When it comes to auditing, being prepared is more than half the battle.
Topics: Auditing
You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
When it comes to auditing, being prepared is more than half the battle.
Topics: Auditing
Remote auditing isn’t new, but it’s becoming more popular as clinical research teams become increasingly distributed.
Remote audits have also become more relevant recently as clinical trial operations transitioned from on-site to remote during the coronavirus pandemic.
If you’ve never considered remote auditing before, you might be wondering how it can benefit your trial and whether it’s the right approach for you.
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.
Topics: Auditing, Clinical Vendor Audits
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 of time and money compared with hosting an in-person audit. So now you may be asking:
Topics: Auditing, Electronic Trial Master File Review, trial master file
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” is there, is accurate, and is complete. Sometimes this is handled internally and sometimes companies hire external contractors to assist. Either way, there can be a huge price tag associated with this. At two recent TMF audits, I found myself asking the following questions:
Topics: Auditing, trial master file
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 to explain?
Topics: Auditing, trial master file
How is auditing different than monitoring? Why do we need to audit? Since these questions are so often asked, we decided to create a graphic that will help you understand when to consider an audit. In short, auditing brings an independent, quality assurance perspective to the clinical research landscape Investigational sites, sponsors, and vendors benefit from high-level process assessments and improvements. Experienced auditors leverage extensive training to help ensure subject safety, data integrity, and protocol and regulatory compliance.
Topics: Auditing, Quality Assurance
In the realm of clinical research, two functions often work together to complement each other to create an additive impact on the overall quality and integrity of a clinical trial. The two functions are clinical monitoring and auditing. But how do these work hand-in-hand, and how are they different?
Topics: Auditing, Monitoring
How is auditing different than monitoring? Why do we need to audit? Since these questions are so often asked, we decided to create a graphic that will help you understand when to consider an audit. In short, auditing brings an independent, quality assurance perspective to the clinical research landscape Investigational sites, sponsors, and vendors benefit from high-level process assessments and improvements. Experienced auditors leverage extensive training to help ensure subject safety, data integrity, and protocol and regulatory compliance.
Topics: Auditing, Clinical Monitoring, Quality Assurance
How is auditing different than monitoring? Why do we need to audit? Since these questions are so often asked, we decided to create a graphic that will help you understand when to consider an audit. In short, auditing brings an independent, quality assurance perspective to the clinical research landscape Investigational sites, sponsors, and vendors benefit from high-level process assessments and improvements. Experienced auditors leverage extensive training to help ensure subject safety, data integrity, and protocol and regulatory compliance.
Topics: GCP, Auditing, Quality Assurance
In the clinical research industry approvals for investigational products are not granted- they are earned. With FDA and International inspections on the rise, so are stress levels of everyone involved in clinical studies. Auditing can be looked at as a quality improvement process, and a way to prepare for inspections and approval by:
Topics: Medical Devices, FDA, Auditing
In the realm of clinical research, two functions often work together to complement each other to create an additive impact on the overall quality and integrity of a clinical trial. The two functions are clinical monitoring and auditing. But how do these work hand-in-hand, and how are they different?
Topics: Whitepaper, IMARC Research, Auditing, Clinical Research, Clinical Monitoring
Recently, a clinical site received a call from an inspector on a Thursday notifying the site of a not-for-cause inspection the following Monday. This was a short gap of time between the notification and actual audit conduct. How can sites make sure they are ready if an inspector calls today?
Topics: BIMO, Auditing, Inspection Ready, Sites
How is auditing different than monitoring? Why do we need to audit? Since these questions are so often asked, we decided to create a graphic that will help you understand when to consider an audit. In short, auditing brings an independent, quality assurance perspective to the clinical research landscape Investigational sites, sponsors, and vendors benefit from high-level process assessments and improvements. Experienced auditors leverage extensive training to help ensure subject safety, data integrity, and protocol and regulatory compliance.
Topics: Infographic, GCP, IMARC Research, Auditing
In the realm of clinical research, two functions often work together to complement each other to create an additive impact on the overall quality and integrity of a clinical trial. The two functions are clinical monitoring and auditing. But how do these work hand-in-hand, and how are they different?
Topics: Whitepaper, IMARC Research, Auditing, Clinical Monitoring
In the realm of clinical research, two functions often work together to complement each other to create an additive impact on the overall quality and integrity of a clinical trial. The two functions are clinical monitoring and auditing. But how do these work hand-in-hand, and how are they different?
Topics: Good Clinical Practice, Auditing, Clinical Research, Clinical Monitoring
As monitors we sort of live by this motto and we always try to remind our sites of this, we do so in order to help protect the subjects, their site, and the Sponsor of the study all at the same time.
Topics: Documentation, FDA, Auditing, Clinical Monitoring
Over the past seven years I have traveled all over the United States and Canada and have even been to Japan once. Due to the great distance, airplane has been the most expedient method for me to travel. Given that, I have looked out of hundreds of airplane windows and am always enamored with the view. I never tire of trying to identify where I am, especially as I get closer to Cleveland Hopkins International Airport. I only live about 25 miles from the airport and really, how hard can it be to find a landmark from the sky? For whatever reason, I have the hardest time trying to do this. So you can imagine my aggravation when my husband accompanied me on a trip a few years back and on our decent into the airport he started to rattle off all of these landmarks and our location. Did I mention my husband has flown in an airplane about six times in his entire life? After I was done being aggravated at his skill, I really enjoyed finding landmarks, too. It was so easy once someone gave me a starting point. Wearing your ‘auditor’s hat’ during your monitoring visits can be just as easy and fun. You just need to have the right starting point and tools.
Topics: FDA, Auditing, Clinical Monitoring
In the clinical research industry approvals for investigational products are not granted- they are earned. With FDA and International inspections on the rise, so are stress levels of everyone involved in clinical studies. Auditing can be looked at as a quality improvement process, and a way to prepare for inspections and approval by:
Topics: Voluntary Audits, FDA, Auditing