Alternatives to SlimEDC

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.

Medrio's Electronic Data Capture (EDC) platform and complimenting eClinical solutions such as ePRO, RTSM, eConsent, and Direct Data Capture (DDC) have been trusted by major pharmaceutical, biotech, CRO, animal health, medical device, and diagnostic companies since 2005. We are known for our easy-to-use solutions, delivering speed and simplicity to clinical trials of all phases, sizes, and complexities. Medrio users can build their databases in an average of 2.8 weeks with no programming required, make mid-study changes with just a few clicks of a mouse, and much more. From bolt-on capabilities to full-service offerings, Medrio offers flexible, modular solutions that give our customers exactly what they need – and none of what they don’t. Our innovative software, as well as the robust and flexible training and support resources we provide our customers, have earned us a 98% customer satisfaction rating.

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.

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.

DrugCard is an advanced data intelligence platform that leverages artificial intelligence to enhance the efficiency of pharmacovigilance by automating the screening of local literature. Supporting over 100 languages, it actively monitors more than 1,000 medical journals in over 55 countries, ensuring thorough, ongoing, and transparent oversight. By automating repetitive tasks, DrugCard allows Contract Research Organizations (CROs) to handle a greater number of pharmacovigilance projects while improving the quality of their screening results. Additionally, Marketing Authorization Holders (MAHs) can perform in-house literature screening more efficiently, and freelancers can reclaim as much as 70% of their time, which can then be directed towards more valuable activities. The platform is built to be adaptable to new markets, affordable, and in line with regulatory standards, thus offering a well-rounded solution for drug safety departments. Its innovative features not only optimize processes but also empower organizations to prioritize safety and compliance in their operations.

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.

Management of clinical data. Comprehensive solution for managing clinical trial information. Easy data entry and creation of CRFs. Support for multi-center complex studies. Data validation and processing is accelerated Multilingual capabilities. Global deployment, cloud-based and on-premise. Clinical researchers understand the importance of reducing time and costs when conducting clinical trials. This is especially true when it comes to the collection, processing, and management of study-specific data. To ensure that the necessary patient data was recorded and sent to the sponsor for analysis and processing, study coordinators used paper Case Report Forms (CRFs). The days of paper CRFs are long gone. The industry now understands that electronic data capture (EDC), systems increase efficiency and improve data quality.

Flex Databases is an innovative, unified, and compliant electronic clinical platform that provides software solutions for clinical trials: pharmaceutical companies and CROs. Our system is composed of: - Clinical Trial Management System - Electronic Trial Master File - Project Management & Budgeting solution specifically designed for the clinical trials industry - Pharmacovigilance System - Learning Management System It was possible to create a flexible platform thanks to our unique experience and a qualified team of more than 100 professionals with a deep understanding the clinical trial process.

TARA PV is an all-encompassing, online pharmacovigilance safety database specifically crafted to handle the processing, storage, analysis, and reporting of adverse events associated with pharmaceuticals, medical devices, and vaccines. Created by MedGenesis Ltd, a UK software development firm accredited with both ISO 9001 and ISO 27001, TARA PV boasts an interface that is user-friendly, straightforward, and fully adheres to regulations such as 21 CFR Part 11, GxP, ICH standards, and international pharmacovigilance data protection laws. As a cloud-based system, TARA PV eliminates the need for installation, allowing users to access it through any web browser, which facilitates swift implementation and seamless workflows for managing individual case assignments. Upon deployment, users receive comprehensive training, and continuous support is offered via an online ticketing system to address any issues that may arise. Prioritizing security, the platform is hosted with multiple redundancies and triple-layer backups to ensure data integrity. Additionally, TARA PV presents a variety of clear pricing options without any hidden fees, making it a transparent choice for organizations. This comprehensive solution is built to adapt as the regulatory landscape evolves, ensuring ongoing compliance and support for its users.

TrialMaster, the most intuitive Electronic Data Capture (EDC), Suite on the Market, offers superior usability and flexibility. It is your EDC solution for Phase I to IV clinical trials. TrialMaster increases efficiencies and reduces workflow impact, while improving data quality, which results in faster study submissions. TrialMaster's built-in ePro enables site researchers, patients to self-report their outcomes, and sponsor staff access the platform from any device (desktop or tablet, smart phone, tablet, or laptop). All system screens adjust in real-time to the device's size. Single sign-on (SSO), which allows sponsors to use their own IdP to authenticate, reduces the need for multiple passwords and user names.

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.

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.

NewTn's SAFETY is a cutting-edge cloud platform for pharmacovigilance that aims to streamline safety processes and ease compliance for pharmaceutical companies, emerging startups, and contract research organizations. This solution presents a wide array of features, such as scalable cloud infrastructure for enhanced data storage and processing, the ability to reuse data to avoid repetitive entries, real-time alerts and monitoring to swiftly detect adverse reactions, and strong reporting capabilities that aid in creating DSUR and PBRER reports. Specific use cases demonstrate its value in building pharmaceutical safety databases for new companies, offering budget-friendly safety solutions for cost-conscious CROs, improving regulatory adherence for small and medium-sized pharmaceutical firms, and providing thorough safety data analysis and reporting. The platform is distinguished by its user-friendly interface and experience, along with its specialized support for DSUR and PBRER reporting, making it a versatile and customized solution for various stakeholders in the pharmaceutical industry. Moreover, NewTn's SAFETY ensures that all users can effectively navigate the complexities of safety management with confidence and ease.

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.

PharmaPendium serves as a robust platform that grants users access to a wide array of FDA and EMA drug approval documents, encompassing essential aspects like pharmacokinetics, pharmacodynamics, and safety evaluations. This resource delivers in-depth insights into drug-drug interactions, side effects, and outcomes from clinical studies, thereby empowering stakeholders to make well-informed decisions during the drug development process and when making regulatory submissions. Its rich database aids researchers and healthcare practitioners in assessing both the efficacy and safety of medications, playing a pivotal role in the progression of pharmaceutical research and enhancing patient care. Users can explore historical regulatory submissions and leverage past precedents to better understand and anticipate agency requirements. The interface allows for a seamless transition from tabular data to dynamic charts, graphs, and other visual tools, making it easier to analyze and interpret findings. Additionally, users can search for information related to adverse events (MedDRA), therapeutic targets, drug indications, and endpoints utilizing standardized data. Result pages effectively connect preclinical research with clinical applications, facilitating a comprehensive understanding of the drug development landscape. Overall, this platform not only streamlines the research process but also fosters collaboration and knowledge-sharing among industry professionals.

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.

GoResearch™ is an advanced and thoroughly validated online platform designed for electronic data capture (EDC), developed by 2KMM specifically for research initiatives like clinical and observational studies as well as patient registries. It boasts a comprehensive suite of features that facilitate these projects across multiple domains, including the customization of data flow and management of Adverse Events procedures, which includes automatic email alerts to safety teams. Additionally, it allows for random assignment to treatment groups via its integrated randomization module, enables data collection through tailored electronic case report forms (eCRF) to align with the specific needs of each study, and supports the integration of ePRO, eSource, and mHealth data through specialized mobile or web applications, as well as a versatile application programming interface (API). This platform ultimately aims to enhance the efficiency and accuracy of data management in research contexts.

Viedoc designs engaging software that modernizes clinical research so that necessary treatments can reach the people who need them faster. We believe in life and science, in people, and in our collective power to change the world and build a healthier future. That unmatched driving force is what pushes us to innovate, accelerate and improve every aspect of modern clinical studies. Since 2003, Viedoc has united scientists and clinical trial professionals in a shared mission of pushing life-changing research forward. Our solution has been used to power thousands of studies, by collecting data from over a million patients and allowing it to flow smoothly across sites and countries. We take great pride in helping bridge the gap between patient and researcher – and, in the best of cases, between research and breakthrough.

CORE (Clinical On-demand Research) provides a variety of specialized services that encompass the design, development, and management of electronic forms utilized in clinical trials both in the UK and internationally. In addition to crafting the necessary forms, CORE facilitates randomization, oversees data management, and supplies crucial study statistics, ensuring researchers have access to essential information. This organization is instrumental in collecting important data for those in both academic and commercial research environments. CORE has established a successful collaboration with FormsVision, which began under an FP7 EU funding initiative, and has implemented the ALEA eCRF (electronic Case Report Form) to enhance trials conducted in the UK and New Zealand. The dedicated team at CORE stands ready to provide an array of services, including database construction for CRFs, management of randomizations, drug supply coordination, and ePRO (ALEA). Furthermore, they offer data hosting solutions for various types of files, as well as expert guidance on funding applications, statistical support, and protocol writing advice. This comprehensive suite of services positions CORE as a vital partner in advancing clinical research efforts.

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

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.

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

OpenSourcePV, established by Lionel Van Holle in 2019, aims to leverage free and open-source technologies to enhance pharmacovigilance standards and offer a cost-effective alternative to costly specialized software in this field. Pharmaceutical companies are required to monitor the safety of their products to meet regulatory requirements, but as they expand their product lines and pipelines, the volume of data that needs to be analyzed quickly becomes overwhelming for manual review. Currently, they face a dilemma: invest in an expensive software suite or attempt to develop a solution in-house. OpenSourcePV supports these companies in their journey towards effective quantitative signal detection by providing access to pre-built modules while also enabling customization to fit their unique requirements and data sources. This flexibility allows them to efficiently handle large datasets and improve their overall pharmacovigilance processes.

The Drug Safety Triager, developed by Clarivate, represents an advanced pharmacovigilance tool aimed at helping life sciences organizations adhere to regulatory standards. This system, which is validated for Good Practice (GxP) compliance and prepared for audits, enhances and organizes the workflow associated with literature reviews, allowing pharmacovigilance professionals to prioritize patient safety by streamlining these processes. Fully compliant with the reporting demands of major global safety regulatory bodies, including the FDA and EMA, the Drug Safety Triager includes a comprehensive validation package with every implementation. The validation documentation is carefully constructed to meet the stringent requirements set forth by the pharmaceutical sector and health authorities. Additionally, every piece of literature referenced is subjected to a meticulous review process that ensures all user actions are recorded, creating a permanent, immutable audit trail for accountability and transparency. This innovative approach not only improves efficiency but also reinforces the commitment to maintaining high standards in patient safety and regulatory compliance.

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.

Veeva Vault Safety is an advanced system designed for the management of individual case safety reports, facilitating the collection, processing, and reporting of adverse events related to both clinical trials and marketed products. This comprehensive platform allows sponsors and contract research organizations (CROs) to handle both global and local adverse events for various categories, including drugs, biologics, vaccines, devices, and combination products. Its integrated gateway connections and established reporting protocols enhance the efficiency of submitting cases to regulatory authorities and sharing information with partners. Additionally, the centralized management of coding dictionaries automates updates for MedDRA, WHODrug, and EDQM on a semi-annual basis. By consolidating pharmacovigilance processes within a single cloud environment, Vault Safety promotes proactive measures in ensuring patient safety. The system also utilizes real-time reports and dashboards, coupled with seamless collaboration, to enhance visibility and ensure compliance regarding adverse event reporting. Ultimately, this innovative solution transforms the approach to safety management in the pharmaceutical industry, fostering a more efficient and effective response to patient safety concerns.

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.

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.

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.

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.

Welcome to Dotter.science, your go-to online resource for enhancing clinical research. Designed specifically for researchers and organizations conducting health research protocols, Dotter enables you to efficiently execute your study while concentrating on what truly matters. You can effortlessly collect and analyze your clinical research data, making the entire process smoother. With Dotter.science, you can quickly create customized data collection forms and enhance the efficiency of your clinical research databases, simplifying both statistical analysis and publication efforts. Targeted at researchers, healthcare professionals, and students, Dotter significantly improves time management and operational efficiency. Features of Dotter include optimized data collection through an intuitive graphical interface for designing your electronic logbooks (eCRF), allowing for rapid patient inclusion with real-time data consistency checks. Moreover, Dotter's streamlined statistical analysis means you can say goodbye to paper records! Your data is securely stored on certified servers throughout your study and can be easily exported in structured formats, ensuring that your research is both safe and accessible. This platform is not just a tool; it's a comprehensive solution for modern clinical research needs.

The genuine open-source electronic data capture (EDC) system for clinical research originated from a collaborative effort by volunteers with diverse expertise, including academia, clinical research services, and the IT sector. Today, this initiative is actively utilized by various academic institutions, hospitals, and emerging companies or startups, showcasing its widespread acceptance and adaptability in the field. This collaborative approach has fostered innovation and efficiency in the data collection process for clinical studies.

LifeSphere EDC offers a budget-friendly solution for sponsors and CROs to efficiently gather, manage, and report clinical trial data, regardless of the trial's stage or complexity. By consolidating various systems into one cohesive database, it eliminates the necessity for expensive integrations and data reconciliation processes. The platform captures clinical information directly from study sites, thereby removing the reliance on paper Case Report Forms (CRFs) and manual data entry. This approach not only shortens study development timelines but also facilitates smooth implementation of adjustments in ongoing studies. Integrated with the LifeSphere Clinical cloud platform, which includes LifeSphere eTMF and LifeSphere EDC, it effectively links operations with data oversight. Additionally, the single sign-on feature simplifies access to a comprehensive suite of applications, while its open architecture promotes swift integration with external applications through APIs. This level of efficiency ensures that clinical research can adapt quickly to changing demands and maintain high-quality data standards.

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.

Medidata's Rave EDC (Electronic Data Capture) stands out as the premier system for managing clinical trial data from sites, patients, and laboratories with unparalleled sophistication and security. Serving as the foundation of the Medidata Clinical Cloud™, it offers a comprehensive platform that integrates various processes, thereby eliminating the need for data reconciliation and providing insightful data analysis across different studies and functions. Users can efficiently oversee their roles, studies, and sites from a centralized dashboard that spans all Rave EDC and other Medidata Clinical Cloud products. This system helps in avoiding the pitfalls of duplicate study master data and inconsistencies, such as varying IDs for the same sites across different applications. At the core of Medidata’s cohesive approach to Clinical Data Capture and Management, Rave EDC facilitates the seamless aggregation and reconciliation of data from diverse sources, including Medidata eConsent, Medidata eCOA, MyMedidata, Rave RTSM, Rave Imaging, and Sensor Cloud; it also enhances data review and analysis through advanced tools like Rave TSDV and Medidata Detect. With these capabilities, Rave EDC not only simplifies data management but also empowers clinical researchers to make informed decisions based on reliable and comprehensive data insights.

Prelude EDC is a web-based EDC (electronic data capture) solution that helps researchers and clinicians with clinical trial management. Key features include electronic data capture, data management, project management, custom fields, and compliance management. Prelude EDC comes with a drag-and-drop functionality, which helps administrators create electronic case report forms that are configured based on parameters such as entry fields, edit checks, calculations, and more. It allows users to streamline processes for searching, report generation, statistical reporting, and data querying, in order to optimize the preparation of datasets. Plus, the system comes with an in-built library of case report forms for producing reports on metrics such as patient demographics, deviations, adverse events, and study completion rates. Prelude EDC includes an XML export capability, allowing managers to import files into statistical analysis software. Its mobile application enables researchers to collect data and schedule daily, weekly, and monthly surveys.

Cloudbyz EDC, a cloud-native application with an intuitive user interface, is designed to store and effectively manage clinical data throughout the life cycle of a clinical trial. Our innovative solution allows clinical research teams the ability to collect, analyze and manage clinical data that is of varying complexity and size. Create your study without coding, using an interface that allows users to create forms and navigate easily to the appropriate screens for data analysis and collection.

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.

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.

Manage your clinical trials data effortlessly and with sophistication. Clincase’s e-Clinical Technology Solutions present a comprehensive suite of features, services, and additional functionalities accessible through a single login. This robust and flexible EDC software ensures that data managers, monitors, and sponsors stay interconnected with the study's performance and advancements, while also promoting greater participation from sites and investigators. Clincase delivers user-friendly, efficient solutions that provide real-time data accessibility. As a zero-footprint solution, it utilizes secure and encrypted data transfers for protection. The clinical trial data is securely hosted in Germany, conforming to the highest physical security standards. Our architecture is fully redundant, guaranteeing that data is continuously mirrored to a secondary data center for added reliability, with full backups conducted daily, ensuring data integrity and availability. With Clincase, you can streamline your clinical trials process and enhance collaboration among all stakeholders involved.

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.

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.

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.

The Thrana Safety Database is a cloud-centric system focused on pharmacovigilance and drug safety management. Crafted to prioritize user experience, this comprehensive solution effortlessly combines essential features like PV Intake, Case Processing, Regulatory Submissions via AS2 Gateways, Regulatory Reports, and Analytics, all conveniently available from a single, unified platform. This integration enhances efficiency and streamlines workflows for users across the industry.

Quanticate delivers extensive services in pharmacovigilance, which include the establishment and oversight of safety databases specific to pharmacovigilance. These safety databases act as the primary collection point for individual case safety reports gathered worldwide for a company's pharmaceutical products. Keeping these databases current with the latest regulatory guidelines and ensuring they are validated according to international standards and business requirements is crucial. Quanticate underscores the necessity of choosing the appropriate database by evaluating factors such as the costs associated with implementation and maintenance, the availability of hosting models (including internal infrastructure, third-party hosting, or vendor cloud solutions), previous experiences, and how well they integrate with existing systems. They warn that, despite many commercial databases claiming adherence to standards like ISO ICSR ICH-E2B, achieving genuine compliance necessitates meticulous configuration, validation, and ongoing management. Furthermore, ongoing support and updates are critical to maintain the integrity and reliability of these safety databases over time.