2nd European Trial Master File Summit
22 Oct 2013 - 23 Oct 2013 - London, UK
In the clinical development phase of clinical trials the pharmaceutical industry maintains a trial master file (TMF) comprised of thousands of pages of regulatory documents required for each clinical trial. For the majority of clinical trials, clinical trial regulatory documents are primarily paper documents captured centrally in physical file cabinets. These paper-based TMFs are a centralized set of central documents that typically are used to support and comply with applicable regulatory requirements and Good Clinical Practices (GCP).