Network
In order to support complex tasks
it is sometimes necessary to collaborate with other experts in the areas
of medical writing, biostatistics, and regulatory. I will be able to
work with your own team of experts, but in cases where there is need for
additional expertise I will also be able to bring in proven experts from
my own network.
Medical writers: PhD
background and experienced in the art of medical writing for the
pharmaceutical industry with high level of integrity and a proven track
record and English as mother tongue.
Biostatisticians: In dept
industry experience with knowledge of regulatory biostatistical
requirements and an interest and experience in designing
state-of-the-art clinical trials with a team work approach in close
collaboration with the clinicians.
Regulatory experts: US and EU regulatory
experts with drug, biologic and medical device development experience
and a long track record of involvement in major development projects.
This group has a clear understanding of how to build clinical
development projects linking the needs of European and US regulators.
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