Compliance
THESE EDC competitors, in base form, are not 21 CFR Part 11 compliant. (100 per +/-)
What are Clincrapture and RedHat?
Testing in petri dishes, prior to preclinical
What is In Vitro Testing?
THESE REASONS are what Medrio beats paper. (100 per +/-)
What are no need for paper transportation, no need for storage costs, reporting features, edit check features, and inherently compliant.
THIS INDUSTRY in particular benefits from our ePRO.
What is medical device?
Undesired actions or effects of treatment
What is adverse events?
GDPR is an EU regulation focused on THIS.
What is data protection and privacy?
When a researcher wants to compare the effects of a drug, they split the patients into two (or more) groups. One group gets the drug; the other gets the ________.
What is the placebo?
Veeva advertised THIS FEATURE on its website, and then took it off.
What is eSource?
Cleveland Brown saw a Medrio demonstration in 2017 and decided it was not a good fit. An SDR can bring up THESE UPDATES to push for a demo. (200 per +/-)
What is customized reporting, eSource and eConsent?
Submission of THIS indicates that a pharmaceutical program will be heading into Phase 1.
What is IND?
HIPAA is the regulation to ensure THIS remains secure.
What is patient information?
Study for generic drugs to test effectiveness compared to drugs already on the market
What is a bioequivalence study?
Onmicomm focuses on early-phase but its study build is rumored to last _______.
What is a year?
When building a study, a customer can use THIS FEATURE to bring up "How many packs a day?" in the case a patient answers "Yes" to "Do you smoke cigarettes?"
What is skip logic?
THIS QUEEN reigns with the most number one singles among solo artists, 18, including her 16-week record-keeper "One Sweet Day" featuring Boys||Men. Can you hear her whistle tones? And can someone bring her her hot tea?
Who is Mariah Carey?
Importantly, Title 21 CFR Part 11 requires THESE to ensure a record of who did what, who edited what, what was edited and to what it was edited.
What are audit trails?
Study evaluating long-term effects, term used in often drug market
What is a registry study?
Openclinica is notably the __________ EDC, but has bad support, a long build, ineffective reporting and a lack of compliance.
What is open-source?
eConsent uses multimedia to enhance patient comprehension and thereby reduce patient ______.
What is attrition?
Former FDA Commissioner Scott Gottlieb advocated for modernizing the clinical trial process. One way he envisioned this modernization is through the utilization, application and assessment of patient records from THIS SYSTEM.
What is EHR/EMR?
Attributable, Legible, Contemporaneous, Original, and Accurate are the five principles for proper _____ to ensure data integrity, validity and subject safety.
What is source data verification?
What is how the drug moves through the body?
This EDC is often compared to Medrio, except it is expensive, requires programming and has no offline capability.
What is Mednet?
Medrio has the lowest total cost of ownership because of our flexible pricing structure and our ___________ interface, which enables for free mid-study changes and a quick, programmerless study build.
What is drag-and-drop?
Law that effectively relates device in question to a device previously approved for the market
What is 510(k)?