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...


  1. “One issue is – pursuing high-tech trials in developing countries: each technological development is limiting possibilities to run trials in developing countries (even if you provide sites with laptops et co (which is additional cost), there may be no stabile internet connection etc), so we will end up at the end running trials in developed countries only and loose in that way valuable patient population for relevant indication... Maybe we could adapt tools to the least developed country of the ones enrolled?

    Another issue is – obligatory storing trial data with respect to the fast developing technology, which may make it impossible (without respective adapters) in 15yr to read electronic data made today. “

    Dr. Sandra Korosec Jensen, experienced pharmaceutical professional, responsible for Project Leadership and Medical Assessment in Basel, Switzerland

  2. There are a number of customized solutions available to support the Clinical Trials. I have found that a blend of using the paper documentation, along with electronic tracking of test records, has worked well.