Valley Writing Solutions
Medical Writing For The Pharmaceutical Industry
Expertise
We have experience of designing, interpreting and reporting a wide range of clinical studies across multiple therapeutic areas.
Furthermore, we have particular expertise in Phase 1/Clinical Pharmacology studies in both healthy volunteers and patients. Examples of the types of studies we have been involved in include:
Phase 1
- First-In-Human Dose Escalation Studies
- Food and Formulation Effects
- Thorough QT Studies
- Renal Impairment
- Hepatic Impairment
- Drug-Drug Interactions
- Bioequivalence
- Mass Balance
- Absolute Bioavailability
Phase 2a/b and 3
- Exploratory and Pivotal Efficacy Studies in Patients
- Biomarker Studies
- Pediatric Studies