Clinical Trial Set-up and Strategic Advice

PharmXL consolidates the vast majority of our startup activities into a global business unit. Our employs state-of-the-art technologies to help facilitate the startup process drive industry-leading cycle times and offer additional flexibility in response to our clients’ outsourcing demands. This area includes service areas aligned in a uniquely holistic manner, including trial optimization/strategic feasibility, country/site selection, strategic site partnerships, investigator qualification, site activation (local regulatory submissions, site contracting and clinical startup) and patient recruitment. Site identification and activation is an important component of clinical trials and has a critical impact on subsequent trial timelines, as well as site relationships.

PharmXL has highly experienced staff to initiate your clinical trials by providing;

  • Regulatory strategies
  • Facilitation with FDA / EMEA / Japan regulatory agencies
  • Development planning / protocol design / biostatistics
  • Guidance on formulation / labeling / packaging
  • Key Opinion Leaders (KOLs)
  • Clinical site feasibility and selection
  • Recruitment and enrollment
  • IND preparation / submission / meeting