Newsletter | June 30, 2025

06.30.25 -- Unlocking AI's Full Potential In Clinical Trials And Regulatory Success

The Power Of AI To Improve Clinical Trial Monitoring

To adequately serve clinical monitoring without introducing new challenges, AI tools must provide seamless, high-quality data integration and operate transparently — especially to mitigate bias — and must also be designed and integrated to assuage regulatory and ethical concerns.

 

Optimizing Clinical Data: Reducing Redundancy For Efficiency

To streamline clinical trial data processes, sponsors, CROs, sites, and patients must avoid collecting redundant or extraneous information in the EDC system. Focusing on raw data early supports more efficient and effective interpretation later in the study.

 

The Write Side Of AI: Augmenting Capabilities, Not Replacing Them

If AI can write the first draft of a clinical study report in less than a day, why pay a medical writer? This is a scary consideration and can leave writers feeling defensive. But medical writers’ true adversary is refusal to embrace this technology and make it work for us.

 

From Crisis To Confidence: Ensuring Smooth Regulatory Submissions

Medical writing submission specialists face a range of complex challenges, from tight timelines and shifting regulatory requirements to cross-functional coordination issues. This webinar explores these obstacles and presents proven strategies to consistently set the stage for successful, high-quality submissions.

 

Regulatory Submission Crisis Rescue: When To Take Action

Many issues affecting regulatory submissions mirror those that derail clinical trials, such as key opinion leaders leaving a company, internal resources being reallocated, or vital equipment/system failures. Learn how these issues can be avoided by reading this article.

 

SOLUTIONS

Strategic Regulatory Documentation Practice

What sets inSeption Group apart from its competitors is its unique ability to tailor teams of exceptional individuals. Delve into how ISG seamlessly manages the complexities of timeline creation and management, resourcing, document interdependencies, and transmission to health authorities.

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Manage Contracts And Legal Documents With Ease

By working with us, you can be assured that all aspects of contract and template development, alternative language and budget parameter development, contract negotiations and execution, investigator grant payment administration, and patient reimbursement will be handled.

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