Insider’s Insights

Mastering the complexities of clinical development requires more than just following a manual; it demands the kind of "handy guides" only decades of experience can produce.

Our Insider’s Insights are a curated library of practical wisdom, designed to help you navigate everything from the "necessary evil" of project meetings and the sting of journal rejections to the strategic design of concept protocols. We believe in sharing our hard-earned expertise to elevate the industry as a whole, providing you with the tools to work smarter, ensure regulatory compliance, and move your innovative medicines toward success with confidence.

Explore our collection, sign up for the latest issues, and let our 25+ years of clinical and medical writing experience become your competitive advantage.

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Tags: All Clinical Clinical Operations Medical writing Publication Planning Regulatory Skills

Investigator's Brochure

Issue 23

The Investigator's Brochure is a crucial multidisciplinary document in the drug development and regulatory submission process. We provide key learnings to ensure you delivery of a well-constructed, fully compliant document.

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Good Laboratory Practice

Issue 27

Good Laboratory Practice is a quality system for planning, performing, monitoring, recording, reporting and retaining non-clinical studies.

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ApaTech

ApaTech was a medical device company that was involved in the manufacturing of orthobiologics, specifically the development of synthetic bone graft materials to enhance bone repair and regeneration.

Astex Pharmaceuticals

Astex employs its proprietary Pyramid™ platform to develop innovative therapies targeting challenging or “intractable” diseases.

MID-Frail Study

A significant European research project aimed at evaluating the impact of a multi-modal intervention on frailty and QoL in older adults.

RASP-UK initiative

The RASP-UK initiative, or Refractory Asthma Stratification Programme, is a UK-based research effort designed to transform the management of severe asthma by adopting a more personalized treatment approach.

FRAILomic

The FRAILOMIC initiative was an international research project aimed at improving the understanding, diagnosis and management of frailty in older populations.

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