Safety Gateway. com, visit our Help Centerfor self service, or use the Support contactsbelow to contact us with any product support needs. We, Medidata, use cookies to give you the best experience on our websites by: measuring their audience and improving their performance, by providing you. The combined use of ARISg and Medidata Rave, leveraging Rave Safety Gateway, addresses the time-sensitive and safety-critical process of alerting regulatory agencies to potential safety events and. Safety Gateway. Safety Gateway. We, Medidata, use cookies to give you the best experience on our websites by: measuring their audience and improving their performance, by providing you. Quick Contact Rave Safety Gateway. Safety Gateway collects and prepares your safety data into a file in the industry-standard ICH E2B R2 or R3 format ready for import into your safety system. Medidata, a Dassault Systèmes company, and Boehringer Ingelheim announced a five-year renewal of their collaboration in the wider area of electronic data capture. We, Medidata, use cookies to give you the best experience on our websites by: measuring their audience and improving their performance, by providing you. Site Cloud - EOS. Medidata’s eCOA capability is built using Designer, enabling Sponsors and CRO partners to build rich patient experiences via intuitive drag and drop screen templates and visual workflow tools. Medidata’s clinical trial roadmap illustrates the key considerations and technologies that add the most value at each step of a trial. Medidata returns to the 2023 SCRS Global Site Solutions Summit in Hollywood, FL as a Site Voice Sponsor. Automate collection, transmission and tracking of adverse event data. Seamlessly generate. In July 2023, The Everest Group positioned Medidata as an industry leader in their Life Sciences Clinical Data and Analytics (D&A) Platforms PEAK Matrix® Assessment. Medidata Solutions Introduces Unified Platform for Randomization,. Medidata developed Rave Safety Gateway to address the challenges outlined above. Medidata has paved the way for the next generation of clinical trials including specialized solutions like decentralized clinical trials, patient-centric solutions, synthetic control arm studies, and advanced analytics. “Regulatory and site approvals are faster with Medidata’s unified platform, and so is site training,” O’Boyle says. The approach adopted was to transfer subjects using Medidata RAVE. APIs vs. Westat is accredited in several Medidata Rave modules, including Electronic Data Capture (EDC), Coder, and Rave Safety Gateway, and our expert teams work directly with clients on the configuration of a wide range of Rave data capture and management solutions. Safety Gateway. NEW YORK, N. Seamlessly generate, distribute, & manage clinical study files at the end of a study. Safety Gateway. Automate collection, transmission and tracking of adverse event data. The Summit provides a unique hub where sites, sponsors, CRO executives, and regulators come together to discuss best. Automate collection, transmission and tracking of adverse event data. This recognition is the latest in a long list of accolades. Safety Gateway. NET, C#, Medidata Rave 5. Seamlessly generate, distribute, & manage clinical study files at the end of a study. Site Cloud - EOS. Rave RTSM is exactly this—it enables seamless mid-study changes by providing the necessary flexibility and scalability while minimizing the costs associated with change orders. Course Type. This cross-vendor solution leverages the E2B standard for SAEs using an AS2-compliant electronic dataMedidata combines the wealth of data, AI powered insights, and patient-centric clinical trial solutions required to bring tomorrow’s breakthrough therapies and devices to life, and into the hands of patients. John has been with […] Medidata Rave Safety Gateway 2023. The SCDM Annual Conference is the leading event for Clinical Data Management. This Accreditation teaches Partners to utilize the configurable EDC-to-safety-system interface to automate advanced serious adverse event (SAE) collection and E2B transmissions. Trials using paper and hybrid data collection tools are in massive decline and this decline is expected to continue. Safety Gateway. Medidata has seen hours of work reduced by more than 50. Safety Gateway. We, Medidata, use cookies to give you the best experience on our. Mar 2022 - Present1 year 8 months. The assessment spoke to the strengths of Medidata’s platform. Safety Gateway – Administration and Setup. By leveraging Rave Safety Gateway, Sentrx is able to overcome this complex challenge by using a more efficient and accurate solution that instantly transfers safety-related data from Medidata Rave. Seamlessly generate, distribute, & manage clinical study files at the end of a study. Site Cloud - EOS. Seamlessly generate, distribute, & manage clinical study files at the end of a study. The project involved transfer of clinical subject data from one study to another. Automate collection, transmission and tracking of adverse event data. “Visibility into patient reporting helps us mitigate protocolTo handle the many possible mid-study changes, RTSM systems must be robust, scalable, and flexible. Automate collection, transmission and tracking of adverse event data. Safety Gateway. This new process allows investigators to enter all SAE data directly into Rave, which then transmits it in E2B format to an ancillary system. Rave Safety Gateway の概要 （8分） 無断複写・転載を禁じます。 – 安全性症例の管理 eラーニング概要 は、重篤な有害事象（SAE）をMedidata Rave Rave から抽出された トピック 目的 お客様の責任 学習目標 Rave Safety Gatewayとは？ Rave Safety Gatewayの必. Seamlessly generate, distribute, & manage clinical study files at the end of a study. （本社：New York U. Medidata’s eCOA capability is built using Designer, enabling Sponsors and CRO partners to build rich patient experiences via intuitive drag and drop screen templates and visual workflow tools. He specializes in Study Administration, Study Build, and Safety Gateway implementations and best practices. Rave Safety Gateway is built on the Medidata Rave Clinical Cloud, a unified data platform, which provides a single source of truth creatfor all study-related data across your entire portfolio. Direct fax. John is a Senior Engagement Consultant at Medidata, working across all facets of the Clinical Data Management Services Practices and is responsible for Data Management Services such as Rave, RaveX, Safety Gateway, Coder, Cloud Administration and iMedidata. Automate collection, transmission and tracking of adverse event data. Discover more at and follow us @medidata. Site Cloud - EOS. Moderna’s COVID-19 Vaccine Clinical Trials Supported by the Medidata Clinical Cloud TA: mRNA Therapeutic Vaccine Stage: Phase 3, 30,000 participants Products: Medidata Clinical Cloud, Rave EDC, eCOA, Coder, Detect, Safety Gateway, Trial Assurance eCOA: Pre-built instruments, once validated, were reused and effort Active engagement with Medidata’s diverse patient advocates to infuse the patient voice into solution design. Medidata Rave Safety Gateway 2023. Safety Gateway: Faster Access to Safety Data. Site Cloud - EOS. • Interface of Electronic Data Capture (EDC) systems (InForm, Oracle Clinical - RDC, Medidata Rave Safety Gateway) to Argus Safety. Safety Gateway. 1. Site Cloud - EOS. Glioblastoma Awareness Day takes place on the third Wednesday of every July. Safety Gateway. Safety Gateway. For 20 years, our technology has provided efficient and. Automate collection, transmission and tracking of adverse event data. As part of its expanded partnership with Medidata, BeiGene also plans to standardize the collection and management of safety cases through Medidata Safety Gateway®, a secure, configurable. Automate collection, transmission and tracking of adverse event data. We would like to show you a description here but the site won’t allow us. Safety Gateway. Medidata recognized for continued growth in market impact and vision in 2023 ‘Everest Group PEAK Matrix Assessment’. We, Medidata, use cookies to give you the best experience on our websites by: measuring their audience and improving their performance, by providing you. Site Cloud - EOS. by enabling and configuring Rave Safety Gateway, Medidata Rave EDC-to-safety-system interface, with EXTEDO’s PcVmanager, a drug safety management solution built specifically with open data standards in mind. Post-COVID-19 data quality will require justification. Automate collection, transmission and tracking of adverse event data. We, Medidata, use cookies to give you the best experience on our websites by: measuring their audience and improving their performance, by providing you. We, Medidata, use cookies to give you the best experience on our websites by: measuring their audience and improving their performance, by providing you. Automate collection, transmission and tracking of adverse event data. We provide a unified platform for full lifecycle management in Life Sciences, in the age of precision medicine. This cross-vendor solution leverages the E2B standard for SAEs using an～Medidata Rave Safety Gateway 日本初のサービス開始～ 当社子会社のシミック株式会社（本社：東京都港区、代表取締役社長：好本 一郎、以下「シミック」） は、このたびMedidata Solutions Inc. Automate collection, transmission and tracking of adverse event data. Medidata Products & Solutions. The first-ever Medidata User Group (known as MUG) took place in Thousand Oaks, California. We help generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies. UI is improved a lot from Classic Rave to Medidata Rave EDC, and is now given in such a way that, all activities in data entry can be done easily. Automate collection, transmission and tracking of adverse event data. Automate collection, transmission and tracking of adverse event data. Medidata Solutions, Inc. Automate collection, transmission and tracking of adverse event data. com: Site Cloud: End of Study: Course: Rave Site Cloud: End of Study - Tasks for. Safety Gateway. Site Cloud - EOS. Direct number. This course covers new features and enhancements for Rave Safety Gateway Mapping and Management in 2023. The Medidata Advantage Rave Safety Gateway is integrated with the most commonly used clinical data management system, Rave EDC, to streamline and improve the accuracy and timeliness clinical safety data management. FOLLOW. Seamlessly generate, distribute, & manage clinical study files at the end of a study. Y. Medidata is unifying RBQM and clinical trial management, delivering the ability to define and execute a holistic, end-to-end. A Sound Investment: Right for Today… Ready for Tomorrow. Site Cloud - EOS. Leverage our innovative digital technology to enable the shift from 100% on-site monitoring to remote monitoring. by enabling and configuring Rave Safety Gateway, Medidata Rave EDC-to-safety-system interface, with EXTEDO’s PcVmanager, a drug safety management solution built specifically with open data standards in mind. Rave Clinical Operations. Automate collection, transmission and tracking of adverse event data. 0, including downloading the study configuration to files from Mapping and Management settings, then upload them to the new URLs. Site Cloud - EOS. Clinical Research Management. Medidata Safety Gateway is a secure, online interface between EDC and safety systems that inte grates investigational sites with safety and data management teams. Clients can benefit from Medidata’s implementation experience with a full planning and optimization workshop. Rave Coder+ is built on the Medidata Clinical Cloud Ⓡ unified platform with a connected, automated medical coding workflow for coding verbatim terms entered in Rave EDC. Seamlessly generate, distribute, & manage clinical study files at the end of a study. Site leaders from numerous organizations will join the new Medidata SiteTech Board powered by SCRS to bridge the gap between sites, sponsors, and CROs to improve collaboration and better. Automate collection, transmission and tracking of adverse event data. Medidata Remote Monitoring in clinical trials enables a hybrid on-site/off-site. Safety Gateway. Consequently, as sponsors and CROs continue to. Automate collection, transmission and tracking of adverse event data. Automate collection, transmission and tracking of adverse event data. Discover more at and. Site Cloud - EOS. Medidata Rave Safety Gateway is a secure, configurable electronic data capture to-safety-system interface that transmits safety case data, entered by sites into. Safety Gateway. Rave Clinical Operations. Contact us at info@medidata. We, Medidata, use cookies to give you the best experience on our websites by: measuring their audience and improving their performance, by providing you. We, Medidata, use cookies to give you the best experience on our. Seamlessly generate, distribute, & manage clinical study files at the end of a study. Over the next 15 years, SHYFT provided commercial data management and insights for over 75 brands across the industry and. Avoiding the complexity of working with multiple vendors significantly reduced startup time. Medidata Customer Support Information - Medidata SolutionsMedidata’s Clinical Data Management solution eliminates complex, manual processes and delivers higher quality data for faster insights in clinical trials. Automate collection, transmission and tracking of adverse event data. Safety Gateway. Safety Gateway. Rave Data Management. We, Medidata, use cookies to give you the best experience on our websites by: measuring their audience and improving their performance, by providing you. Learn about the increasing complexities of phase 1 clinical trials and how Medidata provides solutions like Rave EDC and Rave RTSM that support accelerated study start-up, direct-to-patient supply management, and any necessary site transfers. Support for current customers. Automate collection, transmission and tracking of adverse event data. We use the most advanced technologies and techniques to protect. The promise and potential of decentralized clinical trials (DCTs) are great, but execution and delivery of the right technologies matters in optimizing patient, site, and sponsor experiences. Safety Gateway. 、会長兼最高経営責任者：タレク・シMedidata Rave Safety Gateway is a secure, configurable electronic data capture to-safety-system interface that transmits safety case data, entered by sites into Medidata Rave, automatically into. Safety Gateway. Seamlessly generate, distribute, & manage clinical study files at the end of a study. Site Cloud - EOS. Your gateway to exclusive, industry-leading tools and resources that position your business to achieve more. Seamlessly generate, distribute, & manage clinical study files at the end of a study. Site Cloud - EOS. With 800 staff members across 21 countries, Synteract is an innovative, full-service contract research organization supporting biopharmaceutical companies in all phases of clinical development to help bring new medicines to market. Site Cloud - EOS. Safety Gateway. Video will be available in the Rave EDC Video Library on 14/Nov/2022. Medidata Solutions コース概要：Rave Safety Gateway 管理とセットアップ © 著作権 2015 Medidata Solutions, Inc. Automate collection, transmission and tracking of adverse event data. Partner Portal. Safety Gateway. Site Cloud - EOS. Automate collection, transmission and tracking of adverse event data. This new process allows investigators to enter all SAE data directly into Rave, which then transmits it in E2B format to an ancillary system. Medidata’s eCOA library—the first in the industry—now contains more than 200 forms and is being actively used to positively impact timelines and quality of ongoing studies. Automate collection, transmission and tracking of adverse event data. Medidata’s approach to sustainability is directly tied to its mission to power smarter treatments and healthier people. Automate collection, transmission and tracking of adverse event data. Medidata offers a cloud-based platform for clients to build their own clinical trials and perform medical research. Learn how valuable Medidata’s EDC solution is and how it can be used to collect, manage, and clean site, patient, and lab-reported data in an electronic format for use in clinical trials in all phases. Seamlessly generate. Medidata takes a consultative approach with CROs—engaging with partners and taking the time to discuss the best approach and strategy for any given imaging trial. 03. Automate collection, transmission and tracking of adverse event data. Safety Gateway. Rave Site Cloud: End of Study – Dashboard, Reports, and Tracking Site Completions (Sponsor Users)Via Rave Safety Gateway, adverse event data entered into Rave EDC is automatically transferred as a safety case to the sponsor’s safety system. A Sound Investment: Right for Today… Ready for Tomorrow. Site Cloud - EOS. With myMedidata Registries, introduce post-trial patient engagement in your clinical trials and enable long term follow-up, patient data return, enhanced safety monitoring, and gathering of new clinical insights. Safety Gateway supports the ICH E2B (R2) and E2B (R3) standards for the electronic transmission of. Site Cloud - EOS. As part of its expanded partnership with Medidata, BeiGene also plans to standardize the collection and management of safety cases through Medidata Safety Gateway®, a secure, configurable. Site Cloud - EOS. Automate collection, transmission and tracking of adverse event data. 阅读LUDWIG研究所案例研究. Show lessDay 1 kicked off with sessions focusing on improving existing or new products, including Medidata Safety Gateway and Medical Coder tools. Eliminate duplicate data entry, accelerate the transmission of safety case data and reduce data reconciliation between clinical and safety teams. Automate collection, transmission and tracking of adverse event data. myMedidata Registries. Site Cloud - EOS. Automate collection, transmission and tracking of adverse event data. Jan 26, 2023 - 2 min read. Seamlessly generate, distribute, & manage clinical study files at the end of a study. Safety Gateway. We, Medidata, use cookies to give you the best experience on our websites by: measuring their audience and improving their performance, by providing you. Seamlessly generate, distribute, & manage clinical study files at the end of a study. Automate collection, transmission and tracking of adverse event data. Medidata Detect – Quality Tolerance Limits (QTLs) Rave CTMS: Configurable Dropdowns. Seamlessly generate, distribute, & manage clinical study files at the end of a study. Seamlessly generate, distribute, & manage clinical study files at the end of a study. Linking clinical and real-world data has allowed for tracking of long-term efficacy, durability, and subpopulation analysis for COVID-19 therapies. Medidata is proud to assist over 1,900 customers and 180+ global CRO partners. Medidata eLearning은 편리하고 안전한 교육 코스로. 1. Supply Management), Site Payments, Safety Gateway, and Rave Coder. S. Safety Gateway. Medidata’s Data Reviewer capability enables aggregated review of data from multiple sources without the need for programming. Medidata Patient Data Surveillance, or PDS, provides that solution. We have 25+ years of extensive pharma/CRO industry experience and expertise. Site Cloud - EOS. Seamlessly generate, distribute, & manage clinical study files at the end of a study. Automate collection, transmission and tracking of adverse event data. Automate collection, transmission and tracking of adverse event data. Direct number. 1-951-821-2621. Safety Gateway. We, Medidata, use cookies to give you the best experience on our websites by: measuring their audience and improving their performance, by providing you. 0 product release. They support the full clinical trial life-cycle and all aspects of documentation. The Medidata Advantage Rave Safety Gateway is integrated with the most commonly used clinical data management system, Rave EDC, to streamline and improve the accuracy and timeliness clinical safety data management. Safety Gateway. Synteract. Ora’s IRT experts will help you select the best technology solution for your clinical trial, then work as an integrated part of your clinical trial team throughout the entire study. Rave Safety Gateway Meet eClinical Solutions and Medidata in Princeton to Talk Clinical Data Control and Visibility Reading Time: < 1 minuteToday’s guest post is from eClinical Solutions. HQ. In the past, physiological markers of severe CRS have been notoriously difficult to. 2010 iMedidata™ launched, central portal for access to all Medidata studies, applications and eLearning. Medidata, a Dassault Systèmes company (Euronext Paris: FR0014003TT8, DSY. Automate collection, transmission and tracking of adverse event data. Automate collection, transmission and tracking of adverse event data. Leverage Medidata’s automated data anomaly detection system, Centralized Statistical Analytics (CSA), focused on critical safety and. Site Cloud - EOS. Course Catalog. Automate collection, transmission and tracking of adverse event data. Safety Gateway. This course will provide you with a thorough understanding ofSafety Gateway. Medidata’s clinical trial roadmap illustrates the key considerations and technologies that add the most value at each step of a trial. Site Cloud - EOS. Seamlessly generate, distribute, & manage clinical study files at the end of a study. Seamlessly generate, distribute, & manage clinical study files at the end of a study. 3 and more, Vijay Chundru contributes valuable insights to the industry. Site Cloud - EOS. Your gateway to exclusive, industry-leading tools and resources that position. PA), is headquartered in New York City and has offices around the world to meet the needs of its customers. This initiative was started in 2018 by a group of bi-partisan senators, following the death of Senator John McCain. Course Description: Rave Safety Gateway is a configurable interface for passing information on Serious Adverse Events (SAEs) from Medidata Rave to E2B -compatible external safety systems. Site Cloud - EOS. Site Cloud - EOS. Any attempts to record training will. eLearning Course Outline . Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and pSafety Gateway. Automate collection, transmission and tracking of adverse event data. Safety Gateway. Medidata, a clinical trials technology developer, has introduced a clinical endpoint adjudication system integrated with its Medidata Clinical Cloud. Site Cloud - EOS. About Us;Medidata’s solution to these challenges is the Rave Safety Gateway, which is designed to automatically transmitting safety data from trial sites to sponsors' in the International Conference on Harmonization (ICH) industry standard E2B file format. Please note that. Safety Gateway. We, Medidata, use cookies to give you the best experience on our websites by: measuring their audience and improving their performance, by providing you. comor the Sales phone. 0 product release. In conjunction with Medidata Rave Coder’s real-time coding and tight EDC integration,Safety Gateway. Seamlessly generate, distribute, & manage clinical study files at the end of a study. Safety Gateway. Bengaluru, Karnataka, India. Seamlessly generate, distribute, & manage clinical study files at the end of a study. Clients can benefit from Medidata’s implementation experience with a full planning and optimization workshop. Seamlessly generate, distribute, & manage clinical study files at the end of a study. Medidata, a Dassault Systèmes company, is leading the digital transformation of life sciences. Combine patient-level clinical trial &. Automate collection, transmission and tracking of adverse event data. This cross-vendor solution leverages the E2B standard for SAEs using an ～Medidata Rave Safety Gateway 日本初のサービス開始～ 当社子会社のシミック株式会社（本社：東京都港区、代表取締役社長：好本 一郎、以下「シミック」） は、このたびMedidata Solutions Inc. Now, you can go beyond just being compliant with ICH E6 guidelines, and instead take a proactive approach to manage study risks and ensuring patient safety. Site Cloud - EOS. Automate collection, transmission and tracking of adverse event data. Our customers trust us to provide the security and quality required to achieve success in. Safety Gateway. Safety Gateway. Medidata’s 20+ years of expertise, dedicated support, and continuous learning with customers and trials. メディデータ・ソリューションズ最高経営責任者（CEO）のTarek Sherifは、次のように述べています。. myMedidata Registries. Safety Gateway. We, Medidata, use cookies to give you the best experience on our websites by: measuring their audience and improving their performance, by providing you. Automate collection, transmission and tracking of adverse event data. Safety Gateway. Automate collection, transmission and tracking of adverse event data. Sponsors and CROs now require digital clinical operations solutions that provide a comprehensive yet flexible. Automate collection, transmission and tracking of adverse event data. Course Description: Rave Safety Gateway is a configurable interface for passing information on Serious Adverse Events (SAEs) from Medidata Rave to E2B -compatible external safety systems. Steps 3 & 4: Conduct: Clinical Data Acquisition, Management, and Monitoring. Site Cloud - EOS. We,. The sponsor chose to connect Rave Safety Gateway, Medidata’s EDC-to-safety-system interface, with their in-house, existing pharmacovigilance database. Read Medidata’s sustainability series to learn about the company’s commitment to environmental sustainability by focusing on reducing carbon emissions, creating a more sustainable workplace, and helping customers be more sustainable. Read about the history of the life sciences’ premier event, as well as what to expect for 2022. Medidata takes a security-by-design approach, building in controls at the design phase. Email. Site Cloud - EOS. RAVE SAFETY GATEWAY FACT SHEET The Medidata Advantage Rave Safety Gateway is integrated with the most commonly used clinical data management system, Rave EDC, to streamline and improve the accuracy and timeliness clinical safety data management. Medidata Rave Safety Gateway 2023. “The addition of Medidata’s CTMS and eTMF platforms will allow for even more standardization across data management and clinical operations, creating efficiency, while reducing integration time and resources. Seamlessly generate, distribute, & manage clinical study files at the end of a study. Safety Gateway도 이와 같은 시스템 모듈 중의 하나다. patient safety, and data integrity – while delivering the. Medidata Safety Gateway | Learn more about Jack Fu, Ph. Automate collection, transmission and tracking of adverse event data. Site Cloud - EOS. Site Cloud - EOS. Automate collection, transmission and tracking of adverse event data. Seamlessly generate, distribute, & manage clinical study files at the end of a study. Medidata Rave® Safety Gateway Speed and Accuracy in Safety Data Capture. Automate collection, transmission and tracking of adverse event data. Seamlessly generate, distribute, & manage clinical study files at the end of a study. by enabling and configuring Rave Safety Gateway, Medidata Rave EDC-to-safety-system interface, with EXTEDO’s PcVmanager, a drug safety management solution built specifically with open data standards in mind. Site Cloud - EOS. Synteract. Safety Gateway. eLearning Course Outline . Medidata Surgical Planning offers real-time, secure sharing of medical images, patient data and live video collaboration including robust viewing and analysis tools. Clinical IT teams may want to automate such. Medidata AI is proud to present their research poster on the creation of an ECA in recurrent Glioblastoma and what it might mean for the future of better understanding early-phase. Automate collection, transmission and tracking of adverse event data. 6. Automate collection, transmission and tracking of adverse event data. Synteract has conducted nearly 4,000 studies on six continents and in more than 60. We, Medidata, use cookies to give you the best experience on our websites by: measuring their audience and improving their performance, by providing you. This course will provide you with a thorough understanding of the Management Tool to help you effectively manage and transmit safety data extracted. Trend and process analysis. Medidata Clinical Cloud is the next generation of clinical trial technology, connecting patients, sites, sponsors, and partners together in a unified platform. This cross-vendor solution leverages the E2B standard for SAEs using an AS2-compliant electronic data Medidata Rave Safety Gateway, for safety case data transmission; Medidata eCOA, for patient data capture; Medidata Detect, for data review and monitoring; Despite this mega trial’s rapid enrollment and high volume and velocity of data collection, we successfully identified missing adverse event data using Medidata Detect and Medidata’s. Automate collection, transmission and tracking of adverse event data. Medidata Link. Safety Gateway. Safety Gateway. Active engagement with Medidata’s diverse patient advocates to infuse the patient voice into solution design. Site Cloud - EOS. Site Cloud - EOS. Today, Medidata leads the digital transformation of life sciences, creating hope for millions of patients. Seamlessly generate, distribute, & manage clinical study files at the end of a study. Safety Gateway: Faster Access to Safety Data. Safety Gateway supports the ICH E2B (R2) and E2B (R3) standards for the electronic transmission of safety case reports, enabling it to work with any compliant safety system. Intensive resources are used to capture patient data, collect study data, and monitor progress throughout a clinical trial.