Design, Planning & Execution

A risk-based approach to clinical trials

We’re driven by one goal: getting critical therapies to the patients who need them.

To best serve those patients — and our partners — we take a risk-focused approach to clinical trial design, planning, and execution. Throughout each of these stages, our team continually assesses risk so we can control it and adapt as we move forward. This strategy, which is a key component of risk-based quality management (RBQM), delivers the right data so your therapies can reach patients.

Begin with insight

To help optimize your product’s potential, we start by building a detailed target product profile (TPP). In this profile, we evaluate the factors that will impact your drug: scientific rationale, competitive landscape, regulatory considerations, therapeutic considerations, and payer landscape.

Our team is made up of more than 1,000 experts, including approximately 100 former regulators and HTA assessors from reimbursement agencies. With this breadth and depth of expertise, we can develop a profile that is more commercially viable across many markets. We consider the addressable market, manufacturability, pricing, and intellectual property protection. And we work sequentially so that we form commercial, business, and marketing assumptions using robust scientific and regulatory analyses.

Reliable guidance from the most experienced professionals

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A balanced study design

A well-designed protocol accounts for patient safety, data integrity, and operational feasibility. Parexel’s team of medical, biostatistical, and operational experts will help you balance these sometimes-competing priorities, creating a protocol designed to:

  • Protect patients and address their needs.
  • Meet regulatory standards.
  • Ensure data integrity.
  • Reduce burden on sites.
  • Maintain scientific rigor.
  • Consider time and cost constraints.

During study design, we also identify potential risks to safety and data integrity, building mitigation into the protocol.

Once a protocol is drafted, our Patient Innovation Center team can make recommendations for minimizing patient burden. We review the frequency and average length of treatments and appointments, the invasiveness of procedures, and any at-home requirements, among other factors.

For support in study design, Parexel offers expertise in:

  • Adaptive design
  • Adaptive Quality-by-Design frameworks
  • Simulation and modeling
  • Endpoint selection
  • Stakeholder engagement
  • Patient-focused optimization
  • Population targeting
  • Protocol development
  • Risk assessment
     

Comprehensive study planning

When preparing to initiate a clinical trial, our experienced team works to anticipate risks to critical data and processes and other significant study risks.  We bring clinical expertise to portfolio- and study-level planning, harnessing the power of data-driven insight, historical knowledge, database intelligence, and thorough scenario planning. Parexel will:

  • Evaluate risk. Our assessment focuses on the tangible and explicit risks of the clinical trial and begins with risks to critical data and processes. Additional risks can pertain to country selection, site-specific variables, or data integrity concerns related to hybrid and virtual DCT models. We begin with risk evaluation because our findings will impact the entire study plan.
  • Assess feasibility. We identify the right mix of countries, sites, and patient populations using a data-driven approach. By synthesizing vast data sources — including commercial databases, unstructured data, and extensive internal performance and site-level intelligence — we develop a precise operational plan to minimize barriers and delays. Our investigator intelligence platform aggregates a wide range of site-specific data points, from patient population diversity to past performance metrics. Using this platform and our other robust feasibility tools, we can eliminate many time-intensive and often redundant site evaluation activities. So we qualify and select sites faster, with greater success — and with each selection, we add more data to our platform, continually making our tools more powerful.
  • Determine protocol acceptability through patient-level data. Our conclusions are the foundation for recruitment, retention, and trial concierge programs, allowing us to tailor our efforts based on real patient feedback.
  • Quantify patients, forecast enrollment, and prepare for recruitment. The first step in recruiting and retaining patients: understanding target populations. Drawing on patient-group knowledge, we build a patient-focused foundation for participation, including targeted outreach and customized mid-trial support programs.
  • Create fit-for-purpose monitoring strategies. Based on the risks to critical data and processes, we plan and implement the monitoring methods that best meet the needs of the clinical trial. We use risk-based monitoring approaches that include central, remote and onsite monitoring. 

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Risk-based study execution

Guided by the protocol and our risk assessment, Parexel can execute your trial with attention and efficiency — continually monitoring for signals and adapting as needed. Modern tools and methods help us focus on critical endpoints. When we conduct trials through a risk-informed lens, we know what data matters and how to protect it.

Parexel can partner with you to provide the following:

  • A focused team handling all study start-up activities, leading to faster time-to-site activation. Dedicated team members, including functional leads and regional support, specialize in critical-path activities and understand every nuance of the work. Thanks to our advanced workflow automation tools, the team has visibility into every step of the process and can manage that process in the most streamlined way.
  • Advanced resource planning tools. These tools dynamically match resource needs at every stage based on a range of variables, including task intensity, data volume, and study scope and complexity.
  • Multidisciplinary project managers centralize efforts and ensure progress. Committed to transparency and collaboration, these experienced leaders know how to reduce risk and to motivate and unify regionalized teams.
  • Iterative risk-based execution and control. This process begins with capturing and quantifying risk early. When a study goes live, we continually evaluate risks and adapt study plans as necessary using data captured across site monitoring, medical monitoring, advanced statistical tools, and interim quality reviews.
  • Data stream integration. We create efficient workflows to ensure regulatory-grade data at every handoff. By mapping data streams in a near-standardized way, we reinforce consistency, boost quality, and reduce the need for re-work.

 

 

 

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We are always available for a conversation.

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