Project & Risk Management

Smarter Oversight for Smarter Trials

Project & Risk Management

Smarter Oversight for Smarter Trials

Project Management Powered by Proven Processes and Purpose-Built Technology

In clinical development, flawless execution is everything—which is why project management is at the core of everything we do. The ability to manage timelines, costs, and deliverables with precision can make or break a program. That’s why we place experienced, strategic project leaders at the helm—ensuring your study stays aligned with expectations, compliant with regulations, and consistently on schedule and within budget.

At Premier, our project managers work closely with risk and cross-functional project teams to bring together deep therapeutic expertise and proven methodologies, with support from a purpose-built technology suite, to deliver full-service oversight from start-up through database lock. Whether you’re running a single trial or overseeing an entire portfolio, we provide real-time visibility, proactive risk management, and collaborative execution that drives study success.

Why You Need More Than Just a Project Manager

You need a strategic partner—one that understands clinical complexity, prioritizes clear communication, and leverages technology to mitigate risk before it becomes an issue. Our teams do more than manage timelines; they orchestrate cross-functional alignment, safeguard study quality, and ensure your expectations and regulatory requirements are met—every time.

Built for Execution: Technology-Driven Project Oversight

Our proprietary project oversight suite, Remarque, empowers project managers and sponsors with real-time risk management visibility into timelines, financials, tasks, clinical and protocol risks, and resourcing. It’s not just software—it’s the foundation of our operational agility.

Key Features Include:

Timeline Management

  • Dynamic task scheduling, dependencies, and milestones
  • Gantt, card, and calendar views for intuitive oversight
  • Real-time risk alerts and status visualizations

Portfolio Oversight

  • Study portfolio dashboards for PMOs to track intake, resource planning, and template alignment
  • Centralized “health checks” to prevent data drift and identify blockers early

 Integrated Trackers & Logs

  • Standardized templates for meeting logs, scope changes, actions/issues/decisions, and more
  • Lessons learned and document tracking across study lifecycle
  • Portfolio-level rollups by sponsor, therapeutic area, and program

Resourcing & Allocation

  • Forecasting and placeholding for initial contracts
  • Real-time alignment of staff assignments with budget, roles, and timeline impacts
  • Bidirectional visibility between resource changes and project delivery

Risk and Issue Management that Meets ICH E6 (R3)

In an evolving regulatory landscape, sponsors must do more than react to risks—they must document, demonstrate, and defend risk management plans from planning to resolution. Our risk and issue management platform enables:

  • Risk Identification & Mitigation Planning
  • Ongoing Risk Oversight (Operational & Protocol Execution)
  • Linked Issue Tracking and Documentation
  • Deviation Management & Root Cause Analysis
  • AI/ML-Based and Rule-Based Issue Generation

With centralized visibility into risks and issues through our Remarque technology, project teams and sponsors have the actionable insights to drive decision making and confidently meet regulatory expectations, while avoiding costly surprises and delays.

Communication That Drives Success

At Premier, communication is never an afterthought—it’s a core competency. We ensure alignment through:

  • Transparent, upfront deliverables shared with your team and ours
  • Consistent updates from kickoff to completion, including weekly meetings and real-time tracking
  • Respectful, responsive coordination with all stakeholders—sponsors, sites, and vendors
  • Remarque technology that provides role-based access, ensuring the project team, sponsor, and sites are working together in one platform

Predictability. Performance. Partnership.

We don’t believe in reinventing the wheel—we believe in building on what has been proven to work. Our project execution models reflect years of success across diverse trials, disease areas, and sponsor needs. We bring:

  • Proven governance and oversight models
  • Efficient, flexible structures built for collaboration
  • Standardized processes supported by the same tools your project teams use every day

And when things change? We collaborate. Our teams work closely with your budget owners and decision-makers to scope accurately, adapt quickly, and manage proactively.

Let’s Build Confidence Into Your Next Study.

Contact Premier today to learn more about how we can deliver your clinical trial with project management and risk oversight that provides clarity, control, and confidence.

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