We collaborate and liaise with the most experienced individuals with advanced degrees including PharmD, MD, and PhD certifications.
As part of our work with sponsors around the world, we routinely collaborate with functional departments including Medical Affairs, Regulatory, Biostatistics, and Clinical Trial Operations, in order to help ensure that regulatory documents are developed to be scientifically, methodologically and operationally sound.
We routinely prepare:
- Investigator Brochures (IBs)
- Protocols & Amendments
- Integrated Summary of Safety (ISS)
- Integrated Study of Efficacy (ISE)
- General medical writing
- Clinical Study Reports (CSRs)
- Systematic literature reviews