The Intergroupe Francophone de Cancérologie Thoracique (IFCT) is an association law 1901 of independent, non-profit academic research specialized in thoracic oncology. Created in 1999, the IFCT sponsors clinical research to improve the survival and quality of life of...
f you are headed to the European Trial Master File Summit in London on November 14th – November 16th, then make sure you visit Agatha Inc. booth.
Also, join Ken Lownie’s session as he discusses the evolution of the TMF from file cabinet to process hub.
How Biotech NS Pharma improves its Quality and eTMF management with Agatha. Listen to Arthur Mate, Senior Quality Director explanations.
European Directorate for the Quality of Medicines (EDQM)The EDQM was established to protect public healthcare by ensuring that medicines meet high standards of quality and safety enabling the development, supporting the implementation and monitoring the application of...
Electronic Trial Master File (eTMF)The Trial Master File is a structured set of files used by sponsors and CROs to demonstrate proof of regulatory and ethical requirements for conducting clinical trials. It includes documentation of the following items:* Regulatory...
Electronic Submissions Gateway (ESG)The Food and Drug Administration’s Electronic Submissions Gateway (the ESG) is an agency-wide solution for accepting regulatory submissions from regulated entities. It allows companies to securely submit their premarket and...
Electronic SignatureAn electronic signature is a compilation of any kind of signature (symbols) executed, adopted, or approved by an individual to be the legally binding equivalent of his/her handwritten signature. Signatures,Electronic signatures,documents,digital...
Electronic Patient Reported Outcome (ePRO)Collect patient reported outcome (PROs) using electronic means, for example through apps, wearables, websites, etc. Patients,patient-reported outcomes,study,symptoms,platform,electronic patient-reported...
Electronic Data Capture (EDC)A system capturing patient case report form information. Time,trial,clinical trials,forms,studies,integration,Electronic Data Capture,process,features,query,electronic case report forms. Application,regulatory compliance,contract research...
Electronic Application Form (eAF)A PDF fillable form will be provided for each MAA and variation, which will be removed from the EMA human and vet MAA and variations. Form,electronic application forms,submissions,competent...