Articles From Our Expert Network
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3 Strategies To Lead Clinical Research With Moral Integrity
9/1/2022
In clinical research, perhaps our oldest code we live by is the Hippocratic oath. Our industry is more complicated today than ever before, so how can we remain loyal to our shared code while also supporting the innovative solutions and approaches of the modern world?
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A 4-Step Strategy For Small Sponsors To Select The Right CRO
8/31/2022
Selecting the right CRO to conduct our clinical study is not a difficult task, right? It's a bit more complicated than choosing a one-stop shop. You need to ask yourself questions such as: "What are our needs and requirements?", "How many providers and vendors do we want to engage?", and more.
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FDA Seeks Comment On Conducting Remote Regulatory Assessments
8/11/2022
The FDA believes the use of both voluntary and mandatory remote regulatory assessments (RRAs) for all types of FDA-regulated products is in the interest of public health. The document describes the difference between voluntary and mandatory RRAs and shares information about the RRA report. Public comment ends on Sept. 30, 2022.
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FDA Seeks Comment On Fit-For-Purpose COAs Guidance
7/14/2022
On June 29, the FDA released the new guidance, Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments. This article sums up the guidance and explains the four types of COAs that the FDA prefers (PROs, ObsROs, ClinROs, and PerfOs). Submit comments to the FDA by September 28, 2022.
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CRO Oversight Essentials
6/30/2022
Sponsors need to proactively identify and manage the risks involved with working with a CRO. This kind of oversight can help reduce the likelihood of negative consequences that could impact the quality of a trial.
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EU MDR’s Benefit-Risk Ratio: Making Your Clinical Evaluations Safety-Focused
5/13/2022
The EU's MDR refers to a benefit-risk ratio multiple times, especially with respect to clinical evaluation and in Sections 1 and 8 of Annex I. However, no universally accepted method exists for calculation of such a ratio. This article proposes a method for calculating it in the spirit of focusing on patient safety and the ability to track changes in products' safety profiles.
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The Supply & Demand For Clinical Trial Staffing In 2022 & Beyond
5/5/2022
The clinical trial staffing market is a high-margin market due to increasing numbers of clinical trials globally and high demand for resources. With the ongoing shortage of CRAs and those in other clinical operations roles, it is important for pharma companies to understand the current trends and how technology providers can help you tackle the attrition problem and manage the growing demand.
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Don’t Neglect This Drug Development Milestone: The Pre-IND Meeting
5/3/2022
The pre-IND meeting takes place when a sponsor presents their planned Phase 1 study design, including their proposed product development plan and regulatory strategy, to the FDA. Think of this as a necessary milestone for a quicker development timeline. This article shares best practices for preparing for the meeting as well as for the meeting itself.
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Can AI/ML Help Solve Underrepresentation In Clinical Trials?
4/26/2022
Too often, there is an underrepresentation of women in clinical trial subject populations, leading to erroneous data since women differ in presentation, clinical manifestations, and outcomes in comparison to men. This article shares tips for how to use AI for better representative trial outcomes, including using it in patient recruitment, trial design, patient monitoring, and postmarket surveillance.
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3 Best Practices For Actionable CRO Oversight
4/7/2022
The ultimate purpose of sponsor oversight is to act when required. Audits, meetings, and documentation are not always enough. Too many sponsors seem to be forgetting that they are the customer; one that’s paying a heavy price for services that can ultimately make or break them. Reset the industry balance with these 3 best practices.