Sponsors

Agatha Inc, is a strategic software solutions provider to the healthcare and life sciences industry, providing SaaS-based business applications for managing SOP, regulatory documents and clinical trial master file records. Agatha is dedicated to helping the world's hospitals, biotechnology, pharmaceutical, contract research organizations and medical device firms optimize the management of their Quality, Regulatory and Clinical documentation and processes. With lower costs and faster on-boarding, Agatha delivers the best ROI on business applications for life sciences that are ready to use and easy to adopt.

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Complion’s mission is to reinvent site regulatory and document management by eliminating human error and redundant work to achieve maximum efficiency and compliance. We are the first and are the largest eRegulatory platform built for sites, health systems, academic medical centers, and cancer centers.

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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®. Information on Covance’s solutions can be obtained through its website at www.covance.com.

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DArcy Consulting was established in 2014 to provide practical support for clinical compliance/ clinical quality functions. We are a Clinical Compliance Consulting Company with a singular focus on building compliance cultures for Life Science companies. One of our major areas of focus is Inspection Readiness: we conduct gap assessments to determine what is needed to ensure inspection success, e.g., Developing SOPs, Developing Training (GCP, Inspection Readiness), Building Quality Management frameworks & supporting processes, Creating Inspection Readiness Guidance, Conducting TMF assessments and Creating Roadmaps for compliant TMFs. Indeed for one of our clients, an FDA inspector commented on the quality of the clinical SOPs particularly the TMF SOP reviewed as part of the Inspection. Our client passed the inspection and subsequently launched its first product in the US.

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Halloran Consulting Group makes life science companies better at what they do. We give you the direction and expertise needed to transform your company into a more efficient organization where quality is part of the culture, not an afterthought. We stick by your side when things get tough by helping to identify and fix problems within your organization. We’ve been there. We can find a solution.

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IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. 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. Formed through the merger of IMS Health and Quintiles, IQVIA has approximately 65,000 employees worldwide.

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inSeption’s insistence upon securing the “right” people to integrate into a true partnership alliance with its clients eliminates the vulnerability so often felt by operational leaders faced with evaluating traditional outsourcing options. inSeption’s core competency of identifying and securing the most experienced and proficient professionals builds the crucial foundation of a successful drug development program. Actively collaborating with its clients to custom design, hand select and assemble high-performing project teams empowers inSeption to tailor its services specifically to meet the needs of their programs. The inSeption model provides increased control, full transparency of project deliverables and timelines, and significant operational and cost efficiencies.

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Just in Time GCP supports small and mid-size pharma companies and CROs in managing their Trial Master Files. Whether you are anticipating a regulatory inspection, need resourcing for routine quality oversight of your TMFs or are planning the implementation of a TMF system, Just in Time GCP can support you. We have extensive industry experience in clinical operations and truly understand the complexities of trial management and drug development. We partner with your organization in ensuring that your TMFs are inspection-ready. We take the stress out of TMF management.

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Phlexglobal is unique among TMF solution providers because we leverage authoritative TMF technologies and expert services to bring order, stability, and control to your Trial Master File—helping you achieve the highest standards for completeness, timeliness, and quality.

We dedicate 100% of our global resources—including hundreds of highly experienced TMF practitioners, leading technologists, regulatory experts, and document management professionals—solely to the development of innovative, standard-driven TMF solutions for the life sciences.

We approach every project, every interaction, every opportunity with a singular mindset: Raise Your Standard. With Phlexglobal, you should always expect, and get, more.

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TRI – The Risk-Based Quality Management (RBQM) Company. Our vision is “Every trial a risk-based trial” and our mission is “To help every Sponsor and CRO deliver better clinical trials through risk-based tools, training and technology”.  TRI’s focus is on people, processes and technology in that order. We’ve trained hundreds of people in ICH E6(R2) and implemented dozens of compliant processes and SOPs for both Sponsors and CROS. Our industry leading RBQM technology platform, OPRA, is a fully validated tool that delivers the entire end-to-end RBQM process, including Risk Assessment, Risk Management and Centralized Monitoring. This enables you to identify and document potential study risks right from the start, then spot and manage emerging trends. This powerful combination of people, processes and technology means you can act much more quickly to target onsite monitoring activities and focus your efforts on those areas that will improve data quality and better ensure patient safety.

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Since 2003, YourEncore has been delivering premier strategic and technical advisory services and solutions to the Life Sciences and Consumer Goods industries. Our subject matter experts are experienced industry practitioners – alumni from some of the most respected companies in the world – offering their extensive hands-on experience in solving the same challenges our clients face today, to help them outthink, outpace, and outperform the competition. Our mission is to enable a world of experience to make a difference in the world.

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