2021 Sponsoring Organizations
Advarra advances the way clinical research is conducted: bringing life sciences companies, CROs, research sites, investigators, and academia together at the intersection of safety, technology, and collaboration. With trusted IRB and IBC review solutions, innovative technologies, experienced consultants, and deep-seated connections across the industry, Advarra provides integrated solutions that safeguard trial participants, empower clinical sites, ensure compliance, and optimize research performance. Advarra is advancing clinical trials to make them safer, smarter, and faster. For more information, visit www.advarra.com.
IQVIA Technologies help you transform your clinical trials and improve patient safety with SaaS-based applications and tech-enabled services designed to streamline processes, improve workflows, and effectively engage and inform patients. The Orchestrated Clinical Trials (OCT) platform eases the burden on your sites and makes it easier and more appealing for patients to enroll and remain engaged, produces faster trials to database lock, and speeds time to market. For more information visit www.iqvia.com/oct or email us at [email protected]
ZS is a professional services firm that works side by side with companies to help develop and deliver products that drive customer value and company results. We leverage our deep industry expertise, leading-edge analytics, technology and strategy to create solutions that work in the real world. With more than 35 years of experience and 9,000-plus ZSers in more than 25 offices worldwide, we are passionately committed to helping companies and their customers thrive. For more information, visit: www.zs.com.
CluePoints provides Sponsors and CROs a better way of detecting and managing risks that may impact the outcome of clinical trials. Our solutions, all of which are underpinned by Central Statistical Monitoring, a technique that’s being investigated by the FDA for selecting sites for inspection, are deployed to drive a Risk-Based Quality Management strategy, as advocated by ICH and FDA. To learn more, visit: www.cluepoints.com/
Complion is successful at getting sites to adopt our eISF system because it’s specifically built for them. Sponsors and CROs that work with sites using Complion see increased quality through accurate submissions, improved TMF quality, completeness, and timeliness. They also gain real-time access to all site files from one location with a single password. For more information, visit: www.complion.com.
Headquartered in Paris, with offices in the US and UK, Ennov provides the most original, comprehensive, and cost-effective suite of software solutions for the Life Sciences industry. From leading pharmaceutical companies to emerging biotechnology companies, we proudly serve over 200 companies and 150,000 users around the world. We are recognized as a global provider of software technology for the Life Sciences in the areas of Clinical, Regulatory, Quality/Manufacturing and Pharmacovigilance. For more than 20 years, we have been developing innovative, powerful and easy-to-use software for regulated content, data and process management. For more information, visit: https://en.ennov.com/
FDA Quality and Regulatory Consultants (FDAQRC) provides trusted compliance solutions to pharmaceutical, biotech, and medical device companies. From routine audits to inspection readiness to Quality Management System development, our Quality Assurance expertise spans all GxPs including: GCP, GLP, GcLP, GMP, GVP, GMP and GDP.
FDAQRC employs a staff of dedicated home-based Project Managers and Auditors and has a global network of more than 200 consultants. Our team has expertise in all areas and includes QA credentialed and former FDA professionals.
Since 2009, FDAQRC has worked to establish long-standing professional relationships with both clients and consultants worldwide. FDAQRC understands client needs and strives to match them with the most highly knowledgeable and trained consultant to assure each deliverable meets our high expectations. For more information, visit us at www.fdaqrc.com
Just in Time GCP is a group of professionals, with a deep depth of Clinical Research experience, who take a holistic approach to managing the TMF. As an organization of 70+ employees, we bring a balance of clinical, GCP, & records management experience to your organization. This expertise, combined with our core values of Quality, Collaboration, Composure, & Balance, makes us the ideal partner for optimizing your organizational commitment to compliance, process optimization, and inspection readiness.
At Just in Time GCP, no initiative is too great or small, let us help you turn your operational challenges into operations excellence. For more information, visit: https://justintimegcp.com/
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 our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. Learn more about and Labcorp at www.Labcorp.com or follow us on LinkedIn and Twitter @Labcorp.
Phlexglobal is the leading technology and services organization for clinical and regulatory matters with a focus on helping clients to master their digital agenda via proven AI solutions. Phlexglobal combines software and leading expert services to offer a unique solutions portfolio that lifts organizations to a new level of effectiveness. To learn more, visit: www.phlexglobal.com
PhlexTMF, the company’s TMF software, and Regulatory Solutions are considered highly innovative in the industry for their out-of-the-box best practices capabilities, use of automation technology, and user-focused design.
PhlexNeuron, a machine learning platform that reads documents and converts unstructured content into structured data, achieves automation of regulatory and clinical processes and completes the end to end solutions offering from Phlexglobal.
Medidata is leading the digital transformation of life sciences, creating hope for millions of patients. Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users across 1,700+ customers and partners access the world's most-used platform for clinical development, commercial, and real-world data. Medidata, a Dassault Systèmes company, is headquartered in New York City and has offices around the world to meet the needs of its customers. Discover more at www.medidata.com and follow us @Medidata.