data management, biostatistics, regulatory affairs and quality assurance capabilities make us a valued partner. He started his career with FDA in 1998. Sun, 24 Apr 2022, 09:00 End. 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. assisTek has been paving the way for integrating technology and data collection in clinical trials for over 25 years. http://citlabels.com/. September 28-29, 2022. AbbVie reports rise in full-year 2022 net revenues; Teva Pharmaceutical reports 5% fall in Q4 2022 revenue; Merck reports 2% increase in worldwide sales in Q4 2022; Companies. She develops strategies to drive greater inclusion of racial and ethnically representative patient populations in clinical research and to advance health equity Gaining patient, clinician and community insights early in program development is integral to developing what is important to patients and improving access to medicines and treatments for all patients, regardless of race, ethnicity, sexual orientation, gender identity, age, socioeconomic status and ability/disability. His PhD research at UC San Francisco established the foundation for PEGylated drugs widely used today. This is also a critical time to determine the development strategy for later study phases. Anca has over 15 years of experience in the biopharmaceutical industry, working both on the CRO and the Sponsor side. THE 2023 AI UPDATE AI & disruptive technology: Harnessing the future of Artificial Intelligence to transform clinical trials, FIRESIDE CHAT: Overcoming the barriers to trial innovation and technology access from a small companys point of view. To learn more , please visit our website - www.emmes.com, Emvenio Research is a leading decentralized research organization (DRO) providing scalable and hybrid decentralized trial solutions improving clinical trial access to underserved and high-risk populations. Dr Jankicevic holds Doctor of Medicine degree, Master of Medical Sciences degree, and Board-certification in Dermatology and Venereology from the University of Belgrade, Serbia. Conferences. deep6.ai, To learn more , please visit our website - 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. Examining how, even as a small company with limited resources you can successfully introduce time and cost saving QMS measures. Medrio is the leading provider of eClinical technology for pharma, biotech, device, diagnostics, and animal health clinical trials. 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. Emmes is a full service contract research organization collaborating with our clients to produce valued, trusted scientific research. Their experienced research team comprises key opinion leaders, board-certified cardiologists and radiologists, sub-specialty scientists, and highly trained technicians who acquire, evaluate, and report high-quality data through an efficient, cloud-based infrastructure. April 28-29, 2016 Dubai, UAE. WHAT TO EXPECT FOR 2023? ARENSIAs outstanding recruitment performance across numerous disease areas substantially reduces the overall number of sites and countries for any early-phase patient trial. Their services include clinical monitoring, clinical monitoring oversight, clinical trial management, data management, biometrics, and medical writing. To learn more , please visit our website - Why having IRT experts involved in your study is important. Oversight with less presence how to make this work, Effectively building strong working relationships remotely, Strategies to deliver training and upskill your team, Handling hard discussions with your CRO/partner when you cant meet in person, Optimizing communication channels/effectiveness with your CRO partner and team, Maintaining a positive working relationship prioritizing and building strategies from the outset, Clinical trial timelines are lengthy and on average a Phase 3 trial can take between 1-4 years. Jay holds an MBA from Villanova University and a degree in Computer Science and Physics from Gettysburg College. 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. https://www.calyx.ai, To learn more , please visit our website - It is a 2 day event organised by Arena International Events Group and will conclude on 24-May-2023. Fun fact: Ndidi was born and raised in Sierra Leone, and is a descendant of the Krio people who were freed slaves that returned to Freetown from Africa, America and The West Indies. In another exclusive data-led investigation, Andrew and Reynald Castaeda investigate which diseases are set to have an increase in clinical trial activity this year. 8th Edition of Global Conference on Pharmaceutics and Novel Drug Delivery Systems (PHARMA 2023) Mon, 13 . Services are available in U.S., Canada and ROW. To learn more , please visit our website - Advance Research Associates is a premier provider of biostatistical and data management services to the pharmaceutical, biotech, and medical device industries. This session examines how scientific rigor can be applied to clinical outcome assessments (COAs) even though they are subjective. Each year, we bring forward the latest experience . 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. See Our Products. Current topics in the Medical Device Regulatory Landscape, Presented by the FDA. How do we move forward from here? Kumar earned his Ph.D. from the University of Vermont and was a post-doctoral fellow at the University of Virginia. 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. Vice President, Clinical Operations, Corvus Pharmaceuticals Inc. Assistant Commissioner for Import Operations, U.S. Food and Drug Administration, Director, Global Patient Engagement and Advocacy, Acceleron Pharma, Associate Director, Site Contracts & Budgets Deciphera Pharmaceuticals, LLC, Program Director, Office Of Medical Device And Radiological Health Operations, FDA.