We are committed to delivering high-quality, cost-effective services according to sponsor timelines and specifications. deep6.ai, To learn more , please visit our website - Philips BioTel Research offers global operational support for cardiovascular monitoring in all therapeutic areas, and advances imaging services in oncology, cardiovascular, metabolic, musculoskeletal, neurologic, and medical device studies. http://www.clindatrix.com/. 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. Extensive Outsourcing and Contracts experience in the area of Clinical Development primarily at small to mid-size biotech organizations. Were a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. Axiom Exhibiting at Outsourcing in Clinical Trials Southeast 2022. These conferences closely focus on the advancements in clinical research and trials. 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. To learn more , please visit our website - http://www.dsg-us.com/. Dr. Hayat received his Ph.D. in process engineering from INP-Toulouse, France and Post-Doctoral Fellowship from Ecole Polytechnique de Montreal, Canada. 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. https://www.propharmagroup.com/. 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. At UCSF he co-invented suitable PEGylated lipids to make the very first PEGylated liposomes. Reimbursement for medical devices in trials, and, understanding the process. https://www.threadresearch.com/, To learn more , please visit our website - Please email me if you'd like to set up a meeting to discuss your upcoming clinical trials: Each roundtable session lasts for 30 minutes, and delegates may attend up to 2 roundtables. Looking forward to another great conference! With more than30 years of experience in over 60 countries, our individualized partnership approach provides experience-driven insights and expertise to assist clients in successfully navigating the complexities of delivering novel treatments to patients. 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. Outsourcing in Clinical Trials West Coast 2023 - Arena International Pharmapack is the European event focal point for the pharma packaging and drug delivery device industry. November 13-14, 2023 Dubai, UAE. Online event and networking. To learn more , please visit our website - http://www.yprime.com/, Curebase leads decentralized clinical research using a sophisticated eClinical software platform that manages all site/patient data capture, along with a fully virtual site that acts much like a traditional site, but with greater flexibility and reach. www.kardia.com. Why having IRT experts involved in your study is important. Mr. Chu began his FDA career in 2002 as a Consumer Safety Officer (CSO). In 2019, THREAD was acquired by strategic health care investors Water Street Healthcare Partners and JLL Partners. To learn more , please visit our website - http://www.novotech-cro.com/. 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. Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. Combined, our clinics offer over 200 beds. The international company is a privately owned organisation which has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia. Learn more at www.iqvia.com. What are global biotech executives asking/concerned about when evaluating Phase I study plans? Francis has lead supplier oversight responsibilities for sponsors, CROs and clinical system vendors. 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). CHI's Clinical Trial Innovation Summit To learn more , please visit our website - 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. http://www.cromsource.com/. 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. Global Clinical Trials Connect 2023 2022 London United Kingdom. Clinical Trials Innovation Programme 2023 is the only platform to . Sun, 24 Apr 2022, 09:00 End. 11 th International Conference on Clinical Trials is scheduled to be held during November 09-10, 2023 at London, UK. From early phase, bioanalytical sciences, late phase, post-approval and real-world evidence,Worldwide Clinical Trialsprovides full-service drug development services for central nervous system, cardiovascular, metabolic, general medicine, oncology and rare disease therapies. Discover effective strategies for outsourcing clinical trial operations to ensure trials run smoothly and within budget . To learn more , please visit our website - Greenphire is the industry leader of clinical payment technology, designed to improve the way research professionals work. To learn more , please visit our website - clinical trials Conferences 2023/2024/2025 is for the researchers, scientists, scholars, engineers, academic, scientific and university practitioners to present research activities that might want to attend events, meetings, seminars, congresses, workshops, summit, and symposiums. Mr. Solis has held many positions within FDA that includes working at the FDA lab in Irvine, Ca. Are you choosing best in class or a bundle? Increasing inclusion in future trials for vulnerable populations with health disparities some success stories, Home visits have evolved since their inception in 2003, Services possible in 2023 an overview of what is possible today, Sourcing the right professionals for visits is essential to success, Addressing the reduced site pool challenge and focussing on sites you know can deliver, Overcoming hurdles with imaging centres with reduced staff when trying to qualify patients in a timely manner. December 07-09, 2015 Atlanta, USA. Review market analysis on location of Phase I studies and discuss why these choices are made. Passionate about novel tech-enabled medical devices that advance the understanding and treatment of diseases. www.medocity.com, To learn more , please visit our website - RadMD, a Medica Group Company, is your full service imaging core lab solution. www.allucent.com. Together with our client partners, we are fulfilling our purpose of Advancing medicine, improving lives., To learn more , please visit our website - https://www.nucleusnetwork.com/au/. Genentech Chief Diversity Office, Patient Inclusion And Health Equity. United States, 94010, To learn more , please visit our website - Deep 6 AI is the leader in precision research software, connecting all research stakeholders in an AI-powered, real-time, data-driven, collaborative ecosystem. theactigraph.com. Our performance is built on years of experience staffing the competitive biopharma job recruitment landscape, leveraging our deep networks to source the most highly sought-after candidates in the industry. To learn more , please visit our website - http://www.medable.com/. Dr. Hsu is anesthesiologist and pain management physician, but also a serial entrepreneur. Clinical Trials 2023. We have successfully been providing exceptional value to our clients for over 30 years. Kumar earned his Ph.D. from the University of Vermont and was a post-doctoral fellow at the University of Virginia. 2022 edition of Outsourcing in Clinical Trials & Clinical Trial Supply East Asia Conference will be held at InterContinental Seoul Coex, Seoul starting on 29th November. Pharmaceutical Development. www.assistek.com, To learn more , please visit our website - Subsequently, Arun lead the Gastric-Immuno-Oncology Rare Disease Bispecific-T cell-Engager portfolio at Amgen on various aspects of clinical research operations. Dr. Apfel is a California licensed physician with 20+ years of clinical experience in anesthesiology, critical care medicine, and emergency medicine. Rigorous scientific background and 9+ years of experience in driving both academic and industry clinical programs. For more information, please contact us at 262-334-6020, or via email at Daniel.Selness@spauldingclinical.com. CLOSING KEYNOTE: FDAs role in maintaining a secure and resilient supply chain. Flexible. Advice for the ClinOps team to avoid unnecessary patient visits, how does your protocol affect the site? To learn more , please visit our website - Sections. Specialized in clinical strategy and projects within digital health, with experience spanning from product ideation to commercialization. OCT DACH Conference 2022 - Outsourcing in Clinical Trials. Founded in 2005, the companys cloud-based EDC, Direct Data Capture, eConsent, and ePRO solutions deliver fast, flexible, and easy-to-use tools for the collection and management of clinical data and patient reported outcome responses. Explore Modern RTSM Solutions. Top Pharma Events and Biotech Conferences in 2023 | Scilife To learn more , please visit our website - Read more . 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. Since 2000, Anne has held supervisory and branch director positions. 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! https://www.almacgroup.com. 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. Going the last millimeter: What you may not know about home visits. http://www.pcmtrials.com/, To learn more , please visit our website - mediantechnologies.com, Medocity is a leading digital health technology company that has been serving the pharmaceutical and life sciences industry for almost a decade. Our latest enhancements include patient genetic and biomarker matching to promote swift site identification and patient enrollment. LinkedIn Bio: https://www.linkedin.com/in/ndidi-rickert-she-her-47197371/, Enhancing a responsible quality mindset and culture. www.tranquilclinicalresearch.com. 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 is driven by listening and incorporating the patient voice and by finding innovative ways to improve the patient experience. http://www.peachtreebrs.com. Prior to Medable, Reem worked in the clinical space in both the industry and academia settings after making a transition from basic science research. 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 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. Global Player in eClinical Solutions . She has actively participated in departmental preparation for the EU CTR implementation and is one of ICONs SMEs on this topic. Dr. Cunningham came from academic background. Clinical Trial Supply New England . Five gene therapy trial readouts to watch in the first half of 2023 New Omicron variant could threaten vulnerable people this winter Inclusive drugs: designing clinical trials for the pregnant population She also has worked within the clinical department at several reputable companies like Axogen, Medtronic, Coloplast and CR Bard. 11 clinical trials that will shape medicine in 2022 - Nature www.harborclinical.com/. Theyre more likely to finish on time and on budget. Our full service offering includes clinical program management, biometrics services and regulatory affairs. How do you arrange with and clean the large amounts of data generated? http://www.medpace.com/. From 7 to 9 November 2022. Stop by to see us at Outsourcing in Clinical Trials New England 2021 conference. WCG measurably improves the quality and efficiency of clinical trials, helping biopharmaceutical companies, CROs, and institutions facilitate the development of new treatments and therapies for patients. www.medpt.com. http://www.axiommetrics.com/. 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. Why should we collect Sexual Orientation and Gender Identity in Clinical Research Studies? ACRP 2023 | April 28 - May 1 | Sheraton Dallas 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. As specialists in clinical regulatory documentation, we provide a service that is more than just writing. Overview. Their services include clinical monitoring, clinical monitoring oversight, clinical trial management, data management, biometrics, and medical writing. www.frontagelab.com. Any Where. 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. Aug 16 International Conference on Clinical Trials in Cardiovascular Medicine (ICCTCM) - Barcelona, Spain. To learn more , please visit our website - https://www.parexel.com/. We offer customized solutions to fit the needs of each study, patient and site, making it easier for your patients to stick with it. Login; Register now; Toggle navigation. Partnerships in Clinical Trials Europe editions. Pro-ficiency converts training from a cost center to a powerful quality improvement system. Outsourcing Clinical Trials New England 2022 - Almac He played a pivotal role in the development and commercialization of Veltassa (USA and EU), a treatment for hyperkalemia, Intermezzo for MOTN insomnia, Kerydin for onychomycosis, and Eucrisa for atopic dermatitis. www.advarra.com. 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. After completing her education in England, Ndidi began her career working for Parexel followed by Merck Sharp & Dohme. Global Clinical Trials Connect 2023 2022 London United Kingdom He investigated mechanisms by which active ingredients in cumin seeds halt Prostate Cancer progression and metastasis at the Vattikutti Urology Institute, Henry Ford Hospital. Founded in 1985, Promedica International, a woman-owned corporation, is headquartered in Orange County, California. It offers its clients a global reach through a network of 38 processing laboratories. Panellists will address the advantages of DCT; from taking the trial to the patient to boosting recruitment. . . Lin, who has been with the company since October 2016, previously served as the Senior Vice President of Sales and Marketing. Dr. Apfel is an internationally known authority on designing, conducting, and publishing highest quality clinical trials with thousands of patients that have changed medical practice with over 100 peer-reviewed publications. Developing successful communication pathways in a more remote world. She has driven program strategy and planning, including implementation of 300+ clinical study protocols in 25+ indications, by leading global cross-functional teams towards successful regulatory submissions, product launches, and innovative lifecycle management. Proven track record of coordinating teams in order to meet tight deadlines, set and communicate expectations, and manage deliverables. https://www.q2labsolutions.com/, You need an Imaging Strategy thats designed and customized for your oncology clinical trial. 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. Her background in Biotechnology and proficiency in Data Management solidified her proven ability to identify data integrity risks, and problem solve the most complaint path to drug submissions and approvals. Dr. David Anderson is a Senior Scientist at Clinical Ink, where he focuses on the development of digital biomarkers in decentralized and remotely-monitored clinical research. 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 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. To learn more , please visit our website - 12 years at Parexel. www.zigzagassociates.com. This event is a great opportunity to get to know the online casino players who will be [] Rave RTSM streamlines your operations and provides real-time visibility for your study teams. www.pro-ficiency.com, To learn more , please visit our website - The company specializes in end-to-end services supporting drug discovery, precision medicine and clinical development for smarter clinical studies. This Clinical Trials Conference includes a wide range of Keynote presentations, Plenary talks, Symposia, Workshops, Exhibitions, Poster presentations and Career development programs. 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. 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. East Coast Clinical Trials Conference | New York US - 03-04 May 2023 https://www.trilogywriting.com/. A NEW paradigm of engineering-forward analytics solutions powering digital biomarkers. 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. Moving to law, in leading law firms he advised major companies on patent matters. The elluminate Clinical Data Cloud provides one source of truth for clinical and operational data to manage trials across sources. 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. Bruce earned his doctorate in biochemistry from UCLA and completed a postdoctoral fellowship at the University of California Berkeley. Previous roles within both CRO and Sponsor organizations which provide valuable perspective from both sides of the industry. Mr. Chu was selected to be the Director of Investigations Branch (DIB) for DWCI in June 2018. dpocentre.com. 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. https://lnkd.in/gEJj4yXX Please come and visit us at stand 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. 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. Decentralized Clinical Trials 2023 Event - Informa Connect Start. August, 2023. 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. Outsourcing in Clinical Trials (OCT) Southern California 2022 Outsourcing In Clinical Trials - Texas 2022 - Ergomed PLC Meraf has over 20 years experience working in biotech, health and the pharmaceutical industry. To learn more , please visit our website - Conference series LLC Ltd Organizes 3000+ Global Events Every Year across . Henry is a Vice President of Data Sciences at Medidata. 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. To learn more , please visit our website - http://www.kpslife.com. WHAT TO EXPECT FOR 2023? Over the past 30 years his focus has been in the areas of drug substance as well as drug product R&D, manufacturing and outsourcing the small molecules as well as biologics. March. Premier Research is a leading clinical development service provider that helps highly innovative biotech and specialty pharma companies transform breakthrough ideasinto reality. His most recent activity is as CEO and Founder of QuiVivePharma, a company he took from inception to a FDA face-to-face PreIND meeting in just 1 year. Over 20 years in clinical research, including patient innovation, feasibility, strategy, patient recruitment, retention, site engagement. www.td2inc.com. Global Clinical Trial Outsourcing Market Report 2022: Increasing Learn more atwww.clinone.com. Why the current state of trials makes it difficult for patients to participate in research, How and when to incorporate patient insights into your programs, How to create a business case to garner support for investing in solutions, The benefit for the study sponsor, and other stakeholders, for investing in solutions to make it easier to be a participant, Barriers to patient participation with a focus on the barrier that became the impetus of the model, Delving into benefits of Patient Navigators and challenges with consistent comprehensive support for patients, Exploring the Enhanced Patient Support Services, Cover proactive strategies to address performance risk and protocol deviations, How to apply performance data from simulation-based training to manage risk areas, Discuss how to interpret and apply learning results to optimize and de-risk your DCT, Rethinking your site management strategy to minimize overburdening sites, dependant on the phase of your study, Pinpointing how site turnover impacts the sponsor and how to help reduce it whilst keeping patient care front of mind. Prioritizing patient diversity. AliveCor protects its customers with stringent data security and compliance practices, achieving ISO 27001 Certification, SOC 2 Type 2 Certification and HIPAA compliance attestation. Headquartered in Sydney since 1996, Novotech has come to be recognised as the CRO of choice for many US and European biotechnology firms in the Asia Pacific. Prior to this position he was the Division Director for the Division of West Coast Imports since February 9, 2018.
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outsourcing in clinical trials conference 2022