Wednesday, 28th Sep 2022 - Thursday, 29th Sep 2022 . 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. Conduct of clinical trials are increasingly becoming expensive. The DPO Centre isEuropes leading life science experts, providing Data Protection Officer (DPO) and Data Protection Representative (DPR) services. She has actively participated in departmental preparation for the EU CTR implementation and is one of ICONs SMEs on this topic. Slope makes clinical trials boring by using real-time data to orchestrate operational complexity. Previously she served as Head of Clinical Outsourcing and Analytics for BioMarin Pharmaceuticals, where she was responsible for vendor contractual, relationship and financial management. Many biopharmaceutical trial sponsors rely on or scientific leaders to help design and optimize their protocols and statistical analysis plans. Decentralized Clinical Trials 2022 was a really good opportunity to . To learn more , please visit our website - CROMSOURCE is an international contract research organization providing a comprehensive services to the pharmaceutical and biotechnology companies. 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. 25 people interested. He held senior level positions with Relypsa (acquired by Galenica for 1.52B US$), Anacor (acquired by Pfizer for 5.2B US$) and Transcept Pharmaceuticals (revers merger with Paratek). Anca has over 15 years of experience in the biopharmaceutical industry, working both on the CRO and the Sponsor side. Clinical Trials Conferences | Clinical Trials Meetings | Japan | USA With the most trusted review solutions, innovative technologies, experienced consultants, and deep-seated connections across the industry, Advarra optimizes research performance, empowers clinical sites, and ensures compliance. This holistic self-service platform provides faster data access and intelligent analytics, empowering clinical trial teams to think innovatively. KPS is a global, innovative, Clinical Outsourcing Provider delivering clinical trial monitoring, management and quality oversight services to pharmaceutical, biotechnology, medical device, and related industries. OMDRHO is one of five programs in the Office of Medical Products Operations within FDAs Office of Regulatory Affairs. Dr. Karl McEvoy has over a decade of industry experience in both the vendor and sponsor sides. . Specialized in clinical strategy and projects within digital health, with experience spanning from product ideation to commercialization. Parexel Introduces Expert SeriesNew Medicines, Novel Insights. The conference will bring together pharmaceutical and biotech experts to connect and explore solutions to current challenges associated with clinical trials. Check out who is attending exhibiting speaking schedule & agenda reviews timing entry ticket fees. Join Premier Research at Outsourcing in Clinical Trials Southern California 2022 as it returns for its 9 th annual event. 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. This conference intends to focus on the global health and clinical trials around the world. Also within Genentech, she is a core member of the Advancing Inclusive Research Site Alliance and leads the company's LGBTQ+ Health equity strategies. 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. 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. To learn more , please visit our website - CLOSING KEYNOTE: FDAs role in maintaining a secure and resilient supply chain. Why drugs fail in clinical trials? Developing successful communication pathways in a more remote world. Zigzag aims to provide straightforward, reliable and flexible Quality Assurance and auditing services on a local or global basis. Flex Databases platform is a secure, unified and compliant system for clinical trials. As specialists in clinical regulatory documentation, we provide a service that is more than just writing. Medidata is leading the digital transformation of life science, with the worlds most used platform for clinical development, commercial, and real-world data. Previous roles within both CRO and Sponsor organizations which provide valuable perspective from both sides of the industry. Exploring the idea of adopting a medical device-like regulatory philosophy/strategy for bringing drugs forwards, with a focus on antimicrobials, Industry is on high alert for bacterial outbreak, with parallels to the covid pandemic. Drivers of failures, Flawed clinical study design leading to failures, Diagnostic indicators and early Go/No-Go decisions in proceeding further during clinical study phases. Amsterdam RAI. 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. Proven ability to organize and manage late-stage development cross-functional teams completing projects on time with meticulous attention to detail. 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. This is also a critical time to determine the development strategy for later study phases. Interactive Response Technologies (IRT) 2022 brings the clinical community together to discuss cutting-edge updates in technology and dives into strategies to help the clinical industry excel in their trials and data management. Frances has been working at Nevro Corp, a medical device company for the past 10 years as Director, Database Management. Medical Writing and Healthcare Communications Conference. Arvinder received her undergrad in Biophysics and doctorate in Cardiovascular Physiology from University of Manitoba, Canada. 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. . 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. The Budget Conundrum. Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that Casimir's research on the development of the Duchenne Video Assessment (DVA) scorecards was published in PLOS ONE. By tapping into patients rich and varied health journeys on Inspire, researchers and health practitioners around the world are advancing treatments and making breakthrough discoveries. This event is a great opportunity to get to know the online casino players who will be performing at this meeting. http://strategikonpharma.com, To learn more , please visit our website - TICKETED. Since 1996, ARA has supported 700+ clinical trials worldwide across all therapeutic areas. Clincierge reduces barriers to trial participation by employing patient-centric strategies to enhance the patient experience, increase patient retention, and improve clinical trial performance. 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. During her career she has supported Class 1-3 devices through the entire product lifecycle. Axiom Exhibiting at Outsourcing in Clinical Trials Southeast 2022. www.allucent.com. www.bsi-lifesciences.com. Partnerships in Clinical Trials Europe 2021. CROMSOURCEis unparalleled in offering an end-to-end guarantee covering trial timelines, enrollment, and price. CHI's Clinical Trial Innovation Summit His thesis was on the role of the Androgen Receptor in Hormone Refractory Prostate Cancer. . pril 28-29, 2016 Dubai, UAE. deep6.ai, To learn more , please visit our website - 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. Examining how, even as a small company with limited resources you can successfully introduce time and cost saving QMS measures. 200+. With headquarters in Dublin, Ireland, ICON employed approximately 41,150 employees in 113 locations in 53 countries as at September 30, 2022. 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. Boring clinical trials are better clinical trials. 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. ACM is certified by the College of American Pathologists (CAP) and the Substance Abuse and Mental Health Services Administration (SAMHSA). www.tranquilclinicalresearch.com. Founded in 1996, ProTrials has been successfully supporting clinical research for over 25 years. MaxisITs clinical data analytics platform is a purpose-fit solution developed to improve clinical trial performance, mitigate risk, and optimize clinical outcomes. Our standard products and services include patient recruitment, eConsent, ePRO/eCOA, interactive digital support and symptom monitoring with the capability to provide an end to end clinical to commercial solution. Proven track record of coordinating teams in order to meet tight deadlines, set and communicate expectations, and manage deliverables. Clinical Trials Conferences 2023/2024/2025 ACM Global Laboratories is one of the largest global independent central labs in the industry. We are committed to delivering high-quality, cost-effective services according to sponsor timelines and specifications. Spaulding Clinical operates a 200-bed Clinical Pharmacology Unit, a Full Service Biometrics Group and Cardiac Core Laboratory. He has been actively involved on both sides of the business in managing CDMOs and CROs. www.assistek.com, To learn more , please visit our website - Mural Health is a participant management platform that helps manage & streamline the trial experience for patients and caregivers. Review market analysis on location of Phase I studies and discuss why these choices are made. Contact: ESMO Registration Office; Phone: [+41 (0) 91 973 19 13]; Email: registration@esmo.org. Global Clinical Trials Connect 2023 2022 London United The company specializes in end-to-end services supporting drug discovery, precision medicine and clinical development for smarter clinical studies. www.clincierge.com. My training is in genetics (Ph.D.) and mechanical/biochemical engineering (M.S. After completing her education in England, Ndidi began her career working for Parexel followed by Merck Sharp & Dohme. FDAs role in maintaining a secure and resilient supply chain. 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. Promedica International is a privately held, full-service CRO providing clinical trial services for the medical device, biotechnology and pharmaceutical industries. We are focused on helping our clients to address their most significant and complex drug discovery and development challenges. He also served on multiple FDA Headquarter working group and committee related to Food Safety Modernization Act (FSMA), import process improvement, strategic framework, rapid screening technology, and partnership agreements. Technology as a methodology: Accelerating Clinical Development timelines. 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. Our experienced project managers and global network of linguists are supported by proven processes and cutting-edge technology. To learn more , please visit our website - Our Australian phase I facilities are in Melbourne and Brisbane, and our US phase I facility is located in Minneapolis. Clinical Services. Taking place in Boston, 17 - 19 October 2022. Communities. Genentech Chief Diversity Office, Patient Inclusion And Health Equity. CA; X-Mine, CA; Delphian Pharma, CA and Certum LLC, CA). Catalyst Clinical Research is a new generation Clinical Research Organization, serving the unique needs of small-to-medium sized biopharmaceutical companies. Experienced in research methodologies and conducting qualitative and quantitative research in a variety of therapy areas including respiratory, cardiology, oncology, immunology rare diseases and emerging therapy areas. http://www.arensia-em.com/. Mr. Chu holds a Bachelor of Science in Applied Ecology from the University California of Irvine. His drive to improve healthcare is based on passion, compassion and hope. Emmes is a full service contract research organization collaborating with our clients to produce valued, trusted scientific research. Presently, Ndidi is the Associate Director, Clinical Quality Assurance & GxP Compliance at Ultragenyx Pharmaceutical Inc. where she has worked for over 6 years. 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. Kris OBrien is an Executive Director in Program Strategy, specializing in Rare Disease and Pediatrics, at Premier Research. Kardia is the first AI-enabled platform to aid patients and clinicians in the efficient detection of atrial fibrillation, the most common arrhythmia and one associated with a highly-elevated risk of stroke. Our simulation-based protocol training prevents study errors, guarantees timely SIV, and frees up thousands of hours for your study team and site-staff. What things do they need a partner to do and what they dont need! We offer both single modules and a unified solution to maintain all processes you can cover all existing software needs with only one vendor. Dr. Lindsay Hughes, Director of eCOA Clinical Science and Consulting at Clario, is a scientist and leader with over 15 years of experience in behavioral and life sciences. Running clinical trials in 2022: what you need to know In his role as BD lead, he is responsible for many aspects of the companys planning and operations. Join thought leaders from regulatory agencies, biotech, pharma, patients, and academia to discuss the latest advances, challenges, and forward-thinking . Long term solutions: could reducing the site certification process be a realistic solution? Premier Research is a leading clinical development service provider that helps highly innovative biotech and specialty pharma companies transform breakthrough ideasinto reality. WORKSHOP: Identifying and overcoming the hurdles associated with global studies including longer timelines, drawn-out budgets and remote teams. We are a certified Minority Business and always do the right thing. To learn more , please visit our website - http://www.novotech-cro.com/. The FDA-cleared KardiaMobile device is the most clinically-validated personal ECG solution in the world. She also has a special interest in innovations that can improve the quality and efficiency of clinical trial execution. Any Where. Topics include feasibility & site selection, clinical data & technology, patient engagement & enrollment, risk-based monitoring, and budeting & clinical outsourcing. Cultural consideration - translations, typical distance from site, etc. He has supervised the management of a clinical portal, eTMF, CTMS, RTSM, EDC, Coding and Grants solutions. 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. The two day, in person conference, Outsourcing in Clinical Trials will deliver top-quality content from industry experts covering all aspects of operational . Myonexis a global complete clinical trial solutions provider. She facilitates policy and procedure development within OMDRHO and collaborates with medical product partners in the Office of Medical Product and Tobacco Operations, and with peers throughout CDRH during daily operations and on special projects. Currently, Arvinder is VP of Clinical Development at Rani Therapeutics, where she is responsible for Clinical and Regulatory functions for all programs. His PhD research at UC San Francisco established the foundation for PEGylated drugs widely used today. Alton Sartor completed a combined MD/MBA from Tulane University. 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. Data-driven operations and oversight with elluminate. The Digital Transformation of Clinical Trials the Importance of Data Accuracy. As an international key opinion leader in dermatology clinical development, Dr. Jankicevic has served as advisor to multiple companies on their path to global regulatory and commercial success. How applying behavioral science insights can better inform the way we do patient engagement. Advarra integrated solutions connects life sciences companies, CROs, research sites, investigators, and academia at the intersection of safety, technology, and collaboration. At Trilogy, medical writing is our passion. To learn more , please visit our website - Company Website:https://eurofinscentrallaboratory.com/biopharma-services/, To learn more , please visit our website - Founded in 1985, Promedica International, a woman-owned corporation, is headquartered in Orange County, California. To learn more , please visit our website - http://www.iconplc.com/. For more information, visit http://www.saama.com. 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. assisTek has been paving the way for integrating technology and data collection in clinical trials for over 25 years. Anju Software is a customer-first organization providing adaptable life science solutions for clinical research, medical affairs, and data science. He worked in fortune 500 companies (Bristol-Myers Squibb Co, NJ-USA and Amgen, CA-USA), mid-size and startups/CROs (Discovery Partners Intl. Applied Clinical Trials Online Panellists will address the advantages of DCT; from taking the trial to the patient to boosting recruitment. Debashish has over 18 years of experience in the life sciences / clinical trials industry, including several leadership roles in Product Management. Imaging endpoints are often used to support go/no-go decision-making in early phase trials. We proactively plan, coordinate and write clinical documents to meet timelines, with a readability that reduces the time for review and approval. I am passionate about the life sciences and the clinical and commercial potential of novel therapeutics and applications of synthetic biology. 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. In 2019, THREAD was acquired by strategic health care investors Water Street Healthcare Partners and JLL Partners. 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. ACM performs more than 20 million laboratory tests each yearspanning all medical disciplines including pathology, microbiology, molecular diagnostics, toxicology and more. 5 th Clinical Nutrition Conference. The 2014 event will focus on how companies from the region can implement effective clinical outsourcing strategies. Digital health technologies and biomarkers in clinical trials requires the highest standards of data collection, transmission, security, quality, and analysis. Dr. Jankicevic is a sought-after speaker, and author of numerous articles in peer-reviewed and trade journals. Outsourcing in Clinical Trials Europe 2023. Online event and networking. 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. 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). We develop new innovations, drive emerging therapies forward and improve patient lives. 12 years at Parexel. Why should we collect Sexual Orientation and Gender Identity in Clinical Research Studies? This experience has allowed her to understand the nuances that set rare and pediatric studies apart from routine clinical studies and develop proper strategies for clients to execute their studies in real world settings. AliveCors enterprise platform allows third-party providers to manage their patients and customers heart conditions simply using state-of-the-art tools that provide easy front-end and back-end integration to AliveCor technologies. The two day programme will take a holistic approach to the latest challenges and innovations in clinical operations, such as, the [] Prior to joining Iovance she served as the VP of Quality at Immune Design which was acquired by Merck. www.maxisit.com/ctos/. Each year, we bring forward the latest experience . Francis has lead supplier oversight responsibilities for sponsors, CROs and clinical system vendors. Scout Clinical, part of the Meeting Protocol Family, provides stress-free, confidential and personalized travel, expense and compensation management services to clinical trial participants on a global scale. Using modern payment, transportation, and communication solutions we help drive retention, compliance, and data quality. David Larwood is a founder, the CEO, and chief chemist for Valley Fever Solutions, running the manufacturing process for a novel antifungal headed for Phase 2a trials in 2022. www.versiticlinicaltrials.org, Viedoc designs engaging software for the life science industry. To learn more , please visit our website - Global Clinical Trials Connect 2023 2022 London United Axiom Exhibiting at Outsourcing in Clinical Trials Southeast 2022 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. Optimizing cell-based Gene Therapy Programs through the continued evolution. Precision medicine is in our blood, our cells, our genes, and our name. Be sure to stop by to visit my colleagues at booth #60. To learn more , please visit our website - To learn more , please visit our website - 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. Clinical ink is the global life science company that brings data, technology, and patient science together. RxE2 Releases . TFS demonstrates scientific and medical competence across populations and therapeutics, with industry-leading capabilities in: -Dermatology, Immunology and Inflammatory Diseases, -Internal Medicine including Neurology & Respiratory, -Pediatrics, Rare Diseases and Orphan Drugs, Detailed information about TFS, and its business offerings can be obtained through. http://www.iconplc.com/, To learn more , please visit our website - Subsequently completed a Neurology Residency at Columbia University with additional Fellowship training in Neuro-Oncology at the Mass General Brigham program. European Clinical Trials Event In Dsseldorf On 18-19 April 2023 In partnership with customers, we build solution-driven teams working for a healthier future. Lin, who has been with the company since October 2016, previously served as the Senior Vice President of Sales and Marketing. Advice for the ClinOps team to avoid unnecessary patient visits, how does your protocol affect the site? To learn more , please visit our website - To learn more , please visit our website - She has over 22 years of experience overseeing GxP quality and compliance for all phases of drug development for biologics and small molecules. 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. La Jolla, CA. Rave RTSM is the only fully pre-validated randomization and trial supply management solution that can be configured in minutes and enables mid-study changes with minimal downtime and no change orders. About Mobile Technologies in Clinical Trials. To learn more , please visit our website - BS in Human and Organizational Behavior, and Communication Studies and authored numerous trade articles and frequently present on behalf of Parexel at trade conferences. Dr Frances Rubenstein has worked in clinical data management for more than 20 years in both medical device and pharmaceutical companies. 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 . The DIA's Digital Technology in Clinical Trials Conference discovers how digital technology is transforming the drug, device, and diagnostics development process in clinical trials.

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