A Phase I Unit In Administration Leaving The Sponsor With No Access To The Trial Master Files (TMF) For Studies In Phase I Development
A Phase I Unit In Administration Leaving The Sponsor With No Access To The Trial Master Files (TMF) For Studies In Phase I Development
1 PagesCase Study: A Phase I unit in administration leaving the Sponsor with no access to the Trial Master Files (TMF) for studies in phase I development Key features: Construction of Sponsor appropriate TMF • Independent management of phase I site files • Archiving of Sponsor and site files Client Scenario: Our client, a global pharmaceutical company, had a programme of six phase I studies contracted to a specialist phase I unit that we
