Success Story:   Pharmaceutical Information Services Organization 

Accelerating Time to Market by Effectively Managing Distribution of Clinical Trial Information

The Challenge

The nature of product development within the pharmaceutical industry is such that there is typically a continual flow of clinical trials.  For larger pharmaceutical companies this can translate into hundreds of unique trials per year or more.  Clinical and drug trials are complex, multi-faceted efforts that involve a variety of participants which must form a cohesive team that needs to work together efficiently.   In order to support these trials, a bevy of forms are typically required to capture and track information ranging from research, to finances, process administration, and reporting.   Managing the distribution of study information among the hundreds or even thousands of research study participants, often distributed globally, can be quite difficult; not to mention, utilizing manual processes makes it extremely challenging to perform all of the tracking and reporting functionality necessary to demonstrate regulatory compliance.   Despite the large and varied scope, these processes are an important undertaking, because they have a direct impact on both the time and cost of successfully completing clinical trials and getting new therapies to market.

In some cases, clinical trial study websites are created and allow information to be shared among the study research participants.  However, managing consistency, security, and compliance across many individual websites is next to impossible.   Additionally, it's often commonplace for an individual researcher to participate in numerous studies simultaneously.  Requiring researchers to manage multiple credentials was inefficient and often proved ineffective, but it was necessary to maintain control over sensitive information ensuring access is restricted only to authorized personnel.

In addition, the existing system made it difficult to determine if all pertinent information being shared was the most up to date available.   On certain projects, team members may be assigned or join a specific trial after it is already in progress.   By not having a central repository with versioning capabilities available for “knowledge management”, these new team members could not be completely sure whether information they received were the most recent versions.   This created the need to check and double check with other members of the team, causing confusion and additional inefficiencies from both time and project management perspectives.