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.
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.
Topics: CRO, Clinical Monitoring
Monitors that perform their job at a high level can drive the growth and reputation of their company. The companies that employ these monitors are equipped to meet the needs of their clients and ensure that patient safety and data integrity are maximized.
Topics: CRO, Clinical Monitoring, 10 Attributes
Having independent oversight is critical to ensuring compliance, keeping your clinical
research trial on track and bringing your device to market faster.
For this reason, many companies hire a clinical research organization (CRO) to monitor, audit and even manage their trial. Outsourcing this work has become more common and is widely accepted throughout the industry, but it can still be difficult to turn over any or all aspects of your trial to a third party.
Medical device trials in particular bring complex compliance challenges, so having a CRO with specific expertise in this area can be tremendously beneficial.
How can you be sure you hire a medical device CRO that is committed to ensuring compliance and is as invested in your success as you are?
This slideshare covers the five factors you need to look for when choosing one.
Topics: Medical Devices, CRO, 5 Keys, Compliance Partners
Clinical research sponsors continue to outsource the management of their clinical trials, spending millions of dollars for a pivotal phase and significant risk medical device trial. Choosing a clinical research organization with compliance expertise will protect your investment and ensure your product is ultimately approved.
Topics: CRO, Compliance-minded
Not all studies require a data safety monitoring board (DSMB) or a clinical events committee (CEC). But should they be implemented for your study, it’s important to know they are not all created equal. The Data Safety Monitoring Boards (DSMB) review cumulative information from a study and monitor safety oversight with teams of independent physicians and medical professors. Clinical Events Committees (CEC) adjudicate finite sets of adverse events within a study to determine if those events are related to the study or not. While it is critical to understand the primary purposes of a DSMB/CEC, you should also look beyond meeting basic requirements in order to be the most confident in your efforts for patient protection and study results.
Quite often – and rightfully so – the phrase it’s a matter of life and death is bandied about throughout the healthcare industry. When the stakes are that high, doing it right – the first time, takes on added importance.
Topics: CRO, ISO 9001:2008; IMARC Research, FDA
As noted in our previous blog, in most cases when a monitor or CRO is brought into a clinical research study, the protocol, case report forms, and informed consent template have already been finalized. Moreover, some or all investigative sites may have already received IRB approval of their protocol and informed consent document. As noted in 21 CRF Part 812.42, the sponsor is required to have all study documents approved by the participating institution’s IRB. The IRB, on the other hand, is required to review clinical research activities, as noted in 21 CFR 56.109.
Topics: CRO, Monitor, IFC Checklist, IRB Approval
Recently, when discussing Institutional Review Board (IRB) adverse event reporting, a Project Manager for a leading medical device Contract Research Organization (CRO) brought up a valuable question regarding reporting compliance- whose job is it to ensure an investigator is compliant with IRB reporting policies?
Topics: Good Clinical Practice, CRO, IRB Reporting Compliance, FAIR Shake technique
Being a CRO that specializes in helping companies gain FDA and world-wide approval through monitoring, auditing, training and consulting services- it’s fair to say we’ve come across a wide range of fellow CROs, investigative sites, research teams, and hospital systems. It’s amazing how much innovation exists- not just with the investigative products- but with technological advances to platforms used the healthcare industry.
Topics: CRO, Integrated EDC/EHR System, Clinical Research
I came across this MedCity News article and just had to laugh. In the article, the author Amy Siegel pokes fun at the fact we all fall into the acronym trap, admitting to a sentence like, “’The CMO called the PI about the IRB process to estimate dates for FPI and CE mark in the PDP.”
Topics: Med-Tech Industry Acronyms, CRO, Top 5