Clinical Operations support

pharma consulting clinical operations

In a cost-intensive business like drug development it is imperative to take measures that facilitate cost effectiveness and risk reduction.
The most important success factor is the optimized planning and execution of clinical studies. Whenever your operational team faces capacity constraints or requires external input CHPC can help with my long-standing experience in Clinical Operations, e.g., by setting up and leading study teams in all development phases, and by assuming lead positions ad interim, developing and shaping structures and processes to run clinical studies in a timely, cost-effective and compliant manner.

EU Clinical Trials Regulation (CTR) 536/2014

A very recent challenge for drug development companies is the implementation of EU Clinical Trials Regulation (CTR) 536/2014.
The regulation introduces new European standards for the interaction with Regulatory Authorities in the context of clinical trial authorization, modification, and reporting.
For most companies this requires new structures and processes in all company departments involved in such interactions. Besides RA interactions the CTR also introduces new regulations for IMPs, safety reporting, and trial transparency.
As of 31 Jan 2023 the CTR has become mandatory for any initial submission of interventional clinical trials.
As of 31 Jan 2025 the Clinical Trials Directive 2001/20/EC will cease, which means that all clinical trials running under the CTD that will go on beyond this timepoint will need to be transitioned to the CTR well enough in advance.

CHPC can help with all of these challenges by offering a comprehensive package of Clinical Operations services like:

  • Assuming the role of a Head of Clinical Operations or Clinical Team Lead / Clinical Study Manager
  • Development, implementation and execution of

    • standards and processes for running clinical studies under the CTR / manage authority interactions via the CTIS portal
    • outsourcing strategies (outsourcing model, vendor selection and qualification processes including RfPs, bid defenses)
    • contract development (vendor contracts, site contracts, investigator sponsored trial contracts)
    • study planning strategies (e.g. feasibility studies for indication, protocol and site/recruitment)
  • Liaison with Key Opinion Leaders; preparation and conduct of Advisory Board meetings
  • Leading task forces for any endeavor
  • Rescue projects and troubleshooting, e.g. vendor alignment, expectation management, root-cause analysis and correction of underperformance