At Premier Research, our project teams leverage the Remarque Systems platform to power a configurable, role-based Clinical Trial Management System (CTMS) that unites all study data and documentation—including analytics, financial oversight, site and project management—into one centralized solution.

This integrated approach gives project teams, executive leadership and sponsors the visibility and control needed to proactively manage study execution. Project teams stay grounded in day-to-day activities, while Premier Research leadership maintains strategic oversight—able to step in, problem-solve, and help keep trials on track when challenges arise. Sponsors benefit from transparent, real-time access to study status, ensuring alignment and confidence throughout the trial lifecycle.

From study planning through close-out, we streamline operations, increase cross-functional collaboration, and enhance performance—ensuring study management and communication efficiencies that deliver high-quality data and on-time milestones.

Core Modules Include:

• Project Management
• Predict Study Forecasting
• Contact Database
• Study Start Up
• Site Management and Monitoring
• Operational Analytics

Project Management

Remarque’s Project and Timeline Management tool provides our project managers with real-time visibility into every phase of the study lifecycle, with real-time, role-based access to dashboards, data, and project materials. Project teams benefit from improved collaboration, reduced administrative burden, and greater accountability—ensuring critical milestones are achieved.

Key Features Include:

• Study Portfolio Management: Streamlines project setup with templated timelines, standard trackers, and oversight tools to ensure data accuracy and health.
• Dynamic Timeline Oversight: Baseline and track study status, task dependencies, and milestone health using Gantt, calendar, and card views.
• Integrated Project Health Dashboards: Manage scope changes, finance logs, action items, protocol deviations, and lessons learned with standardized templates to streamline project reporting and communication.

Predict Study Forecasting

Using Predict, our clinical experts model and forecast key operational aspects of your trial—before launch and throughout execution—to support more strategic planning and decision making. Accurately forecasting study enrollment before launch and beyond, we adjust our approach in real-time using actual data.

Forecasting Capabilities Include:

• Country and Site Start Up Modelling
• Enrollment Modelling
• Patient Visit Forecasting
• Investigator Grant Forecasting

Contact Database

Using our Contact Database, we maintain complete records of all study and vendor contacts for quality, compliance, and regulatory oversight. Tracking all contacts on a clinical study both historical, active, and those yet to start, we can monitor past performance, track capabilities, and catalogue specialized services to ensure the selection of high-performing vendors and sites that meet the needs of your study.

Modules Include:

• Site Network Database: Tracks more than 150 global site networks comprised of more than 5,000 potential sites, managed under master nondisclosure agreements to fast track interest and capabilities for upcoming trials.
• Institution and Investigator Database: Tracks more than 19,000 participating and potential investigators, capturing site capabilities and past performance.
• Vendor Database: Monitors vendor qualifications and performance by service provided.
• Site and Study Contacts: Centralizes tracking of all team members across studies.

Study Start Up

Premier’s innovative CTMS transforms study start up by streamlining site selection and activation while ensuring compliance. Our platform enables our clinical teams to quickly identify optimal sites, track documents, and manage all start up tasks, including approvals, contracts, and site activation activities, with greater efficiency.

This approach accelerates trial initiation, reduces administrative burden, and maintains momentum across global studies while supporting full visibility, operational analytics, and flexibility during study activation.

Study Start Up Capabilities:

• Seamless Collaboration: Empowers our CRA and SSU teams to work together more effectively with task tracking all in one place.
• Site Selection and Feasibility: Target the most appropriate sites for site selection.
• Streamline Regulatory Submissions: Speed the regulatory approval process with built-in templates that reflect our team’s vital in-country regulatory knowledge, simplifying compliance with one click.
• Budget and Contracts Management: Track status of all budgets and contract negotiations.
• Clinical Activation Activities Tracking: Oversight and visibility on all activation tasks including all site level details and vendor activities.
• Key Actions and Milestones Tracking: Supports the team in prioritizing sites for activation each month so they can stay on top of the critical milestones and deadlines.

Site Management and Monitoring

Premier’s CTMS delivers an end-to-end solution for monitoring and site management, fully integrated with our Start Up and RBQM modules. It enables Clinical Leads, CRAs, and Central Monitors to efficiently schedule visits, track SDR, manage protocol deviations and action items, and streamline site communication. The platform simplifies visit reporting, automates documentation filing to the eTMF, and streamlines site closure activities for accuracy, efficiency, and complete oversight.

Key Benefits of Our Monitoring and Site Management Module Include:

• Ease of Use: CRAs can easily schedule visits and complete reports in a timely manner.
• Actionable Views: With CRAs often traveling, the platform provides an actionable page of alerts, upcoming visits, and pending documents, action items and tasks.
• Automated Workflows: Our Central Monitors and other team members can send site-specific workflows to CRAs which allowing our team to effectively collaborate.
• Reduced Administrative Burden: SDR tracking, action items, and protocol deviations are entered once and then pull into visit reports.
• Automated Filing to eTMF: With an integration to the eTMF, all visit documentation will automatically be filed providing efficiency for the team and ensure quality.
• Self-Service Data Exports: Allows users to export data to flexibly address customized review needs, including data quality reviews.
• Reporting Through Operational Analytics: Visit reporting is integrated with our Operational Analytics providing for visibility on visit metrics and compliance with workflows and action items.

Operational Analytics

At Premier Research, Remarque Operational Analytics empowers proactive oversight by delivering real-time visibility into every facet of clinical trial execution. With a centralized platform that integrates data across systems, stakeholders—from project teams to executive leadership to sponsors—gain the transparency they need to stay informed, identify risks early, and make confident, data-driven decisions.

This Approach Supports Project Engagement at All Levels:

• Study Teams track day-to-day performance, enabling quicker responses and better operational control.
• Premier Research Leadership maintains strategic, at-a-glance oversight—ready to intervene, guide, and support teams when challenges arise.
• Sponsors have clear, consistent visibility into study progress, ensuring alignment, confidence, and accountability.

With Operational Analytics, You Gain More Than Data

You gain the clarity and control needed to keep trials on track and deliver results with confidence. The system consolidates operational and financial data in one place, enabling real-time monitoring of:

• Project Status and KPIs: Stay aligned with milestones and timelines
• Site Selection and Activation: Track site readiness and launch progress
• Patient Enrollment: Monitor recruitment performance across all locations
• Site Management and Monitoring: Ensure quality and compliance at the site level
• Protocol Deviations, Action Items and Queries: Proactively resolve issues to maintain study integrity
• Project Financials: Access detailed financial tracking, including grant payments

A Centralized View of Operations

Serving as a centralized, real-time view of clinical trial operations by seamlessly integrating data from multiple technology platforms, Remarque Operational Analytics empowers sponsors by providing:

• Unified, Updated Reporting: Our integrated reporting solution consolidates all operational data into a single, accessible platform that is updated daily. You have access to a comprehensive view of your trial’s progress when you want to look at it.
• Data-Driven Decision Making: Make informed decisions faster with instant access to key metrics and performance indicators. Our teams are able to address issues proactively – ensuring that our trials stay on track and within budget.
• Full Visibility: From start-up to close-out, our platform provides visibility into every phase of the clinical trial process.
• Ease of Use: Underlying technology is straightforward and requires no training. Users can apply filters to drilldown into data and export visualizations as needed.

Why Work With Premier?

By leveraging Premier processes and technology, we can streamline and improve the delivery of your study:

• Improved forecasting and study planning
• Reduced admin burden
• Improved oversight of study start up
• Real-time insights and end-to-end visibility
• Fully integrated with RBQM and eTMF

Contact Premier today to how we can deliver enhanced study management and leverage the Remarque platform to streamline your study.