outsourcing in clinical trials conference 2022

The Investigations Branch handles: importer inspection, import sample collection, field examination, entry review, investigation, and inspection of imported FDA regulated products. To learn more , please visit our website - This is also a critical time to determine the development strategy for later study phases. 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. What are global biotech executives asking/concerned about when evaluating Phase I study plans? She is currently the Founder and CEO of Strategikon Pharma, developer ofClinical MaestroTM, the industrys only end-to-end cloud-based platform for clinical trial budgeting, sourcing and budget management including strategic alliance/partnership management. Join us in Philadelphia, May 10th-11th, to shape best practice on: Refining patient recruitment strategy. Dr. Cunningham came from academic background. ClinChoice is a leading full-service clinical CRO offering high-quality solutions to pharmaceutical, biotechnology, medical device and consumer products clients. She advises on eCOA best practices, diary and instrument design and training for participants, caregivers and raters. Medable offers the most flexible decentralized clinical trial platform streamlining trials for patients, sites, and clinicians whether in-clinic or at home. From 1990 to 2008 he held various Clinical Operations positions at Abgenix, Pharmacyclics, Quintiles, Covance and Syntex. Theyre more likely to finish on time and on budget. To learn more , please visit our website - Curebase is also pioneering the Bring Your Own Physician (BYOP) model, allowing patients the comfort to make decisions with support from their trusted physician, To learn more , please visit our website - www.curebase.com. https://www.anjusoftware.com/, To learn more , please visit our website - Key changes for the implementation of the EU CTR, Preparation for the EU CTR implementation, Submission efficiencies when using a CRO in the EU, Exploring how to introduce a new digital quality compliance management system. https://www.intrinsequehealth.com/. Conferences. www.prevailinfoworks.com. Isabel Brown (she/her) currently works on the Inclusive Research and Health Equity team for Genentech's Research and Early Development, Clinical Operations group. Rho, a contract research organization (CRO) located in Chapel Hill, NC, provides a full range of services across the entire drug development process. 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. Conversis is built on one goal: To provide you with the highest-quality clinical trials translations. For more information, visitwww.eclinicalsol.com, or contact us atinfo@clinicalsol.com. Prior to starting SageMedic, he was an Associate Professor at UCSF. Basel, Switzerland. Medidata is leading the digital transformation of life science, with the worlds most used platform for clinical development, commercial, and real-world data. You might have known us as Myoderm as we have recently changed our name but not our high-quality services as the complete clinical trial supply partner. 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. 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. 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. He enjoys connecting like-minded people, introducing new ideas, and immersing himself in an environment of continuous learning. 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. WORKSHOP: Identifying and overcoming the hurdles associated with global studies including longer timelines, drawn-out budgets and remote teams. 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. Before joining Clinical Ink in 2021, he was an Assistant Professor in the Department of Ophthalmology & Visual Sciences at the University of Nebraska Medical Center. He started his career with FDA in 1998. Saamas unified, AI-driven clinical data analytics cloud platform seamlessly integrates, curates, and animates unlimited sources of structured, unstructured, and real-world data to deliver actionable insights across all therapeutic areas. www.saama.com. 8 th Pharmaceutics and Novel Drug Delivery Systems Conference. http://www.spauldingclinical.com/, To learn more , please visit our website - Dr. Kumar Gadamasetti is an experienced pharmaceutical and biopharmaceutical executive. Making the patient stories the centre of your study with a focus on feedback, Important topics to address with patients, Best timing and approach to successfully engage patients. Prior to this position he was the Division Director for the Division of West Coast Imports since February 9, 2018. Our full service offering includes clinical program management, biometrics services and regulatory affairs. 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. As a community leader and healthcare advocate she partners, collaborates with initiatives including the U.S. Department of Health and Human Services Office of Minority Health and the U.S. Food and Drug Administrations Office of Minority Health and Health to increase awareness on the need for diversity in lupus clinical trials, All Of US Research, Scripps Digital Trials Center and Congresswoman Grace Napolitanos Mental Health Consortium. 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. After 3 years as a patent lawyer at Apple Computer, he took a VP role at startup FormFactor, staying in an IP role, then became the first General Counsel for startup Verisity Design, taking them public in 2001, then ultimately through successful acquisition in 2005. PANEL DISCUSSION THE PATIENT IMPACT: Patient recruitment, patient centricity & virtual trials Navigating the New Normal, QUICK FIRE ROUNDS: The Patient Perspective, Keynote Not just ticking a box: Outreach to minority groups is improving but the focus now is on establishing trust and relationships. To learn more , please visit our website - For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. Additionally, Funwie collaborates with colleagues to co-create educational resources as a part of the core team of the Advancing Inclusive Research Site Alliance, which focuses on addressing disparities in clinical research. She also has a special interest in innovations that can improve the quality and efficiency of clinical trial execution. AWT Healthcare is solely focused on providing the clinical pharmaceutical and custom labels & packaging industry with state-of-the-art solutions at a fair price and competitive timing. Clinical Outcome Assessments (COAs): Applying scientific rigor and good instrument design. assisTek has been paving the way for integrating technology and data collection in clinical trials for over 25 years. Developing and supporting your quality initiatives from Day 1, the Harbor team is committed to quality through each functional service we provide. With a dual clinical appointment in Robotic-Surgery at the Institute, Arun focused on post-surgical outcomes of Da-Vinci Robotic Prostatectomy for Hormone Refractory Patients. 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. Eurofins BioPharma Services, Laboratory Testing is a group of Eurofins companies with dedicated testing facilities for global Central Laboratory Services, Bioanalytical Services, and Specialty Virology and Oncology Services. Since 2000, Anne has held supervisory and branch director positions. Discuss a pathway to extend biotech cash burn runway while still meeting Phase I objectives and meeting investor expectations! Based outside Philadelphia, Pennsylvania, we pride ourselves on being boutique by design and always customer focused. Were your solution. She has executed a variety of clinical trials involving therapeutic areas including autologous breast reconstruction, heart failure, hypertension, arrhythmia management and erectile dysfunction. His expertise is in regulated content management, and he is a member of the TMF Reference Model Project Team. 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. 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. http://catalystcr.com/. We contribute to a safer and better world by helping our sponsor clients accelerate drug and device approvals to market. Spaulding Clinical operates a 200-bed Clinical Pharmacology Unit, a Full Service Biometrics Group and Cardiac Core Laboratory. Amsterdam RAI. Scalable, Reliable. Wayne resides in Miami, Florida. Our experts are ready to discuss how our solutions can best support your live studies. I am very excited to be attending Clinical Outsourcing Group UK this year in London! Minimize site activity- could decentralization and Direct-to-Patient trials be the answer to staff shortages? Can you share some of your workflow procedures? Slope makes clinical trials boring by using real-time data to orchestrate operational complexity. ), pharmacovigilance and safety solutions, translation and language services, and call center support. Discover effective strategies for outsourcing clinical trial operations to ensure trials run smoothly and within budget . In her role at Nevro, Frances is responsible for leading the data management team, driving the adoption of new technologies and innovative data management processes to bring new treatments to patients. Why should we collect Sexual Orientation and Gender Identity in Clinical Research Studies? 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. Any Device. 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. The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Commercial Services. An international speaker, Dr. Hughes is responsible for a team of scientific experts who provide guidance and analysis services related to the creation of electronic data collection systems for clinical trials. Topics include feasibility & site selection, clinical data & technology, patient engagement & enrollment, risk-based monitoring, and budeting & clinical outsourcing. 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. To learn more , please visit our website - Henry earned his B.S. Parexel Recognized by Frost & Sullivan with 2022 Global Customer Value Leadership Award . Wednesday, 28th Sep 2022 - Thursday, 29th Sep 2022 . Learn more at www.iqvia.com. 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. In this presentation we will discuss the following: Clinical development has shifted from a scientifically driven journey to a patient-focused one. Other companies he has founded or co-founded include: 1) IMTH, a real estate investment trust with properties through the state of California; 2) iPill Dispenser, a medical device that uses a mobile app to control a secure, stand-alone pill dispenser to prevent opioid sharing, diversion, and drug overdoses; and 3) NAOMI systems, a practice management software company that integrates digital X-rays devices in PACS, EMR and RCM billing modules. March. 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. Valley Fever Solutions is a small startup working first on a new and improved treatment for Valley Fever (coccidioidomycosis), for which NikZ will transform the standard of care. 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. March 07-09, 2016 Madrid, Spain. 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. By harnessing digital data, we power sponsors, CROs, researchers, and patients to recenter decentralized trials and rewrite the clinical development experience. To learn more , please visit our website - Passionate about novel tech-enabled medical devices that advance the understanding and treatment of diseases. Analytical & Solid State Services. 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. Discover effective strategies for outsourcing clinical trial operations to ensure trials run smoothly and within budget Join us for a two day event filled with case studies, panel discussion and face to face networking opportunities around clinical operations, technology and innovation, and data management. Read more . Ndidi Rickert is an experienced Quality Assurance leader with over 20 years of experience in the Pharmaceutical/Biotechnology industry. Precision for Medicine (PFM), the full-service global CRO, is purpose-built to accelerate clinical research and development processes to bring life-changing therapeutics to those who need them most. Complimentary. SCOPE 2022 attracted more than 2,300 leaders in clinical operations and research and all conference tracks will feature best practice case studies relevant to clinical operations experts and those new to the field. 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 and drug development post COVID, Clinical Trials Innovation Programme 2023 will feature tailored sessions presented by the leading experts from across the . Clinical Trial Supply New England . Effective management of essential clinical trial documents using eTMF solutions. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancements, drive the industry standard for data precision and usher in a new generation of clinical trials. About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . Phase 1 Trials: How to globalize to accelerate value inflection. She has worked with Calyx for over 7 years as a key strategic leader and director in IRT solutions and services. The Budget Conundrum. 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. Our high-caliber project management, clinical monitoring, medical safety, data management, biostatistics, regulatory affairs and quality assurance capabilities make us a valued partner. Partnerships in Clinical Trials Europe 2022. Experienced in research methodologies and conducting qualitative and quantitative research in a variety of therapy areas including respiratory, cardiology, oncology, immunology rare diseases and emerging therapy areas. Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture. Start. 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. After years of watching the opioid crisis develop, John has developed an innovative drug and dispenser to safely treat pain and deter abuse. We offer both single modules and a unified solution to maintain all processes you can cover all existing software needs with only one vendor. 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. 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. The elluminate Clinical Data Cloud provides life sciences companies with greater control of their clinical trial data with one platform for all data sources, from aggregation through to standardization, visualization, and preparation for submission. She has a unique perspective in leading clinical programs in a dynamic startup environment. 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. . What should we be doing now to anticipate, prepare, prevent and respond? He works cooperatively and collaborates with Federal, State, and local agencies to ensure appropriate consumer protection. www.td2inc.com. 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. Founded in 1996, ProTrials has been successfully supporting clinical research for over 25 years. The company has a wealth of experience in the execution of global, regional and local clinical development programs with a special focus on addressing unmet needs in areas such as analgesia, CNS, oncology, pediatric, and rare disease. CROMSOURCE operates offices across Europe and North America. Catalyst Clinical Research is a new generation Clinical Research Organization, serving the unique needs of small-to-medium sized biopharmaceutical companies. Electronic clinical outcome assessments (eCOA)and interactive response technology (IRT) platforms introduce greater speed, precision and data quality to 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. The therapeutic areas include: Cancer, CV, CNS and infectious diseases. Prior to working at Genentech, she graduated from the Johns Hopkins Bloomberg School of Public Health with a Master of Bioethics. Project Leader, Health Equity And Population Sciences, Hoffman La Roche. To learn more , please visit our website - In 2021, ERT and Bioclinica merged to become Clario creating the broadest endpoint technology platform in the industry and enhancing our scientific expertise.

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outsourcing in clinical trials conference 2022