Medidata Clinical Cloud: Innovative Technology to
Optimize Your Clinical Trials from Concept to Conclusion
Medidata’s solutions can address the entire clinical development process through innovative technology and platform interoperability. Whether for your first study or an enterprise solution across multiple phases and therapeutic areas, our suite of products streamlines key clinical development operations, including study and protocol design, trial planning and management, site collaboration and management, randomization and trial supply management, electronic data capture (EDC) and management, monitoring, safety event capture, medical coding and business analytics.
Study and Protocol Design
Medidata Designer is an innovative study and protocol design solution that helps sponsors focus resources on the science of the study design, improving its quality by enabling line of sight between objectives and endpoints, structuring design components and streamlining trial execution through reuse of design information in downstream systems.
Medidata Grants Manager® and Medidata CRO Contractor®
Trial Planning and Management
Medidata Grants Manager is the industry-leading investigator site benchmarking tool, based on the PICAS® database of industry-wide negotiated site cost information, to ensure fair and consistent investigator payments, mitigate compliance risks and reduce elapsed time of site enrollment.
Grants Manager Contracting™ provides clinical trial sponsors and contract research organizations (CROs) with an online environment to efficiently negotiate budgets with investigative sites. Sponsors can now speed the agreement and completion of budgets as well as monitor contracting progress with a few or thousands of sites.
Medidata CRO Contractor leverages the CROCAS®, the industry database of thousands of negotiated outsourcing arrangements, to provide clinical research sponsors the benchmarking data and analysis tools to optimally plan, budget and manage CRO contracts.
Enterprise Trial Management
Medidata CTMS is a SaaS-based trial management solution with powerful yet affordable tools that can be quickly set up to streamline operational workflows, such as site payments and monitor visits, increase site performance and provide study managers with real-time visibility into milestones and metrics.
Randomization and Trial Supply Management
Medidata Balance provides a unique and unified approach to randomization and trial supply management in clinical trials, transforming the process into a self-service operation of randomization and supply planning, simple and fast unification with Medidata Rave EDC and ease of operation at sites.
Unified EDC/CDM Platform
Medidata Rave is the leading EDC and CDM platform to capture, manage and report clinical, operational and safety data for clinical studies. A robust and flexible feature set, ease-of-use at sites and advanced data import/export integration tools effectively support any trial design, fast study starts and quick access to meaningful data.
Medidata Patient Cloud™
Electronic Patient Reported Outcomes (ePRO)
Medidata Patient Cloud brings the patient’s voice to clinical data in a seamless fashion, enabling sponsors to easily capture and manage data from patient questionnaires. By allowing patients to use their own iOS® devices, the Patient Cloud lets participants answer clinical trial questionnaires in a fashion that is integrated into their daily lives.
Risk-Based Site Monitoring
Medidata TSDV is an EDC-based source document verification (SDV) solution that enables sponsors and CROs to implement risk-based site monitoring strategies with an efficient, scalable and auditable approach. With Medidata TSDV, researches can greatly improve site monitoring efficiencies, reduce monitoring cost and focus operational resources where they are most critical.
Site Quality Management
Medidata SQM is a cloud-based site quality management tool that proactively alerts study teams to emerging site quality issues during a clinical trial, removing the guesswork from site management. Powered by advanced analytics, SQM’s turnkey, color-coded and intuitive dashboards continually assess site data to predict when a site’s quality deviates from the study norm.
Rave Safety Gateway
Safety Data Capture
Rave Safety Gateway is a secure, configurable EDC-to-safety-system interface that enhances Medidata Rave EDC with adverse event (AE) and serious adverse event (SAE) collection and E2B transmission capabilities. With Safety Gateway, sponsors can greatly improve the accuracy and speed of safety data collection and transfer to safety systems, yielding significant savings in time and resources.
Medidata Coder is a software-as-a-service (SaaS) solution that streamlines your clinical trials with an easy-to-use, centralized coding environment that works out of the box with Medidata Rave, seamlessly integrates with any source system, simplifies dictionary upgrades and supports unlimited coding segments.
Clinical Business Analytics
Medidata Insights is a turnkey clinical business analytics solution providing advanced visualizations of clinical operational performance metrics alongside company and industry performance. Insights delivers pre-built reports on dozens of critical operational metrics, seamlessly captured and developed without impacting existing processes. From study design to enrollment to data quality, Insights enables clinical executives to make more informed decisions throughout the clinical lifecycle.
Clinical Management Portal
iMedidata is a cloud-based clinical trial portal and user rights administration platform, which enables an enhanced user experience for all Medidata applications, leveraging single sign-on for end users to easily manage multiple clinical research processes from a single point of access.