ClinChoice Alternatives

With the ever-increasing complexity of global medical device registration regulations, more companies are turning to regulatory information management systems software (RIMS software) to streamline the application life cycle and manage medical device applications. RegDesk is the most comprehensive AI-enabled RIMS platform for Medical Devices, Pharmaceuticals, and IVD companies offering enhanced performance and positive results more consistently than any standard regulatory information management solution. Our capabilities are as follows: • AI Application Builder • Regulatory Intelligence • Change Assessment • Standards Management • Country-Specific Templates • Distributor Collaboration • AI Document Management • Tracking & Reporting • Alerts and Notification • Product Management • Claims Management • EUDAMED For more information, visit our website.

ACE is a quality management software solution for companies of any size, in any stage, in any highly regulated industry. ACE is fully configurable allowing your company to adapt ACE to fit into your exact quality needs. Empower all levels of your organization with intuitive user interfaces, easily search for all your documents and records, and transform your data into actionable intelligence with advanced analytics all on a single platform. Our one-stop software includes: -Office 365 Integration -Inspection Management -Document Management -Risk Management -Product Lifecycle Management -Learning Management -Audit Management -Quality Events -Paperless Validation -Electronic Signatures (21 CFR Part 11 Compliant) -Endless Workflow Configurations -And so much more! ACE comes with everything you need, all included at one price. Every application is included, no more a la carte pricing. No more nickel and diming. One software, endless solutions.

Bringing breakthrough products to market in highly regulated industries can feel like an endless series of trade-offs. MasterControl's software simplifies GxP workflows so you never have to sacrifice quality for cost or innovation for regulation. Complete and connected meets fast and flexible. From quality event management to document control and integrated training - MasterControl Quality Excellence transforms your quality data and processes into a competitive advantage. Modernizing your manufacturing operations starts with modern software. From work orders to work instructions and production records (EBR or eDHR) to logbooks, MasterControl Manufacturing Excellence is the simplest way to digitalize manufacturing.

At ClinCapture our mission is to build software that saves lives. Our technology lowers the cost of clinical trials by streamlining data capture processes while providing a platform that protects patient privacy. Clincapture advances the evaluation and development of drugs, biologics, and devices that demonstrate promise for the diagnosis and/or treatment of a wide range of diseases or medical conditions.

With ever-changing national regulations, data standards, and complexities around preparing for regulatory submissions, regulatory affairs organizations in the healthcare and life sciences industry are convinced and driven towards smarter processes and intelligent systems to optimize costs, maximize accuracy and minimize timelines for the submission. Addressing the concern, regulatory information management, RIMTrack, is a cloud-ready artificial intelligence (AI) based new age regulatory information management system. It’s developed from scratch with the mission to help organizations to prepare submissions accurately and efficiently and by streamlining the regulatory processes related to tracking, licensing, approvals, regulatory and competitive intelligence, clinical trials, and reporting across global sites and stakeholders. Integrate with existing RIM system and achieve complete end-to-end management of regulatory life cycle process.

ViSU™ is a cloud based End-to- End Regulatory Information Management (RIM) platform designed specifically for the medical device industry enabling global users to access and manage Regulatory Data (Product Master, Registrations, Tracking), Dossiers/Tech Files (Submission planning, building & life cycle), HA/NB correspondence, Obligations tracking, UDI, eIFU, Reg Requirements DB and Change Control. ViSU helps you embrace digitization in regulatory that delivers connectivity, traceability and automation leading to regulatory management efficiency, less compliance risks & cost reduction.

Rimsys is bringing regulatory order to the medtech industry. The Rimsys Regulatory Information Management (RIM) platform digitizes and automates regulatory activities, freeing teams from inefficient administrative work, and helping them confidently establish and secure global regulatory compliance. Unlike complex, color-coded spreadsheets, or expensive external consultants, Rimsys seamlessly centralizes all regulatory information, automates submission processes, and monitors relevant expirations, standards, and global regulations. Traditional approaches to regulatory affairs can’t keep pace with the growing complexity of the global landscape, and overburdened teams face increasing compliance risks. Rimsys streamlines all regulatory activities including registrations, essential principles, UDI, standards management, and regulatory intelligence in a single, integrated platform.

Essenvia drives business value and brings cross-functional efficiency gains to all teams and departments. Centralized repository for all regulatory information, enabling collaborative authoring and reporting while eliminating technical holds, RTAs, and RFIs. Empowerment of regulatory affairs department to accelerate product launches and eliminate revenue loss due to submission delays and missed renewals. Helicopter view of the total regulatory lifecycle. Executive dashboards, metrics, and proactive alerts for global registrations, submissions, and change assessment. Essenvia is a RIM Platform that enables you to manage regulatory workflows across the total product lifecycle, accelerate global market access, and generate exponential business value. Consolidate your regulatory activities into one centralized platform and bring your devices to market faster. Central repository for all registration docs linked to product master data. Manage product registration lifecycle by country.

All-in-one global regulatory affairs system, complete with registration management software and worldwide assistance from regulatory experts. The registration system you need to initiate, renew, amend or transfer your medical device or IVD market access approval. LICENSALE®‘s intuitive user interface with real-time data includes complete project management, infographic analytics, an effective collaboration platform, future market access planning and advanced reporting. It puts you in control of your global medtech registration activities. Arazy Group “in-country” regulatory experts review your compliance documents, assisting in the preparation and submission of your applications. They work with authorities until you obtain your desired marketing approvals. LICENSALE® includes submission and compliance requirements specific for your product in over 140 countries as well as regulatory experts to assist with each of these markets.

Samarind RMS provides a smarter way to manage your medical product information. Using Samarind RMS, you only need to enter data once and can reuse it as many times as required. For example an ‘INN’ can be entered once and reused for all related IMA submissions, renewals, variations, PSURs and XEVMPD submissions. This concept applies to all key data held within the system and is proven to streamline workflows and help to increase data quality. Our pragmatic approach to systems design and implementation means that our customers can manage their licenses smoothly and efficiently, safe in the knowledge that our single-place-of-truth™ approach for regulatory affairs professionals delivers a complete end-to-end system. An electronic document management system (EDMS) with version control, template creation and the ability to link to external document management systems such as Documentum™ or SharePoint™.

End-to-end regulatory information management on a single platform. The Vault RIM Suite streamlines global regulatory processes on a single, cloud-based platform, enabling life sciences companies to improve visibility, data quality, and agility. Respond faster to changing regulations and increase process efficiency from submission planning to publishing. Coordinate regulatory efforts across HQ, affiliates, and partners within a single RIM system. Ensure teams are developing reliable regulatory content with high data integrity. Veeva Vault Registrations manages product registration data worldwide, including registration status, variations, and health authority interactions. Veeva’s flexible data model accommodates IDMP data points and will continue to support evolving regulatory data standards. Veeva Vault Submissions streamlines submission planning through approval by automating regulatory process steps.

Kalypso provides life sciences companies with a cost-effective accelerator for a RIM system implementation - Accel for RIM. The solution enables an integrated platform to effectively manage and track product registrations, accelerate and improve the submissions accuracy, manage global UDI information, and enable efficient product distribution. It consolidates compliance and quality data from various enterprise solutions into a global source of truth for product registrations and tracking to accelerate regulatory submissions. Deployed using modern APIs to aggregate product data, regulatory documentation and submission packages. Pre-configured for rapid implementation with a validated software system. Based on industry-leading RIM practices and implementations.

DXC RIM platform manages regulatory affairs content, data, and workflows in one central location, helping teams accelerate innovation and reduce time to market. The sensitive nature of regulatory affairs (RA) content demands a unified platform to handle regulatory data and workflows. Teams need simple, always-ready access to all relevant data. They also require an intuitive, customizable user interface that is easy to navigate. Collaborative tools and configurable reporting are crucial for success, but legacy technology can frustrate teams and slow processes. Achieving compliance is a struggle. Collecting data and documenting processes is time-consuming. Problems are compounded when life sciences organizations run fragmented legacy systems using disparate technologies. In some cases, they need to resort to spreadsheets to manage key operational processes. Bringing products to market and managing RA requires a centralized, enterprise-grade solution.

Everything you need to successfully register your medical device or IVD product in any market around the world and manage your market access license through the product life cycle. REGISLATE® provides users with medical and IVD device-specific at country-specific complete submission file requirements. Users can manage milestones, timelines and estimated and actual completion dates for initial registrations, renewals, amendments and license transfers in real-time. Infographic data and proprietary indicators for clear monitoring and management of each project are available. Utilize collaboration tools for preparation and review of submissions, compliance requirements and documents. Recieve progress reports in real-time for current and future submissions including market access readiness index. REGISLATE® includes GR-MAP registration tracking for both country and product.

RegDocs Connect gives your operational and regulatory teams the tools they need to prepare complete and compliant submission ready documents and records. Built with the end user in mind, collaboration, automation and quality are the foundation of this solution. Automated workflows manage your records lifecycle from draft to final, enabling your team to be in complete control of your regulatory documents at all times. Mapping of document types to the EDM reference model and eCTD facilitates organization and retrieval of documents for inclusion in regulatory submissions. Proprietary tools such as PDF/A Publishing, document classification, and unique document identifiers provide a powerful regulatory document management solution that pulls information from across your organization, into one manageable solution. With the rise of electronic submissions to regulatory agencies and the increased complexity of drug development, the ability to produce submission-ready, quality content

Imagine all of your regulatory information regarding products, registrations, submissions, correspondence and commitments in one centralized place accessible from anywhere. With Ennov RIM, life sciences companies can streamline their regulatory processes, improve their data quality, quickly answer business-critical questions and effectively respond to health authority requests. Ennov RIM is a purpose-built application (based on Ennov Process) for the management and tracking of therapeutic product details and registration information. Whether you are planning the launch of a new product or handling variations to existing registrations, Ennov RIM provides Regulatory personnel with the key information and functionality to effectively manage your product portfolios worldwide.

RIMExpert™ addresses regulatory planning, tracking and data management by managing the global rollout plans and automating the creation of regulatory applications, activities and medicinal products, RIMExpert™ reduces data entry needs, improving data quality and increasing global oversight and control. Standardize regulatory planning, tracking and registration management processes. Strengthen collaboration between headquarter(s) and affiliates. Create one common place to work in all registration activities. Having one access point to all activities, questions, commitments, correspondence and authorizations for every application. Synchronize efforts for maximum efficiency of enterprise regulatory resources. Control registration activities throughout the lifecycle of the product keeping abreast of timelines and status of commitments and agency questions. Interactive dashboards for actionable regulatory activities and registrations overview.

Dow Jones Risk & Compliance is a global provider of best-in-class risk data, web-based software applications and scalable due diligence services that help organizations manage risk and meet regulatory requirements related to financial crime, third-party risk management, sanctions and international trade. Built on the legacy of one of the world’s most trusted newsrooms, Dow Jones Risk & Compliance combines the expertise of a multilingual research team with industry-leading data scientists and technologists to provide actionable content structured specifically for compliance needs. Our solutions were developed in partnership with top legal and political advisors — including former regulators — to help our clients maintain consistency across global business units and teams.

PhlexRIM will dramatically improve compliance with efficient and effective real-time access to your global registration information. PhlexRIM 2.0 contains a library of pre-configured automation assistants, or “bots,” as well as built-in regulatory use cases based on industry best practices. Utilizing an intuitive drag-and-drop design tool, regulatory teams can automate their business processes without programming knowledge or IT support. Manage the lifecycle of pharmaceutical product registration activities. Get extensive status information and use the alert management which is included in all workflows. Illustrate reports using standard reports or design your own reports. Create and assign regulatory tasks across your organization – for management, departments, headquarters, and affiliates.

OpenText™ Information Management solutions help life sciences organizations leverage insights from data and content to improve decision-making processes and accelerate product development. Integrate, manage, and securely exchange data across people, systems and things. Leverage information assets from R&D to commercialization. Freedom of choice with cloud-native software that can run anywhere. OpenText for life sciences accelerates the discovery process by extracting actionable insights that drive pipeline innovation. Capture and manage research papers into electronic lab notebooks with intelligent capture. Find insights with text mining. Extract knowledge trapped in the unstructured text contained in clinical trial reports, study protocols, clinical safety and efficiency findings. Find out how to intelligently analyze, classify and extract clinical trial documents to reduce the risk of costly stops and starts.

Accelerate speed to market by planning, executing, and tracking all regulatory activities in a single, unified RIM application, with seamless access to regulatory documents and full support for all major eCTD submission requirements. Built-in automation streamlines workflows to reduce administrative burden and provide greater confidence in product registration data quality. Accelerate speed to market by planning, executing, and tracking all regulatory activities in a single, unified RIM application, with seamless access to regulatory documents and full support for all major eCTD submission requirements. Built-in automation streamlines workflows to reduce administrative burden and provide greater confidence in product registration data quality.

AmpleLogic Regulatory Information Tracker is built on the LOW CODE AND NO CODE (LCNC) PLATFORM and comprises two modules: ANDA and DMF Tracker. This Pharmaceutical RIMS Software can help you improve the quality of your data, boost operational efficiency, decrease mistakes, and streamline communication across departments.

The RecordPoint Data Trust platform helps highly regulated organizations manage records and data throughout their lifecycle, regardless of system. The customizable platform is comprised of records management and data lineage tools that work together to give you full context of your data. RecordPoint’s capabilities span six core areas, which are the essential building blocks for solid data governance - data inventory, categorization, records management, privacy, minimization, and migration.

harmon.ie makes it easy for knowledge workers to capture and classify emails and documents to SharePoint and Teams directly from Outlook, the place they already spend their work time. As such, it is easy to discover and share important content when needed, right from the email client. By making it easy to do the right thing, harmon.ie increases SharePoint adoption, workplace productivity, as well as information governance and compliance. That is why thousands of enterprise customers count on harmon.ie's SharePoint and Office 365-based user experience products for email and records management, collaboration, knowledge retention, and SharePoint adoption. harmon.ie has won numerous Microsoft Best App awards and is a long time Microsoft Partner. Our flagship solution breaks down data silos from Office 365 apps, by grouping information using Descriptive Labels. harmon.ie SmartAssistant helps organizations bring together all their information so employees can focus on work

Streamline your regulatory processes with our new, end-to-end regulatory information management system, IQVIA RIM Smart. Free your team from labor-intensive maintenance to focus on delivering valuable products to market. RIM Smart is the modern regulatory information management solution built to increase speed, collaboration, efficiency and visibility across your entire global portfolio, improving performance at a lower cost. Delivered securely in the cloud, IQVIA RIM Smart provides interconnected, comprehensive and intelligent management of the entire regulatory process. IQVIA safety and quality platform integration will heighten performance and enhance flexibility. Automate manual processes and increase connectivity for improved efficiency, cost savings, and better coordination and cross-enterprise visibility.

Regulatory functions hinge on high-cost contributors across a variety of regulatory content. A cloud-based offering like Infosys regulated document management platform is the perfect solution to this problem. Externalization, collaborative authoring and editing. Simplify governance, processes, and implement consumption-based commercial model; provide support for audit trails. Create custom workflows, and provide support for versioning; implement a proven solution with 99.95% guaranteed uptime in production. Our solution enabled business users to search documents from a vast repository within 3/4 seconds. The new system also offered users unlimited on-demand storage. The DMS uses Google application programming interfaces (APIs) to reduce operational and maintenance costs. The company’s overheads are limited to API usage and storage space.

EXTEDOpulse is a comprehensive RIM software solution consisting of five hubs that address every step of pharmaceutical product development. Use the applications individu­ally or gain additional value by using them together based on your requirements. Developing pharmaceutical products can be a multi-faceted process, involv­ing input and efforts from across an organization. The complexities of operat­ing within a highly regulated industry only further compound the challenges that a life science organization faces with every release. Having our finger on the pulse of the life sciences anatomy allows us to provide you with great synergy, connection and innovation for effortless compliance. EXTEDOpulse has been designed with these aspects in mind to help you connecting the dots throughout the entire lifecycle of pharmaceutical products. EXTEDO understands the complexities of the regulated pharmaceutical product journey.

Secure Multi-Data Archiving from a Single Interface OneVault archives email AND all the new data types your organization uses today. Email, Instant Messaging, Teams, Zoom, Webex & more. With OneVault you get a single interface to archive from many systems. Important data is centralized in a secure cloud platform that makes it easy to orchestrate consistent policies that also supports your business continuity plans. The single pane of glass for managing and working with records makes e-Discovery process secure, accountable, and best of all, intuitive to use. OneVault incorporates the powerful features of our stand-alone archiving solutions under a single pane of glass in an intuitive, secure, and scalable system. Start with email, expand as new systems are adopted where retention will either be required for compliance or just for ensuring access to de-facto operational commitments.

Keep all your documents and drawings in one place with our top-performing enterprise document management software. Meridian provides a single source of truth, configurable workflows to streamline collaboration with all internal departments and ensures every document change is versioned and audited to demonstrate regulatory compliance. Engineering document management is the process of effectively searching for, finding and managing the complex engineering documents – including CAD files, drawings, designs, technical documents and communication documents, that exist in AEC organizations (Architecture, Engineering & Construction). Effective engineering document management can often be difficult for businesses in these industries. Meridian’s document management system for engineering projects can resolve these concerns. Meridian can centralize an organization’s relevant documents and drawings while automating key processes.

At Calyx, we know that the success of your clinical development program comes down to data. Which makes the effectiveness of your electronic data collection (EDC) system key. Used in over 2,600 worldwide clinical trials, Calyx EDC streamlines clinical trial data collection and reporting—in one easy-to-use platform. Don’t trust your important data to just anyone. Contact us to learn how Calyx can propel your program’s success. Calyx EDC gives you the flexibility to easily plan, design, and conduct studies, regardless of their complexity. With features that help reduce costs, improve site visibility, and drive efficiency, Calyx EDC keeps your trial on track.

Choose just the solutions you need right now. Later on, you will be able to add more capabilities with no problem. The LORENZ Foundation handles Controlled Vocabularies, Repository Management, Interoperability Management and User Management by centrally streamlining system management as well as maintenance and deployment. Benefit from a network of specialized systems that harmonize with each other. LORENZ solutions work flawlessly with third-party software, giving you the flexibility to choose your perfect fit even outside of the LORENZ portfolio.

Actionable insights, driven by the industry's #1 AI-powered clinical analytics platform, enable your teams to manage risk and improve performance across studies, systems, sites, and vendors. State-of-the-art clintech from Saama is designed to streamline your workflows, automate time-consuming processes, and improve collaboration across clinical operations, medical review, data management, biostatistics, and pharmacovigilance. Sponsors and CROs rely on Saama for data aggregation and artificial intelligence solutions that lead to better decision-making, eliminate delays, and significantly shrink drug development costs and timelines. Saama can put you on the fast track to clinical trial process innovation. When all your clinical data is in one place and updated in real time, life’s much easier for your ClinOps and medical review teams. Data Managers have been underappreciated for too long. Eliminate manual work so they can pay attention to the data points that matter.

Remove inefficiency, complexity, and manual repetitive tasks from your localization process with the all-in-one Lionbridge Translation Management Platform, where you can automate your workflow, track your tasks, and view project status updates in a central online portal for all your translation projects. To translate your highly regulated content, you need to ensure it satisfies regulatory requirements and resonates with your global readers. Whether you need legal translation services, financial translation services, or translation services for the life sciences industry, Lionbridge can help. Our clinical trial translation services teams translate the full range of documents related to clinical trials, whether they contain scientific, medical, legal, or plain language content. We translate and validate primary, secondary, and tertiary labels for investigational drugs, placebo, comparator drugs, or auxiliary medicinal drugs used for clinical protocol endpoints.

A web based software that uses Quality Risk Management to organize, analyze and trace Quality information directly to the specific risk it represents to the patient and drug product. Why Us? CINCO, a risk-based quality management software for the Life Sciences Industry. It provides paperless traceability of every critical to quality aspect of a drug or medical device to enable transparent quality decisions at every moment. Why Risk Management? Quality Risk Management is methodology that provides an objective approach into identifying and mitigating the risks of a drug or medical device manufacturing process. It is currently required by most regulatory agencies. However, the paper-based approach the Life Sciences Industry currently uses its ineffective in managing the significant and valuable risk data. It is prone to errors, introduces too much friction to the users and ends up not adding the potential value to the operations. On-demand access to what is critical to the product qua

Ennov Regulatory Suite, a world-class regulatory content and information management is a unified, centralized, end-to-end solution that is robust enough to support the regulatory information workflow from the earliest stages of research and development through market authorization. It is a common principle shared by companies striving to achieve regulatory operational excellence. These companies understand that an such a solution will help them drive harmonization, promote standardization, improve collaboration, ensure compliance, eliminate waste, reduce costs, accelerate product release and allow them to operate and compete more effectively in global markets. The Ennov Regulatory suite combines the power and flexibility of Ennov Doc, Ennov Dossier and Ennov Process to support the entire regulatory product lifecycle from the early planning of registration targets through product retirement. The Ennov Regulatory suite is an invaluable tool for regulatory activity planning.

ClinicalWave.ai built on AWS cloud platform is an integrated AI platform tailored for life sciences organizations. It offers automated redaction and extraction of sensitive data and leverages cutting-edge NLP technology to extract valuable insights from clinical documents, streamlining your workflows like never before. It consists of: 1. ClinRedact AI- Our Redaction product which automatically identifies and redacts sensitive information in clinical documents, saving time and ensuring data integrity. 2. ClinExtract AI- The AI Data Extraction product that utilizes NLP and machine learning to extract relevant data points from clinical documents, providing valuable insights and streamlining workflows. 3. ClinDICOM AI- Experience the power of our feature-rich DICOM data extraction and redaction product offering targeted redaction, customizable rules, intelligent contextual analysis, audit trail compliance, redaction preview, and a user-friendly interface.

Nimonik offers access to standards from 40 + standards development organizations such as ISO, IEC, API, IPC, ACI, IEEE, ASTM and many others. Nimonik also offers access to laws and regulations from 40+ countries and 500 states and provinces around the world. This data is integrated into Nimonik's workflow tools and enables companies to properly manage their compliance and issue management reports. Global Standards and Regulatory Compliance Software. Software that helps organizations identify, extract, and organize requirements from regulatory documents, industry standards, contracts, and permits. Compliance Management System and Audit Software. A centralized platform for managing compliance obligations, conducting audits, and ensuring adherence to regulations and standards. Regulatory Updates Newsletter & Library. A service providing updates on regulatory changes and trends, helping businesses stay informed and compliant with the latest regulations.

Our Pharmacy Information System will help you modernize your operations, improve patient safety and medication charge collection without increasing manpower requirements. CLIN1 Pharmacy allows you to do more with the same resources. Let us help you with your documentation, whether it be repackaging, medication order review, interactions or pharmacist interventions. Don't put your facility or yourself at risk. In order to understand how and where your medication and medication order related issues are coming from, you need to collect the appropriate data. Instead of using Excel or some other "general purpose" application that, while capable, still leaves a mountain of manual processing to deal with; why not use an application designed specifically to collect, process and interpret exactly what you need to be tracking.

Clinevo electronic Trial Master File (eTMF) is an easy-to-use electronic Trial Master File in electronic (digital content) format for organizing and storing documents, images, and other digital content of clinical trials. Clinevo electronic Trial Master File (eTMF) has an inbuilt DIA reference model and meets regulatory guidelines. Clinevo MICC Intake is a web-based tool for Medical Information Call Center (MICC) and PV users to Log, Track and Monitor Product Quality Complaints (PQCs), Medical inquiries (MIs) and Adverse Events (AEs). Clinevo Safety is a cloud-based, user-friendly, easy-to-use, regulatory-compliant end-to-end Pharmacovigilance / Drug safety system. The All-in-one system provides PV Intake, Case Processing, Regulatory Submissions / AS2 Gateway, Analytics, and Safety signals capabilities under one platform. Clinevo Website Intake is a web-based tool which can be connected to Sponsor / CRO websites to provide Consumers and Reporters a User friendly web interface.

RQM+ is a global medical technology service provider focused on accelerating compliance and market success. Through our unparalleled expertise and industry knowledge, we deliver specialized solutions and expedite the journey along the full product lifecycle for medical technology companies, from concept to commercialization to post-market. Our portfolio of services enables the delivery of end-to-end solutions across the complete medical device product lifecycle. RQM+’s quality assurance engineers review material lists, set up suppliers, and support the design change process. RQM+’s design quality engineers help support packaging, sterility, biocompatibility, and device testing that may be needed. RQM+’s regulatory affairs consultants provide guidance and help with submissions to the FDA, notified bodies, or other government agencies. We use our extensive experience with the latest reimbursement requirements and value-based compensation models.

ClinAccess™ 5.1 is the next generation of our industry leading Clinical Data Management System based entirely on SAS® 9. It leads the way in simplifying clinical data management, clinical trial analysis and preparation of electronic submissions. Having your data keyed directly into SAS® data sets enhances your staff’s productivity by eliminating the time spent transfering data from Oracle/SQL into SAS. ClinAccess™ is designed expressly for ease-of-use study definition, data entry and management with features to monitor the progress and quality of ongoing clinical trials. Whether for review, analysis, or FDA submission, your data is always in SAS®and ready for analysis. The database structure is designed to support and accelerate statistical analysis and reporting. The result is less time and effort for data analysis and a shorter time to market. For reliability, auditing and security, there is no better solution than ClinAccess™.

Our SmartInsights™ Global Market Access Platform is an online subscription service created for you to quickly and easily access current, accurate and complete regulatory requirements for global market access. The information is presented in a user-friendly interface tailored to help you achieve global compliance. Immediate access to critical regulatory data and information for effective day-to-day management of multistage product development life cycles and strategic business decisions, such as entering new geographic markets or introducing a new line of products. Up-to-date information on an ever-changing regulatory landscape, with easy access to new or updated regulations for your product category. Information in the database is continually updated to provide you with timely and current requirements. Access is customized based on the countries and product categories you need.

Cloudbyz Safety & Pharmacovigilance Solution is a cloud-based software solution designed to streamline the drug safety and pharmacovigilance operations for pharmaceutical and life science companies. The solution helps to automate the process of collecting, processing, analyzing and reporting adverse event data in compliance with global regulatory requirements. Cloudbyz Safety & Pharmacovigilance Solution enables companies to reduce risk, improve compliance, and enhance patient safety while accelerating drug development. Cloudbyz provides end-to-end management of the pharmacovigilance lifecycle, including adverse event processing, case management, regulatory reporting, signal detection, and risk management. With Cloudbyz, you can optimize your pharmacovigilance processes, accelerate case processing, and increase the accuracy of your safety data, while minimizing risk and ensuring compliance.

Moody's Analytics regulatory reporting solution delivers comprehensive, automated, and streamlined regulatory reporting for Basel I, II, and III, IFRS 9, and ECB, CCAR, and DFAST stress testing. It supports regulatory reporting to over 50 regulators globally. This award-winning solution leverages Moody's Analytics data management platform and regulatory capital calculation engines to deliver accurate, streamlined, and automated regulatory reporting. It consolidates the regulatory capital calculations banks need to populate a wide range of regulatory reports, helping banks align their regulatory reports and ensuring they present a consistent picture across multiple reporting regimes. Its report templates handle complex banking regulatory reports and support a range of reporting of formats including Microsoft Excel, XBRL, ASCII, and others. Leveraging powerful OLAP data cubes allows reporting managers to view results across the entire business.

adWATCH - AE helps pharmaceutical organizations manage and report adverse events that occur during clinical trials. adWATCH - AE gives the reporter at a clinic, hospital, or investigative site a fast and effective means of generating and managing Adverse Event Reports (AERs) and reporting to the regulatory departments and government agencies. An adverse effect is a negative or dangerous effect experienced by a patient and caused by drugs and/or medical devices. Adverse event reporting requires the tracking of all medical complaint case information, resulting in the generation of MedWatch reports, CIOMS reports and additional reports for management. adWATCH - AE allows researchers, physician investigators, Contract Research Organizations (CROs), clinical trial specialists, and other health professionals to produce and file AERs in the FDA mandated MedWatch and/or CIOMS format.2

VerifyRx is a real-time, compliance-driven prescriber verification solution, designed specifically for pharmacies and PBMs, that seamlessly integrates into existing workflows. VerifyRx processes millions of transactions a day, updating comprehensive prescriber data in real-time, including Drug Enforcement Administration (DEA) and State data (when available) and daily National Technical Information Service (NTIS) data. As part of the pharmacy workflow, VerifyRx processes millions of transactions a day, updating comprehensive prescriber data in real-time, including Drug Enforcement Administration (DEA) and State data (when available) and daily National Technical Information Service (NTIS) data. The highly configurable and responsive tool provides real-time compliance checks on all prescription transactions before they are transmitted to payers, helping retail and specialty pharmacy reduce regulatory risk. It identifies potential claims submission errors prior to dispensation.

Improve your biomedical research with the world’s most comprehensive biomedical literature database. More biomedical evidence by searching comprehensive, relevant, and up-to-date biomedical research. Create systematic searches and automate query building using intuitive search forms. Uncover drug-disease relationships and drug-drug interactions, manually curated from deep indexing. The accelerated pace of biomedical research and development demands comprehensive information. You anticipate risk by assessing everything that is known. You track safety to meet regulations. You uncover connections to push innovations. Embase is a unique medical literature database where comprehensive goes beyond content. With Emtree indexing of full-text content and dedicated search terms, you find all relevant and current results. This includes information that may not be uncovered in other databases. Scroll down to find out why regulatory agencies recommend Embase in their best practice guidelines.

Compliance Suite platform is a powerful and dynamic technology solution that assists in the preparation and submission of the Securities and Exchange Commission’s Form N-PORT, Form N-CEN, Form N-MFP, and Form PF, as well as other regulatory filing requirements, such as Annex IV of AIFMD and CFTC, and NFA Form CPO-PQR. It also features robust risk management, performance monitoring, and pipeline and relationship tracking needs of the asset management industry. This intuitive, easyto-use, and scalable solution provides the flexibility that is essential for today’s rapidly evolving business, risk, and regulatory landscape. Compliance Suite’s user-defined architecture allows the system to be extended to other value-added uses beyond the regulatory filing process. Data repository for internal risk management and investor reporting information. Includes user customizable dashboard and fund performance charting functionality.

ClinLab is a Windows-based, Internet and Web-enabled Laboratory information management system. It acts as a data warehouse for all your lab results and includes reporting, data acquisition, label printing, electronic signoff and more. It provides numerous interface capabilities to a multitude of reference labs and practice systems. It can be used at a small practice, large practice, a reference laboratory and can be just as easily deployed at a full Internet presence lab. ClinLab’s highly secure remote access features allows it to connect to multi-location databases to view patient orders and results from any location. Clinlab is dedicated to helping you improve your laboratory productivity and compliance, whether it be CLIA and/or CAP.

Monitor business operations, minimize risk, and support health and wellness initiatives to simplify store operations analysis and reporting. Our solutions drive real-time, point-of-sale actions with robust analytics to reveal insights into all areas of pharmacy business to improve margins, reduce costs, and streamline operations. Optimize pharmacy operations with a comprehensive suite of technology solutions to improve financial results. Simplify pharmacy billing and improve revenue cycle with tools for third-party submission and reconciliation, outsourced “chasing claims,” contract management, appeal submission, and tracking services. Optimize pharmacy operations to improve drug dispensing, patient engagement, and loyalty. Our solutions help provide streamlined drug dispensing, optimized revenues, and reduced direct and indirect remuneration fees (DIR) to ensure clinical and operational compliance and enhance patient engagement and loyalty.