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.
Selecting clinical sites for research purposes may be a difficult and seemingly overwhelming task for a sponsor. Familiarity with a site might help with selection, but multiple contributing factors can influence whether or not a site is ultimately chosen. Choosing the wrong sites could have a detrimental effect on the study including:
Topics: Sponsors, Site Selection
Selecting clinical sites for research purposes may be a difficult and seemingly overwhelming task for a sponsor. Familiarity with a site might help with selection, but multiple contributing factors can influence whether or not a site is ultimately chosen. Choosing the wrong sites could have a detrimental effect on the study including:
Topics: Sponsors, Site Selection, FDA
For the fifth year, IMARC has searched through the warning letters posted on the FDA’s website to compile a list of the top findings for clinical investigators. This year, we noted twelve warning letters that were issued in 2013. In the past years, the most common citings tend to revolve around failure to follow the clinical investigational plan, insufficient recordkeeping, and inadequate subject protection. Interested to see if the trends continued for 2013?
Topics: Sponsors, FDA Warning Letters, IRBs, IMARC Research
If you work in clinical research, chances are you are familiar with the FDA regulations (21 CFR and all of its parts). If you’re like me though, you may have a strong understanding of these regulations but still need to reference a regulatory book from time to time if you want to be sure or cite something. Well IMARC’s present to you this year is a quick reference guide for regulatory time requirements for Investigators and Sponsors of medical device research, as well as IRBs. For space sake, we are paraphrasing. Please don’t feel obligated to get us any gifts in return. You can give the gift of human subject protection to every research subject involved simply by striving to meet these requirements.
Topics: FDA Regulations, Sponsors, IRB
Binders, huge files, and tons of paper….this is what researchers have become accustomed to. Some Sponsors have allowed sites to house certain items electronically, most often communication either emails between the site and Sponsor or IRB communication. But more often than not Sponsors require these items to be printed and housed in files or binders.
Topics: Research Coordinators, Regulatory Binder, Sponsors