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 Situation
Solution
Benefits
SituationPharmaceutical companies can spend 12 to 15 years and up to $900 million to bring a drug to market. About 45 percent of this cost is accrued during the clinical trial phase. Additionally, studies indicate that 75 percent of all trials conducted in the United States are behind schedule by one to six months. Because improving time-to-market for new drugs is critical for pharmaceutical companies, managing the clinical trial process is one of the most significant areas of opportunity for improvement. Today, pharmaceutical companies struggle with the following challenges: | • | Lengthy and complex trial design and planning process. Clinical trials can often involve thousands of patients and hundreds of support staff. | | • | Inefficiencies and delays capturing patient data. Consistent, streamlined capture of patient data is critical for success. | | • | Inability to connect to a wide variety of systems. Clinical trials often involve interaction with numerous trial sites using disparate systems and processes. | | • | Difficulty remaining compliant with FDA guidelines. Stringent FDA regulations are placing more pressure on how clinical trials are managed. | | • | Lack of archived materials to build best practices. Each clinical trial often is started from scratch, not utilizing historical best practices and feedback. |
Overall, pharmaceutical companies will benefit from streamlining the clinical trial management process through a clinical trial management solution.
SolutionThe goal of a clinical trial management solution is to facilitate the planning, execution, and tracking of relevant clinical trial activities. A clinical trial management solution built on the Microsoft Office System provides the following benefits: Improved Process Planning | • | Design and prototype trials faster and easier | | • | Model visit schedules, data schema, edit checks, and form design using a drag-and-drop interface | | • | Build powerful form libraries and collaboration processes to facilitate even faster design cycles |
Standardized Data Collection Processes | • | Increase the speed and accuracy of data entry and exchange through Web-based data collection | | • | Generate more consistent reports through an FDA-compliant library of templates | | • | Provide single sign-on access to multiple clinical processes including electronic data capture (EDC), data management, and adverse events reporting |
More Effective Data Management and Analysis | • | Provide one centralized place to track progress by study, site, and staff member | | • | Exchange protocol synopsis, confidentiality agreements, and other critical documents electronically and securely | | • | Integrate with different site systems for faster data exchange, query resolution, and data reconciliation | | • | Provide the pharmaceutical sponsor of the trial with greater visibility of clinical data |
Improved Trial Administration | • | Streamline administrative processes through one central location for tasks, issues, and schedules | | • | Integrate with budgeting and finance applications. | | • | Get team members up and running faster with both real-time and archived online training modules | | • | Provide sites with online access to sponsor and CRO information, archived documents, and frequently asked questions (FAQs) |
The following graphic shows how a clinical trial management solution gathers and centralizes data for easier access, greater visibility, and more efficient processing.  Figure 1 Clinical trial management solution gathers and centralizes data
BenefitsA solution built with the Microsoft Office System enables pharmaceutical companies to more effectively and efficiently implement and realize: | • | Faster trial design and planning processes. | | • | More efficient collection and management of both patient and trial administration data. | | • | Improved FDA compliance. | | • | Secure, centralized access to sites, trials, and programs. | | • | Reduced administrative costs. |
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