Expert Advice and Documents for All Stages of Development

We Will PRODUCE IT.

When you have questions about your drug development program, Clinipace provides the answers you are looking for. Our team of industry professionals — from medical to market access professionals — provides the experience, data and information you need to design your program. We provide dedicated support as part of a full-service contract or as individual projects.

Documentation Services

  • Agency meeting briefings
  • Analytical validation reports
  • Clinical protocols and SOPs
  • Clinical study reports
  • CMC documents, including QOS
  • DSMB reports
  • Environmental assessments
  • Expert reports/clinical overviews
  • Informed consent documents
  • Investigator brochures
  • IRB communications
  • Literature summaries
  • Medical monitoring/medical data review
  • Patient information brochures
  • Product monographs
  • Regulatory services
  • Reporting to health authorities
  • Scientific abstracts, manuscripts, posters, conference reports
  • Study protocols