Alternatives to ClinChoice

RegDesk is the most comprehensive AI-enabled RIMS platform for Medical Devices, Pharmaceuticals, and IVD companies. • Our proprietary Regulatory Intelligence for over 120+ countries is translated and accessible in a standard format. In addition, it provides alerts on evolving regulatory changes • Our AI-powered Application Builder allows RA teams to prepare and publish global applications in 1/10th of the time • Our Change Assessment capability helps RA teams understand the impact of the change(s) on an existing product(s) and the action required • Our Distributor Collaboration provides seamless workflow solutions to interact, communicate, and share documents with external business partners • Our Standards Management makes it easy for RA teams to search and manage not only international but also country-specific standards • Our Tracking & Reporting functionality allows teams to track regulatory projects across the globe, receive renewal notifications, and generate reports on KPIs within seconds For more information, visit our website.

Adaptive Compliance Engine® (ACE®) is a highly configurable, workflow based eQMS/eDMS and more that can adapt to any business process, allowing for real-time tracking, management, and reporting of all compliance, quality, and operational activities. With ACE®, you will minimize the administrative hassles and maximize ROI with productivity gains from day one – all while 21 CFR Part 11 compliant. 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! 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. 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.

ClinCapture's mission is to create software that saves lives. ClinCapture's technology reduces the cost of clinical trials. It streamlines data capture and protects patient privacy. Clincapture is a platform that facilitates the evaluation and development drugs, biologics and devices that have the potential to treat a wide variety of medical conditions or diseases.

Five of the most important regulatory agencies in the United States use MasterControl Quality Excellence solutions. A leading software-as-a-service (SaaS) provider, MasterControl helps companies get their life-improving products to market sooner. It does this by providing cloud-based solutions that manage an organizations documents, training and exams, corrective/preventive action, validation, and more. MasterControl offers solutions throughout the product's entire lifecycle.

ViSU™, a cloud-based End-to End Regulatory Information Management platform (RIM), is specifically designed for the medical device industry. It allows global users to access and manage regulatory data (Product Master and Registrations, Tracking), Dossiers/Tech files (Submission planning and building & lifecycle), HA/NB correspondence and Obligations tracking. ViSU helps you embrace digitalization in regulatory. It provides connectivity, traceability, and automation which leads to regulatory management efficiency, lower compliance risks, and cost reduction.

The regulatory affairs departments in the healthcare and life science industry are driven to improve efficiency and create intelligent systems that optimize costs, maximize accuracy, and reduce submission times. RIMTrack, a cloud-ready, artificial intelligence (AI)-based, new age regulatory information management system, addresses this concern. It was created from scratch to assist organizations in preparing submissions accurately and efficiently. It streamlines regulatory processes related to licensing, approvals, regulatory, competitive intelligence, clinical trials and reporting across global stakeholders. Integrate with existing RIM systems to achieve complete management of the regulatory lifecycle process.

Global regulatory affairs system that includes registration management software and support from regulatory experts around the world. This registration system is required to renew, amend, transfer, or modify your IVD market access approval or medical device. The intuitive user interface of LICENSALE®, which includes real-time data and infographic analytics, allows for project management, collaboration, future market access planning, advanced reporting, and effective project management. It allows you to take control of your global medical technology registration activities. Arazy Group's "in-country regulatory experts" review your compliance documents and assist in the preparation of your applications. They will work with authorities until you receive your desired marketing approvals. LICENSALE®, which includes compliance and submission requirements for your product in over 140 countries, as well as regulatory experts to help you with each market.

Essenvia delivers business value to all departments and teams, and increases efficiency across the board. Centralized repository of all regulatory information allowing collaborative authoring, reporting, and eliminating technical holds, RTAs and RFIs. The regulatory affairs department is empowered to accelerate product launches, and eliminate revenue losses due to delays in submissions and missed renewals. Helicopter view over the entire regulatory lifecycle. Executive dashboards, metrics and proactive alerts are available for global registrations and submissions. Essenvia, a RIM Platform, allows you to manage regulatory workflows throughout the entire product lifecycle. It also accelerates global market access and generates exponential business value. Consolidate all regulatory activities onto one platform to bring your devices faster to market. All registration documents linked to product master information are stored in a central repository. Manage the product registration lifecycle per country.

Rimsys provides a single, cloud platform for end-to-end regulatory process digitization and automation. Designed by and for regulatory affairs professionals, Rimsys helps medtech companies reduce repetitive administrative work, speed time to market, respond faster to changing regulations, and drive alignment across internal teams, affiliates, and partners. Only Rimsys provides a holistic platform that supports a full range of regulatory activities. Use regulatory intelligence and digital templates to guide regulatory strategy and streamline submissions. Create compliant, submission-ready content, and consolide PDF packages for electronic and print submissions. Digitally collect and maintain evidence of compliance. Link to relevant standards and get notified of changes. Get notified of changing standards, laws, regulations, and guidance documents that impact your products. Create self-service application, product, and country reports to see exactly where your products can be sold and their current registration status.

Samarind RMS is a smarter way for you to manage your medical product information. Samarind RMS allows you to only enter data once, and you can reuse it as often as necessary. An example of this is the 'INN' which can be used once and reused for all IMA submissions, renewals and variations. This concept is applicable to all key data within the system. It has been proven to improve data quality and streamline workflows. 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), which includes version control, template creation, and the ability to link with external document management systems like Documentum™, SharePoint™.

Kalypso offers life sciences companies a cost-effective accelerator to implement a RIM system - Accel for RIM. The integrated platform allows for efficient product distribution and management, as well as a global platform to track and manage product registrations. It consolidates compliance data and quality data from different enterprise solutions into one global source of truth to facilitate product registrations and tracking in order to speed up regulatory submissions. Modern APIs are used to combine product data, regulatory documentation, and submission packages. Pre-configured for quick implementation with a valid software system. Based on industry-leading RIM practices.

End-to-end regulatory information management from a single platform. The Vault RIM Suite streamlines global regulatory process on a single cloud-based platform. This allows life sciences companies to increase visibility, data quality, agility, and efficiency. You can respond faster to changes in regulations and improve process efficiency, from submission planning to publication. Coordinate regulatory efforts across HQ and affiliates within a single RIM platform. Assure that teams are creating reliable regulatory content with high data integrity. Veeva Vault Registrations manages product data worldwide, including variations, registration status, and interactions with health authorities. Veeva's flexible data structure supports IDMP data points, and will continue to support changing regulatory data standards. Veeva Vault Submissions automates regulatory process steps and streamlines submission planning.

All the information you need to register your IVD product or medical device in any market worldwide and manage your market access licence throughout the product's life cycle. REGISLATE®, which provides information about medical and IVD device-specific submission file requirements for each country, allows users to manage their market access licenses through the product life cycle. You can track milestones, timelines, estimated and actual completion dates, as well as estimated and actual completion dates, for initial registrations, renewals, amends, and license transfers, in real-time. For clear monitoring and management, infographic data and proprietary indicators are available. Collaboration tools are available to assist with the preparation and review submissions, compliance requirements, and documents. Receive progress reports in real time for current and future submissions, including market access readiness index. REGISLATE®, which includes GR-MAP registration tracking, for both country AND product.

DXC RIM platform manages regulatory content, data and workflows in one central place. This helps teams accelerate innovation and reduces time to market. A unified platform is required to manage regulatory data and workflows due to the sensitive nature of regulatory affairs content (RA). All relevant data must be easily accessible to all teams. They also need an intuitive, customizable user interface that is simple to use. While configurable reporting and collaborative tools are essential for success, legacy technology can frustrate teams or slow down processes. Compliance is difficult. It is difficult to collect data and document processes. Life sciences organizations that use disparate technologies and have fragmented legacy systems can create problems. They may need to resort to spreadsheets in some cases to manage key operational processes. A centralized enterprise-grade solution is required to bring products to market and manage RA.

Imagine all your regulatory information about products, registrations and submissions, correspondence, and commitments in one central place, accessible from anywhere. Ennov RIM allows life sciences companies to streamline their regulatory processes, improve data quality, quickly respond to business-critical questions, and effectively responds to health authority requests. Ennov RIM, a purpose-built application based on Ennov Process, allows for the tracking and management of therapeutic product details as well as registration information. Ennov RIM gives regulatory personnel the essential information and functionality they need to manage product portfolios globally, whether you're planning to launch a new product or handle variations to existing registrations.

RegDocs Connect provides the tools for your regulatory and operational teams to create compliant, submission-ready documents and records. This solution is built with the end user in view. It focuses on collaboration, automation, and quality. Automated workflows allow you to manage your records from draft to final. This allows your team to have complete control over your regulatory documents at any time. The mapping of document types to the EDM Reference Model and eCTD allows for organization and retrieval of documents that can be used in regulatory submissions. The powerful tools of PDF/A Publishing, document classification, unique document identifiers, and EDM reference model facilitate regulatory document management. This solution pulls together information from all levels of your organization into one easy-to-use solution. The ability to produce submission-ready and quality content has become more difficult due to electronic submissions to regulatory authorities and the complexity of drug development.

PhlexRIM dramatically improves compliance by providing you with real-time, efficient and effective access to your global registration information. PhlexRIM 2.0 includes a library of pre-configured automation "bots" and built-in regulatory use case examples based on industry best practice. The intuitive drag-and drop design tool allows regulatory teams to automate their business processes without the need for programming knowledge or IT support. Manage the entire lifecycle of pharmaceutical product registration activities. Access detailed status information and make use of the alert management feature that is part of all workflows. You can either use standard reports to illustrate your reports or create your own reports. You can create and assign regulatory tasks to your organization for management, headquarters, and affiliates.

RIMExpert™, which addresses regulatory planning, tracking, and data management, manages the global rollout plans and automates the creation of regulatory activities, medicinal products, and regulatory applications. RIMExpert™, reduces data entry requirements, improves data quality, and increases global oversight and control. Standardize regulatory planning, tracking, and registration management processes. Increase collaboration between affiliates and headquarter. All registration activities can be done in one place. One point of contact for all applications, questions, correspondence, and commitments. To maximize the efficiency of enterprise regulatory resources, sync your efforts. You can monitor registration activities throughout the product's lifecycle, keeping track of deadlines, status of commitments, and agency questions. Interactive dashboards to monitor and control regulatory activities and registrations.

Dow Jones Risk & Compliance, a global provider, provides best-in class risk data, web based software applications, and scalable due-diligence services to help organizations manage risks and meet regulatory requirements in relation to financial crime, third party risk management, international trade, and sanctions. Dow Jones Risk & Compliance is built on the legacy of the world's trusted newsroom. It combines the expertise and knowledge of a multilingual team of researchers with the industry-leading data scientists, technologists and analysts to provide actionable compliance content. Our solutions were created in partnership with leading legal and political advisors, including former regulators, to help our clients maintain consistency among global business units and teams.

You can speed up the time to market by organizing, executing and tracking all regulatory activities within a single RIM application. This allows you seamless access to all regulatory documents and full support for all eCTD submission requirements. Automation is integrated to streamline workflows and increase confidence in product registration data quality. You can speed up the time to market by organizing, executing, tracking, and planning all regulatory activities in a single RIM application. This allows you seamless access to all regulatory documents and full support for all eCTD submission requirements. Automation is integrated to streamline workflows and increase confidence in product registration data quality.

AmpleLogic Regulatory Tracker is built using the LOW CODE AND NEUTRAL CODE (LCNC PLATFORM) and consists of two modules: ANDA Tracker and DMF Tracker. This Pharmaceutical RIMS Software will help you improve data quality, increase operational efficiency, reduce mistakes, and streamline communications across departments.

OpenText™, a leading provider of information management solutions for life sciences organizations, helps them to harness insights from data and content to improve their decision-making and accelerate product development. Integrate, manage and securely exchange data between people, systems, and things. Use information assets to drive innovation and commercialization. Cloud-native software can run anywhere, giving you freedom of choice. OpenText for life sciences accelerates discovery by delivering actionable insights that can be used to drive innovation in pipelines. Intelligent capture allows you to capture and manage research papers in electronic lab notebooks. Text mining can help you gain insights. Unstructured text in clinical trial reports, study protocol, clinical safety and efficiency findings, can be used to extract knowledge. Learn how to intelligently analyze and classify clinical trial documents and extract them to reduce the risk for costly stops and starts.

harmon.ie allows knowledge workers to easily capture and classify email and documents to SharePoint and Teams from Outlook, where they spend most of their work time. It is easy to find and share important content right from your email client. harmon.ie makes it easy to do the right things, increasing SharePoint adoption and workplace productivity as well as information governance compliance. Thousands of enterprise customers rely on harmon.ie's SharePoint- and Office 365-based user experiences products for email, records management, collaboration, knowledge preservation, and SharePoint adoption. harmon.ie is a Microsoft Partner since 2003 and has won many Microsoft Best App Awards. Our flagship solution eliminates data silos in Office 365 apps by grouping information with Descriptive Labels. harmon.ie SmartAssistant allows organizations to bring together all their information so that employees can concentrate on work.

Secure Multi-Data Archiving with a Single Interface OneVault archives email and all new data types that your organization uses today. Email, Instant Messaging and Teams, Zoom, Webex, and many other data types. OneVault gives you a single interface to archive from multiple systems. It is easy to organize consistent policies and support business continuity plans by centralizing important data in a secure cloud platform. e-Discovery is a single platform for managing and working with records. It is secure, transparent, and easy to use. OneVault combines the powerful features of our stand alone archiving solutions under one pane of glass. It is intuitive, secure, and scalable. Start with email and expand as new systems become available.

High-cost contributors are essential for regulatory functions. They can be found in a wide range of regulatory content. This problem can be solved by a cloud-based solution like Infosys' regulated document management platform. Externalization, collaborative authoring, and editing. Simplify governance and processes; implement a consumption-based model. Support audit trails. Implement a proven solution that guarantees 99.95% uptime in production. Our solution allowed business users to search documents in a vast repository in just 3/4 seconds. Users also had unlimited storage on-demand. To reduce operational and maintenance costs, the DMS uses Google's application programming interfaces (APIs). The company's overheads are restricted to API usage and storage space.

IQVIA Smart, our new end-to-end regulatory information management software, streamlines regulatory processes. Your team can focus on delivering high-quality products to the market instead of labor-intensive maintenance. RIM Smart, the modern regulatory information management system, is designed to improve speed, collaboration, efficiency, visibility, and performance across your entire global portfolio. It also reduces costs. IQVIA RIM Smart is a secure cloud-based solution that allows for interconnected, comprehensive, and intelligent management of all regulatory processes. IQVIA safety platform integration will increase performance and improve flexibility. Automate manual processes and increase connectivity to improve efficiency, cost savings and coordination as well as cross-enterprise visibility and visibility.

Our enterprise document management software is the best in its class. Meridian offers a single source for truth and configurable workflows that streamline collaboration with all departments. It also ensures that every document change is versioned, audited, and reported to the regulatory authorities. Engineering document management refers to the process of finding, finding, and managing complex engineering documents, including CAD files, drawings, technical documents, and communication documents, in AEC organizations (Architecture, Engineering & Construction). Businesses in these industries can find it difficult to manage their engineering documents effectively. Meridian's document management software for engineering projects can address these concerns. Meridian can centralize documents and drawings within an organization while automating key processes.

The RecordPoint Data Trust platform helps highly regulated organizations manage data throughout its lifecycle, regardless of system. We work with organizations in highly regulated industries to ensure their data is right where it should be - safeguarded for privacy, security, and governance.

Calyx understands that data is key to the success of any clinical development program. Your electronic data collection (EDC), system is crucial to your success. Calyx EDC is used in more than 2,600 clinical trials around the world. It streamlines data collection and reporting through one platform. Don't give your sensitive data to anyone. We can help you make your program a success with Calyx. Calyx EDC allows you to plan, design, and carry out studies of any complexity. Calyx EDC helps you keep your trial on track with features that reduce costs, improve site visibility and drive efficiency.

EXTEDOpulse, a comprehensive RIM software solution, consists of five hubs that address all stages of product development. You can use the applications separately or combine them to get additional value based on your needs. The development of pharmaceutical products can be complex and require input from many people. Life science organizations face many challenges due to the complexity of operating in a highly regulated industry. We are able to provide you with great synergy and connection, as well as innovation, for compliance. EXTEDOpulse was designed with these aspects in view to help you connect the dots throughout the entire lifecycle pharmaceutical products. EXTEDO is familiar with the complexities involved in the regulatory pharmaceutical product journey.

The industry's best AI-powered clinical analytics platform provides actionable insights that enable your teams to manage risk, improve performance across sites, studies, and vendors. Saama's state-of-the art clintech is designed to streamline workflows, automate tedious processes, and improve collaboration across clinical operations. Saama is trusted by sponsors and CROs for data aggregation, artificial intelligence solutions, and improved decision-making. This can help to reduce drug development costs and timeframes, as well as eliminate delays. Saama can help you get on the fast track for clinical trial process innovation. Your ClinOps and medical review team will find it much easier to access all of your clinical data in one place. Data managers are often undervalued. They can now focus on the data points that are important by eliminating manual work.

Select the only solutions that you need right away. You can add more capabilities later on. The LORENZ Foundation manages Controlled Vocabularies and Repository Management, Interoperability Management, and User Management. This centrally streamlines system management, maintenance, and deployment. You can benefit from a network that integrates with other specialized systems. LORENZ solutions are compatible with third-party software. This gives you the freedom to choose the perfect fit for you, even if it is not in the LORENZ portfolio.

ClinAccess™, 5.1 is the next generation in our industry-leading Clinical Data Management System, based entirely upon SAS®. It simplifies clinical data management, clinical trial analysis, and electronic submissions. Your staff will be more productive if your data is directly linked into SAS®. This eliminates the need to transfer data from Oracle/SQL into SAS. ClinAccess™, which is specifically designed for ease-of use, data entry, and management, includes features to monitor and track the quality and progress of ongoing clinical trials. Your data is always available in SAS®, ready for analysis, review, and submission to FDA. The database structure was designed to facilitate and accelerate statistical analysis. This results in less time and effort to analyze data and a shorter time to market. ClinAccess™ is the best solution for security, auditing, and reliability.

Ennov Regulatory Suite is a world-class solution for regulatory content and information management. It is a unified, centralized and end-to-end solution that supports the regulatory information workflow, from the earliest stages through market authorization. This is a common principle that companies who strive to achieve regulatory operational excellence share. This is because they know that such a solution will allow them to drive harmonization and promote standardization, improve collaboration and ensure compliance, eliminate waste and reduce costs, accelerate product releases, and allow them operate and compete in global markets more effectively. Ennov Doc, Ennov Dossier, and Ennov Process combine to provide support for the entire regulatory product cycle, from early planning of registration targets to product retirement. The Ennov Regulatory Suite is a valuable tool for planning regulatory activity.

RQM+, a global service provider for medical technology, is focused on accelerating market success and compliance. We deliver specialized solutions to medical technology companies and accelerate the journey along the entire product lifecycle, from concept through commercialization and post-market. Our portfolio of services allows us to deliver end-to-end products and solutions throughout the entire medical device lifecycle. RQM+ quality assurance engineers review materials lists, establish suppliers, and support design change processes. RQM+’s design quality engineers support any packaging, sterility or biocompatibility testing that may be required. RQM+ regulatory affairs consultants offer guidance and assistance with submissions to FDA, notified authorities, or other government agencies. Our extensive experience with the most recent reimbursement requirements and value based compensation models is what we use.

Software that allows you to track and organize Quality Risk Management information online. It uses web-based technology to trace Quality information to the specific risk it poses to the patient or drug product. Why Choose Us? CINCO is a risk-based software for quality management in the Life Sciences Industry. It allows transparent quality decisions by allowing for paperless traceability of all critical quality aspects of a drug or medical device. Why Risk Management? Quality Risk Management is a method that identifies and mitigates the risks associated with a drug or medical device manufacturing operation. Most regulatory agencies require it. The paper-based approach used by the Life Sciences Industry is ineffective in managing significant and valuable risk data. It is susceptible to errors, introduces too many friction to users, and does not add any value to the operations. Access to the most critical information about the product on-demand

Our Pharmacy Information System will allow you to modernize your operations, increase patient safety, and collect medication charges without increasing the manpower requirements. CLIN1 Pharmacy allows for more with the same resources. We can help you with all your documentation needs, including repackaging, medication order review and interactions, pharmacist interventions, and pharmacy intervention. Don't risk your facility or your life. You need to gather the data necessary to understand where and how your medication is coming from. Instead of using Excel, or another "general purpose" program that leaves you with a lot of manual processing, why not use an application specifically designed to collect, process, and interpret the data you need.

ClinicalWave.ai, built on AWS' cloud platform, is an integrated AI platform designed for life sciences companies. It uses cutting-edge NLP to extract valuable insights and automates the redaction and extraction sensitive data from clinical documents. It is made up of: 1. ClinRedact AI - Our Redaction Product that automatically identifies and removes sensitive information from clinical documents. This product saves time and ensures data integrity. 2. ClinExtract AI - The AI Data Extraction Product that uses NLP and Machine Learning to extract relevant data from clinical documents. This product provides valuable insights and streamlines workflows. 3. ClinDICOM AI - Experience the power and features of our DICOM data extraction product. It offers targeted redaction, customizable redaction rules, intelligent context analysis, audit trail compliance and a user friendly interface.

Clinevo electronic trial master file (eTMF), is an electronic Trial Master File in electronic format (digital content). It can be used to organize and store documents, images and other digital content for clinical trials. Clinevo electronic Trial Master File eTMF has an inbuilt DIA reference model that meets regulatory guidelines.

Yordas Hive is the best way to stay ahead of regulatory changes in chemical industry. Yordas Hive is the complete solution to chemical risk management and regulatory compliance. Yordas Hive provides access to the most current, accurate, and up-to date regulatory information on chemical substances as well as global regulatory lists. Our solutions integrate seamlessly with your company's data, allowing for centralization of chemical regulatory workflows and risk management in one place. Comprehensive chemicals management solution for businesses that have complex products or large portfolios. Unlimited training and implementation support, so you can be confident in your compliance starting from day one.

The all-in-one Lionbridge Translation Management Platform can help you automate your work flow, track your tasks, view project status updates, and eliminate inefficiency, complexity, repetitive tasks, and manual tasks from your localization process. You must ensure that your highly-regulated content is translated in accordance with all regulatory requirements. Lionbridge can provide translation services for the life sciences sector, as well as legal and financial translation services. Our clinical trial translation teams can translate any type of document related to clinical trials. We validate primary, secondary and tertiary labels of investigational drugs, comparator drugs or auxiliary medicinal drugs for clinical protocol endpoints.

Cloudbyz Safety & Pharmacovigilance Solution, a cloud-based solution, is designed to streamline drug safety and pharmacovigilance for pharmaceutical and life sciences companies. The solution automates the process of collecting data, processing it, analyzing it and reporting it in compliance with global regulations. 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. The benefits of our solution are listed below- 1. Improved Efficiency with Automation 2. Increased data accuracy 3. Real-time visibility 4. Improved Collaboration 5. Enhanced regulatory compliance

Monitoring business operations can reduce risk and support health and wellbeing initiatives. This will simplify analysis and reporting in store operations. Our solutions provide real-time point-of-sale action with robust analytics that reveal insights into all aspects of pharmacy business. This will help improve margins, reduce costs and streamline operations. A comprehensive range of technology solutions can optimize pharmacy operations to improve financial results. With tools for third-party submission, reconciliation, outsourced "chasing claims", contract management, appeal submission, tracking services, and contract management, simplify pharmacy billing. Optimize pharmacy operations for improved drug dispensing, patient engagement and loyalty. Our solutions allow for streamlined drug dispensing, optimized revenue, and lower direct and indirect remuneration (DIR) to ensure clinical compliance and patient engagement and loyalty.

No matter how experienced or novice you are with the regulatory submission process, you should not take the risk of your electronic common technical documents (eCTDs) being rejected lightly. This is especially true given the evolving regulatory environment. There are also differences in eCTD submission requirements by region. This makes it difficult to manage the entire document lifecycle and meet your organization's goals for accelerating your release to market. Certara's GlobalSubmit™, eCTD submissions management program, will give your regulatory team the tools to publish, validate, review, and approve your eCTD submitted documents. You can reduce risk and avoid unnecessary steps by using a simplified eCTD submissions process that supports your regulatory department as they race to meet deadlines to deliver treatment to patients. It is crucial that your eCTD submissions are filed as your regulatory department races for treatment delivery and deadlines.

adWATCH – AE assists pharmaceutical companies to report adverse events that may occur during clinical trials. adWATCH – AE provides a quick and efficient way for a reporter at a clinic or hospital to generate and manage Adverse Event Reports (AERs), and report to regulatory agencies and government agencies. A negative or dangerous effect is one that a patient experiences due to the use of drugs or medical devices. Adverse event reporting involves the tracking of all medical complaint cases. This allows for the generation of MedWatch reports, CIOMS and additional reports for management. adWATCH – AE allows researchers, physician-investigators, Contract Research Organizations, clinical trial specialists, and other healthcare professionals to create and file AERs in FDA mandated MedWatch or CIOMS format.

Moody's Analytics' regulatory reporting solution provides comprehensive, automated and streamlined regulatory reporting for Basel I and II and III and IFRS 9. ECB, CCAR and DFAST stress tests. It supports regulatory reporting to more than 50 regulators worldwide. This award-winning solution uses Moody's Analytics data management platform, regulatory capital calculation engines, to provide accurate, streamlined and automated regulatory reporting. It consolidates the regulatory capital calculations banks require to populate a wide variety of regulatory reports. This helps banks align their regulatory reports and ensures they present a consistent picture across multiple reporting systems. Its report templates can handle complex banking regulatory reports. They also support a variety of formats, including Microsoft Excel, XBRL and ASCII. Reporting managers can view the results across the entire company by using powerful OLAP data cubes.

VerifyRx, a real-time, compliance driven prescriber verification solution, is specifically designed for pharmacies. It seamlessly integrates with existing workflows. VerifyRx processes millions upon millions of transactions per day, updating comprehensive prescriber information in real-time. This includes Drug Enforcement Administration (DEA), State data (when possible) and daily National Technical Information Service data (NTIS). VerifyRx is part of the pharmacy workflow and processes millions of transactions per day. It updates comprehensive prescriber data in real time, including Drug Enforcement Administration and State data (when possible) and daily National Technical Information Service data (NTIS). This highly configurable and responsive tool allows for real-time compliance checks of all prescription transactions before they are sent to payers. This helps retail and specialty pharmacies reduce regulatory risk. It detects potential errors in claims submissions before dispensation.

A new-age business process automation platform to develop and manage operations workflow. The highly scalable workflow management software is widely used by utilities to track energy efficiency and demand-side management programs as well as interconnection agreements. The platform is both a database as well as a tracking solution that works with any application process from start to fulfillment. ANB currently supports multiple companies’ program tracking and reporting needs across the United States. Our eTRACK+ platform provides program administrators, implementers, and evaluation, measurement, and verification personnel with comprehensive data tracking and reporting from application creation to submission. This comprehensive tool empowers our clients to become data-savvy, realize operational efficiencies, comply with regulatory requirements, improve customer satisfaction, and lower operating costs. ANB is a certified minority business enterprise headquartered in Sugar Land, Texas. Our team of over 100+ project managers, business analysts, technology developers, and marketing specialists is uniquely qualified to support a wide variety of information technology needs.

ClinLab is a Windows-based and Web-enabled Laboratory Information Management System. It serves as a data warehouse for all lab results. It includes data acquisition, label printing and electronic signoff. It can interface with many reference labs and practice system systems. It can be used in a small, large, or reference laboratory. It can also be deployed at an entire Internet presence lab. ClinLab's secure remote access features allow it to connect to multiple-location databases to view patient orders or results from any location. Clinlab is committed to improving your laboratory productivity, compliance, and quality control.

The Compliance Suite platform is a powerful and flexible technology solution that aids in the preparation and submission for the Securities and Exchange Commission's forms N-PORT, N-CEN and N-MFP. It also assists with other regulatory filing requirements such as Annex IV of AIFMD and CFTC and NFA Form PQR. It provides robust risk management, performance monitoring, pipeline and relationship tracking, as well as robust risk management. This easy-to-use, scalable solution is intuitive and simple to use. It also allows for the flexibility necessary to adapt to today's changing regulatory, business, and risk landscapes. The user-definable architecture of Compliance Suite allows it to be used for other value-added purposes beyond regulatory filing. Data repository for investor reporting and internal risk management. Features user-definable dashboard and fund performance charting functionality.