Brandy Chittester, Chief of Clinical Operations, IMARC In clinical research, we often say “If it’s not documented, it’s not done.” Throughout a clinical trial, this adage guides decision-making processes when securing compliance. If a study team member was no longer working on the study, would the rest of the team know what happened well enough […]
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Why con-meds are important
Christian Barille, Clinical Research Associate, IMARC Concomitant medications (con-meds) are any prescription or over-the-counter drugs and supplements taken in addition to an investigational therapy by a study subject. Many study protocols require capturing con-med usage into subject’s study record. This can be an extremely difficult task as it relies on the honest and accurate reporting […]
FDA enhances the transparency of clinical trials
Ashton Steinhagen, lead clinical research associate, IMARC When the FDA reviews a new drug application (NDA), they typically review multiple data sets, summaries, and other reports provided by the Sponsor. However, the amount of information that is usually released by the FDA at the time of approval was limited at best as well as sporadic. […]
How GDPR affects personal data use in clinical trials
Lisa Wickert, Clinical Research Associate, IMARC On May 25, the General Data Protection Regulation (GDPR) goes into effect in the European Union (EU). This regulation has a broad scope beyond companies performing clinical research – all personal data falls under this jurisdiction which includes web search engines, social media, and much more. But specifically, how […]
Why clinical vendor audits are important
John Lehmann, Director of Business Development, IMARC In today’s business environment, it’s important to have reliable partners who can help you achieve your business goals and objectives. In clinical research, this is especially true. One proactive way to ensure your trial partners are meeting your standards is to conduct vendor audits. Clinical vendor audits assess […]
What makes a well-controlled clinical trial?
John Lehmann, Director of Business Development, IMARC A well-controlled clinical trial is much like a well-controlled experiment. They are both rooted in the cornerstone of the scientific method. What exactly is a clinical trial? According to clinicaltrials.gov, “In a clinical trial (also called an interventional study), participants receive specific interventions according to the research plan […]
How to stay informed as research systems evolve
John Lehmann, Director of Business Development, IMARC Clinical research professionals need to keep up to date with changes to the industry to ensure their studies remain compliant and human subjects are protected as research becomes more complex. Several important changes have taken place over recent years, including greater emphasis on risk-based and quality-focused thinking, as […]
Choosing the right clinical project manager
The right clinical research project manager will keep your trial on track so you can bring your device to market faster. The wrong one can bring unwelcome interference, hindering progress. How can you ensure you hire a project manager who looks out for the best interests of your team and your trial? This short checklist […]
Outsourcing administration of your safety oversight group
You may think your team has covered all the bases when it comes to protecting the safety of human subjects in your clinical trial. You have a team of monitors in place to review reports and ensure your trial follows safety protocols. However, every trial needs a system of checks and balances. Your monitors are […]
Four steps to safety oversight: DSMBs, CECs and medical monitors
Rachel Silver-Kessler, Director of Clinical Support Services, IMARC Research sponsors and sites know the importance of implementing quality assurance processes for their clinical studies. For safety oversight, what steps can be followed to incorporate Quality Assurance into data safety monitoring boards, clinical events committees and medical monitoring? Take a look at these four tips: 1. Follow […]
Safety oversight options from medical device sponsors
Rachel Silver-Kessler, Director of Clinical Support Services, IMARC A safety monitoring group may be called many different things— a data monitoring committee, a data safety monitoring board, a clinical events committee, a medical monitoring group, among others. The sponsor will determine if and what type of safety monitoring group will be needed based on study […]