Sandra Maddock, president and CEO, IMARC Research Thanks in large part to innovation in the medical device industry, the average human lifespan has nearly doubled in the past hundred years. Medical devices have undoubtedly improved the quality of life for millions of people, too. But a provocative new Netflix documentary raises an important question: Is […]

John Lehmann, Director of Business Development, IMARC Research Training programs should build proficiency in core job skills and be based on a strong regulatory foundation. Course curriculum should include practicum/on-the job training as well as exposure to emerging topics such as future trends in clinical data and patient centricity. As trials continue to become more […]

John Lehmann, Director of Business Development at IMARC Research In order to comply with applicable regulations and requirements, the intention of clinical trial monitoring is to protect the rights and well-being of study subjects, ensure data integrity, and ensure that the trial conduct is in compliance with the clinical investigational plan (CIP), agreements, GCP, requirements […]

Melissa Wollerman, Clinical Research Associate, IMARC Research In a previous blog published towards the end of 2013 titled “Essential Documents – What Will Regulatory Binder Look Like in 5 Years?”, the blog encompasses the potential of Regulatory Binders becoming electronic. Now, almost five years later, many sites and sponsors have explored and implemented the electronic filing […]

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 […]