Clinical Trial Management is the most critical business process in a Life Sciences firm.  Clinical trial progress is the final step to Regulatory Approval and must be monitored and optimized to assure maximum prescribing life for a company's multi-million dollar product investment.  We are Clinical Operations Efficiency Specialists dealing with firms who see trial efficiency as a core competency.

3C brings years of experience working in and serving the Pharmaceutical Clinical Business area to each and every engagement.  Our teams include experienced mangers who have worked in the industry in line functions from CRA to Director level, and who speak the language of Clinical Trials fluently.  These abilities allow us to make immediate progress moving your operations forward with a blend of technology and business process adjustment solutions.

Clinical Trial Management Systems (CTMS)

A Large Global Pharmaceutical had outgrown its Trial Management system and after an extensive search decided to custom develop the tool.  The project was outsourced to a large and well-recognized consulting firm for design and development. After expenditures totaling several million dollars, it was clear that the vendor did not understand the clinical business and would not be delivering a successful product.   The firm disengaged the vendor and brought the project in-house. Peter Oudheusden, founder and current President of 3C Company, re-designed key areas of the application to better meet the user expectations and deliver a tool that was a tight fit to the needs of the ever-growing, ever-changing trial management process. 

Years later, the Trial Management System has become the hub of Clinical Operations - accepting external feeds from labs and EDC, interfacing with a data repository for reporting, and feeding the grant management system to generate site payments.  3C staff continue to play critical roles in its continued evolution with Business Analysts, Developers, Validation Specialists and Technical Support staff. The 3C contribution continues stronger than ever, reaffirming the company’s commitment to the success of its clients and the hundreds of system users around the globe. We are not done with a project until the client is experiencing the benefits they initially set out to attain.

Study Planning

Global Clinical trials are conducted regularly by this large pharmaceutical company, and the efforts need to be coordinated among dozens of subsidiary corporations around the world. Additionally, different departments within the company have steps they need to perform in the various stages of the study, from Medical Writing to Clinical Operations and from e-Clinical to Clinical Data Management, and the traditional “hallway conversations” had outlived their usefulness in this regard.

Use of the planning features within the organization’s CTMS had grown to a point where study planning involved hundreds of tasks, making it complex and unwieldy for practical use. 3C Company was engaged to rewrite the planning tool, providing project plan views based on the user’s role within the organization. Additionally the capability was added to update multiple plans simultaneously, using a spreadsheet-like interface to update similar tasks for all the sites in a study. As a result, Study Monitors are keeping their plans more current with less effort, and Clinical Operations is effectively coordinating across departments without reliance on the infamous “hallway conversations”.

• Trial Progress Tracking: Study Start Up, Conduct, and Closeout

• Inter-departmental and Global Trial Execution Coordination