Creating a full project team
We started by putting together a team comprising a regulatory writer, a CRA, an IT team, a data manager and a project manager. The regulatory writer developed the mandatory regulatory documents that were submitted and accepted by the authorities. The IT team created the electronic platform on which the client can approve and enroll patients and supply treatments as needed – all via a centralized interface.
A lighter administrative burden
By developing the mandatory documents for the relevant authorities and establishing an electronic enrollment platform with a centralized interface, we enabled our client to treat early-access patients with unmet medical needs in a fully electronic way, thus reducing their administrative burden.
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