www.eclinicalsol.com. http://www.endpointclinical.com/. To learn more , please visit our website - 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. Dan is responsible for presenting the robust data management solutions made possible with elluminate, and can customize product demonstrations to address specific customer needs. ProTrials works with sponsors in the pharmaceutical, biotechnology and medical device industries to deliver high-quality clinical development services in a wide range of therapeutic areas. She is currently Director of Patient Safety Medical Device for AstraZeneca and supports products across the enterprise. To learn more , please visit our website - She is mastering the logistics of dosing and testing clinical trial participants where they live, work, and study. To learn more , please visit our website - Our platform allows site staff to pull data from various sources such as EHR and legacy systems automatically into their eCRFs (Fully agnostic) hence helping significantly reduce the double-data entry efforts (demographics, labs, vitals, adverse events, allergies, medications) and time spent with CRAs during monitoring visits. She also has worked within the clinical department at several reputable companies like Axogen, Medtronic, Coloplast and CR Bard. He was Senior Director of Clinical Operations at Pharmacyclics from 2012 to 2017 where he was responsible for the development, implementation and maintenance of the Clinical Operations infrastructure, as well as the GCP inspection hosting platform and processes, and regulatory authority marketing approval inspection hosting. To learn more , please visit our website - TICKETED. This is also a critical time to determine the development strategy for later study phases. Join us in April 2023 to learn from the best in the drug development industry and have an opportunity to learn from their experiences. ACM provides a powerful combination of operational excellence, scientific expertise and unsurpassed global service to customers in more than 65 countries. His expertise is in regulated content management, and he is a member of the TMF Reference Model Project Team. www.saama.com. Europe's leading clinical trials conference focusing on partnerships, outsourcing, operations and technology is now In-person event. With 2,000 annual trials and projects, around 200 active clients and global access to source drugs in over 60 countries,Myonex is your complete partner around clinical trials around the globe reliable, trusted and by your side. Specializing in clinical development and staffing solutions, we offer a flexible approach to ensure our clients unique needs are supported. His last company, TheraSim, trained over 1 million physicians worldwide and was sold to WebMD in 2013. 21 October 2022 Outsourcing In Clinical Trials - Texas 2022. 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. She has managed and overseen large global clinical trials in various therapeutic areas and multiple phases of development. Communities. To learn more , please visit our website - August, 2023. 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 Join thought leaders from regulatory agencies, biotech, pharma, patients, and academia to discuss the latest advances, challenges, and forward-thinking . Find out about the events you can meet the Caidya team at and stay updated about the latest conferences and clinical research events. 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. Regional Director, Business Development, Novotech, Executive Vice President Business Development, Nucleus Network, VP of Clinical Development, Rani Therapeutics, VP of Clinical Operations, CymaBay Therapeutics, Inc, Associate Director, Clinical Operations, Santen, Senior Lead, Global Compliance and Strategy, Medidata, Therapeutic Strategy Lead, Gene Therapy Think Tank, Worldwide Clinical Trials, Vice President, Quality Iovance Biotherapeutics, Vice President, Program Management, Iovance Biotherapeutics, Head of Product, Trial Interactive, TransPerfect, M.A. WHAT TO EXPECT FOR 2023? Premier Research is a leading clinical development service provider that helps highly innovative biotech and specialty pharma companies transform breakthrough ideasinto reality. 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. AWT Healthcare manufacturers clinical trial labels. He received M.Sc. TransPerfect Life Sciences specializes in supporting the global development and commercialization of drugs, treatments, and devices designed to improve and save lives. Exceptional quantitative and analytical skills with a passion for high quality outcomes and business profit. Were a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. 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. 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. She is currently managing a Ph3 program in rare liver disease. Mr. Chu was also the Import Program Manager (IPM) for the FDA Los Angeles District. www.allucent.com. The DPO Centre isEuropes leading life science experts, providing Data Protection Officer (DPO) and Data Protection Representative (DPR) services. https://www.medidata.com/, To learn more , please visit our website - GxPs in Cell Therapy and key considerations for Quality and Project Management. 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. www.ledgerrun.com/, To learn more , please visit our website - To learn more , please visit our website - Combining OCT, CTS and Medical Devices events, this is the perfect platform for professionals from . Saama Technologies is the advanced clinical data and analytics company, unleashing wisdom from data to deliver better actionable business outcomes for the life sciences industry. During her career she has advocated for critical partnerships with vendors supporting integration with internal stakeholders. They have fewer surprises, faster outcomes, and stronger data integrity. To learn more , please visit our website - Amy has been a drug discovery and development professional for 25+ years, including progressive roles in clinical operations and clinical strategy. Bruce started his career on the faculty in the Chemistry Department at Purdue University where his independent research focused on neuronal signal transduction. Keeping them can be an even bigger challenge. Dr. Cunningham came from academic background. To learn more , please visit our website - 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. I went into industry for post-doctoral studies at the biotechnology research center at Ciba-Geigy Corp. (Novartis) and have over three decades of academic and industrial research and senior management experience in protein and metabolic engineering, bio-based manufacturing, and drug discovery / development. Are Hybrid trials the more realistic and practical approach compared to full DCT agree or disagree? Arena International are delighted to announce Outsourcing in Clinical Trials West Coast will be returning to Burlingame for the annual event on March 1st & 2nd 2023! To learn more , please visit our website - www.Clario.com. Rated 4.5 by 2 people. Program and Alliance Management professional with 15+ years of product development, project management and operations experience within the biotechnology and biopharmaceutical sectors. To learn more , please visit our website - To learn more , please visit our website - The 15th Annual Outsourcing in Clinical Trials New England event will bring together clinical trial professionals from big and small biopharma to uncover new technologies and processes, to optimize their clinical and outsourcing operations. Mr. Luciano joined Corvus Pharmaceuticals in 2018 and has served as Vice President of Clinical Operations since 2021. Explore Modern RTSM Solutions. Clincierge reduces barriers to trial participation by employing patient-centric strategies to enhance the patient experience, increase patient retention, and improve clinical trial performance. For more information, visitwww.eclinicalsol.com, or contact us atinfo@clinicalsol.com. Reimbursement for medical devices in trials, and, understanding the process. His goal is to help you accelerate your clinical research career and be a more effective leader. Our experienced team has been in this niche of clinical research with deep domain experience for decades and client solutions has been our passion for over two decades. www.advanceresearch.com. Sun, 24 Apr 2022, 09:00 End. In her role at Nevro, Frances is responsible for leading the data management team, driving the adoption of new technologies and innovative data management processes to bring new treatments to patients. Why should we collect Sexual Orientation and Gender Identity in Clinical Research Studies? Mural Health is a participant management platform that helps manage & streamline the trial experience for patients and caregivers. LinkedIn Bio: https://www.linkedin.com/in/ndidi-rickert-she-her-47197371/, Enhancing a responsible quality mindset and culture. 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. 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. 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. http://strategikonpharma.com, To learn more , please visit our website - http://www.spauldingclinical.com/, To learn more , please visit our website - This talk will provide an overview of the application of Artificial Intelligence methods in clinical operations. Advance Research Associates is a premier provider of biostatistical and data management services to the pharmaceutical, biotech, and medical device industries. Advantages of working alongside grass root organisations and PAGs what groups are out there? 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. Mr. Luciano earned a B.A. Why drugs fail in clinical trials? 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. 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 mission is to eliminate the barriers to clinical trials by bringing access to people where they live, work and are willing to engage. To learn more , please visit our website - Be sure to stop by to visit my colleagues at booth #60. She is also a Certified Clinical Research Professional, and a trained journalist. To learn more , please visit our website - Booth #4. 200+. http://www.medable.com/, To learn more , please visit our website - Helping you take advantage of the speed of study start-up and R&D tax incentives in Australia and allow for smooth trial transition in the US. http://www.peachtreebrs.com. Overview. Quickly upscaling digital technologies. 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. http://www.arensia-em.com/. SDC delivers top-tier clinical trial services to pharmaceutical, biologic and device/diagnostic companies. The Association of Clinical Research Professionals (ACRP) supports clinical research professionals through membership, training and development, and certification. She is currently the Founder and CEO of Strategikon Pharma, developer ofClinical MaestroTM, the industrys only end-to-end cloud-based platform for clinical trial budgeting, sourcing and budget management including strategic alliance/partnership management. This presentation will discuss: With increasing site staff/physician burnout and sites taking on less projects, we are still feeling the ripple effect of this on trials. Prior to Medable, Reem worked in the clinical space in both the industry and academia settings after making a transition from basic science research. The conference will bring together pharmaceutical and biotech experts to connect and explore solutions to current challenges associated with clinical trials. Register. Arena International are delighted to announceOutsourcing in Clinical Trials West Coastwill be returning to Burlingame for the annual event onMarch 1st& 2nd2023! 2023 will see the return of the Clinical Trial Supply Europe conference to Milan where pharma, large and small, alongside biotechs will have the opportunity to discuss, debate and consider new technologies and processes to streamline supply chain operations. www.flexdatabases.com. Aditya is the Regional Director of Business Development at Novotech, the Asia Pacific specialist CRO. https://www.chillipharm.com/. Clinical Trials 2023. For the past 10 years, Estela has co-facilitated support groups, led, and participated in educational symposiums, advocated locally and nationally. 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 - 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. 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). CROMSOURCE is an international contract research organization providing a comprehensive services to the pharmaceutical and biotechnology companies. Spaulding Clinical Research is a global CRO providing Phase I IV drug development services to pharmaceutical and biotechnology companies. Clinical Trial Supply New England . 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. 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. To learn more , please visit our website - www.rad-md.net. With headquarters in Dublin, Ireland, ICON employed approximately 41,150 employees in 113 locations in 53 countries as at September 30, 2022. Our experienced project managers and global network of linguists are supported by proven processes and cutting-edge technology. atreo.io, To learn more , please visit our website -