Industry knowledge, webinars and more for clinical research sites
It is no secret that CRA turnover is a huge issue in the clinical research industry. It is not uncommon for sponsors or CROs to spend thousands of dollars onboarding a CRA, only to have them leave within one to two years after starting. Recent reports from the ACRP1 show that CRA turnover rates were as...
Boston, MA – The Delegation of Authority log is one of the “Essential Documents” in clinical research. In the DOA log, the Principal Investigator delegates study-specific duties to different members of the research study team. Each duty has a start and end date and should be signed off by both the Principal Investigator and individual...
CRIO recently received attestation from Kinetiq (now Advarra) that our policies and procedures conform to the requirements of 21 CFR part 11 and Annex 11. Part 11 is the FDA’s requirement for use of electronic data in clinical trials, which is a part of Good Clinical Practice (GCP) and Good Documentation Practice (GDP). Annex 11...
Hire your dream Clinical Research Coordinator. Reveal your applicant’s true capabilities with these 10 questions. When I interviewed for my first coordinator job, I was left alone in a back-office waiting for at least 45 minutes before the Prime Coordinator remembered I was there. She rushed out of the room to collect her materials and...
What are the main costs of clinical trials, and why are they so expensive? Our team at Clinical Research IO searched the literature to find out how clinical trial costs differed by indication, and what the main cost drivers were. Successful clinical development of a drug, from preclinical testing to marketing approval, requires a vast...
In a survey commissioned by Clinical Research IO (CRIO), 62% of sites, who mainly conduct non-oncology trials, reported that they use their Electronic Medical Record (EMR) system as their primary system for recruiting patients, but only 13% reported that they use their EMR as their primary system for source data collection. For source data collection,...
See exclusive survey data on what technologies clinical research sites are currently using, how much they’re spending, and why Electronic Source (eSource) and eRegulatory software is poised to break out in the clinical trials industry. Motivation for eSource and eRegulatory Survey Clinical Research IO (CRIO) was founded on the belief that we can get life-altering...
While much of the research and development conducted by the global pharmaceutical industry relies on cutting-edge technology, one aspect of the process of developing and testing new drugs is decidedly low tech: clinical research. That’s what Raymond Nomizu, a Harvard-trained lawyer and former management consultant discovered when he decided to launch a company focusing on...
Most discussion about electronic source (eSource) documentation in the clinical research enterprise starts from a sponsor standpoint, with eSource being viewed as an extension-almost a mobile version of electronic data capture (EDC). In this view, sponsors provide sites with eSource systems that the sites use to collect data, which are then transmitted to the EDC...
When a study coordinator uses eSource, he or she enters data into an electronic system like an electronic medical record or tablet computer, rather than onto paper. Data can then be transferred from the eSource system into the electronic case report (eCRF) system (also known as the electronic data capture (EDC) system), thus eliminating the...
