Kardia is the first AI-enabled platform to aid patients and clinicians in the efficient detection of atrial fibrillation, the most common arrhythmia and one associated with a highly-elevated risk of stroke. In this role, Mr. Chu develops, manages, and evaluates inspectional matters for DWCI covering all FDA import activities associated with air and sea port operations in the States of Hawaii, California, Nevada, Oregon, and Washington. Explore Modern RTSM Solutions. We leverage our proprietary payments platform and workflow automation to help clients improve operational efficiency, reduce costs, mitigate regulatory risks, improve the patient and site experience and produce quantifiable results that improve clinical operations and strategic planning. 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. Were a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. Are Hybrid trials the more realistic and practical approach compared to full DCT agree or disagree? http://www.novotech-cro.com/, To learn more , please visit our website - AliveCor protects its customers with stringent data security and compliance practices, achieving ISO 27001 Certification, SOC 2 Type 2 Certification and HIPAA compliance attestation. Our comprehensive solutions include clinical trial management technology and services (TMF services, eTMF, CTMS, regulated content management, etc. 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. To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit almacgroup.com. Ms. OBrien has been conducting clinical research for more than 35 years and has covered multiple functions during that time. Consulting Dermatologist, Clinical Development & Medical Affairs RAPT Therapeutics, Inc. https://www.calyx.ai, To learn more , please visit our website - Our Sponsor Edition includes dedicated applications for clinical study planning and budgeting, outsourcing and forecasting. AliveCor, Inc. is transforming cardiological care using deep learning. ClinOne, a leader in virtual clinical trial management, provides a single platform technology experience to accelerate clinical trial enrollment and remote patient care, compliance and retention. She has been with Calyx for 17 years as a key strategic leader, with a specific focus on IRT solutions. 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. http://www.iconplc.com/, To learn more , please visit our website - Specialized in clinical strategy and projects within digital health, with experience spanning from product ideation to commercialization. The Calendar Industry Events and Conferences, including SPECIAL DISCOUNTS Coming ATTRACTIONS The 5th Annual Outsourcing in Clinical Trials East Coast Conference will convene in Philadelphia in May 13-14, 2014. Review market analysis on location of Phase I studies and discuss why these choices are made. https://www.almacgroup.com. Founded in 1996, ProTrials has been successfully supporting clinical research for over 25 years. We have conducted clinical trials contributing to the market approval of nearly 100 new drugs to date. Clinical Trials Innovation Programme 2023 is the only platform to . In 2019, THREAD was acquired by strategic health care investors Water Street Healthcare Partners and JLL Partners. March. Employee turnover continues to impact global market for talent. Scalable, Reliable. https://lifesciences.transperfect.com/, To learn more , please visit our website - Debashish has previously managed successful eTMF products at Veeva and Medidata, as well as clinical trial imaging tools at Synarc (now part of Clario). www.medocity.com, To learn more , please visit our website - Meraf has over 20 years experience working in biotech, health and the pharmaceutical industry. 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. It offers its clients a global reach through a network of 38 processing laboratories. Kunal has over 18 years of experience managing and conducting clinical trials. To learn more , please visit our website - To learn more , please visit our website - A NEW paradigm of engineering-forward analytics solutions powering digital biomarkers. ProTrials Research, Inc., is a full-service clinical research organization (CRO) and woman-owned business headquartered in San Jose, CA, with clinical operations personnel located throughout North America and across the world. Post doctoral research studies in Human Behavior. Having worked within all major biopharma markets including USA, Japan, China, EU and Australia has enabled him to become a trusted advisor to many customers and help them achieve their clinical drug development objectives. Learn more atwww.clinone.com. Why having IRT experts involved in your study is important. To learn more , please visit our website - http://kpslife.com/. The 15th Annual Outsourcing in Clinical Trials New England event will bring together clinical trial professionals from big and small biopharma to uncover new technologies and processes, to optimize their clinical and outsourcing operations. Rhonda has more than 30 years of experience in FDA, starting as an ORA Investigator in Portland, OR before becoming a manager located in FDA's Minneapolis office. Meghan serves as the VP, Clinical Trial Financial Management at Medidata driving roadmap and strategy across our Grants Manager and Site Payments products. 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. Our scientific knowledge base, technical expertise and reputation for high quality services have been integral to our ability to turn our services into your solutions. https://www.discoverinternational.com/. 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. 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). To learn more , please visit our website - Medidata is leading the digital transformation of life science, with the worlds most used platform for clinical development, commercial, and real-world data. He also conducted undergraduate research on osteoporosis progression and has authored several papers, abstracts and a book chapter on protein signal transduction. She has managed and overseen large global clinical trials in various therapeutic areas and multiple phases of development. To learn more , please visit our website - Current topics in the Medical Device Regulatory Landscape, Presented by the FDA. The conference is tailor-made to address the concerns of trial sponsors based in Texas who are conducting . 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. Kumar earned his Ph.D. from the University of Vermont and was a post-doctoral fellow at the University of Virginia. With locations in the US and EU, Catalyst offers highly flexible and customized, customer-centric solutions from Global Resourcing and FSP, to Full Service Managed Solutions, with a focus on oncology product development. 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. www.deeplink-medical.com. We integrate clinical operations excellence, laboratory expertise, and advanced data sciences to deliver on the promise of personalized therapy; translating research into real-world results and forever reimaging how to get there. February 27, 2023. 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. Our Precision Matching software mines millions of patient records, including unstructured physician notes, to pin-point eligible study patients in real-time. He also been instrumental in enhancing FDA relationship with U.S. Customs and Border Protection (CBP) and other Partnering Government Agencies. To learn more , please visit our website - Dr. Richard Abelson, President & CEO of Statistics & Data Corporation (SDC), founded the company in November of 2005. INTERACTIVE SESSION: Establishing and maintaining strong CRO/sponsor relationships and building trust in a more virtual landscapeWhat have we learned and what should we focus on? http://www.medable.com/, To learn more , please visit our website - Kris OBrien is an Executive Director in Program Strategy, specializing in Rare Disease and Pediatrics, at Premier Research. 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 . http://www.axiommetrics.com/. Attendees. To learn more , please visit our website - Partnerships in Clinical Trials Europe 2022. Combined, our clinics offer over 200 beds. Read more . This conference will explore the latest regulatory updates, global clinical trials, advanced technologies and more. Contact us for more information and for a live demo tailored to your use case and needs. For more information, please contact us at 262-334-6020, or via email at Daniel.Selness@spauldingclinical.com. With presentations and panel discussions on the top industry trends and outsourcing challenges, and . Liza has extensive experience in managing and overseeing phase I-IV clinical trials globally as well as building and growing clinical operations teams in oncology, cardiovascular, metabolic and liver diseases, HIV and trials in gene therapy. Moving to law, in leading law firms he advised major companies on patent matters. 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). Estela is an exceptional community engagement liaison for both English and Spanish speakers. She also has a special interest in innovations that can improve the quality and efficiency of clinical trial execution. www.greenlightclinical.com, To learn more , please visit our website - Meet Inspiring Speakers and Experts at our 3000+ Global Events with over 1000+ Conferences, 1000+ Symposiums and 1000+ Workshops on Medical, Pharma, Engineering, Science, Technology and Business. She advises on eCOA best practices, diary and instrument design and training for participants, caregivers and raters. 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. Estela has supported her sister and her passion to help others has evolved to iLOOMinating, Engaging, Empowering and Supporting the community as a whole to take control of their healthcare. Be sure to stop by to visit my colleagues at booth #60. She has 20+ years of diverse global experience in the biotechnology industry including roles within Clinical Development, Medical Affairs, and Risk Management. To learn more , please visit our website - Long term solutions: could reducing the site certification process be a realistic solution? Aug 09 International Conference on Drug Development, Clinical Trial Phases and Technology (ICDDCTPT) - Lagos, Nigeria. She has actively participated in departmental preparation for the EU CTR implementation and is one of ICONs SMEs on this topic. Spaulding Clinical operates a 200-bed Clinical Pharmacology Unit, a Full Service Biometrics Group and Cardiac Core Laboratory. Our digital solutions enable sites to be more productive, with online study training, study eBinders (eISF), digital study alerts and SUSARs, patient visit guides, and a wide range of study tools, available via web portals and mobile apps. Headquartered in Uppsala, Sweden, Viedoc also has offi ces in America, France, Japan, Vietnam, and China. Prevail InfoWorks improves the probability of clinical trial success by providing stakeholders real-time actionable intelligence to effectively manage endpoints and key deliverables with the Single Interface, its patented cloud-based tool that aggregates, reconciles, analyzes and single-view reports/visualizes all clinical, operational and project accounting data, regardless of the source or format. . Richard holds a Ph.D. in Industrial Engineering with a focus on applied statistics, quality, and reliability engineering from Arizona State University (ASU), a Master of Science in Industrial Engineering focused in Operations Research and Production Systems (ASU) and a Bachelor of Science in Engineering in Industrial Engineering (ASU), and is certified as a Six Sigma Black Belt. How do you arrange with and clean the large amounts of data generated? His goal is to help you accelerate your clinical research career and be a more effective leader. Discuss a pathway to extend biotech cash burn runway while still meeting Phase I objectives and meeting investor expectations! Panellists will address the advantages of DCT; from taking the trial to the patient to boosting recruitment. We offer both single modules and a unified solution to maintain all processes you can cover all existing software needs with only one vendor. Hang Nguyen brings over 20 years of medical device clinical research and is currently the Sr. Director of Clinical Affairs at Materna Medical, a novel OBGYN platform company defining a $6B market in the most common pelvic conditions women face. To learn more , please visit our website - https://www.threadresearch.com/. www.harborclinical.com/. Debashish has over 18 years of experience in the life sciences / clinical trials industry, including several leadership roles in Product Management. April 18-20, 2016 Dubai, UAE. To learn more , please visit our website - Dr. Lindsay Hughes, Director of eCOA Clinical Science and Consulting at Clario, is a scientist and leader with over 15 years of experience in behavioral and life sciences. An opportunity at Gilead Sciences sparked her move to the West Coast, and she is now settled in the San Francisco Bay Area. To learn more , please visit our website - https://www.parexel.com/. His last company, TheraSim, trained over 1 million physicians worldwide and was sold to WebMD in 2013. 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. ESMO TAT, known as "The Home of Phase I in Oncology", is the leading congress focusing on promising new anticancer targets and agents, with a particular emphasis on those in early phase clinical development. Last year alongside talks from industry leaders Pfizer, Bristol Myers Squibb, [] CLOSING KEYNOTE: FDAs role in maintaining a secure and resilient supply chain. Genentech Chief Diversity Office, Patient Inclusion And Health Equity. Prior to working in FDA, Mr. Solis worked in the Bioresearch field focusing on Medical Device and Drug Application Products after graduating from the University California of Irvine and the University of La Verne. Proven track record of coordinating teams in order to meet tight deadlines, set and communicate expectations, and manage deliverables. We offer global DCT participant-centric approaches that provide flexibility, meet the most challenging clinical trial demands and provide convenience for patients/caregivers in a compliant manner. Date: January 18 - February 17, 2023. Join Premier Research at Outsourcing in Clinical Trials Southern California 2022 as it returns for its 9 th annual event. We look forward to welcoming you In-Person to Amsterdam for Clinical Trials Europe 2022 to celebrate our 21st birthday. Practiced Neuro-Oncology and General Neurology at the VA and Boston Medical Center. www.precisionformedicine.com. 5 th Clinical Nutrition Conference. To learn more , please visit our website - 2023 edition of Outsourcing in Clinical Trials East Coast will be held at King of Prussia starting on 23rd May. 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. September 28-29, 2022. Tactical clinical operations in digital health studies, First-hand learnings, breakthrough device system, a case study. Passionate about novel tech-enabled medical devices that advance the understanding and treatment of diseases. The impact DCT has on diversity, equality and inclusion (DEI) have we finally managed to tap into under-represented communities? To learn more , please visit our website - 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.prevailinfoworks.com. Her experiences in academia, biotech, and CROs confirm that meeting the needs of all stakeholders payers, regulators, patients, families, and sites is a critical success factor for efficient development programs. Greenphire is the industry leader of clinical payment technology, designed to improve the way research professionals work. actalentservices.com, To learn more , please visit our website - Optimizing CRO Success: Relationship, contribution and oversight, PANEL DISCUSSION Defining your outsourcing strategy to contain costs and accelerate drug development time-to-market: what should you consider in the new COVID-19 era, Executing clinical trials on a shoestring: Optimizing the CRO Functional Service Provider model. To learn more , please visit our website - Dr Jasmina Jankicevic is globally recognized as an expert in dermatology drug/device development. To learn more , please visit our website - Compare and contrast the FDA, MHRA and TGA regulatory requirements for Phase I clinical entry.