He received M.Sc. Outsourcing in Clinical Trials DACH 2022 | 4G Clinical Advanced Clinical is a global clinical research services organization, providing CRO, FSP, Strategic Resourcing and Consulting Services for biopharmaceutical and medical device organizations. 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. Or has the noise around DCT quietened? 5 th Clinical Nutrition Conference. Dr. Cunningham came from academic background. Mr. Chu began his FDA career in 2002 as a Consumer Safety Officer (CSO). She is also a Certified Clinical Research Professional, and a trained journalist. TFS HealthScience is a global Contract Research Organization (CRO) that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey. 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. . http://strategikonpharma.com, To learn more , please visit our website - The must attend clinical outsourcing event in the Southeast region where industry professional can encounter a platform to explore new solutions to common issues within their clinical trial. Were a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. 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. 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. Medable offers the most flexible decentralized clinical trial platform streamlining trials for patients, sites, and clinicians whether in-clinic or at home. The company serves over 600 customers globally, with headquarters in San Francisco and offices in numerous domestic and international locations. Vice President, CMC and Supply Chain, Union Therapeutics, Umar Hayat, Ph.D. is VP of CMC and Supply Chain at Union Therapeutics and has more than two decades of experience in pharmaceutical development, manufacturing and supply chain. Mr. Chu has served as a mentor for the Federal Executive Board in Los Angeles, CA. Learn more at www.iqvia.com. Currently he is the CEO of Certum Bio in San Francisco Bay area and honors the co-appointment as the Member of the Board of Advisors, UC Berkeley Postdoc Entrepreneurs Program (BPEP). In 2010 she became the Deputy Director of ORAs Southeast Region, and in 2012 she assumed the responsibilities of Acting Director for the Southeast Region. We offer customized solutions to fit the needs of each study, patient and site, making it easier for your patients to stick with it. We proactively plan, coordinate and write clinical documents to meet timelines, with a readability that reduces the time for review and approval. Since 2000, Anne has held supervisory and branch director positions. Dr. Hayat received his Ph.D. in process engineering from INP-Toulouse, France and Post-Doctoral Fellowship from Ecole Polytechnique de Montreal, Canada. What can small biotech ClinOps teams learn from large Pharma, and vice versa? 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. The FDA reportedly rejected Neuralink clinical trials a year ago AI-ML, a Hype or Hope. AliveCor, Inc. is transforming cardiological care using deep learning. PANEL DISCUSSION: The concept of DCT, is it the future? Lin, who has been with the company since October 2016, previously served as the Senior Vice President of Sales and Marketing. SDC delivers top-tier clinical trial services to pharmaceutical, biologic and device/diagnostic companies. 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. http://www.celerion.com. http://www.spauldingclinical.com/, To learn more , please visit our website - To learn more , please visit our website - By accelerating clinical trials on all levels, our solutions support major pharmaceutical, biotech, and medical device companies, as well as renowned research institutions worldwide. Advantages of working alongside grass root organisations and PAGs what groups are out there? 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. 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. 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. Does it offer a solution? Aug 05 International Conference on Clinical Trials in Endocrinology (ICCTE) - Montreal, Canada. GreenLight Clinical is a physician-led, boutique full-service clinical CRO with its own central clinical, bioanalytical, histopathology laboratories in Sydney, Australia. 8 th Pharmaceutics and Novel Drug Delivery Systems Conference. 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. TORONTO, Oct. 12, 2022 (GLOBE NEWSWIRE) -- Axiom Real-Time Metrics ("Axiom"), a premier provider of unified eClinical solutions and services focused on small-to-medium life science organizations, will be exhibiting at Outsourcing in Clinical Trials New England 2022, October 12-13 in Boston, MA. Spaulding Clinical operates a 200-bed Clinical Pharmacology Unit, a Full Service Biometrics Group and Cardiac Core Laboratory. Rigorous scientific background and 9+ years of experience in driving both academic and industry clinical programs. Datacubed applies innovative solutions for the capture of active and passive data for engagement with patients in in-person, hybrid, or fully virtual clinical studies. Amy has been a drug discovery and development professional for 25+ years, including progressive roles in clinical operations and clinical strategy. About Mobile Technologies in Clinical Trials. Reem holds a PhD in genetics from the Hebrew University of Jerusalem. It is a 2 day event organised by Arena International Events Group and will conclude on 24-May-2023. To learn more , please visit our website - 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. My training is in genetics (Ph.D.) and mechanical/biochemical engineering (M.S. She was an assistant professor at Loyola University Chicago and a practicing vascular surgeon in Shanghai, China. 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). DCT was previously done out of necessity but are we seeing it as a new world order? Global Player in eClinical Solutions . Dan is responsible for presenting the robust data management solutions made possible with elluminate, and can customize product demonstrations to address specific customer needs. 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. Medical Writing and Healthcare Communications Conference. 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. The "Global Clinical Trial Outsourcing Market by Clinical Trial Phase, Therapeutic Area, End-user and Region: Competition Forecast and Opportunities to 2027" report has been added to . We look forward to welcoming you In-Person to Amsterdam for Clinical Trials Europe 2022 to celebrate our 21st birthday. http://www.medpace.com/. Through innovative eClinical and Regulatory solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market reliably. Our leading clinical show will focus on providing delegates with practical take-aways and solutions to their most current operational and outsourcing challenges in clinical trials, this is an [] TICKETED. Outsourcing In Clinical Trials . Enhance site negotiations and pay with ease, with the industrys first Procure-to-Pay solution designed specifically for clinical trials. From 7 to 9 November 2022. Triomics is a technology company offering an enterprise-grade platform for clinical trial sites to automate data collection practices. To learn more , please visit our website - https://www.threadresearch.com/. Reimbursement for medical devices in trials, and, understanding the process. We have conducted clinical trials contributing to the market approval of nearly 100 new drugs to date. We go beyond traditional events and offer, The main program of the conference is discussion and debate on the outsourcing of clinical research. TransPerfect Life Sciences specializes in supporting the global development and commercialization of drugs, treatments, and devices designed to improve and save lives. 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. Agilex Biolabs operate a fully quality-assured, FDA-inspected laboratory (ISO/IEC17025 and OECD GLP). www.bsi-lifesciences.com. Dr. Raymond completed her doctoral training in molecular biology at University of California San Diego and post-doctoral training in molecular biology at Memorial Sloan-Kettering in New York City, New York, USA. The Investigations Branch handles: importer inspection, import sample collection, field examination, entry review, investigation, and inspection of imported FDA regulated products. He investigated mechanisms by which active ingredients in cumin seeds halt Prostate Cancer progression and metastasis at the Vattikutti Urology Institute, Henry Ford Hospital. 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. Anju Software is a customer-first organization providing adaptable life science solutions for clinical research, medical affairs, and data science. Caidya Events | Caidya Conferences | Clinical Research Events Includes management of the RFP process for outsourced services as well as contract/proposal and budget negotiations, vendor selection, and vendor oversight/relationship management. Our experienced project managers and global network of linguists are supported by proven processes and cutting-edge technology. 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. eClinical & Clinical Data Management Innovation Conference 2022 . Our latest enhancements include patient genetic and biomarker matching to promote swift site identification and patient enrollment. www.emvenio.com, To learn more , please visit our website - Weve all had to sit through several pitches from vendor companies telling us what they can do for us, but now its time to reverse the conversation! ClinChoice is a leading full-service clinical CRO offering high-quality solutions to pharmaceutical, biotechnology, medical device and consumer products clients. 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. www.advanceresearch.com. 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. NikZ shows promise against other important fungal diseases. https://www.rad-md.net/, To learn more , please visit our website - She is a Nurse Practitioner by training and spent over 10 years caring for patients before coming to industry. Clinical Trial Conferences to attend in 2022 - McDougall Scientific Company Website:https://eurofinscentrallaboratory.com/biopharma-services/, To learn more , please visit our website - http://www.clinicalink.com/, To learn more , please visit our website - ACRP 2023 | April 28 - May 1 | Sheraton Dallas 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. Outsourcing in Clinical Trials & Clinical Trial Supply East Asia Conference 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. What things do they need a partner to do and what they dont need! Commercial Services. Gordon Chu is the Director of Investigations Branch at the Food and Drug Administration (FDA) Division of West Coast Imports (DWCI) within the Office of Enforcement and Import Operations (OEIO). She currently serves as Vice President of Clinical Affairs at Endogenex, a medical device company developing innovative solutions for the treatment of Type 2 diabetes. Combining medical expertise and deep industry knowledge, we develop bespoke solutions to accelerate your innovative treatment development for patients with unmet needs, one trial at a time. 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. Decentralized Clinical Trials 2023 Event - Informa Connect He has been actively involved on both sides of the business in managing CDMOs and CROs. She has over 22 years of experience overseeing GxP quality and compliance for all phases of drug development for biologics and small molecules. 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 impact DCT has on diversity, equality and inclusion (DEI) have we finally managed to tap into under-represented communities? Proven track record of coordinating teams in order to meet tight deadlines, set and communicate expectations, and manage deliverables. Outsourcing in Clinical Trials East Coast - 10times Slope makes clinical trials boring by using real-time data to orchestrate operational complexity. Meraf Eyassu is a Executive Director of Clinical Operations at Terns Pharmaceuticals. eClinical Solutions is a leading global provider of cloud-based enterprise software and software-driven clinical data services. Dr. Cunningham came from academic background. Visit our website to learn more about how we deliver a Better Clinical Experience. 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. Celerion provides full study services including statistics, data management and biostatistics (including PK/PD analysis), and bioanalytical services. Our Leukopaks are available for Research Use Only and Clinical Grade (FDA 21 CFR 1271-compliant) applications. Specifically for Clinical Trials and RWE studies, Medocitys modular and flexible architecture ensures swift configuration and deployment in less than 4 weeks, through a fully interoperable and connected SaaS cloud database. In the life sciences vertical, we help pharmaceutical and medical device companies with clinical trial management, data management, biometrics, medical affairs, regulatory affairs, and quality and compliance initiatives. 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. 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. To learn more , please visit our website - Headquartered in Uppsala, Sweden, Viedoc also has offi ces in America, France, Japan, Vietnam, and China. Nucleus Network is Australias largest Phase 1 clinical research organisation and the only Phase 1 specialist globally with phase I facilities in the US and Australia. Emmes is a full service contract research organization collaborating with our clients to produce valued, trusted scientific research. www.medpt.com. 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.
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