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. www.flexdatabases.com. Outsourcing in Clinical Trials Southeast . She leads the scientific development of digital clinical measures and the modernization of clinical development models under the banner Technology As Methodology. 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. Over the years, Lin has achieved success at both large corporations and startups. Lin, who has been with the company since October 2016, previously served as the Senior Vice President of Sales and Marketing. deep6.ai, To learn more , please visit our website - 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. The company delivers high-quality laboratory testing and diagnostic lab services in support of both clinical trials research, toxicology and individual patient care. Premier Research is a leading clinical development service provider that helps highly innovative biotech and specialty pharma companies transform breakthrough ideasinto reality. 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. Global Clinical Trial Outsourcing Market Report 2022: Increasing Learn how elluminate delivers: Empowering excellence in supply through digital quality management systems, In this session our guest speaker will address the challenges with these drugs in development and looking at parallels in a medical device regulatory strategy. Dr. Apfel is a California licensed physician with 20+ years of clinical experience in anesthesiology, critical care medicine, and emergency medicine. Clinical Trials 2023. https://www.intrinsequehealth.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. ARENSIA is based with its headquarters in Dsseldorf, Germany, and operates with 400+ talented employees in 7 countries, To learn more , please visit our website - Infectious disease clinical trials; Biometrics functional outsourcing; We also provide: Drug development consultancy and services to assist the development plan of molecules in early clinical phases; Clinical pharmacology units, bioanalytical laboratories and trial management offices across Europe and North America to perform your clinical . Alexis Garelli has over 15 years of diverse healthcare information and pharmaceutical software technology experience. Conversis is built on one goal: To provide you with the highest-quality clinical trials translations. 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. He received M.Sc. Dr Morimoto has over 25 years of industry experience in leading project teams in the development of innovative medicines, providing guidance in the design and execution of preclinical, clinical and regulatory strategies with a therapeutic focus in Parkinsons, Alzheimers and frontotemporal dementias. Our Ergomed team is looking forward to exhibiting at Outsourcing Clinical Trials - Texas 2022, December 7th & 8th . She develops strategies to drive greater inclusion of racial and ethnically representative patient populations in clinical research and to advance health equity Gaining patient, clinician and community insights early in program development is integral to developing what is important to patients and improving access to medicines and treatments for all patients, regardless of race, ethnicity, sexual orientation, gender identity, age, socioeconomic status and ability/disability. www.clinone.com, To learn more , please visit our website - 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. Arena International are delighted to announce that our Outsourcing Clinical Trials Europe event is returning to an in-person format in 2022. Clinical Trials Conferences | Clinical Trials Meetings | Japan | USA Advance Research Associates is a premier provider of biostatistical and data management services to the pharmaceutical, biotech, and medical device industries. Global Clinical Trials Connect 2023 2022 London United Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. Through innovative eClinical and Regulatory solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market reliably. 4G Clinical, a leader in randomization and trial supply management (RTSM) for the global life sciences industry, is sponsoring the 2022 Outsourcing Clinical Trials DACH. Our platform consists of 13 modules that cover every aspect of clinical trials, from project startup to pharmacovigilance. Reem holds a PhD in genetics from the Hebrew University of Jerusalem. Panellists will address the advantages of DCT; from taking the trial to the patient to boosting recruitment. 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. Join us in Philadelphia, May 10th-11th, to shape best practice on: Refining patient recruitment strategy. Mr. Chu has served as a mentor for the Federal Executive Board in Los Angeles, CA. 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. 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. 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. Wed, 25 May 2022, 18:00 WebSite. Why expert partners and staff matter; what metrics dont tell. We offer customizable specimen collection kits, specialty testing capabilities, dedicated project management and trial site support, biostorage, and real-time data management and reporting. Debashish has previously managed successful eTMF products at Veeva and Medidata, as well as clinical trial imaging tools at Synarc (now part of Clario). in Psychology and Biology from the University of California at Santa Cruz. 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 Topics include feasibility & site selection, clinical data & technology, patient engagement & enrollment, risk-based monitoring, and budeting & clinical outsourcing. She has held key national leadership roles including advisor within the Obama/Biden administrations global HIV response team, advisor to United Nations leadership and instructor at the CDC and USAID. The therapeutic areas include: Cancer, CV, CNS and infectious diseases. AliveCor protects its customers with stringent data security and compliance practices, achieving ISO 27001 Certification, SOC 2 Type 2 Certification and HIPAA compliance attestation. United States, 94010, To learn more , please visit our website - AbbVie reports rise in full-year 2022 net revenues; Teva Pharmaceutical reports 5% fall in Q4 2022 revenue; Merck reports 2% increase in worldwide sales in Q4 2022; Companies. 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. 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. DCT was previously done out of necessity but are we seeing it as a new world order? Theyll ensure your translations will be of the highest quality, on time, and within budget. www.rad-md.net. To learn more , please visit our website - Are Hybrid trials the more realistic and practical approach compared to full DCT agree or disagree? http://www.endpointclinical.com/. The Global Clinical Trials Connect 2022 will focus on futuristic advancements in the clinical research industry and clinical trials. I am the CEO at OrPro Therapeutics, a biotechnology company in San Diego, CA developing biologic drug solutions to unmet needs in serious epithelial diseases including cystic fibrosis. http://www.kpslife.com. www.assistek.com, To learn more , please visit our website - Our Precision Matching software mines millions of patient records, including unstructured physician notes, to pin-point eligible study patients in real-time. Global Clinical Trials Connect 2023 2022 London United Kingdom Developing and supporting your quality initiatives from Day 1, the Harbor team is committed to quality through each functional service we provide. Local vendor oversight vs global provider oversight how would you manage this differently? 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. OCT DACH Conference 2022 - Outsourcing in Clinical Trials. 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. Estela Mata is the President and co-founder of Looms for Lupus, a non-profit organization that provides Lupus, Fibromyalgia and Mental Health Awareness, advocacy, and support to those living with these conditions, their loved ones, and caregivers. She is a Registered Respiratory Therapist, holds the CPPS (Certified Professional in Patient Safety) credential from IHI and has a Masters degree from Johns Hopkins in Patient Safety and Healthcare Quality. Deep 6 eliminates months of manual data validation, to de-risk and accelerate clinical trials, because clinical trials should be a gatekeeper (accelerator), not a bottleneck to innovation. 3 rd Clinical Pharmacy Conference. East Coast Clinical Trials Conference | New York US - 03-04 May 2023 Our goal each day, every day is to make sure our partners have whatever they need when and where they need it to execute a successful clinical trial, while also minimizing delays, unnecessary costs, and surprises. Clinical ink is the global life science company that brings data, technology, and patient science together. To learn more , please visit our website - Esther Marfo, is a Project Leader within the Health Equity and Population Sciences department at Genentech. theactigraph.com. 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. Long term solutions: could reducing the site certification process be a realistic solution? To learn more , please visit our website - Henry is a Vice President of Data Sciences at Medidata. https://www.muralhealth.com/. Are you attending Outsourcing in Clinical Trials West 2023 conference? Datacubed Health is a pioneering technology company making better science and healthier communities a reality. Login; Register now; Toggle navigation. CISCRP Conferences - Clinical Research Industry 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. 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. In a separate article, Manasi Vaidya discovers that, fuelled by the successful use of mRNA vaccines in Covid-19, RNA therapeutics are expected to make larger strides in 2022.. Based on available data, there are emerging trends . Altasciences helping sponsors get better drugs to the people who need them, faster. With strategic scientific consulting and clinical data services (biostatistics, data management/EDC, and IRT/WRS) expertise at our core, our services are scalable via our strategic partnerships to provide full-service clinical trial solutions that are The Right Fit For You. To learn more , please visit our website - 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. We provide personalized patient logistics management, reimbursement, and convenience services to support clinical trial participants. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. 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. Our Provider Edition offers a CRO costing module and bid benchmarking. 85356 Mnchen-Flughafen , Join NAMSA 5-6 April in Munich, Germany for Outsourcing in Clinical Trials: Medical Devices Europe. Subsequently completed a Neurology Residency at Columbia University with additional Fellowship training in Neuro-Oncology at the Mass General Brigham program. Recognising how Social Determinants of Health contribute to outcomes in disease, Assessing which communities you arent successfully recruiting from and exploring data to understand why, Focussing on education in this space and what we can all do moving forward. 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! He has worked for CROs as well as small and large biotechnology companies. 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 2022 program boasts two full streams including: Medrio is the leading provider of eClinical technology for pharma, biotech, device, diagnostics, and animal health clinical trials. Improving communication, relationships and work-life balance with your internal team as well as partners. https://www.trilogywriting.com/. 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. 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. 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. His current work focuses on deep collaboration with an interdisciplinary team of engineers and scientists to successfully integrate data from multiple assessments and sensors, implement high-dimensional feature engineering, and both evaluate as well as apply scalable machine learning algorithms. Our commitment to excellence, innovative technologies, and therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience. Ops components of various FIH studies and global P1-P3 drug development programs and post-marketing studies in Oncology, Hematology-Oncology, Immuno-Oncology, Infectious Diseases, Immunology, Metabolic Diseases, Ophthalmology, and Critical Care conducted in North America, Europe, Africa, Central and South Americas, Asia-Pacific regions including Japan, China, So Korea, and Australia *Lead cross-functional teams and successfully contributed to several INDs, NDAs, FDA, EMEA, TGA, and NMPA regulatory filings and approvals of marketed products within HIV/Virology Therapeutic Area *Mentor, motivate, and develop clinical operations teams and direct reports *Strong, flexible, strategic team leader with extensive change management successes *Track record to develop, problem-solve, and execute creative and innovative process improvements and quality efficiencies within development operations *Motivated and driven to continue contributing to drug development in transformative medicines with a focus on unmet medical needs, CLOSING KEYNOTE: ClinOps team focus: Managing relationships, retention and hiring in the new world. She has authored or co-authored 10 publications and has been an advocate for STEM education throughout her career. In the life sciences vertical, we help pharmaceutical and medical device companies with clinical trial management, data management, biometrics, medical affairs, regulatory affairs, and quality and compliance initiatives. Held annually in Paris and online, this event unites 5,000 attendees and 360 exhibitors centered around innovation, networking, and education. Medocitys platform is the only solution that provides a fully interactive clinical trial ecosystem enabling early decision making and safety monitoring in real time. Prior to working at Genentech, she graduated from the Johns Hopkins Bloomberg School of Public Health with a Master of Bioethics. This conference is always a great opportunity to share and learn with our colleagues across the industry. Were a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. Kris OBrien is an Executive Director in Program Strategy, specializing in Rare Disease and Pediatrics, at Premier Research. To learn more , please visit our website - Conferences > Medicine & Healthcare > Translational Medicine, Clinical Richard holds a Ph.D. in Industrial Engineering with a focus on applied statistics, quality, and reliability engineering from Arizona State University (ASU), a Master of Science in Industrial Engineering focused in Operations Research and Production Systems (ASU) and a Bachelor of Science in Engineering in Industrial Engineering (ASU), and is certified as a Six Sigma Black Belt. Mr. Luciano earned a B.A. Her experiences in academia, biotech, and CROs confirm that meeting the needs of all stakeholders payers, regulators, patients, families, and sites is a critical success factor for efficient development programs. Outsourcing in Clinical Trials Southern California 2023 Eurofins BioPharma Services, Laboratory Testing is a group of Eurofins companies with dedicated testing facilities for global Central Laboratory Services, Bioanalytical Services, and Specialty Virology and Oncology Services. Conference . 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. To learn more , please visit our website - The main program of the conference is discussion and debate on the outsourcing of clinical research. To learn more , please visit our website - His mother started a foundation in 1998 and raised some $20M for research into vaccines against Valley Fever. 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. AliveCor, Inc. is transforming cardiological care using deep learning. Phase 1 Trials: How to globalize to accelerate value inflection. As the IPM, he is the District liaison to FDA Headquarter handling import related issues and concerns. www.agilexbiolabs.com. Where do the opportunities lie for further acceleration in clinical development? Minimize site activity- could decentralization and Direct-to-Patient trials be the answer to staff shortages? 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. Each year, we bring forward the latest experience . Our experts are ready to discuss how our solutions can best support your live studies. Supported by top pharmaceutical and biotech partners across 20 different therapeutic areas, Care Access is scaling and globalizing its new model for clinical trial delivery, where more physicians and patients can engage in life-saving research to develop new therapies faster. To learn more , please visit our website - To collaborate with CISCRP for your upcoming event, please contact Joan Chambers at jchambers@ciscrp.org or Lindsey Elliott at lelliott . Caroline Cooper is the Director of Clinical Operations at CymaBay Therapeutics, Inc. with over 10 years of experience in clinical research. Swiss Biotech Day 24th April 2023 to 25th April 2023 Basel, Switzerland. How best to go about educating the patient community? http://www.cromsource.com/. Over 20 years in clinical research, including patient innovation, feasibility, strategy, patient recruitment, retention, site engagement. https://www.slope.io/. As a CSO, he conducted domestic food inspection, consumer compliant investigation, recall traceback investigation, and inspection of imported FDA regulated products. 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.