Articles
Pharma Has the Data But Not the Information: Why Process Matters
Are you involved with Clinical research? If so, take a moment to imagine what if every clinical research assistant, monitor and project manager working with a study were given a personal assistant to be at their sides at all times, watching everything, and keeping track of all the details of the study...
Article posted: Friday, September 1, 2006
Adaptive Methods for Faster, Safer and Cheaper Clinical Trials
The traditional approach to clinical research is to design the trial, conduct the trial and analyze the data, in three distinct, sequential steps. In contrast, adaptive trials use incoming information to modify the study-in-progress to save time, money and even generate more statistically useful data. In addition,...
Article posted: Saturday, July 1, 2006
The Site Monitor Reborn as Consultant, Trainer and Manager
Michael Rosenberg discusses the current evolution of the clinical research site monitor and their role.
Article posted: Wednesday, March 1, 2006
It's Data, Jim, But Not as We Know It
Within the dynamics of today's market place - amid efforts to decrease the time required to bring a product to market and increased focus on providing the safety and efficacy data needed to obtain a product license - is the industry missing out on the chance to collect and use data that could impact the product's ultimate success?
Article posted: Saturday, May 1, 2004
Pharmacovigilance: Is This the Missing Link?
With licensing deals becoming increasingly popular, pharmacovigilance is often overlooked in the rush to agree the commercial aspects of the contract…
Article posted: Thursday, September 25, 2003
Paying for the Pitch
Unless money is invested in clinical trial proposals, too many assumptions and guesses must be made, usually based on past performance metrics which may well have changed…
Article posted: Monday, September 1, 2003
Innovation, Efficiency and Outsourcing
Thanks to better discovery techniques, the number of candidates in the pipeline has increased. But the flow of products from discovery to market is being choked at the clinical development stage…
Article posted: Thursday, May 1, 2003
Electronic Systems and Decision Making
Can technology reduce development time? Introducing electronic systems can actually slow the process - as many companies have found out. However, 'appropriate' use of clinical technologies is key…
Article posted: Thursday, May 1, 2003
Opening a Gateway to E-Reporting SAEs in Europe
The EudraVigilance gateway for centralised electronic reporting of serious adverse events is now open, but are pharma companies and national regulatory authorities ready to use it in the EU?…
Article posted: Saturday, February 1, 2003
The Little Company that Could
Fed up with the manual process of running clinical trials, Health Decisions takes a chance on a new way of doing business - and succeeds in an industry of large competitors unwilling to change…
Article posted: Saturday, February 1, 2003
