outsourcing in clinical trials conference 2022

This is the unmissable event that the pharmaceutical, biotechnology, and medical device communities need to come together and discuss strategies for operational success in clinical trials. Founded in 1985, Promedica International, a woman-owned corporation, is headquartered in Orange County, California. We have been driving the success of our clients, consultants, and employees in staffing and consulting services since 2004. OMDRHO's Key Initiatives, inspectional and compliance activities, Define RWE and real-world data sources/needs, Making progress during pandemic for a first-in-human device study, Designing a hybrid trial for a novel interventional device, Navigating the complexities of multi-specialty study, Determining the technologies to move studies off site in order to move forward with the new norm, Investigating technology to save costs and improve accuracy of pharmacokinetic and pharmacodynamic data, Learning how to improve study drug adherences so only the study participant has access and, can only take the drug as per study protocol, Case Study looking at Digitization for objective data and cost saving, Defining the reimbursement strategy to prove medical benefit and value, Understanding codes for medical device technologies, Working with the FDA to secure your reimbursement, Programming for efficient data management, Generating metrics for data tracking and study progress, Overview of how we interface with our organization, Discussing the technologies accessible for the smaller biotechs, Assessing how to make access to innovations affordable for companies on a smaller budget and how to best allocate limited resources, How to work with a vendor partner as a smaller biotech to get access to new technologies, Removing the barriers: what still needs to be done to improve access to innovation for all, Key drivers for trial enrolment and in time completion, Population and high prevalence of disease in developing countries, Barriers and hurdles to access vast pool of patients, Strategies/solutions to penetrate through barriers and pass hurdles, Common operational, security and regulatory issues around the collection, management, and reporting of essential clinical trial documents, How eTMF solutions can help to address these issues, and ensure inspection-ready and regulatory compliant storage of trial content, How eTMF solutions reduce business risk, improve team collaboration and productivity, reduce auditing and reporting costs, and ensure enhanced artifact quality, Major capabilities that current eTMF solutions should provide. Viroclinics-DDL, a Cerba Research Company is a leading specialty contract research organization, serving the biopharmaceutical community with a broad range of non-clinical research, clinical diagnostics, assay development, laboratory, and clinical trial logistic services. To learn more , please visit our website - Our Leukopaks are available for Research Use Only and Clinical Grade (FDA 21 CFR 1271-compliant) applications. www.myonex.com. 6 th Clinical & Forensic Pathology Conference. Anne came to FDA in 1990 with an undergraduate degree in Biochemistry and a masters degree in Food Science and segued into FDAs laboratory science regulatory operations. https://www.advancedclinical.com/. PANEL DISCUSSION: Decentralized/Hybrid Trials: Discussing the current challenges and debating best practises for a successful virtual study, Considerations and best practices in direct-to-patient (DTP) / decentralized clinical trials (DCT) lessons learned from past trials, PANEL DISCUSSION: Reversing the Conversation What the clinical trial industry really wants from its service providers, KEYNOTE A playbook for how to handle an undesirable CRO-Sponsor partnership & how to turn it around, A playbook for how to handle an undesirable CRO-Sponsor partnership & how to turn it around. Currently a Medical Director/Patient Safety Physician Digital & Devices at Astrazeneca. www.viedoc.com, To learn more , please visit our website - 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. August 29-31, 2016 Atlanta, USA. 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. To learn more , please visit our website - She was an assistant professor at Loyola University Chicago and a practicing vascular surgeon in Shanghai, China. Mr. Solis has held many positions within FDA that includes working at the FDA lab in Irvine, Ca. March 07-09, 2016 Madrid, Spain. As specialists in clinical regulatory documentation, we provide a service that is more than just writing. March. 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. Mr. Chu was selected to be the Director of Investigations Branch (DIB) for DWCI in June 2018. 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. Post doctoral research studies in Human Behavior. What is critical to get right to make a digital QM System work? 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. We have successfully been providing exceptional value to our clients for over 30 years. Dont miss out; join us in Burlingame on March 1st& 2nd2023! He has supervised the management of a clinical portal, eTMF, CTMS, RTSM, EDC, Coding and Grants solutions. Powered by the IQVIA CORE, IQVIA delivers unique and actionable insights at the intersection of large-scale analytics, transformative technology and extensive domain expertise, as well as execution capabilities. To learn more , please visit our website - Local vendor oversight vs global provider oversight how would you manage this differently? 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. For more information, visit http://www.saama.com. Since our inception in 2003, over 1 million patients in more than 75 countries have participated in studies powered by Viedoc. Subsequently completed a Neurology Residency at Columbia University with additional Fellowship training in Neuro-Oncology at the Mass General Brigham program. 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. An opportunity at Gilead Sciences sparked her move to the West Coast, and she is now settled in the San Francisco Bay Area. We offer customizable specimen collection kits, specialty testing capabilities, dedicated project management and trial site support, biostorage, and real-time data management and reporting. Overview. She then ventured across the pond to the United States where she worked for Novartis, Pfizer, Johnson & Johnson and Aeras (one of the Bill Gates Foundation companies specializing in TB and Malaria). 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. She is a career FDA federal service veteran with vast experience in technical and managerial positions across multiple commodities. She has a unique perspective in leading clinical programs in a dynamic startup environment. 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. Philips BioTel Research is an industry leader in medical imaging and cardiovascular safety testing for clinical trials. ACM is certified by the College of American Pathologists (CAP) and the Substance Abuse and Mental Health Services Administration (SAMHSA). Spaulding Clinical Research is a global CRO providing Phase I IV drug development services to pharmaceutical and biotechnology companies. With headquarters in Dublin, Ireland, ICON employed approximately 41,150 employees in 113 locations in 53 countries as at September 30, 2022. By accelerating clinical trials on all levels, our solutions support major pharmaceutical, biotech, and medical device companies, as well as renowned research institutions worldwide. Arena International are delighted to announce Outsourcing in Clinical Trials Europe will be returning to Barcelona on the 3rd-4th May 2023! 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. Theyre more likely to finish on time and on budget. He has been a visiting professor at Catholic U., Louvain, Belgium and U. Pittsburgh, Pittsburgh, PA and visiting speaker at Humboldt U. in Berlin, Germany. Alton Sartor completed a combined MD/MBA from Tulane University. Joined industry with a goal of developing digital and devices to improve patient care. View Event. To learn more , please visit our website - Additionally, our tech-enabled trial management system, streamlined study startup processes, centralized pre-screening call center, and unparalleled approach to patient recruitment will successfully deliver a superior CRO experience. To learn more , please visit our website - http://greenphire.com/. From 1990 to 2008 he held various Clinical Operations positions at Abgenix, Pharmacyclics, Quintiles, Covance and Syntex. Brandi Coffin has been in the medical device industry for over 15 years with various roles in post market surveillance, quality, compliance and patient safety. Anca has over 15 years of experience in the biopharmaceutical industry, working both on the CRO and the Sponsor side. 25 people interested. 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. To learn more , please visit our website - 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. To learn more , please visit our website - Ellen Weiss is the Vice President, In-Home Solutions, Decentralized Clinical Trials at PCM Trials. Were your solution. The Investigations Branch handles: importer inspection, import sample collection, field examination, entry review, investigation, and inspection of imported FDA regulated products. . What are global biotech executives asking/concerned about when evaluating Phase I study plans? We have earned a solid reputation around the globe by delivering customized solutions used in over 500 clinical research trials, across 90 different languages in 80 different countries. www.medpt.com. 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. To learn more , please visit our website - Advanced Clinical is a global clinical research services organization, providing CRO, FSP, Strategic Resourcing and Consulting Services for biopharmaceutical and medical device organizations. Interactive Response Technologies (IRT) 2022 brings the clinical community together to discuss cutting-edge updates in technology and dives into strategies to help the clinical industry excel in their trials and data management. He has worked for CROs as well as small and large biotechnology companies. It offers its clients a global reach through a network of 38 processing laboratories. Meghan received her Masters Degree in Human Biology at San Francisco State University and her Bachelors Degree in Economics at University of North Carolina, Chapel Hill. Our standard products and services include patient recruitment, eConsent, ePRO/eCOA, interactive digital support and symptom monitoring with the capability to provide an end to end clinical to commercial solution. To learn more , please visit our website - To learn more , please visit our website - The two day programme will take a holistic approach to the latest challenges and innovations in clinical operations, such as, the [] 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. Parexel is among the worlds largest clinical research organizations (CROs), providing the full range ofPhase I to IV clinical development services to help life-saving treatments reach patients faster. Tickets. https://www.q2labsolutions.com/, You need an Imaging Strategy thats designed and customized for your oncology clinical trial. News; . 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. To learn more , please visit our website - Register. http://www.labconnectllc.com/. www.flexdatabases.com. San Diego Marriott La Jolla. We proactively plan, coordinate and write clinical documents to meet timelines, with a readability that reduces the time for review and approval. May 3 - May 4 @ Barcelona, Spain. Before joining Curebase, Wayne served as Vice President at mid-sized Florida based CRO Biorasi, where he helped to lead that company to a successful acquisition by a private equity partner in 2018. Kristina leads the Patient Insights team at Parexel and is dedicated to bringing a thorough understanding of the patient journey, and the patient voice to the entire spectrum of research services. Signant unites eCOA, eConsent, Patient Engagement, IRT, Clinical Supplies and Endpoint Quality into the industrys most comprehensive patient-centric suite an evolution built on more than 20 years of proven clinical research technology. Industrial Pharmacy Conference. Clinical Outcome Assessments (COAs): Applying scientific rigor and good instrument design. 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. Our comprehensive solutions include clinical trial management technology and services (TMF services, eTMF, CTMS, regulated content management, etc. As a supervisor, he had the opportunity to manage an Import Field Operation Team, an FDA team in the Centralized Examination Stations (CES), and the Los Angeles International Mail Facility. Mobile in Clinical Trials is the first conference, founded in 2013 to convene R&D operations and digital leaders to get the best access, deploy and scale strategies for applying mobile/digital tools to connect and empower patients, and obtain better outcomes in drug development/clinical research. Jowita Marszewska, Ph.D. is a Scientific Advisor at Clario, a global data and technology company that helps minimize risk in clinical trials. Also within Genentech, she is a core member of the Advancing Inclusive Research Site Alliance and leads the company's LGBTQ+ Health equity strategies. Tranquil Clinical Research is an early phase CRO with a fully accredited Hospital Phase I unit. She was an assistant professor at Loyola University Chicago and a practicing vascular surgeon in Shanghai, China. From 2 to 4 November 2021. Outsourcing in Clinical Trials Southeast . A NEW paradigm of engineering-forward analytics solutions powering digital biomarkers. 2023. She is definitely not afraid of being the least popular girl in the room in order to support patient safety! dpocentre.com. To learn more , please visit our website - She was an assistant professor at Loyola University Chicago and a practicing vascular surgeon in Shanghai, China. Electronic clinical outcome assessments (eCOA)and interactive response technology (IRT) platforms introduce greater speed, precision and data quality to clinical trials. Prior to SDCs inception, Richard served on the Board of Directors of Ora, Inc. (www.oraclinical.com) for over 10 years. European Union Clinical Trial Regulation: Strategic Considerations, Hyatt Regency San Francisco Airport Hotel 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 . To learn more , please visit our website - http://www.novotech-cro.com/. Chris deep knowledge of the global early phase drug development industry strengthens the tradition of success of Nucleus Network, our customers and partners in Advancing Medicines, Improving Lives. pril 28-29, 2016 Dubai, UAE.