LMK Clinical Research Consulting is a leader in Trial Master File (TMF) document management services and solutions for the life sciences industry.
Trial Master fileNowadays clinical trial protocols are written in a fashion that was introduced with the first version of GCP-- and didnot improve since then.Three main areas are opening rooms for relevant improvements:. 1.The scientific rationale is still primarily based on individuals' (often ...
trial master file (TMF)syn. clinical trial manual, project book note, study file; hard copy of all the documentation relating to a clinical trial; includes e.g. also audit certificates and reports, data on adverse events.doi:10.1007/978-3-211-89836-9_1419Gerhard Nahler...
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With built-in content management, site feasibility, study start-up, learning management, and CTMS solutions, you have a complete, central solution for on-site and remote clinical trial management. eTMF Features Reduce the risk of inspection findings with features that simplify trial master file mana...
myTI Access the power of the Trial Interactive unified platform on-the-go myTI is the mobile eTMF app for the Trial Interactive e-clinical platform, ensuring uninterrupted access to the eTMF for study teams. CRAs, site personnel, and sponsors can save valuable time by eliminating the need for...
除了临床试验流程本身的信息化以外,临床试验项目管理也开始走向信息化,出现了CTMS(clinical trial management system)和eTMF(Electronic Trial Master File)等系统。 2010年左右,临床试验的信息化在中国也开始起步,主要是外资企业在中国发起的某些试验中最早出现了EDC,比如药品上市后研究项目和医疗器械试验项目。我记得,在...
as well as with colleagues within the organisation, theClinical Trial Assistant is responsible for tracking site budget relatedmatters, including processing invoices, tracking payments etc. The maintenanceand updating of the Trial Master File (and preparation for relevant QC checkswhen applicable) also ...
Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and...
解析 A. Maintaining the clinical trial master file. B. Supplying and disposing of Investigational Drug. C. Ensuring the Investigators are conducting the trial according to the protocol. D. Providing investigators with the information they nee d to conduct the investigation....