At PharmSupport, each project is a collaboration designed to achieve clearly-defined objectives. Together with you, we will define some key outcomes for your project, and we will design ways to measure the achievement of those outcomes.
Following are just some examples of outcomes that can be assessed and value created by taking this approach:
- Increase investigator compliance with study protocols. For example, do our carefully crafted protocols and the matching case report forms (CRFs) reduce confusion at the investigator site? Do well-designed documents increase investigator satisfaction, retention, or recruitment of patients? Can we increase your chance of obtaining usable and valuable study data by eliminating some common protocol and CRF design flaws?
- Develop new ideas from your study data, which could add to your product’s value or help guide your decisions about your product’s future development. For example, do your data suggest possible new indications? Expanded claims? Identification of safety signals that deserve more attention? Imagine how just a single observation, when discussed and acted upon, can save a company from conducting additional clinical trials or add millions of dollars to a company’s eventual bottom line.
- Evaluate the contribution of your study to your overall clinical development plan and your planned product label. For example, are your study data adequate to make the decisions outlined in your development plan? Does your clinical study report clearly describe the contribution of the study to your overall plan (or is it appropriately silent in the case of ambivalent or difficult data)? Imagine how attention to detail and documentation of key study objectives and messages can improve corporate memory and reduce rework, particularly during times of staff turnover. Imagine also how this approach can lead to more rapid product development.
- Decrease the incidence of poor study data due to common issues such as the capture of redundant (and therefore potentially conflicting) information, or data containing insufficient detail (such as the location of adverse events that may or may not have occurred at the application site for a topically administered drug). These situations require remediation. How much does this remediation add to the overall time and cost for your clinical study, and how much can we save by reducing or eliminating it?
- Decrease the time required for review of your submission by regulatory authorities due to questions about poorly-presented material. How much regulatory resource is saved, and how much faster might final approval be obtained, by reducing the number of questions?
At PharmSupport, we provide more than just documents. We provide value. Together we create a plan for each project to address your most important objectives and outcomes.