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 Situation
Solution
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SituationPharmaceutical companies can spend 12 to 15 years and up to $900 million to bring a drug to market. About 40 percent of this cost is accrued during the clinical trial phase. Because the duration of patent protection for new drugs is limited, pharmaceutical companies must move drugs to market rapidly in order to recover their investments before competition from generic drug companies erodes their revenue potential. Each day saved during development can translate into significant revenues when the drug reaches the market. Therefore, expediting any phase of the clinical trial, including the initiation phase, can speed time to market, leading to greater company profits and improved patient care. One of the main deliverables in the clinical trial initiation phase is the clinical trial protocol, which is a business plan that lays out the objectives, subject selection, study design, project plan, and budget of the clinical trial. This protocol is submitted to the FDA and is updated throughout the duration of the clinical trial. The process of creating the protocol, however, is often more cumbersome and time-consuming than it should be. The following challenges are common during the protocol creation process: | • | Time is wasted searching for and re-creating protocol data and scientific research. | | • | Too much time is spent coordinating people and sharing project information among study design team members. | | • | Delays and inaccuracies occur due to inefficient processes for managing the creation, authoring, assembly, and review of protocol documents. | | • | It is difficult to access information from clinical trial management systems, company databases, and other line-of-business applications. |
SolutionA clinical trial initiation solution built using the Microsoft Office System can help pharmaceutical manufacturers expedite the study design phase of the clinical trial process by making it easy to find and re-use protocol content, facilitating the coordination of protocol contributors, and improving the collaboration and communication among study team members. Such a solution has four major components: Content Library: | • | Store previous protocol document content in a central content library. | | • | Easily search, preview, and insert approved text from the content library without leaving the authoring environment. | | • | Easily publish new content to the content library from within the authoring environment. |
Collaboration: | • | Share relevant documents, contacts, links, and milestones on a central team site for effective team collaboration. | | • | Provide a central location for document creation, review, and approval. | | • | Control access through site user management. | | • | Use a single instance of the document to manage versions. |
Document Coordination: | • | Manage document status and ensure accountability by assigning document sections to contributors. | | • | Protect sections to ensure that only designated sections can be edited. |
Interoperability: | • | Read from and write to line-of-business systems, such as a clinical trial management system or an investigator database from within the protocol authoring environment. |
Watch the Video
See how the Microsoft Office System can help expedite clinical trials by reducing the time it takes to complete the study design phase of the trial.
BenefitsA clinical trial initiation solution built using the Microsoft Office System can help pharmaceutical companies maximize revenues by streamlining clinical trial initiation processes and speeding time-to-market. The benefits of a clinical trial initiation solution can include: | • | Helping clinical study administrators and authors save time and improve quality by reusing approved content. | | • | Reducing the time and effort required for the study design phase by providing a central location where the project team can find and share information. | | • | Improving protocol quality and avoiding the need for rewrites with section assignment, version control, and user access management. | | • | Populating documents more quickly by enabling information retrieval from clinical trial management systems and other line-of-business systems. |
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