Tuesday, May 12, 2009

Renaissance in Clinical Trials

As discussed in the previous article, the clinical trials industry today is in a rapid transition phase. As there has been a move from paper based to computer based system, there is an another era that clinical trials industry is all set to witness. Renaissance in Clinical trials is the buzz word.

This renaissance in clinical trials has anounced its arrival on the clinical world scenario by bagging the Bio-IT World, Best of the show award and is set to achieve much more and revolutionize the clinical trials process, by reducing the cost, time of study, at the same time assuring the safety and efficacy of the drug.

This renaissance of clinical trials which is set to revolutionize the clinical trials is the product named CT Renaissance from the brians of MaxisIT, which is a pioneer solution provider in the clinical trials industry. With CT Renaissance in hand the clients, customers or Sponsors,CRO can focus on the other aspects of the Clinical Trials leveraging the software needs on CT Renaissance. This ensured a complete success of the clinical study


Sunday, May 10, 2009

Clinical Trials: Paper Based to Computer Based What next???

Clinical Trials Industry today is in Transition Phase. It has moved out from traditional paper based approach of conducting clinical trials to the electronic ways to conducting clinical trials. Paper based was good old convenient procedure that was in place right from the origin of Clinical Trials till last 5 years ago.

As the world, people, technology are under contant change, and it is believed that change is for good, Clinical Trials industry has also witnessed change. Paper based Clinical Trials were tedious, taking 15 long years of time for the completion of a study, there was always a commotion about roles and responsibilities, documentation, submissions and approval process.

During the paper based clinical trials, regulatory authorities did not have proper guidelines in place, hence the data bieng submitted by the sponsor was tough to interpret for the regulatory authorities and thus taking a long period of time for the approval of the drug. There was every chance of duplicating the documents, Information Security was the biggest concern

Slowly independent Computer softwares, which address, automate a part of the clinical trials process have started ruling the space left by paper based clinical trials. There were also certain standards and guidelines prepared by the regulatory authorities, which every clinical study needs to be in compliance with.

With the emergence of these independent software solutions, certain areas of the clinical trials were speeded up and also reliability was a good success with these systems. There was a sense of success all around, but this has not addressed all the needs of the clinical trials softwares. Is there anything available beyond this?

Where is the clinical trials Software Industry heading to? Is the industry set to see something which can redefine the process of clinical trials? Please add your views regarding this interesting discussion...