Clinical Development and Operations

In a cost-intensive business like drug development it is imperative to take measures that facilitate cost effectiveness and risk reduction.
One important success factor is the optimized planning and execution of clinical trials. Whenever your operational team faces capacity constraints or requires external input, I can support your company by setting up and leading trial teams in all development phases, or by assuming lead positions ad interim, overseeing the trial portfolio and shaping structures and processes to run clinical trials in a timely, cost-effective and compliant manner.

Updated GCP Guideline ICH-E6 (R3)

After the recent challenge of implementing the EU Clinical Trials Regulation (CTR) 536/2014, a new significant change in the regulatory environment is lying ahead of us. The updated GCP Guideline ICH-E6 (R3) has recently been adopted and will become effective on 23 July 2025. Key concepts of the GCP (R3) guideline are focussing on clinical trial design and planning, like:

• Quality by Design
• Operational feasibility
• Avoidance of unnecessary complexity and unnecessary burden for participants and investigators

The new revision reinforces the concept of risk-proportionate approaches, thereby encouraging trial sponsors to use innovative clinical trial desings and new technologies, whilst demanding a clear focus on efficient clinical trial protocols, tools and procedures.

I will support your company in planning and conducting clinical trials in an efficient and compliant manner by offering a comprehensive package of Clinical Development and Operations services, like:

• Assuming an interim management role as Head of Clinical Operations
  
  
  • Building up and leading a strong Clinical Operations team.
  • Operational oversight of the trial portfolio; planning, tracking and reporting of timelines, costs and quality on portfolio level.
  • Development and implementation of standards and processes for running clinical trials in compliance with ICH-GCP (R3) and applicable regulations.
  • Definition and execution of outsourcing strategies.
  • Liaison with Key Opinion Leaders; preparation and conduct of Advisory Board meetings.
  • Rescue projects and troubleshooting, e.g. vendor alignment, expectation management, root-cause analysis and correction of underperformance.
    
    
• Assuming a role as Clinical Project Lead / Trial Manager
  
  
  • Leading cross-functional teams in all clinical phases.
  • Planning, tracking and reporting of timelines, costs and quality on trial level.
  • Ensuring robust vendor management, site selection and management, patient recruitment and retention strategies.
  • Leading vendor selection and qualification including RfPs, bid defenses.
  • contract development (vendor contracts, site contracts, investigator sponsored trial contracts).