INSIGHTS

Important Clinical Research Insights

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Billing Compliance

5 Crucial Considerations for Selecting a CTMS

With a clinical trial management system (CTMS), you can more efficiently manage the day-to-day operations of running a clinical trial as well as easily organize trial data in one central location. Learn what to consider when selecting a CTMS.

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eReg Binder
eRegulatory

eRegulatory Binder Checklist: What Does the FDA Require?

eRegulatory binders help clinical sites organize and digitize the regulatory process, but each binder is different depending on the specific clinical trial site protocol. Here, we provide an overview of the specific sections and documents that must be included for an FDA-regulated study.

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Investigator file checklist
eRegulatory

What Goes Into An Investigator Site File?

The investigator site file (ISF) plays a critical role in a study’s success. But only if the people in charge of it – clinical trial investigators – keep its contents accurate and up to date. In this post, we provide an overview of all essential documentation in an effective, compliant ISF.

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SIP integration
Clinical Research Trends

SIP integration developed for KU Cancer Center

Clinical researchers are looking for ways to reduce the operational challenges of clinical trials which can often occur by working with multiple sponsors. Some of these challenges include working with individual sponsor portals, using disparate processes and numerous platforms — each with a unique login credential – which can all lead to increased probability for error and placing patient safety in jeopardy.

As a result, a Shared Investigator Platform (SIP) integration, which can streamline the interaction with multiple sponsors, has become a high priority for many sites.

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