Alternatives to Flex Databases

Numerous organizations globally rely on IQVIA to accelerate the drug development process, guarantee the safety and quality of products, enhance commercial efficacy, deliver appropriate treatments to patients, and ultimately promote improved health outcomes by facilitating access to and delivery of healthcare. Transform your approach to clinical development by seamlessly integrating data, technology, and analytics to streamline your trials. The outcome? Quicker decision-making and minimized risks, enabling you to provide transformative therapies at a faster pace. With its expertise rooted in data, sophisticated analytics, and deep industry knowledge, IQVIA offers tailored capabilities to clients throughout the healthcare landscape. Stay informed by exploring the latest insights and updates from IQVIA's data scientists, healthcare professionals, researchers, and other industry experts on crucial topics that resonate with your interests. From emerging industry developments to practical applications of our capabilities, a wealth of information awaits you here. Engaging with this content also empowers you to stay ahead in a rapidly evolving healthcare environment.

Castor offers an intuitive and comprehensive platform for managing clinical trial data, focusing on electronic data capture (EDC), eConsent, and patient-reported outcomes (ePRO). The platform is optimized for decentralized trials, providing seamless tools for remote patient engagement and data collection. With real-time reporting, Castor helps researchers track trial progress and make data-driven decisions. The solution ensures compliance with industry regulations such as HIPAA, GDPR, and 21 CFR Part 11, making it ideal for life sciences organizations looking to enhance trial efficiency while maintaining high data integrity.

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

OpenClinica is a leading provider of clinical data management software solutions. OpenClinica provides powerful tools to ensure that clinical trials are compliant and efficient. OpenClinica Enterprise, OpenClinica Participate and OpenClinica Randomize are the core products. OpenClinica is a powerful clinical trial platform that offers a wide range of tools for data collection, patient engagement, and study management. From electronic data capture (EDC) and eConsent to patient recruitment and real-time reporting, OpenClinica’s solutions automate and simplify the clinical trial process. With features like EHR-to-EDC integration and advanced reporting dashboards, the platform improves data accuracy, reduces delays, and enhances compliance. OpenClinica has been used in over 15,000 clinical studies, providing support for organizations around the globe, including government agencies and pharmaceutical companies, to conduct trials with confidence.

Clinevo's electronic Trial Master File (eTMF) is a user-friendly digital solution for the organization and storage of documents, images, and various digital assets related to clinical trials. This eTMF incorporates an integrated DIA reference model and complies with regulatory standards. Additionally, Clinevo offers the MICC Intake, a web-based platform designed for Medical Information Call Centers (MICC) and Pharmacovigilance (PV) professionals to efficiently log, track, and monitor Product Quality Complaints (PQCs), Medical Inquiries (MIs), and Adverse Events (AEs). Furthermore, Clinevo Safety serves as a comprehensive cloud-based system that ensures ease of use and regulatory compliance throughout the entire Pharmacovigilance process, encompassing PV Intake, Case Processing, Regulatory Submissions/AS2 Gateway, Analytics, and Safety Signals, all within a single platform. Lastly, the Clinevo Website Intake tool can seamlessly integrate with Sponsor or CRO websites, offering consumers and reporters an intuitive web interface for easy access and reporting. This innovative suite of tools enhances the efficiency and effectiveness of clinical trial management and safety reporting.

TrialKit is a cloud-based platform available via both a web and native mobile app, enabling end-to-end clinical trial management for medical device, diagnostics, digital therapeutics, and biopharma companies of all sizes. Design and deploy validated studies in days not weeks using our intuitive study builder that requires no programming. Thousands of global users have leveraged the flexibility of TrialKit to deploy over 8,000 studies across all phases of development.

Harnessing actionable insights from the leading AI-driven clinical analytics platform allows your teams to effectively manage risk and enhance performance throughout studies, systems, sites, and vendor relationships. The cutting-edge technology from Saama is specifically crafted to optimize workflows, automate labor-intensive tasks, and foster improved collaboration among various clinical functions such as operations, medical review, data management, biostatistics, and pharmacovigilance. Both sponsors and CROs depend on Saama's capabilities for data aggregation and AI solutions, which facilitate superior decision-making, minimize delays, and drastically reduce costs and timelines associated with drug development. By leveraging Saama's tools, you can accelerate the pace of clinical trial innovation. When your clinical data is centralized and continuously updated, it simplifies the lives of your ClinOps and medical review teams considerably. Furthermore, Data Managers, often undervalued, can shift their focus from repetitive tasks to the critical data points that truly drive project success, ensuring that their expertise is fully utilized in the process. This transformation not only enhances efficiency but also contributes to the overall quality of clinical outcomes.

Achieve a comprehensive understanding of your research operations by utilizing a robust and standardized clinical trial management system that has been developed in partnership with prominent academic medical and cancer centers. Streamline billing designation processes to promote uniformity across various teams and systems. Enhance your budgeting strategies, ensure accurate routing of charges, and perform more effective audits and monitoring of billing compliance. This integrated approach provides deep visibility and insight into all elements of clinical research, particularly in financial management, thanks to collaboration with elite research institutions. Moreover, by connecting OnCore with your existing electronic medical records (EMR), including seamless integrations with Epic and Cerner, you can significantly boost patient safety, minimize redundant data entry, improve billing compliance, and elevate overall operational efficiency. Ultimately, this system not only simplifies processes but also fosters a more effective research environment.

SafetyEasy by EXTEDO is a robust software solution for managing pharmacovigilance and multivigilance, aimed at simplifying the handling of safety cases and vigilance information. It adheres to a wide range of drug safety regulations such as E2B(R3) and HL7 eMDR, while facilitating the necessary creation of regulatory documents including PSUR, PBRER, and DSUR. The software is equipped with features that optimize workflows through email alerts and online dashboards, allowing users to efficiently monitor project progress and adhere to submission timelines. Additionally, SafetyEasy features sophisticated tools like CasEasy AI, which leverages Natural Language Processing to streamline the automation of case creation, alongside a Business Intelligence module that offers an insightful 360° perspective on scientific data, thereby improving case evaluation and safety signal identification. This cloud-based platform is not only quick to deploy but also designed for ease of use, requiring very little training for effective operation. Furthermore, the integration of these advanced functionalities makes SafetyEasy an invaluable asset for organizations aiming to enhance their pharmacovigilance processes.

DF mSignal is a modular and scalable safety signal management system that enhances the efficiency of signal detection processes and risk management across pharmaceuticals and medical devices. It also includes cosmetics and nutraceuticals. The platform provides active and passive monitoring with real-time monitoring product-event combination, customizable clinical risk indicators, and an interactive interface with advanced analytics. It integrates seamlessly into MedDRA, WHO DD, clinicaltrial.gov and electronic data collection systems, providing a comprehensive safety solution for professionals. DF mSignal AI automates statistical scores to save time and ensure accuracy in signal detection. The system is designed to comply with all applicable regulations, including 21 CFR Part 11, data privacy and integrity controls, as well as GxPs. This ensures compliance and security.

Mosio allows research teams to improve subject adhesion, communications, data collection, and communication on mobile's most popular channel, text messaging. Our software helps research teams communicate more efficiently with participants by delivering interactive elements to mobile phones and messaging automation. WHO CAN WE HELP? + Clinical Trial Sponsors (Pharma & Biotech) + Cancer Centers and Clinical Research Organizations + NIH-Funded Studies + Public Health Agencies + Clinical Trial Managers/Directors and Clinical Operations Managers/Directors. Clinical Project Managers. Principal Investigators. Clinical Research (Study). Coordinators. All research staff who regularly communicate with study participants. BENEFITS + Interactive medication reminders and medication compliance alerts + Automate data collection. + Increase engagement and adherence. + Get SMS appointment reminders to fix your no-show problem. + Increase retention with automated check ins

Fusion is Axiom’s proprietary, cost-effective and easy-to-use eClinical solution. It is aimed at small to medium-sized device, pharma and biotech companies. Axiom's Fusion eClinical Suite allows you to add-on any Modules that meet your study needs. Are you running a small study? You can choose the base configuration with EDC and DM, as well as AE/SAE tracking. Are you looking for something more? To make managing your study easier, you can include powerful Modules like Inventory Tracking, RTSM, Safety Management. You can save time by electronically capturing your study data - even offline! Once you have an internet connection, your data will sync to your Fusion databases. Real-time records available for subject screening activities. Fusion Safety Database allows you to manage pharmacovigilance events.

Jeeva's patent-pending modular system is built on the most powerful cloud platform. One login from any browser-enabled device can be used to remotely screen patients, educate, enroll, send SMS, email and generate evidence including electronic patient-reported outcomes. They are tired of waiting for patient recruitment and retention to happen. It is crucial to provide sufficient evidence of safety and efficacy for investigational new medicines in order to receive regulatory agency approval. Jeeva is a great tool for saving time and money for patients, biopharma sponsors, and long-term follow up studies for gene therapy.

Data MATRIX offers a comprehensive SaaS solution specifically designed for clinical trials. Since its inception in 2009, the Data MATRIX team has specialized in the processing and analysis of clinical data, creating documents that comply with the standards set by the Russian Ministry of Health, FDA, and EMA. Our software streamlines clinical trial processes, allowing users to efficiently manage and track progress online. Before launching a project, we meticulously adjust and validate our software to ensure that every aspect is considered for optimal performance. With a proven track record of completing 180 projects for pharmaceutical companies, biotech firms, and CROs, our solutions have led 6 out of the top 10 Big Pharma companies to achieve a 15% reduction in R&D expenses. Our dedicated team members take pride in their involvement with professional organizations that connect clinical data professionals such as CDISC, ACDM, SCDM, biostatisticians like ISBC, and medical writers associated with EMWA and AMWA. By continually enhancing our offerings, we remain committed to driving innovation in the clinical research landscape.

Ennov's Pharmacovigilance Suite serves as a comprehensive solution for the collection, management, assessment, and reporting of adverse events in both human and veterinary fields, all within a single database framework. It boasts sophisticated tools for signal detection and data analysis, reinforcing adherence to international regulatory standards. Notable features encompass streamlined case intake and triage processes, enhanced user interfaces for data entry, adaptable case input forms, and an extensive range of searchable vocabulary lists. The system accommodates various reporting formats, including both paper and electronic submissions, compatible with CIOMS guidelines, MedWatch 3500s, and ICH E2B standards (R2 and R3). In terms of signal detection and management, it offers extensive data querying options, robust analytical tools, and the ability to compute essential statistical measures such as PRR, ROR, and MGPS. Entirely web-based and user-friendly, the platform is built to meet the standards of 21 CFR Part 11, thereby guaranteeing the integrity and security of data. Moreover, its adaptability makes it suitable for organizations of all sizes, ensuring that users can efficiently navigate the complexities of pharmacovigilance.

At Calyx, we understand that the foundation of a successful clinical development initiative lies in the quality of your data, which underscores the importance of an efficient electronic data collection (EDC) system. Employed in over 2,600 clinical trials globally, Calyx EDC facilitates the streamlined collection and reporting of clinical trial data through a user-friendly platform. It’s essential to safeguard your critical data with a reliable partner—reach out to us to discover how Calyx can enhance the success of your program. With Calyx EDC, you gain the adaptability to effortlessly plan, design, and execute studies of any complexity. Its features are crafted to lower costs, enhance site visibility, and boost efficiency, ensuring your trial remains on course. Trust Calyx to be the ally you need for navigating the complexities of clinical trials.

AI-driven analysis of medical imagery is complemented by sophisticated automation of clinical data processes. Offered as a web-based SaaS or an on-premise solution, UNITY has garnered global trust from leading medical technology firms and healthcare institutions for its ability to gather comprehensive, consistent, and compliant data. Its integrated modules for Patient-Reported Outcome Measures (PROM), electronic Case Report Forms (eCRF), and medical image analysis optimize essential data collection tasks, thereby facilitating quicker and more cost-effective clinical trials. RAYLYTIC's Imaging Core Lab brings decades of expertise in the precise, automated, and independent assessment of musculoskeletal structures and device efficacy in areas such as the spine, hip, and knee, providing clients with unmatched analytical and operational assistance. This advanced capability ensures that medical professionals can rely on high-quality data to inform their decision-making processes, ultimately improving patient outcomes.

Zelta is a cloud-powered platform for unified clinical data management and acquisition, designed to streamline and enhance clinical trial processes. Its modular architecture adapts to the unique demands of each study, enabling faster and more efficient outcomes. With capabilities such as electronic data capture, clinical operations management—including randomization and trial supply tracking—clinical trial management, and electronic trial master file functionality, Zelta supports comprehensive study oversight. It also enhances patient and provider engagement with electronic clinical outcome assessments and e-consent solutions. Built for studies across all phases, therapeutic areas, and global regions, Zelta offers an intuitive user experience with secure single sign-on access from anywhere. Its flexible and scalable design allows for seamless customization and integration with both native and third-party technologies, ensuring adaptability to diverse research needs.

Tepsivo offers innovative pharmacovigilance software solutions that enhance the efficiency of drug safety processes through automation and intelligent templates, leading to a significant decrease in administrative workload and related expenses. The Tepsivo Platform is an all-encompassing, cloud-based system that empowers users to oversee all aspects of pharmacovigilance from a single, unified interface. Its notable features encompass a Quality Management System, oversight by a Local Contact Person for Pharmacovigilance (LCPPV), efficient safety reporting and follow-up mechanisms, PSUR tracking, management of signal detection, automated audit trails, compliance monitoring, tools for adverse event intake, literature surveillance, tracking of risk management systems, solutions for managing PSMF, automated reconciliation with partners, and CAPA management. By integrating these modules, the platform guarantees complete transparency, full compliance with regulations, preparedness for inspections, high-quality outputs, rapid processing times, elimination of administrative overhead, and reduced costs. With Tepsivo's solutions, organizations can enhance their pharmacovigilance capabilities while ensuring that they meet industry standards efficiently and effectively.

Mahalo Health is an integrated digital health platform aimed at expediting the creation of patient-focused digital health solutions and clinical trials. By providing a variety of prebuilt modules, Mahalo facilitates the swift launch of customizable white-label applications that cater to particular therapeutic fields. The platform boasts comprehensive data capabilities, featuring a predictive health engine for forecasting diseases and diagnoses, a behavior modification engine to encourage beneficial patient behaviors, and a notification system that ensures timely communication through push notifications, SMS, or emails. Committed to maintaining high security and compliance standards, Mahalo follows regulations such as HIPAA, GCP, ISO27001, and GDPR. Its extensive range of services encompasses multiple therapeutic areas, including diabetes, cognitive health, cardiovascular issues, musculoskeletal conditions, mental health, oncology, rare diseases, and nonalcoholic steatohepatitis (NASH). Additionally, Mahalo Health empowers healthcare providers with tools to enhance patient engagement and outcomes through its innovative digital solutions.

Clinevo Safety serves as a comprehensive, cloud-based pharmacovigilance and drug safety solution that is both user-friendly and compliant with regulatory standards. This all-encompassing platform incorporates various functions, including PV intake, case processing, regulatory submissions via an AS2 gateway, analytics, and safety signal detection. Leveraging a straightforward technology architecture, it allows for significant configuration options with minimal need for customizations, resulting in reduced total ownership costs and straightforward maintenance. Users benefit from alerts for cases approaching their deadlines, ensuring they remain compliant in a timely manner. The system features advanced automation and AI capabilities that enhance case processing efficiency, while its easily configurable dynamic workflows facilitate faster case management. Through sophisticated analytics, the platform provides users with impactful and actionable insights. As a web-based application, it can be accessed from any device, at any time, using common browsers such as Internet Explorer, Chrome, and Firefox, making it exceptionally convenient for users on the go. Furthermore, its design prioritizes usability, ensuring that all users can navigate the system with ease and confidence.

PvEdge is a state-of-the-art cloud-based pharmacovigilance software crafted to deliver comprehensive and compliant safety solutions for pharmaceuticals, medical devices, vaccines, and their combinations. It features an all-encompassing safety database that streamlines the management of pharmacovigilance intake, case processing, submissions, AI-driven analytics, and safety signal detection within a single user-friendly interface. This platform is designed to meet both current and forthcoming regulatory standards, including 21 CFR Part 11, ANNEX 11, GxP, and GDPR, thus ensuring worldwide compliance. By harnessing the power of advanced automation through AI and machine learning technologies, PvEdge significantly boosts the efficiency of drug safety database management. Notable functionalities encompass automated literature review, expedited ICSR submissions, intelligent triage processes, automated signal detection, and streamlined document automation. Additionally, the system incorporates a controlled document management feature that facilitates the creation, oversight, and dissemination of essential pharmacovigilance documentation, alongside a risk-based enterprise quality management framework aimed at establishing robust quality control processes and maintaining meticulous training records. Through these diverse capabilities, PvEdge stands out as an invaluable tool for organizations committed to upholding the highest standards in drug safety.

Orbit is a comprehensive platform geared towards improving patient safety by aiding biopharma companies of all sizes in expanding their safety operations across international markets. This platform provides cutting-edge solutions for global pharmacovigilance, safety management, and risk oversight, with the goal of enhancing overall quality, ensuring compliance, boosting productivity and efficiency, and offering significant oversight of processes that are often complex and compartmentalized. Among its essential features are risk management and minimization, which facilitate the monitoring of commitments within global risk management plans while also supporting the implementation of local risk mitigation measures; management of safety data exchange and pharmacovigilance agreements, which enables effective oversight of global collaborations; as well as signal and surveillance management, which encompasses everything from strategy planning to detection activities, signal evaluation, and ongoing tracking. Additionally, Orbit’s user-friendly interface ensures that teams can easily navigate the platform and utilize its features to their fullest potential.

DF mSafety AI, a cloud-based platform, uses AI/ML and automation for a great user interface and efficiency in Safety Case Management, Neutraceutical, Vaccines and Medical Devices. DF mSafety AI was built on Datafoundry’s Integrated Cloud Platform – DF Safety 4.0, which supports scalable, secure AI/ML-driven Safety Case and Signal Management. It also includes pre-built connectors for enterprise systems and adheres to industry standards and regulatory requirements.

Replior is a pioneering company specializing in software solutions for clinical trials, featuring an integrated platform that encompasses EDC, eConsent, ePRO, and Virtual Visits to enhance trial execution. Our comprehensive system, known as Trial Online, facilitates the seamless collection and management of data from investigators, participants, and wearable devices in an efficient manner. It is designed to accommodate decentralized clinical trials (DCT), allowing for flexibility with site visits, remote interactions, or a combination of both. Our journey commenced two decades ago when we were approached to create an online CRF service for a major pharmaceutical firm, marking our transition from an IT operations provider to a dedicated software developer for clinical data collection. Over the years, we have expanded our offerings to include a complete suite of data collection services, while our IT operations are expertly managed by our highly qualified sister company, Complior. As we continue to innovate, our commitment to enhancing clinical trial processes remains at the forefront of our mission.

Dacima Clinical Suite, the most advanced web-based solution, combines electronic data capture (EDC), medical data management software (CDMS) and clinical trial management software into one platform. Dacima Clinical Suite is designed for clinical trials, epidemiological studies, web randomization, ePRO, surveys, and patient registers. Dacima Clinical Suite comprises three core modules: the Manager (Administrator), Designer Module, and the Data Entry Module.

Secure and user friendly cloud-based EDC platform for managing clinical trials and studies of all sizes and complexities: ePRO, eConsent, eCOA, eSource, PROMs, PREMs, functional health assessments and participant education/engagement.

Signant Health operates as a worldwide leader in evidence generation, striving to transform the landscape of clinical trials by connecting with patients in their environments and rethinking the route to validation. Their extensive range of clinical technology solutions includes electronic Clinical Outcome Assessments (eCOA), Electronic Data Capture (EDC), electronic clinician evaluations, and a cohesive eClinical platform. Additionally, they offer patient engagement solutions featuring a user-friendly app, eConsent for informed consent processes, and telemedicine functionalities. Furthermore, Signant Health delivers clinical data and analytics services, which include COA data analysis as well as the aggregation and interpretation of data. With a rich history spanning over three decades, they have played an instrumental role in supporting numerous trials and have been pivotal in hundreds of drug approvals, establishing themselves as a reliable ally for sponsors and CROs eager to provide high-quality data for informed trial decisions and regulatory submissions. Their commitment to innovation continues to shape the future of clinical research.

Streamline your clinical studies with Clinvigilant, your global cost-effective eClinical tools provider for CROs, Pharma, Biotech, Nutraceuticals and Academic organizations in clinical and post-marketing stages. Most of our clients choose and stay with us for thanks to our: ♦ Fast EDC set-up (less than 4 weeks). ♦ Cost-effectiveness. ♦ 3rd party integrations (including legacy systems). Our cloud-based suite (Microsoft Azure) is HIPAA, ICH-GCP, GDPR & 21 CFR part 11 compliant and we have been audited by the FDA, EMA and MHRA. The Clinvigilant eClinical suite includes: EDC, CTMS, eCRF, eTMF, eSource, IWRS, ePRO, eConsent and eCOA. Just pick the tools that you need and we will integrate them within your existing software ecosystem. Every interaction and data exchange creates Audit Trails, which provide compliant real-time data visibility across all relevant roles. Our products are modular, highly customizable, and available on the web, iPad, and Mobile App for both Android and iOS. We also support Patient's Own Device (BYOD) and interface with Devices and Wearables. Clinvigilant💊, your one-stop🌐solutions provider for clinical trials☁️ .

Mednet is an eClinical technology company that specializes in healthcare solutions for the global life science community. Mednet's flexible, EDC-centric eClinical platform increases the efficiency of clinical research of all sizes. Mednet's comprehensive solution suite provides all the tools necessary to create and manage clinical research. It can also adapt to changing demands and requirements. Mednet has been trusted by CROs in every sector of the pharmaceutical, medical device, and biotechnology industries for almost 20 years. They provide the expertise, reliability, and innovation that they need to succeed. Mednetsolutions.com has more information.

As a provider specializing in Data Management, we deliver comprehensive services that include both data management and the planning and development of statistical analyses alongside suitable CRF design. We ensure that all necessary documentation complies with FDA standards and other relevant regulations. Our previous experiences indicate that investing more time in the planning stage significantly enhances the overall efficiency and speed of the trial's final phases. Our databases are meticulously created by seasoned data managers who possess extensive knowledge of various eCRFs and understand the essential aspects of electronic data capture system design and data collection. This expertise enables us to construct the eCRF in a remarkably short timeframe. Additionally, the validation and testing of the eCRF are critical components of our design process, handled by separate personnel to guarantee a thoroughly detailed and functional eCRF. By prioritizing these elements, we can ensure the highest quality outcomes for our clients.

DFnet is a company specializing in healthcare technology that delivers eClinical solutions such as electronic data capture, eSource, and comprehensive data management services. We enhance clinical trials globally by providing increased flexibility, improved data quality, and enhanced efficiency. Our platform allows for data collection from various sources, including paper CRFs, EDC, and other electronic systems, along with online and offline tablet entries and ePRO. You can either set up our system on your premises or utilize our secure cloud hosting options. Our advanced optical recognition technology accelerates SDV and RBM processes, significantly reducing the time required for manual data entry. Designed for optimal adaptability in multi-center studies, our web-based data capture system makes data from any source readily accessible in a centralized real-time platform. This capability ensures that researchers can make informed decisions quickly and efficiently, ultimately improving the overall conduct of clinical trials.

EvidentIQ's eCOA streamlines the collection of real-time, direct-from-patient data through an easy-to-use interface that facilitates sophisticated patient assessments, ultimately enhancing both the patient experience and the quality of the data gathered. Clients have the option to choose a complete, all-inclusive eCOA solution or to mix and match various components tailored to their specific needs. By scheduling a demo with our knowledgeable team, you can discover how to maximize the return on investment for your research studies. The eCOA platform merges data science services with technology to provide a versatile solution. It operates independently of particular eClinical technologies like EDC systems, while also offering seamless integration with existing eClinical software ecosystems. Designed to efficiently gather a wide range of outcome data reported by patients, clinicians, or observers, this solution ensures compliance and enhances the overall data collection process. With such flexibility, organizations can adapt the eCOA framework to suit a variety of clinical trial scenarios, enhancing their research capabilities significantly.

The integration of eCOA and digital technologies is paving the way for the future of clinical research, seamlessly connecting traditional methods with innovative, patient-centered approaches. Choose YPrime's eCOA solutions to not only obtain high-quality patient data but also to enhance the overall user experience for sponsors, investigator sites, and patients alike. By employing a flexible software development strategy, YPrime is able to swiftly tailor and adapt functionalities to meet specific study requirements within an impressive timeframe of 8 to 12 weeks. Our engaging and visual design process allows clients to review the system at various stages of development, ensuring they are informed before the system goes live. Additionally, our pre-validated and customizable authoring environment not only streamlines startup timelines but also accommodates post-production adjustments, such as changes to study protocols, making it an indispensable asset for clinical research. This commitment to agility and responsiveness positions YPrime as a leader in the evolving landscape of clinical trials.

AccelSafety is an all-encompassing pharmacovigilance solution crafted by Techsol Life Sciences, centered around the Oracle Argus Safety application, designed to streamline the unified gathering, medical evaluation, and regulatory reporting of safety surveillance data for both clinical and post-marketing purposes. This fully managed cloud-based platform empowers emerging biopharma companies, device manufacturers, and service providers to effectively handle safety data while ensuring their business decisions align with global compliance standards. Among its primary advantages are expedited Argus Safety implementation, migration, and validation that reduce effort by 70%; secure transfer of existing safety data to the AccelSafety Cloud; and enhanced case processing efficiency through tailored configurations and built-in automation. Additionally, users benefit from extensive operational insights provided by advanced reporting tools, line listings, and analytics packages, as well as round-the-clock support from the Argus Safety Service Desk for user inquiries, incident resolutions, and change management needs. Overall, AccelSafety stands out as a pivotal tool for organizations looking to optimize their pharmacovigilance processes and uphold regulatory obligations effectively.

Streamlined surveillance of diverse data sources, seamlessly integrated with a GVP IX compliant signal management platform, can revolutionize your safety data handling. The Evidex platform offers a ready-to-go, GVP-IX compliant signal management solution that simplifies your operations without the hassle of switching between various services. By modernizing your management processes, you can ensure they are audit-proof and efficient. This automation not only helps meet regulatory standards but also enhances the overall value generated for your organization. With automated signal detection, you can identify safety signals from established sources such as ICSR databases, the FDA's Adverse Event Reporting System (FAERS), VigiBase, and clinical trial data. Furthermore, you can incorporate additional data sources, including claims, electronic health records (EHR), and other unstructured information. By aggregating these diverse data pools, you can significantly improve signaling algorithms, streamline validations and assessments, and accelerate responses to pressing drug safety inquiries. Ultimately, this approach transforms how organizations manage and leverage safety data for better outcomes.

CoVigilAI is a cutting-edge solution for monitoring medical literature that leverages artificial intelligence and sophisticated data analysis to identify and manage adverse drug reactions proactively, thereby safeguarding patient well-being and adhering to regulatory standards in real time. This platform simplifies the tracking of scientific and medical literature by sourcing information from major global databases like PubMed and Embase, offering customizable search parameters that enhance the pharmacovigilance literature review process. Additionally, it systematically reviews scientific articles and publications from various local journals, ensuring comprehensive global and localized literature oversight. Utilizing advanced algorithms, the system classifies Individual Case Safety Reports (ICSRs) into three categories: valid, potential, and invalid cases, while its automated key entity recognition capability adeptly identifies essential elements such as patients, medications, adverse reactions, and relevant medical events. This holistic approach not only streamlines the monitoring process but also significantly enhances the accuracy and efficiency of drug safety assessments.

Sentria is a cutting-edge platform that utilizes artificial intelligence to manage adverse event cases and conduct post-marketing surveillance. This software solution is user-friendly, highly customizable, and automated, ensuring it meets industry regulations to improve the efficiency, speed, and accuracy of adverse event handling. It supports pharmacovigilance compliance with international ICH guidelines while adhering to local regulatory requirements for the assessment of adverse events. By providing an easy-to-use interface enhanced with pharmacovigilance automation, Sentria minimizes reporting errors through smart alerts and simplifies report processing by employing international coding standards such as MedDRA and ATC/WHO. The platform enhances analytical capabilities through the use of semantic artificial intelligence tailored for pharmacovigilance needs. Notably, Sentria offers features like secure access controlled by user credentials, comprehensive auditable logs to ensure compliance, and a secure encrypted cloud environment for data protection. These functionalities collectively empower organizations to manage adverse events more effectively, contributing to better patient safety outcomes.

AnjuEPS stands out as a premier solution for eSource and site automation, specifically crafted to enhance the efficiency of early-phase clinical trials, encompassing everything from the recruitment of volunteers to the final submission of studies. By capturing data directly from medical devices and implementing real-time edit checks, it guarantees the accuracy of data while eliminating reliance on traditional paper sources. The platform enhances safety monitoring with real-time alerts for out-of-range values and provides insights through historical safety data, ultimately facilitating improved management of volunteer safety. Its user-friendly Design & Build Module significantly accelerates the study setup process, which in turn helps lower both time and financial expenditures. Among its notable features are ad hoc reporting capabilities, sample tracking for intricate pharmacokinetic and pharmacodynamic activities, and comprehensive modules for recruitment and pharmacy management. With AnjuEPS, the collection of clinical data is not only efficient but also characterized by high levels of accuracy and transparency, making it an invaluable resource for clinical researchers. The solution's ongoing updates ensure that it remains at the forefront of technological advancements in the clinical trial landscape.

DF Literature Monitor is a cutting-edge AI-driven tool that streamlines the process of monitoring extensive literature and enhances safety oversight procedures. It connects with key local and global literature sources to retrieve articles simultaneously, utilizing semantic search technology to efficiently pinpoint pertinent research. The system includes features such as automatic de-duplication, the extraction of essential safety information, and the capability to auto-fill safety case forms, which can be easily submitted to safety databases in E2B or Excel/PDF formats with just one click. Furthermore, it provides automated translation services for abstracts and complete articles into English. DF Literature Monitor is equipped with customizable workflows that promote teamwork and ensure quality control within pharmacovigilance teams. By adopting this solution, organizations can significantly reduce the time and resources spent on literature monitoring by as much as 60% or more, all while maintaining high standards of quality and regulatory compliance. Ultimately, the tool represents a significant advancement in the field of pharmacovigilance, allowing teams to focus on critical analysis rather than manual processes.

The IQVIA Vigilance Platform represents a holistic solution designed to streamline safety and pharmacovigilance tasks, enhancing speed, precision, and overall efficiency. Operating within a secure Software-as-a-Service (SaaS) environment and leveraging advanced proprietary technologies such as artificial intelligence, machine learning, and natural language processing, the Vigilance Platform provides valuable insights that enhance compliance, ensure product safety, and contribute significantly to the product development lifecycle. It comprehensively addresses every facet of pharmacovigilance, managing cases from initial patient reports through processing and submission to regulatory authorities, encompassing all types of cases. With its user-friendly interface, the IQVIA Vigilance Platform is accessible for affiliates, case processing teams, and those involved in signal detection. By adopting a transformative methodology in pharmacovigilance, it bolsters compliance, allowing organizations to concentrate on the rapid delivery of safer and more effective pharmaceuticals and medical devices. This innovative platform not only meets current industry needs but also anticipates future requirements in the evolving landscape of drug safety and efficacy.

Enhance the efficiency of regulatory operations within your organization to bolster compliance and facilitate research advancements. Veeva SiteVault simplifies the process of managing clinical trials by integrating your regulatory tasks, leading to improved effectiveness and adherence to regulations. You can oversee regulatory and source documents through a unified platform that complies with 21 CFR Part 11 and HIPAA standards. With real-time insights across all trials, SiteVault Enterprise boosts operational effectiveness, accelerates study initiation, and fosters swift, high-quality trial management. Transition away from manual workflows and customize your own processes to enhance both quality and speed in study activation. By granting monitors secure, direct access to your regulatory and source documents, you eliminate the hassles of EMR access and document redaction. Furthermore, you can tailor your workflows, generate reports, and create dashboards to gain deeper insights into start-up timelines and regulatory workflows, ultimately driving better outcomes for your clinical trials. This comprehensive approach not only streamlines processes but also enhances collaboration across teams.

Honeywell's TrackWise Digital® serves as an innovative cloud-based Quality Management System (QMS) aimed at enhancing the efficiency of quality and compliance processes within organizations. Drawing on nearly thirty years of expertise in the field, it features integrated modules that cater to various elements of quality management, such as document control, training oversight, and corrective and preventive actions (CAPA). The platform utilizes cutting-edge digital technologies, including artificial intelligence and machine learning, to deliver actionable insights in real-time, which fosters a proactive approach to quality management. Its adaptable, modular framework ensures smooth integration with current enterprise systems, allowing for quick deployment and growth. By optimizing quality processes and maintaining adherence to industry regulations, TrackWise Digital® enables organizations to accelerate product launches while effectively reducing risks. This comprehensive system not only enhances operational efficiency but also supports continuous improvement initiatives across the quality management spectrum.

Bibliovigilance serves as a dedicated platform for pharmacovigilance literature, designed to enhance the efficiency of monitoring scientific and medical publications for vital safety information. It boasts an extensive database that encompasses notable national scientific publications from Europe and beyond, including those related to both human and veterinary products. Users can conduct comprehensive global searches by utilizing queries in PubMed and can access safety recommendations from the PRAC regarding various signals, thereby centralizing their literature searches in a single interface. The platform allows for the saving of search queries, scheduling of automatic searches, and the option to filter results to only include new articles since the last query, which effectively minimizes redundancy and saves valuable time. Each user’s search history is conveniently stored in a personal area, enabling easy documentation and review at any moment. Furthermore, the database is regularly updated, offering insights into publication dates, the latest updates, and the number of articles indexed, which guarantees clarity and transparency in the information provided. This innovative approach not only aids researchers and professionals in staying informed but also contributes to the overall advancement of pharmacovigilance practices.

Your partner in clinical trial technology… together we enhance the trial experience. We offer cutting-edge software solutions while emphasizing the importance of personal interaction. Our goal is to collaborate with you to ensure your upcoming trial excels beyond expectations. Study set-up can be accomplished in just a few days. We can handle the setup for you, or you have the option to create your own. Data collection can be led by either investigators or subjects, and is compatible with any device. Our application is designed with all necessary features in a user-friendly and cohesive manner. We help you achieve both regulatory and business goals. A dedicated and knowledgeable professional will address your inquiries and ensure timely solutions. We are currently assisting medical device companies in fulfilling their business and compliance objectives effectively. Let us transform your clinical trial experience together.