Research and development

The acceleration of clinical development pipelines to stay competitive, sustain growth and meet patient needs more effectively is now critical. Revising traditional methods of drug development, including processes, operating models, and technologies, is necessary to deliver products to patients more quickly, at a lower cost, and with better global access.

To achieve the ambitious goal of 30% reduction in drug development timelines, a well-tuned, efficient, and future-ready clinical development landscape is essential, below are some examples of what you can do: 

1. Design Smarter Trials

• Use real-world data such as electronic health records Electronic Health Records (EHRs) and wearables to optimize trial feasibility, resource planning, and predictability.

• Leverage advanced analytics to capture novel endpoints and gain deeper insights into patient experiences.

• Employ digital tools to refine trial designs and enhance the decision-making process.

The benefits of smarter trials include improved design with greater accuracy, leading to more reliable results. Additionally, there is an enhanced ability to predict outcomes and allocate resources more effectively, ensuring optimal efficiency throughout the process.

2. Streamline Site Selection

• Utilize data-driven analytics to objectively identify, qualify, and engage high-performing sites.

• Move beyond subjective decision-making by leveraging clinical trial registries to enhance site efficiency and collaboration.

• Incorporate data insights to match the best sites with the right trials for faster study initiation.

These actions will result in faster site qualification with reduced administrative burden, as well as more efficient trial execution through higher-performing sites.

3. Enhance Patient Recruitment

• Use claims data, population health insights, and benchmarking to match patients to trials more quickly and accurately.

• Leverage digital tools for trial awareness, proactive pre-screening, and engagement to improve patient recruitment.

• Apply data-led strategies to drive better patient retention and compliance throughout the trial.

Doing so will reduce recruitment times and better patient matching as well as improve patient engagement and retention rates.

4. Ensure Seamless Data Flow

• Integrate and analyze data from diverse sources (e.g., clinical, operational, and patient data) using advanced methodologies like machine learning and AI for actionable insights.

• Establish a holistic view of data to drive better decision-making, improving trial speed and outcomes.

• Minimize manual data entry and ensure real-time data accessibility to support quick, informed decisions.

The benefits include streamlined data processes that lead to faster decision-making and enhanced trial efficiency through consistent data flow and analysis.

5. A Data-First Approach to Modernize Clinical Development

• Digitally transform clinical development processes by integrating advanced technologies and data science capabilities.

• Use AI, machine learning, and automation to accelerate decision-making, reduce costs, and enhance the predictability of clinical trial outcomes.

• Boost productivity by minimizing inefficiencies across people, processes, and technology, leading to quicker clinical development cycles.

Transform your regulatory processes by leveraging intelligent automation to enhance efficiency, compliance, and decision-making.

Key strategies for optimizing regulatory processes include:

• Adopt advanced technologies:
  • Implement RIM technology, generative AI, and digital tools to streamline operations.
    
    
  • Use cloud-based solutions to centralize submission documents, clinical trial data, and regulatory correspondence, enabling global, real-time collaboration.
    
    
  • Consolidate data in unified repositories to eliminate inefficiencies and ensure up-to-date accessibility.

• Streamline workflows and standardize data:
  • Apply data standardization and master data management to maintain data uniformity across product registration, labeling, and clinical trials.
    
    
  • Use robust data governance to ensure compliance with evolving global regulations, enhancing traceability and visibility into submission statuses.

• Leverage advanced analytics:
  • Use AI and machine learning to analyze historical regulatory data, predict trends, and optimize submission strategies.
    
    
  • Identify and address bottlenecks in the approval process, reducing cycle times and improving efficiency.

• Automate submission creation:
  • Automate document creation for submissions like CTDs or Module 3 using pre-filled templates, reducing errors and preparation time.
    
    
  • Enable faster responses to regulatory inquiries and ensure manufacturing schedules align with the latest regulatory updates.

By adopting these strategies, you can reduce manual workloads, enhance global collaboration, and achieve faster, more reliable regulatory approvals while maintaining compliance and driving innovation.

Reimagine R&D operations through business process outsourcing (BPO) to shift from a cost center to a strategic value driver, addressing growing drug development complexity, reducing costs, and accelerating innovation. Key actions include outsourcing data management, optimizing site payments, and providing expert support in complex areas like oncology. By adopting next-gen operating models and leveraging digital transformation, R&D functions can be streamlined for better decision-making and efficiency.

Additionally, BPO services, such as AI-driven pharmacovigilance and automated quality management through eQMS solutions, improve compliance, enhance collaboration, and deliver measurable business impact, driving faster innovation.

An AI-driven solution designed to automate the creation of regulatory documents, particularly the Common Technical Document (CTD), required for pharmaceutical submissions. It streamlines the process of ingesting and summarizing hundreds of files in various formats, enabling quick and accurate document drafting.

Key Features

• Automated Document Drafting: Ingest and summarize data from various formats (PDFs, tables) to quickly generate CTDs and other regulatory documentation.

• Intelligent Content Generation: Uses AI/ML to select and populate CTD templates with relevant content, which is then human-verified and completed.

• Pre-Built Templates: Access 450+ CTD and 100+ medical device templates to expedite document creation.

• Microsoft Word Integration: Custom toolbar in Word for efficient formatting, ensuring compliance with regulatory guidelines.

• Validation and Compliance: Built-in tools for document validation, PLR functionality, and reference management, ensuring adherence to ICH guidelines and regional requirements.

Key Benefits

• Streamlines the creation of submission-ready documents, saving time and ensuring compliance with regulatory standards.

• Reduces manual effort by automating content generation and validation, improving efficiency and accuracy in regulatory submissions.