Domain Areas

Clinical Development

Patient-centered, integrated process and tools for highly outsourced and mixed-model delivery organizations driving growth through better outcomes

rightSolution svg

There is a revolutionary shift in the way that companies are collecting, analyzing, reporting, and monitoring clinical, safety, and regulatory data. Organizations tasked with the need to do more with less are employing novel business models, combined with innovative digital transformation tools, to reach superior conclusions more effectively and efficiently.

TriRadial’s 360-degree perspective focuses on Planning, Process, Vendor Management, Innovation, and Performance Improvement.  Our Clinical Execution Readiness Program, delivered by our team of seasoned domain experts, is aimed at ensuring that your organization has the appropriate people, processes, procedures, partners, and systems in place to achieve successful clinical outcomes while avoiding delays and roadblocks that have become all too common in clinical research endeavors.

TriRadial offers a broad range of advisory services ranging from assessments of current capabilities, design of new business models to implementation of technology-enabled processes to improve efficiencies and assure compliance.

Clinical Trials

In today’s changing clinical landscape, companies that are increasingly pressured to reduce time and costs, while increasing throughput, are leveraging new tools and business models. TriRadial is focused on helping organizations move from legacy, document-centered processes to more automated, data-driven environments to drive significant productivity gains, better decision making and reduced risks. 

We believe the patient should be at the center of everything we do within life sciences, so we are committed to helping our clients more closely integrate patients and sites into the drug development process. Enabling tools and digital technologies can assure that patients, sites, sponsors, and regulators collaborate seamlessly, as we bring novel drugs to market.  

Regulatory Affairs 

Biopharma companies are facing an increasingly dynamic and complex regulatory environment, especially given evolving regulations in emerging markets, recent uncertainty surrounding US regulations, and an overall heightened focus on data. Companies are looking for new operating models that allow them to break down internal silos, leverage data more effectively and increase their use of global partners to reduce investments in fixed assets. TriRadial works with Regulatory groups to assess and improve their global capabilities. Technology is playing a significant role in the evolution of regulatory operations across the industry. We help companies develop future-state architectures and navigate the wide array of vendors in the market that are targeting RIM, IDMP and other data-driven solutions. We also assist in the development of outsourcing strategies and how to optimize global partnerships with regulatory service vendors. 


Companies need the ability to collect, analyze and communicate safety related information, both internally and externally, with speed and integrity. Signal detection, risk mitigation and medical oversight all depend on time-sensitive and accurate data. In an environment of increasing patients touch points, having the ability to scale and manage safety information has never been more critical to a company’s success. TriRadial helps companies optimize outsourcing, information exchange, technology platforms and oversight to align solutions with strategic goals and operating realities.

Let us know how we can help you improve your Clinical, Regulatory, and Pharmacovigilance capabilities. 


Click here for more information on our Solutions and Capabilities

TriRadial_FactSheet_Clinical Execution Readiness ebook_icon

Fact Sheet

Clinical Execution Readiness

Example Projects

Example Projects – Business Transformation

  • Capability Assessment and Gap Analysis 
  • Process Optimization and Global Harmonization 
  • Quality System Assessment and Remediation 
  • Change Management for Large-Scale Transformations 
  • Organization and Team Design
  • Benchmarking Against Leading Practices 
  • Metrics and Dashboard Development 

Example Projects – Domain-Specific

  • Outsourcing Strategy and Partnership Optimization 
  • Next Generation Monitoring Solutions
  • Structured Content Authoring Solutions 
  • RIM solution design and vendor selection 
  • IDMP Readiness
  • Risk-Based Quality Management Design and Implementation

Example Projects – Innovation and Data Strategy

  • Digital Health Technology Readiness
  • Digital Data Flow Strategy and Architecture
  • Process Automation using BPM, AI, and ML components.
  • Patient Engagement through Patient Enablement
  • Electronic Quality Management Solutions
  • Collaboration Solutions
  • Program Management and Governance

Let us know how we can help you improve your Clinical Development capabilities. Click here to Contact Us

Download Fact Sheet