A global sponsor organization that develops pharmaceuticals, biologics, medical devices and over-the-counter products, sought a better approach to clinical trial registration and results disclosure requirements in the US. Using templates and spreadsheets, the sponsor team was spending approximately 20 hours to draft, finalize, approve and release one initial study registration to the US clinical trial registry (www.clinicaltrials.gov).
This paper looks at clinical trial transparency and the driving forces behind it to better understand the role of technology in the execution of a solid clinical trial transparency policy.
Managing multiple outcome measures and rapid patient recruitment for Phase IIB clinical trial on targeting relapse-remitting Multiple Sclerosis
The Sponsor’s current system required redundant data entry, consisted of disjointed tools, and was a drain on valuable resources.
To address non-compliance and improve the ratio of completed trials with results, we recommend the following two-step process to take control of your compliance.
As you evaluate clinical trial enrollment acceleration strategies, be sure to understand the root causes of slow enrollment and the reasons why traditional acceleration programs do not work.
How a cloud-based SSU Solution with a SaaS-based platform manages the complexities of study activation.
Five considerations to help organizations make better planning and forecasting decisions in an environment with such strict parameters.
Submission of PADERs to the FDA is required during post-marketing drug safety surveillance. Instill confidence in your results and regulatory submissions by partnering with an experienced partner.
PV activities will continue to grow in volume and complexity. Trusting an experienced partner to help manage PV requirements can free your team to concentrate on patient efficacy outcomes.
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