ACDM20 Sponsor Details
PHASTAR is a global CRO offering statistical consulting, clinical trial reporting, data management and data science services by providing expert consultants and managing and delivering in-house projects, FSP style arrangements and preferred partnerships. PHASTAR currently has over 250 staff across 10 offices (United States, United Kingdom, Australia, Germany and Kenya) with plans to open additional locations in Asia and the West Coast of the United States to serve prospective and existing clients. PHASTAR’s number one priority is to ensure that the work we produce is of the highest quality. Every project PHASTAR undertakes utilizes our unique internal processes which are designed to ensure optimal quality.
Kayentis, a global expert in electronic data capture for patients in clinical trials, helps sponsors and CROs bring simplicity, efficiency and quality to the collection of clinical trial data from both patients and sites. Kayentis is specialized in electronic Clinical Outcome Assessment (eCOA) solutions for phases IIB/III and is increasingly extending its services towards late phase studies and Real World Evidence (RWE) in a broad range of therapeutic areas. It has conducted digital data collection for over 200 clinical trials in 75 countries (9,000 sites and 70,000 patients) and employing 90 different languages.
XClinical offers an integrated suite of software products unified under the product name Marvin which helps CROs, pharmaceutical and medical device corporations accelerate study setup and improve data quality. Marvin is an integrated solution comprised of various eClinical modules, all of which combine to optimally support clinical trial processes and enable seamless data flow. These modules include study build, IWRS randomization, WebPRO, SDTM tabulation, coding, double data entry, reporting, logistics and more. With fast set up, an all-in-one platform, the highest standards in data security, and no need for programming, Marvin streamlines the process of delivering vital medications and devices to market.
Uppsala Monitoring Centre
Uppsala Monitoring Centre (UMC) advances the science of pharmacovigilance and inspires patient safety initiatives all over the world. As an independent, non-profit foundation, we engage stakeholders who share our vision and collaborate to build a global patient safety culture. For over 40 years, we have provided scientific leadership and operational support to the WHO Programme for International Drug Monitoring, expanding the global pharmacovigilance network to reach more than 95% of the world’s population. We are also the developers of WHODrug Global, an international drug dictionary for medicinal product information. Use of WHODrug Global is required by both the U.S. FDA and Japan’s Pharmaceutical and Medical Devices Agency (PMDA). We are now introducing WHODrug Koda, an automated coding service, uniquely combining the use of Artificial Intelligence by machine learning, thorough and continual training of the engine, best practice agreed by industry, and UMC’s accumulated insights on drug coding. WHODrug Koda is specifically designed for increasing the efficiency, consistency and quality of drug coding, with the end goal of safer use of medicines.
Based in Amsterdam, The Netherlands and New Jersey, US, Castor is an international health-tech company founded in 2012 by CEO Derk Arts, MD, PhD to leverage the power of machine readable data to increase clinical trial efficiency. Castor’s Electronic Data Capture (EDC) platform enables every researcher worldwide to easily capture and integrate medical research data from any source in real-time, including clinicians, patients, devices, wearables, and EHR systems.
Castor is currently collaborating with 30,000 researchers, academic institutions and commercial companies across 90 countries to help them accelerate their studies. The platform has supported more than 4,000 studies that cover a broad range of disease areas including diabetes, cardiovascular disease, heart disease, rare diseases, and cancer. Researchers on the platform generate vast amounts of data from traditional and decentralized trials, and Castor recently reached milestones of 100,000,000 data points and 1,000,000 enrolled patients. As one of the first companies to leverage machine readable data for clinical research, Castor’s platform will enable AI-driven clinical trials and provide invaluable insights to commercial research.
Want to get your clinical trials designed, built & submitted faster? Now you can, with our off-the-shelf clinical metadata repository (MDR) and clinical trial automation platform. We’ve taken away those time-consuming and expensive manual tasks – from study set up to submission.
Our clinical MDR provides a central home to govern your organizational standards. Here you can manage, update, approve and share organizational standards. Even import existing content – lie standards, studies, forms and datasets – from your EDC and e-clinical databases.
And by building your standards library in a central MDR, you can easily reuse content across studies and standards. Think about all the time and resources you’ll save not having to retype and duplicate content many times over.
What’s more, the Formedix platform is built on CDISC standards. Both current and previous versions of CDISC are supported. So you know you’ll always comply with the relevant regulatory requirements.
And if you need help automating study design and build, we can do that too. Our clinical trial automation tools use the content in your MDR to build your studies much faster. Whether you want to design eCRFs, build EDCs, design or convert datasets, or make define files… Formedix helps you do it in a fraction of the time.
- Easily create, maintain & reuse standards in 1 library
- Comply with latest & previous CDISC standards
- Easily automate CRF annotations & EDC builds
- Convert datasets to SDTM in 1 click
- Start right now, it’s off-the-shelf – no complex implementation
Cmed provides specialist data and analytics services for clinical trials. We have the expertise, systems, processes and resources to ensure we deliver timely results to the highest quality.
Cmed’s approach is to design each trial database and dataflow with flexibility to deliver results efficiently and have the ability to adapt to unforeseen changes in the trial lifecycle.
The company has delivered over 700 studies and has a team with over 350 specialist staff based in Europe and North America. We work with all types of clients – from top 10 pharma companies to small biopharma. We have the flexibility to use multiple technologies and we are experts with encapsia, a clinical data suite that allows actionable insights of live data from multiple sources.
ICON plc is a global provider of outsourced drug development and commercialisation solutions and services to pharmaceutical, biotechnology, medical device and government and public health organisations. The company specialises in the strategic development, management and analysis of programs that support clinical development – from compound selection to Phase I-IV clinical studies.
With headquarters in Dublin, Ireland, ICON currently, operates from 99 locations in 40 countries and has approximately 14,600 employees.
Covance FSPx offers a customized global solution of functional, clinical, technical and laboratory services that are flexible, scalable and Designed Around You®. Covance Inc., the drug development business of Laboratory Corporation of America Holdings (LabCorp) headquartered in Princeton, New Jersey, USA, is the world’s most comprehensive drug development company, dedicated to advancing healthcare and delivering Solutions Made Real®.
IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. Formed through the merger of IMS Health and Quintiles, IQVIA applies human data science —leveraging the analytic rigor and clarity of data science to the ever-expanding scope of human science — to enable companies to reimagine and develop new approaches to clinical development and commercialization, speed innovation and accelerate improvements in healthcare outcomes. 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. With approximately 65,000 employees, IQVIA conducts operations in more than 100 countries.
IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific advances, in an effort to advance their path toward cures.
For more than 20 years, we have supported life sciences companies with data management, medical coding, and EDC services, including:
- Medical coding systems and support
- Process reengineering and business optimization
- Regulatory compliance
- System design, development, implementation, and configuration
- System optimization and enhancements
- Data and study migrations
- Study set-up
- Report optimization
- Custom development (e.g., reports and interfaces)
- Dictionary loading/versioning
- Artificial intelligence and machine learning
We simplify and support our clients’ most complex business and technical challenges.
We understand the value of time and efficiency. That’s why we’ve built the Viedoc system using the technology of tomorrow, making electronic data capture smarter, faster and easier than ever before. We can provide you with modern tools that will revolutionise the way you conduct your clinical trials. Less effort. More fun. Experience the power of Viedoc.
Anju Software is a leading provider of comprehensive software solutions to the life sciences industry, from clinical operations to medical affairs. Anju offers eClinical Solutions for EDC/CTMS and more through TrialMaster, ClinPlus, IRTMaster and TrialOne. Additionally, Anju’s end-to-end reporting and analytics systems, including ta-Scan which optimizes trial planning/feasibility, site selection, competitive insights, medical expert identification/profiling, and Acuity for comprehensive risk-based monitoring and operational insights, complement your Personalized Platform™ to perfectly meet YOUR needs.
We offer innovative IT solutions with a specific focus on the Life Sciences value chain aiming to increase efficiency in different business areas: Clinical Trials conduct, Pharmacovigilance and Project Management. It is ISO 9001:2015 certified concerning Quality Management System and ISO 27001:2014 certified ensuring the compliance of Information Security Management System.
Main solutions in our portfolio:
- Symphony – proprietary Software as a Service Electronic Data Capture solution
- Oversight – integrated and validated environment to ensure constant alignment and real-time data sharing in compliance with ICH GCP E6 (R2)
- Agatha – Quality and content management system for the Life Sciences and healthcare
- Kairos – end-to-end Business Intelligence tool for monitoring data and KPIs
Arithmos also collaborates to develop solutions in the eHealth sector using big data, IoT and AI.
Veeva Systems Inc
Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva has more than 625 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices in Europe, Asia, and Latin America.
Premier Research is a leading, full service global contract research organisation with a headcount of in excess of 1,600 employees across 31 countries. We are a CRO that is proud to be ‘Built for Biotech’.
Premier Research is not about being everything to everyone. Instead, our deep, focused expertise targets the therapeutic areas and indications where today’s biotech and specialty pharma pioneers are doing the most amazing work. Our customers are highly innovative biopharmaceutical companies doing incredible things. It’s amazing and often very complex science, and we’ve positioned ourselves right in the middle of the action, supporting therapeutic areas where pioneers are doing the most exciting work.
We’re looking for talented Data Managers who are inspired to transform an industry. If you have the right skills and the right attitude, Premier Research needs you.
You’ll enjoy great benefits and very flexible working conditions in a company which values your contributions, rewards your achievements, and is committed to helping you reach your full potential.
Interestedto join our growing global Data Management team? Please visit the careers pages of our website to apply for current openings https://premier-research.com/careers/
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