Pharmaceuticals
My areas of expertise include:
– Clinical research
– Drug discovery
– Pharmacovigilance
– Marketing authorisation
– Post-marketing studies
– Good manufacturing practices
– Quality control and assurance
– SmPCs
– PILs
– ADR reports
– SOPs
Clinical trial documentation (see below)
– Investigator’s brochures
– Protocols and amendments
– Informed consent forms
– Case report forms
– Opinions of independent ethics committees
– Clinical study reports
Some of my recent projects in this field include:
– Contract between a university hospital and a research centre for conducting a clinical trial (12,000 words)
– Proofreading of a study on an investigational medicinal product compared to placebo in participants at the risk of onset of Alzheimer’s disease (7,000 words)
– Transcription of interviews with patients regarding their experience of an investigational medicinal product (5 hours of audio)
– Clinical trial authorisation documents (3,000 words)
– Translation of SmPCs and PILs (around 45,000 words – ongoing)