Marketing Clinical Trials

Phase IV and Post-Marketing Clinical Trials

TransCom is highly experienced in managing clinical studies for the marketing departments and business units of pharmaceutical companies.
In order to ensure that both the marketing and sales departments’ interests and ethical considerations are observed, our team works in full cooperation with our clients' marketing and sales departments and sales representatives:
 

• A direct communication line between sales reps and TransCom’s team is established
• Regular meetings are held throughout the entire study period
• Initiation visits are scheduled and performed jointly by both the client and TransCom
• TransCom’s team assists the client’s team in the design and writing of the study protocol, the CRF design and the building of the database with statisticians, etc.
• TransCom’s team is available for the handling of special situations. A  Senior CRA responsible for the study characterizes and identifies the changing needs at every stage of the study together with the client’s marketing team, and directs the monitoring team accordingly
• TransCom’s modus operandi makes it possible to assign a dedicated team for each study, regardless of its size and scope. This model makes it possible to achieve the marketing departments’ strategic targets within the established budget

A Recent Success Story

A case-study to illustrate the way in which we work and think:
A clinical study in Rheumatology performed in 17 clinical sites in community clinics, with a final recruitment target of 150 patients.

The recruitment target was achieved, and the study is being conducted according to the Study Master Plan, with high quality results.

The initial client’s assumption was that 1.0 Senior CRA FTE would be needed for a period of 2 years. TransCom’s proposal was to assign a team composed of a Senior CRA at 0.25 FTE, a Junior CRA at 1.0 FTE and an Administrative Assistant at 0.10 FTE.
TransCom’s added value for the client is shown in the following table:

Result:
The study achieved the recruitment goals while the added value for the client was equivalent to an additional year of outsourcing work to TransCom. 

This added value allowed the client to recruit an additional 50 patients to the study, within the existing R&D Budget!