Investigators and other site staff work at the coal-face of clinical research. Listening to their issues and adapting trial processes pays dividends in reducing trial time and costs.
Research into investigator dissatisfaction ("Investigator Dissatisfaction with the Conduct of Clinical Trials." Glass H. The Monitor August 2009) has identified some common issues that an IXR can address, helping you to complete clinical trials of high quality in a timely fashion.
Making IXR Affordable for Smaller Trials.
The advantages of using a centralized unblinded application such as an IXR are just as applicable to a small trial as to a large one. Real-time subject and supplies information to support management decisions, centralized unbiased randomization with easy stratification methods, automated supply chain management and much more. Pricing methods, however, which rely on deliverables unrelated to trial size (development milestones, validation exercises, etc) can push the cost to the trial too high.
The Fragmented Clinical Trial Supply Chain.
Vanishingly few clinical trials have a comprehensive and automated flow of information across their project. Yet site activity information is vital to accurately inform a demand-driven supply chain. Instead, paper-trails, key individuals, spreadsheets, and isolated databases dominate. Managing, collating and analysing the information costs money and introduces risk to the trial supply chain.
Stride further - leave a smaller footprint
Using Software as a Service (SaaS - software applications remotely hosted and deployed over the internet) will help pharmaceutical companies reduce their energy and carbon footprint across their clinical trial operations and supply chains.
Manual Data Edits in IxR systems. Reducing cost and risk.
People make mistakes, so clinical trial systems need measures in place to correct data errors. How can we reduce the risks and costs associated with these data edits?
FDA - New Safety Reporting Requirements.
The FDA has issued a final rule detailing safety information that must be reported during clinical trials of investigational medicinal products (drugs and biologics). The new rules are aimed at minimizing uninformative reports and enhancing reporting of meaningful, interpretable information.
FDA guidance can be found here.
FDA guidance can be found here.
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