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. 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. Bioethics, regulations, patient recruitment, site selection, real-world data, data integration & Strategy, outsourcing, vendor management, quality (QbD) in Trial Conduct, risk-based . Q2 Solutions is a leading global clinical trials laboratory services organization that helps biopharmaceutical, medical device and diagnostics customers improve human health through innovation that transforms science and data into actionable medical insights. Altasciences helping sponsors get better drugs to the people who need them, faster. Previous roles within both CRO and Sponsor organizations which provide valuable perspective from both sides of the industry. Advice for the ClinOps team to avoid unnecessary patient visits, how does your protocol affect the site? theactigraph.com. Combining patient-reported health data, personal medical records, and conversations in the Inspire community uncovers critical insights unattainable with traditional research methodologies. INTERACTIVE SESSION Data matters in health outcomes and equity: Collecting and understanding Social Determinants of Health (SDOH) data in clinical trials and beyond. Frances has an undergraduate degree in Physiology and a PhD in medical science from the University of Sydney. Dr Frances Rubenstein has worked in clinical data management for more than 20 years in both medical device and pharmaceutical companies. Medrio is the leading provider of eClinical technology for pharma, biotech, device, diagnostics, and animal health clinical trials. DGE invites you to return to the industry's first, most detailed, and most trusted conference on this topic - our 7th Decentralized & Hybrid Clinical Trials Summit. 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. She also has worked within the clinical department at several reputable companies like Axogen, Medtronic, Coloplast and CR Bard. Anne Reid is the Program Director of the Office of Medical Device and Radiological Health Operations (OMDRHO). To learn more , please visit our website - 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? In this presentation we will discuss the following: Clinical development has shifted from a scientifically driven journey to a patient-focused one. Focusing on life sciences, Datacubed offers software and services driven by behavioral science to improve patient retention and compliance, resulting in better data and positive health outcomes. Commercial Services. http://www.kpslife.com. Reem enjoys working in startups bringing forward long-term vision and strategies. www.signanthealth. The two day programme will take a holistic approach to the latest challenges and innovations in clinical operations, such as, the [] degree in Neurobiology and is the author of several peer-reviewed papers in prostate cancer and premature ovarian failure. Earlier as a bench chemist, he was the first to make Iotrolan, a CT X-ray contrast agent, generic for decades, replaced in about 2005 by newer agents. Vendor/CRO Paid Ticket . 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. 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. This experience includes in vivo viral- vectored gene therapies, ex-vivo viral vectored and gene edited treatments for oncology and non-oncology patient communities, and RNA medicine modalities. ARENSIAs outstanding recruitment performance across numerous disease areas substantially reduces the overall number of sites and countries for any early-phase patient trial. Digital health technologies and biomarkers in clinical trials requires the highest standards of data collection, transmission, security, quality, and analysis. www.allucent.com. She is mastering the logistics of dosing and testing clinical trial participants where they live, work, and study. https://www.medidata.com/en/clinical-trial-products/clinical-data-management/rtsm/, To learn more , please visit our website - https://www.medidata.com/. To collaborate with CISCRP for your upcoming event, please contact Joan Chambers at jchambers@ciscrp.org or Lindsey Elliott at lelliott . Spaulding Clinical operates a 200-bed Clinical Pharmacology Unit, a Full Service Biometrics Group and Cardiac Core Laboratory. A significant portion of the cost in a clinical trial can be attributed to operational conduct of the trial such as site monitoring related activities, data management and site oversight. Conferences. Francis is an expert in clinical system regulatory compliance with over 20 years pharma experience spanning R&D, manufacturing and clinical research. Arena International are delighted to announce the Outsourcing in Clinical Trials Southern California Event will be returning to California's La Jolla on September 26th & 27th 2023! Company Website:https://eurofinscentrallaboratory.com/biopharma-services/, To learn more , please visit our website - After years of watching the opioid crisis develop, John has developed an innovative drug and dispenser to safely treat pain and deter abuse. There, he employed a broad range of methodologies, including: visual psychophysics, neuropsychological and computer-based cognitive assessments, eye tracking, electrophysiology, and structural imaging. To learn more , please visit our website - Dan Solis is a recognized expert in FDA import operations and is the Assistant Commissioner for ORAs Office of Import Operations. Home / Events /. ClinDatrix, Inc., a CRO, helps pharmaceutical, biotechnology and medical device innovators with clinical projects ranging from Phase I studies to multinational pivotal Phase III trials and post-marketing studies. 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. Why drugs fail in clinical trials? assisTek has been paving the way for integrating technology and data collection in clinical trials for over 25 years. To learn more , please visit our website - European Union Clinical Trial Regulation: Strategic Considerations, Hyatt Regency San Francisco Airport Hotel Previously, Bruce held leadership roles at Alkahest, Celerion and Allon Therapeutics, and works closely with the Michael J Fox Foundation, chairing one of their scientific review panels. To learn more , please visit our website - www.prevailinfoworks.com. Dr. Marszewska has experience with electronic data capture and data management in clinical research. 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. To learn more , please visit our website - Conversis is built on one goal: To provide you with the highest-quality clinical trials translations. 8 th Pharmaceutics and Novel Drug Delivery Systems Conference. 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. She has a unique perspective in leading clinical programs in a dynamic startup environment. Partnerships in Clinical Trials Europe editions. Anca has over 15 years of experience in the biopharmaceutical industry, working both on the CRO and the Sponsor side. 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). 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.zigzagassociates.com. Solution-oriented professional, with strong problem solving capabilities. Emmes is a full service contract research organization collaborating with our clients to produce valued, trusted scientific research. Booth #4. Embassy Suites Raleigh-Durham Research Triangle, Cary, NC. He investigated mechanisms by which active ingredients in cumin seeds halt Prostate Cancer progression and metastasis at the Vattikutti Urology Institute, Henry Ford Hospital. The FDA-cleared KardiaMobile device is the most clinically-validated personal ECG solution in the world. Partnerships in Clinical Trials Europe 2021. What can we do to take advantage of high prevalence of disease in populous countries but systems are either rudimentary or non-existent? Medables completely modular approach allows pharmaceutical companies and clinical research organizations (CROs) to use only what they want, while scaling capabilities to better suit their unique studies. Dr. Cunningham came from academic background. https://www.muralhealth.com/. 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. This event is a great opportunity to get to know the online casino players who will be [] 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. Using modern payment, transportation, and communication solutions we help drive retention, compliance, and data quality. Genentech Chief Diversity Office, Patient Inclusion And Health Equity. 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. Mr. Chu was selected to be the Director of Investigations Branch (DIB) for DWCI in June 2018. The company serves over 600 customers globally, with headquarters in San Francisco and offices in numerous domestic and international locations. As the worlds largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. 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. Ms. Lea is the Director of Global Patient Engagement and Advocacy for Acceleron, a wholly-owned Subsidiary of Merck. 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. April 18-20, 2016 Dubai, UAE. Subsequently, Arun lead the Gastric-Immuno-Oncology Rare Disease Bispecific-T cell-Engager portfolio at Amgen on various aspects of clinical research operations. Sun, 24 Apr 2022, 09:00 End. 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. http://www.medable.com/, To learn more , please visit our website - To learn more , please visit our website - http://www.medable.com/. Extensive Outsourcing and Contracts experience in the area of Clinical Development primarily at small to mid-size biotech organizations. To learn more , please visit our website - Topics include feasibility & site selection, clinical data & technology, patient engagement & enrollment, risk-based monitoring, and budeting & clinical outsourcing. She serves as an advisor for early phase study teams in developing inclusive clinical trials. 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. Since 2003, Conversis has supported our life sciences clients to successfully and effectively communicate with patients and medical professionals worldwide. With presentations and panel discussions on the top industry trends and outsourcing challenges, and . We offer customizable specimen collection kits, specialty testing capabilities, dedicated project management and trial site support, biostorage, and real-time data management and reporting. For over 30 years, we have been the leading global clinical trial supply company and we have expanded our service portfolio to offer complete solutions around clinical trials for our partners. Examining the behaviors of clinical trial stakeholders to better understand challenges in patient participation. We provide a comprehensive digital solution for Ph 1-4 studies with enterprise-level capability that is configurable to be fit for purpose to support biopharmaceutical companies, CROs and research sites. 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 - www.harborclinical.com/. CROMSOURCEis unparalleled in offering an end-to-end guarantee covering trial timelines, enrollment, and price. 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. Europe's leading clinical trials conference focusing on partnerships, outsourcing, operations and technology is now In-person event. Who we are; 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. March 1 - March 2,2023 Outsourcing in Clinical Trials West Coast. Combined, our clinics offer over 200 beds. He has supervised the management of a clinical portal, eTMF, CTMS, RTSM, EDC, Coding and Grants solutions. This enables earlier submissions with the potential of coming to market sooner and recovering R&D investments ahead of projections. http://www.mlm-labs.com. We are now in the position now to share our practical experiences with Decentralized & Hybrid Clinical Trials; The bedrock of a successful trial is a well-designed protocol with reliable measurements of biomedical and health-related outcomes to satisfy regulatory standards. UPCOMING EVENT. David Hadden is the pioneer of AI-driven Virtual Patient Simulation technology. In 2021, ERT and Bioclinica merged to become Clario creating the broadest endpoint technology platform in the industry and enhancing our scientific expertise. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionalscollaborateswith biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. 11 th International Conference on Clinical Trials is scheduled to be held during November 09-10, 2023 at London, UK. Dr. Hayat is managing partner of Revive Pharm USA. Electronic clinical outcome assessments (eCOA)and interactive response technology (IRT) platforms introduce greater speed, precision and data quality to clinical trials. AWT Healthcare manufacturers clinical trial labels. Mr. Chu holds a Bachelor of Science in Applied Ecology from the University California of Irvine. Any Disease. I will be there with my colleague Georgi Govedarov, come visit us at booth Isidora Teodorovi on LinkedIn: I am very excited to be attending Clinical Outsourcing Group UK this year 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. Minimize site activity- could decentralization and Direct-to-Patient trials be the answer to staff shortages? To learn more , please visit our website - A NEW paradigm of engineering-forward analytics solutions powering digital biomarkers. We have successfully been providing exceptional value to our clients for over 30 years. What things do they need a partner to do and what they dont need! FDAs role in maintaining a secure and resilient supply chain. The impact DCT has on diversity, equality and inclusion (DEI) have we finally managed to tap into under-represented communities? MedPoint Digital develops intuitive, ICH-GCP compliant eClinical platforms for virtual investigator meetings, trial portals, interactive modules, and virtual clinical trials. Estela has worked in healthcare for over 30 years, currently supporting private practices with electronic medical records, office workflows to help the practice and patients for a top leading healthcare organization. To learn more , please visit our website - This is a great opportunity to network and share knowledge with regions leading pharmaceutical firms, biotechs and med device companies, discuss operationally efficient, specifically targeted clinical trials. From 2008 to 2011, he was Senior Clinical Trial Manager at Seattle Genetics where he was responsible for the oversight of multiple oncology clinical trials, as well as support for the development of the Clinical Operations infrastructure and regulatory authority marketing approval inspection hosting. We provide personalized patient logistics management, reimbursement, and convenience services to support clinical trial participants. Catalyst Clinical Research is a new generation Clinical Research Organization, serving the unique needs of small-to-medium sized biopharmaceutical companies. 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.careaccess.com. Anju is a portfolio company of Abry Partners serving the worldwide pharmaceutical, biotech and contract research Life Sciences markets. Clinical research professional with 25 years of experience in clinical and medical affairs, most recently as Director of Clinical Affairs and Associate Director of Medical Affairs for a global medical device manufacturer focusing on endovascular and surgical repair of aortic disease. May 02-03, 2016 Chicago, USA. This conference is always a great opportunity to share and learn with our colleagues across the industry. 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. Executive Director, Program Strategy, Rare Disease and Pediatrics, Premier Research, https://www.medidata.com/en/clinical-trial-products/clinical-data-management/rtsm/, https://www.linkedin.com/in/ndidi-rickert-she-her-47197371/, https://eurofinscentrallaboratory.com/biopharma-services/, eurofinscentrallaboratory.com/biopharma-services, Hyatt San Francisco Airport, Burlingame, San Francisco, Best practices for engaging the patient community and growing that relationship using real life case studies. in Psychology and Biology from the University of California at Santa Cruz. www.td2inc.com. We are known for our superior statistical leadership and data management expertise and proud to have supported thousands of studies across a diverse range of diseases. . Presently, Ndidi is the Associate Director, Clinical Quality Assurance & GxP Compliance at Ultragenyx Pharmaceutical Inc. where she has worked for over 6 years. We have been driving the success of our clients, consultants, and employees in staffing and consulting services since 2004. His goal is to help you accelerate your clinical research career and be a more effective leader. Cognizing & mitigating Does AI-ML offer a solution? Signant Health provides solutions that simplify every step of the patient journey to make it easier for people to participate in, and for sites and study teams to run, clinical trials. www.ACMGlobalLab.com. Our intense focus on the patient experience, deep therapeutic area expertise and global operational scale enable hundreds of sponsors and CROs (including all Top 20 pharma) to extend the reach of drug development, expand patient opportunities and improve data quality helping them bring life-changing therapies to our families and communities around the world. 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. It is a 2 day event organised by Arena International Events Group and will conclude on 30-Nov-2022. The last decade of this time has been solely focused on the investigator grant administration domain driving strategy and leading teams implementing payment technology in both BPO and enablement models. Read more. With nearly a decade of home visits learnings, Ellen has a unique perspective on how decentralized clinical trials have changed over the years and what the future looks like. 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. Importance of teams meeting face-to-face so that human touch and team cohesion isnt lost, Setting up rules and expectations creating space for communication, Strategies for prioritising work and tracking milestones with remote teams, Assessing the impact on the trial of remote vs in-person working; how to find a happy medium, How to best leverage remote trial management platforms, How to best utilize critical and non-critical data validation plans, What trial management services are best provided by the sponsor vs. CRO, How to best manage SOW/budget throughout the course of the trial. 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. 200+. Looking forward to another great conference! To learn more , please visit our website - To learn more , please visit our website - Patient Inclusion and Health Equity, Chief Diversity Office, Genentech, Vice President, In-Home Solutions, Decentralized Clinical Trials, PCM Trials, Executive Director, Clinical Operations, Terns Pharmaceuticals. To learn more , please visit our website - Frances has been working at Nevro Corp, a medical device company for the past 10 years as Director, Database Management. Embedding fit-for-purpose technology solutions enhances access, accelerates enrollment, improves representation, and increases compliance and retention, Strategies for successfully hiring and growing a ClinOps team in this day and age, Discussing how training improvements can increase retention, WFH vs in office: Pros and cons of managing a more remote ClinOps team in the US. What is critical to get right to make a digital QM System work? It is a 2 day event organised by Arena International Events Group and will conclude on 24-May-2023. To understand site-side difficulties in trial recruitment and conduct, Arun served as a Senior Clinical Research Coordinator for Cardiology Phase 4 trials at the Loma Linda VA Medical Center, and as a Lead Clinical Research Specialist for Investigator-Initiated and Phase 0 3 Gastric Neuroendocrine Rare Disease trials at Stanford Cancer Center. Outsourcing in Clinical Trials Southern California 2022. 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. In partnership with customers, we build solution-driven teams working for a healthier future. Our full service offering includes clinical program management, biometrics services and regulatory affairs. Karl has collaborated with the world's top 20 pharmaceutical companies and has extensive experience in patient-centered outcomes research, eCOA strategy, and drug development. Please email me if you'd like to set up a meeting to discuss your upcoming clinical trials: www.ledgerrun.com/, To learn more , please visit our website - 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. This session examines how scientific rigor can be applied to clinical outcome assessments (COAs) even though they are subjective. 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. Data-driven operations and oversight with elluminate. https://www.trilogywriting.com/. Read more. www.saama.com. 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. 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.
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