Archemin

Advice & reporting for the chemical and pharmaceutical industries

Clinical Research

since 1989

Post-Approval Safety Studies (PASS)

Whereas during clinical trials, organised for regulatory approval, limited efficacy and safety data in well-defined populations are collected, Post-Approval Safety Studies in real-world settings (i.e. real-life long-term dosing, in patients with various co-morbidities, who receive other drug treatments concomitantly and present various other risk factors) have the potential to demonstrate the safety of any drug product. (also see Pharmacovigilance).

Post-Approval Efficacy Studies (PAES)

PAES can be conducted to substantiate "value-based" price claims (also see Pricing and Reimbursement). Trials are designed by a team that combines thorough knowledge of class I Pricing and Reimbursement with extensive hands-on experience in clinical trial conduct.

Study Design

  • Organization of various types of small-scale clinical trials: fast, efficient and with a minimum of overhead costs.
  • Collection of in-market data
    • with the intention to substantiate "value-based" price claims (also see Pricing and Reimbursement). Trials are designed by a team that combines thorough knowledge of class I Pricing and Reimbursement with extensive hands-on experience in clinical trial conduct.
    • designed to provide additional safety information (also see Pharmacovigilance)
  • Advice and support for investigator-driven clinical trials.

Trial Organsiation and Conduct

  • Site selection and initiation
  • Organization of Investigator Meetings
  • Handling of parallel Ethics Committee Submissions
  • On-site monitoring & data cleaning
  • Analysis & reporting
  • Development of Clinical Trial Documents (also see Medical and Technical Writing)

Clinical Trial Regulatory Affairs

  • IMP files
  • Clinical trial submissions to EU health authorities
  • EC submissions

Want to know more / require a quote ?

Send your request to cr [at] archemin [dot] eu