Corporate Banner
Satellite Banner
Scientific Community
Become a Member | Sign in
Home>Events>This Event
  Events - January 2013

2nd Trial Master File Summit

24 Jan 2013 - 25 Jan 2013 - VA, USA

Bookmark and Share

Improving Quality in your TMF Documentation through a Compliant Centralized Filing System

During the clinical trials phase of a products’ life cycle involving patients, the pharmaceutical industry is required to create and maintains a trial master file (TMF) comprised of upwards of 100s of thousands and even approach 1 million in longer trials of required clinical documentations. These documents are designed to demonstrate compliance to an investigator or sponsor, and to maintain Good Clinical Practice standards.

Currently through a demand to improve TMF quality, the industry is making a transformation from eTMF had become easier for an organization to create a centralized eTMF system that is affordable, flexible, and can act as a real-time trial monitoring tool. eTMFs have also created advantages such as reducing clutter, enabling new organizational capabilities, and facilitating trial document quality management of a multi-site trial on a global scale.

At ExL Pharma’s 2nd Trial Master File Summit will provide industry professionals a forum to discuss best practices of data management filing through paper TMF, eTMF, and hybrid systems. Additionally the event will allow TMF Process Owners, Quality, Clinical, Regulatory, and Information. Technology professionals who are responsible for TMF to share insights and

best practices to facilitate successful TMF management. Clinical trial leaders can focus on advancing science to improve and save lives by more effectively using advanced TMF management concepts and management and regulatory considerations.

Further information
Scientific News
Researchers Construct Atomic Model of an Immature Retrovirus
Using molecular modeling and large-scale molecular dynamic simulation, Beckman researchers have constructed an atomic model of an immature retrovirus.
New Mathematics Advances the Frontier of Macromolecular Imaging
Berkeley Lab’s M-TIP solves the reconstruction problem for fluctuation X-ray scattering.
Exploring Living cells
JPK reports the exploration of living cells using nanoscale and single molecule techniques through the application of scanning probe microscopy.
The Perfect Partnership: Research & Industry; Software & Instrumentation. It really starts to come together at ASMS 2015
Collaboration and knowledge-sharing were evident everywhere: on the bus, in the hallways and in the bars. This article aims to capture this theme and share with you some of the fruits of this coming together of science and industry.
Designing New Pain Relief Drugs
Researchers have identified the molecular interactions that allow capsaicin to activate the body’s primary receptor for sensing heat and pain, paving the way for the design of more selective and effective drugs to relieve pain.
Antibody Pries Loose Bacteria’s Grip
Study finds novel method of improving antibody efficacy.
CLAIRE Brings Electron Microscopy to Soft Materials
CLAIRE works by essentially combining the best attributes of optical and scanning electron microscopy into a single imaging platform.
Sample & Analysis Tracking in Oncogenomic Experiments
The study outlines Onco-STS, a web-based laboratory information management system for sample and analysis tracking in oncogenomic experiments.
Pittcon Announces Wide Variety of Short Courses
Courses range from beginner and intermediate to advanced levels.
Ultra-enriched Silicon Paves the Road to Quantum Computing
Using a relatively straightforward technique, a team of NIST researchers has created what may be the most highly enriched silicon currently being produced.
Scroll Up
Scroll Down

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,600+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos