John Lehmann, Director of Business Development for IMARC Research We have had many conversations with sponsors regarding their needs for monitoring support services. It is clear that while many sponsors consider the outsourcing of their monitoring needs to a CRO, they have many concerns that they have shared with us. These concerns or pain points […]

Reviewing a medical chart can be a daunting task for anyone on the research team. However, ensuring proper data extraction and source data verification is paramount to ensuring data integrity and subject safety in your clinical trial.  Understanding that source data may be located in a multitude of areas within a medical chart is one of […]

While procedures, checklists, guidance documents, report templates and all sorts of other things combine to form the infrastructure for monitoring, what is possibly even more important is the shared mindset.  The acceptance by all that regardless of the title, there is a shared responsibility in calling out issues, in looking purposefully at this document, in […]

Understanding the similarities and appreciating the differences between drug and medical device clinical trials is important for every trial participant—from the patients to the researchers. Whether the product being investigated is a drug or device, a well-organized, efficient clinical trial can save time and money for each individual and organization involved. Additionally, the faster and […]

Rachel Silver-Kessler, director of clinical support services, IMARC You may already know all the documents that your Trial Master File should contain to tell the right story about your study. (Check out our infographic for guidance.) And you can probably guess that a remote audit of your electronic Trial Master File could provide significant savings […]

Sandra Maddock, CEO and president, IMARC Research Anyone who’s ever prepared for an FDA Inspection of their clinical study has undoubtedly spent hundreds of hours sifting through all of the essential study documentation that makes up the Trial Master File (TMF) in an effort to make sure every single document needed to tell the study’s “story” […]

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 […]

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 […]

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. […]

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 […]

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 […]