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
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