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Home » Authors » James Miessler

Articles by James Miessler

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Regulatory Requirements Now the Biggest Hurdle to Adopting DCTs, Sites Say

December 12, 2022
James Miessler
It’s been widely agreed that technology is the greatest hurdle sites face in implementing decentralized trial (DCT) components, but a recent think tank discussion has unveiled a new revelation: sites are now naming unclear regulatory requirements as the top barrier they face as DCTs continue to take form. Read More
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Data Monitoring Committees — Are They Right for your Trial?

December 5, 2022
James Miessler
Data monitoring committees (DMC) have seen growing use in clinical research and can play a critical role in monitoring for unanticipated problems as trials progress. For this reason, it’s important to know the situations DMCs are best suited for, how they should function and what to consider when deciding to assemble one. Read More
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Inspection Essentials: Critical Factors to Consider When Prepping for an FDA Visit

December 5, 2022
James Miessler
FDA inspections can glide smoothly or run off the rails, depending on how thoroughly and thoughtfully sites and sponsors prepare for them. Before the agency shows up, consider 10 key factors to gauge your inspection readiness. Read More
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Crucial CTA Clauses Must Be Phrased Carefully to Avoid Delays

December 1, 2022
James Miessler
The language in clinical trial agreements (CTA) must be very specific to avoid legal problems during the trial, but certain terms have the potential, if not handled correctly, to derail the negotiation process before the trial gets off the ground. Read More
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Post-BIMO Update, FDA Trial Inspections Heavy on Outsourcing Scrutiny

November 21, 2022
James Miessler
FDA inspections have been heavily focused on sponsor, CRO and site outsourcing activities since the Bioresearch Monitoring (BIMO) Program revised its manual for inspection processes in September 2021. Read More
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Revamp Organizational Structure to Focus on People, Not Performance, Expert Advises

November 14, 2022
James Miessler
With clinical research professionals exiting the industry in droves, it’s high time for research institutions to step back and assess themselves internally, evaluating how their own paradigms, cultures and priorities affect employees. Read More
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FDA Looks for Relevance and Reliability of RWD Used in Clinical Trials, Experts Say

November 7, 2022
James Miessler
The FDA has signaled its support for the use of real-world data (RWD) — information gleaned from health records, patient registries and other sources — through pilot programs and guidances but has yet to set standards for the quality of that data, leaving sponsors, investigators and sites to find their own way to evaluate its relevance and reliability. Read More
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Centralized Monitoring Focuses on KRIs Sponsors Use to Evaluate Sites

November 1, 2022
James Miessler
At the intersection of risk-based quality management (RBQM) and performance metrics, sponsors are increasingly using centralized monitoring approaches to analyze data from sites that can predict risk and identify sites that may need additional support. Read More
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Site Spotlight: St. Lawrence Health Evaluates Soft Skills to Hire Strong Candidates

October 31, 2022
James Miessler
Resumes and traditional interviews don’t always provide a complete and accurate picture of job candidates, as St. Lawrence Health System learned the hard way. Seeking a better view of potential hires, they’ve created a process that appraises soft skills and traits that can’t be adequately assessed through resumes and generic interview questions. Read More
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Phase 1 Oncology Trials Uniquely Challenging for Sites, Experts Say

October 31, 2022
James Miessler
Close sponsor contact, rapidly moving targets and timelines, unique facility and staff needs — these are only some of the factors that can make phase 1 trials more challenging for sites than the other phases, say several oncology research experts who offer advice for sites considering signing up for early-stage research. Read More
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