“If it’s not documented, it didn’t happen.” This is a well known saying to Quality teams in biotechnology. What it means is that every step in the development, clinical, and manufacturing processes needs to be documented or else regulators can’t accept that it happened. In the eyes of the FDA, without documentation, the research, the clinical trials, or the manufacturing process needs to be repeated. This results in added expense, costly delays, and an erosion in trust from regulators, investors, and consumers.
In this piece, Egnyte chronicles the nine elements that successful Quality & Compliance teams adopt to keep pace with the speed of discovery. Learn the best practices for an effective quality documentation process.
In this Q&A, E.K. Koh, chief product officer at Suvoda, discusses what separates a trustworthy AI assistant from one that adds risk, why curated clinical knowledge matters more than general-purpose flexibility, and what safeguards must be in place when assistants move from answering questions to taking actions in clinical trial systems.
In this video interview, Kent Thoelke, CEO of Paradigm Health, explains why patients in community and rural settings too often lack access to clinical research as a care option, and how closing that gap could improve outcomes and lower long-term costs.
In today’s ACT Brief, we examine why anti-kickback guidance and EHR-integrated trial matching must work together in community settings, why real-time trials depend on mature risk-based quality management, and how pharma is applying digital clones to predict outcomes.
The FDA’s RTCT initiative transmits predefined, clinically meaningful signals to regulators during active trials, so its value depends entirely on the maturity of sponsors’ upstream RBQM signal intelligence, KRIs, QTLs, and root-cause context, rather than on data speed.
In this video interview, Kent Thoelke, CEO of Paradigm Health, outlines why anti-kickback guidance and modern EHR-integrated trial matching technology must work in tandem to reach representative patient populations at the community level.
In today’s ACT Brief, we examine how legacy workflows pull community clinics away from patient care, why medical writing capacity depends on training rather than technology, and how an antiviral aims to prevent COVID-19 after exposure
Medical writing capacity pressure is fundamentally a talent development problem, not a technology problem, since hybrid resourcing and AI cannot substitute for the experienced judgment needed to review AI output and mentor the next generation of writers.
In this video interview, Kent Thoelke, CEO of Paradigm Health, describes how manual eligibility screening and swivel-chair data entry force community sites to trade billable patient care for research, and why that burden is so hard to absorb.
