PharPoint Research

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White Papers

The Benefits of Employing a Functional Service Provider for Data Management

For years, pharmaceutical and biotechnology companies have employed the strategy of establishing preferred provider relationships in order to streamline the process of outsourcing clinical research studies. Often the preferred provider would provide discounts to their customers based on efficiencies the service provider may realize from working on multiple trials for a single compound or the sponsor organization. Typically the preferred partnerships focused on the selection of one service organization providing all of the functional services for a clinical trial. While there were cost-savings experienced by the sponsor, often the result was that the service provider with the greatest clinical strength received the designation of preferred provider, but then the sponsor was “stuck” with that service provider or additional services from that provider that were not as good.

 

PharPoint Research Announces Target SAE System Initiative

On September 29, 2010, FDA published a Final Rule amending the IND safety reporting requirements under 21 CFR part 312. The new requirements clearly describe circumstances in which adverse event reports should be aggregated and compared to a control group in a systematic analysis. The effective date for the Final Rule has been extended to September 28, 2011.

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Download this file (Target SAE Initiative.pdf)Target SAE Initiative
 

Key Factors for Successful Study Implementation and Determining If You Need a Study Rescue

Three of the greatest fears that a Sponsor experiences when initiating a new trial are: “What if the study does not enroll according to corporate timelines?”, “What if the study runs over budget?”, and “What if the data quality is subpar?” Each of these “what ifs” can have a significant cost implication for the Sponsor company, since a delay in timeline carries with it a delay in revenue actualization.