The following case scenario illustrates the difficulty Contract Research Organizations (CROs) and Pharmaceutical companies have when it comes to managing multiple people and teams involved in the clinical management phase of a drug lifecycle.This scenario is an example only, and is not meant to be a complete overview of the entire clinical research process.
Scenario. A promising drug compound is being researched to see if it can be developed into a viable product. ThePre-clinical studies on this drug compound are coming to an end. Now, it is time for the drug sponsor, Greg Hammond,to prepare the trial team.
The Process. Clinical trial management is similar to the management of pre-clinical studies, though the work starts further upstream.The trials start with the sponsor, Greg, who has received indication that the pre-clinical studies are coming to an end. Greg can now begin to prepare the trial teams. The first step is to select the clinical project manager, Mary Stern. One of the first tasks for Mary is to identify site locations where the trial will take place.
The site locations require nurses, doctors and other medical personnel As? as the principal investigators. Throughout the progress of the trial, Jeff, as the drug sponsor, and Kasie, as the clinical project manager, should be constantly aware of the trial’s status and know when road blocks are preventing further progress. Because of the complexity of the trial and the number of people involved, Jeff and Kasie are depending on consistent communication to manage the trial in a timely manner.
The site locations require nurses, doctors and other medical personnel – all of whom will coordinate with Mary and the principal investigators. Throughout the progress of the trial, Greg, as the drug sponsor, and Mary, as the clinical project manager, should be constantly aware of the trial’s status and know when road blocks are preventing further progress. Because of the complexity of the trial and the number of people involved, Greg and Mary are depending on consistent communication to manage the trial in a timely manner.
The Problem. There is a communication breakdown within the clinical trial. Somewhere between the principal investigator and the research associate, both of whom report updates to Mary, status documents are either not received on time or are incomplete. Eventually, when the problem is identified, Mary must track the work backwards to find the source of the communication breakdowns, causing a delay in the clinical trial that results in budget overruns and rework.
The Solution. DLTA provides a structured approach to tracking each phase of the drug lifecycle. Within DLTA, every step in the clinical trial process produces a check point. Coordination between nurses, doctors and other medical personnel are recorded within the application. Status reports are visible by all involved, and alert notifications are distributed when there are any delays or breakdowns in the process. Documents are uploaded to a central repository in the application – any missing or incomplete work is readily identified. Using DLTA, the investigator, clinical project manager and sponsor can be immediately alerted when the check points are not met.
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