phase IV,phase IV clinical trial- sometimes the FDA approves a drug for general use but requires the manufacturer to continue to monitor its effects; during this phase the drug may be tried on slightly different patient populations than those studied in earlier trials ...
An Electronic Trial Master File provides an industry best practice approach to document management which allows you to gain the insight you need to efficiently manage clinical trials and accelerate time to market. In order to move toward an all Electronic Trial Master File, organizations typically ...
LMK Clinical Research Consulting is a leader in Trial Master File (TMF) document management services and solutions for the life sciences industry.
Fundamentals of the Trial Master File Discovery Level Accreditation* *Recommended TMF Experience: 6 MO. $899 Discovery course modules cover the fundamental topics concerning the TMF: Introduction to TMF, Document Quality Control, and TMF Indexing. These modules will ensure that Clinical Trial Assi...
The Trial Master File (TMF) is one of the most important deliverables of a clinical trial because it’s the basis for inspection. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has developed Good Clinical Practice (GCP) standards for...
Create, review, and archive clinical content. Launch compliance focused training. Index all required records in the eTMF All within one system Make it easy to show the story of your study to regulatory agencies. Learn More Here From site identification to close-out, clinical document processes an...
Clinical Trial Assistant, Sponsor “Our search for an eTMF solution required that we find a product that met DIA requirements and was designed and backed by people who truly understand the world of clinical trials. The claims made by the Trial Interactive team during our evaluation process were ...
This CTMS software is designed to provide organizations with a comprehensive trial platform that is seamlessly integrated with an Electronic Trial Master File (eTMF), resulting in improved efficiency, accuracy, and security in consolidating clinical data. Sitero’s core features include: Contact ...
We have an established framework for bringing a prototype clinical trial assay along the codevelopment continuum into a companion diagnostic. With more than a decade of experience working with different clients, ICON Specialty Laboratories has the facilities and skilled intellectual capital to work togeth...
The conduct of a clinical trial requires numerous software and technology tools to make the trial process more efficient. These include a clinical trials management system (CTMS), AI and machine learning, trial master files (TMF), virtual trial and remote monitoring tools, risk-based monitoring (...