Y Prime eClinical Software | Cloud-Based eClinical Software

Born in the Cloud

Y Prime’s innovative software solutions are bringing a new level of transparency to meet the challenges of today’s increasingly complex and competitive clinical and regulatory environment. Working for industry leaders worldwide, Y Prime harnesses information to help clients effectively plan and manage clinical trials on time and within budget.

By applying novel techniques to software, processes, and individuals within the enterprise, Y Prime creates innovative and visual understanding of the sensitive ecosystem of companies involved in a clinical trial. Our collaborative approach to influence a successful project ultimately provides you with the peace of mind you seek.

i am interested in IRT

Interactive Response Technology

Far too often, legacy systems force companies to make decisions based off of history and without the assistance of today’s technology. Y Prime’s Interactive Response Technology is the result of countless experiences of subject matter experts from Trial Managers to Investigators who assessed the shortcomings and pitfalls of existing IVR and IWR offerings. Y Prime’s IRT combines IVR and IWR into a fluid, fully customizable, integrated voice and web response system that can be installed in half the time of other options. Experience the difference with direct communication to a development and support team associated specifically with your study for fast turnaround on new features. Work alongside your dedicated Y Prime team to visually configure the initial system from the kick off meeting to the final system at go-live. This drastically reduces time, cost, and your frustration because you’ve already been familiarized with the system that you’ll be using long before UAT. The reporting platform allows you direct access to define which information is needed. Centered around your trial’s real-time usage, our dynamic resupply logic automatically adjusts levels of investigational product to ensure minimal waste and accurate delivery.

image description

a fully featured IRT that scales depending on your needs.

features and benefits

  • Visual interaction with the system from kick-off
  • Unlimited, Real-Time data transfers
  • Dynamically configurable randomization schedules
  • Integrated Supply Chain visibility through direct link to eCSF
  • Dedicated, Sponsor-Specific Project Managers
READ MORE READ LESS

more information about IRT

IRT’s platform architecture allows your designated project team to select modules from a central repository and instantly configure them to meet study- specific requirements, effectively eliminating confusion at UAT or costly Change Orders. Because of reduced validation time associated with this architecture, our clients continually rely on us to meet accelerated system launch times and challenging randomization schemes. IRT provides role based views of the system that gives users instant access to high priority items for: Investigators, Study Coordinators, Supply Managers, Project Managers, and CRAs – empowering your team to make informed decisions.

In addition to reusable feature modules, IRT delivers reusable reports available for multiple client trials without costly ad hoc pricing.

i am interested in eMVR

Monitoring Visit Reports

Y Prime’s eMonitoring Visit Report solution is a complete and amazingly flexible tool giving companies unparalleled levels of control over the management of the Monitoring Visit Report responsibilities. “Our goal was to create a more intuitive and flexible eMVR system to make it easy to set up and display the information you need, and complete reports quicker with fewer revisions,” says Jaime Cook, Chief Customer Officer. Experience the ability to review and track comments which are displayed beside each report entry. What you see is a fully personalized application allowing you search, re-size, hide, filter and sort capabilities to see data the way you want, whether you’re a CRA or a reviewer.

image description

eMVR ensures complete regulatory compliance and transparency

features and benefits

  • Ensure sites are within FDA compliance and avoid costly issues at inspection
  • Produce high quality visit reports with far fewer review and edit cycles
  • Sponsor-specific spell check built-in to eliminate time consuming ‘cut-and-paste’
  • Generate real-time reports
READ MORE READ LESS

more information about eMVR

Y Prime eMVR gives users a flexible, intuitive tool to plan, perform, and finalize all of their daily MVR tasks. Usable as a standalone application or on top of an existing system, our eMVR interface provides real time, configurable work flows, simplifying functions and reducing user fatigue and error. Complete with an intuitive custom report generator and calendar view, Y Prime eMVR places every necessary tool at the users’ fingertips.

i am interested in ePRO

Patient Recorded Outcome

Imagine being able to adapt drug dosing or patient visit schedules based on quality data received in real time from an ePRO solution. With Y Prime ePRO technologies you can. Our ePRO solution can be customized for use on a number of cutting edge smartphone or tablet solutions, such as the cost effective Google® Nexus® 7 or through a traditional web-based portal. Data is securely transmitted in real time to our cloud based system, providing real time access to the patient outcome data and for the integration of the data into gates and workflow decisions in the IWR/IVR system. Our ePRO technology works with more mobile networks worldwide than our competitors. Additionally, all prompts, questions, and navigation buttons can be customized to any language to support the needs of your global trial. Data inputs can range from drop down selectors and radio buttons, to more advanced inputs such as sliding scales and grid entry supported by touch-screen or stylus based devices or entry from a web-based portal. The ePRO features built-in training simulations and user guides, that when coupled with our intuitive design leads to better patient compliance, reduced patient intimidation of the technology and decreased support issues generated to the sites.

image description

Our ePRO technology is globally mobile ready and easy to use ensuring greater patient compliance

features and benefits

  • Available in mobile and web-based platforms
  • Mobile ePRO can be easily adapted to specific protocol requirements and is compliant with all regulatory requirements
  • Design and Management Platform: A role-based online portal provides instant visibility and access to data with an easy-to-use configuration engine
READ MORE READ LESS

more information about ePRO

Y Prime’s ePRO is seamlessly integrated with our advanced Interactive Web Randomization System and Drug Supplies Management Solution which significantly reduces cycle time associated with adding new subjects. This integration also allows the IWR/IVR system to be customized with gates and work flow checks based on the ePRO data. The ePRO system can be fully customized depending on the needs and indication of the trial. Compliance related alerts and custom reports are available to aid in ensuring time sensitive data is managed accordingly.

i am interested in CTMS

Clinical Trial Management System

Designed for human interface, Y Prime’s CTMS provides an intuitive and easy to use system with a focus on the ability to access data easily and quickly. The system has streamlined study creation, utilizing our industry research to help managers forecast and execute clinical trials in an efficient, intuitive manner, meaning set-up and training time are minimal. Fully supported by Y Prime’s industry experts, our CTMS is designed with a flexible framework allowing it to evolve with changing business processes, hence meeting the potentially endless requirements of all trial management needs. Our CTMS is available with multiple, flexible pricing models.

image description

CTMS gives you real time visibility and control over clinical study resources

features and benefits

  • Plan and manage your study recruitment and milestones
  • Maintain a comprehensive study repository
  • Integrate with other eClinical solutions (IVR/IWR, EDC, Document Management, etc.)
  • Maintain a central database of investigators, sites, and CROs
READ MORE READ LESS

more information about CTMS

Our CTMS enables you improve the efficiency and quality of clinical trials by reducing manual effort, streamlining workflow processes, improving communication and collaboration, increasing transparency, and improving compliance with clinical trial protocols. CTMS helps study managers effectively deploy critical resources, proactively address performance issues, and streamline operational workflows. This represents huge opportunities for budget savings and timeline reductions. Advanced reporting functionality provides easy access to metrics, workflow events, action items, documents collected and protocol deviations, providing a detailed view of your entire study in real time.

Y Prime’s CTMS functions as a stand-alone system, but its greatest strength is the ease with which it can be integrated with other eClinical systems, both Y Prime developed as well as other vendors’ products.

i am interested in eCSF

Clinical Supply and Forecasting

Clinical Supply Forecasting and Logistics is under great pressure to provide significant savings without affecting study timelines. Y Prime has created a solution that provides the ability for sponsors to keep investigational product overage under 10% on Phase III global trials. The solution is driven by a proprietary and proven algorithm process that can predict different enrollment rates across therapeutic areas for the world’s top pharmaceutical providers. Real time integration with your latest IWR figures will allow Supply Chain managers to make informed decisions faster, and finally quantify information that was previously unavailable to them. The eCSF toolkit is designed to maintain cross-functionality with our IVR & IWR supply design and management service while ensuring that Logistics professionals are able to see "the big picture," and act according to the real-time data provided by the system.

image description

eCSF keeps investigational product overages to under 10%

features and benefits

  • Accurately track projections vs. actuals for patient recruitment and drug supply on a per-protocol basis.
  • View real-time reports generated in a highly visual and intuitive interface
  • Maintain situational awareness of events at the global, depot, or individual site level
  • Generate and run hypothetical scenario analysis based on your actual data
READ MORE READ LESS

more information about eCSF

Y Prime's eCSF provides a quick and easy way for Drug Supply Manager's to gain real-time visibility into their supply and demand needs. The system delivers high end supply plans and re-forecasts for trials by allowing users to run scenarios iteratively using a trend based algorithm that draws on an extensive understanding and expertise around global regulatory compliance, manufacturing, packaging/labeling, distribution, logistics. eCSF enables you to easily manage any fluctuations in resource demand, making you more responsive to changing market needs.