Life Science R&D

Meeting the organizational challenges of risk-based monitoring

In this continuing blog series, we explore the adoption challenges of risk-based monitoring (RBM) of clinical trials. So far, we’ve addressed the risk assessment process and centralized monitoring of analytics….

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The Challenges of Risk-Based Monitoring: Statistical Analysis

The shift to risk-based monitoring (RBM) is not without challenges for clinical research teams. In a previous blog, I outlined three key adoption challenges teams face. That blog also provides…

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A Case Study in Adopting Trancelerate’s Risk Assessment and Categorization Tool

By now, there is strong consensus that Risk Based Monitoring (RBM) is an essential practice in clinical research. There are ample resources and supporting data on the benefits of a…

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Leverage Your eTMF to Better Monitor Clinical Trials

Let’s face it – traditional on-site monitoring is becoming obsolete. Given the complexity of today’s global, multi-site clinical trials landscape, traditional site monitoring can be an inefficient method to ensure…

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Ensure the Integrity of Your Clinical Research Data

It may be no surprise that during a sponsor audit, data management and source documentation rank among the top ten most common categories for critical inspection findings. According to a report…

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Lifecycle Impact on your Tendering Organization

Setting up a tender organization for life sciences can be a challenge. Not only do you need to deal with the way the tender governance is structured, on top of that,…

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Harmonized Governance in Tendering: Why It’s So Crucial

Harmonization of the tendering process seems like a tremendous task. Local laws are so different from country to country, making you ask yourself, how can it be achieved? Also, what…

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Are You Ready to Migrate to an Electronic Document Repository?

Getting your EDMS in place

Delays in IDMP Implementation Timelines

Time to relax or time to do more work? Q4 2018 may seem far, far away, but there is still lot to prepare for between now and then.

Streamlining Life Science Processes: How Technology can Improve Vendor Management

In our first Life Science R&D blog, Paul Nelson talked about the major data challenges facing our industry today. Ultimately, those challenges boil down to what our team refers to…

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