Trial Interactive
Which of eFeasibility product’s features are not part of the functionality?
Separate, configurable folders for content containing PHI
Put the following development phases in order: Toxicology, Safety pharmacology, Discovery
Discovery, Toxicology, Safety pharmacology
If a company says they are a full service CRO, what are at least 3 typical services they offer?
PM, monitoring, data management, statistics, medical writing, safety/pharmacovigilance, regulatory
IND
Investigational New Drug
What’s the name of Veeva’s Regulatory System?
RIM
Which solution would you offer for document de-identification & redaction to protect PHI
eISF
List three activities conducted during study start-up
Investigator initiation
Site feasibility
Database preparation
Collection of essential documents
Pre-study investigative site visits
Name the federal document a Principal Investigator must sign to participate in a clinical trial
1572
CRF
Case Report Form
Which competitor’s product is called Rave?
Medidata
Name at least 2 features of the latest 10.6 version of TI
TI Automate, TI Analytics, Central Help Portal, Contact Start and End Dates
For most pharma pre-clinical development, what are the three common mammals of using for testing products?
Rats/mice, dogs, monkeys
What is the threshold of how many people it affects in US to qualify as an Orphan drug ? (+- by 50,000)
200,000
CSR
Clinical Study Report
Name 3 CROs that use Veeva as their own eTMF
Parexel, ICON, Covance, Medpace, PRA, Syneos
In which year Trial Interactive has been awarded Best Sponsor-Facing Technology for its eClinical platform at Citeline Awards?
2023
For the FDA to consider a drug product for approval, how many "well controlled" pivotal trials must be done?
2
What is the concept of 21 CFR part 11 compliance?
Electronic records, electronic signatures and audit trails
electronic Common Technical Document
Name 2 other competitors within eClinical or TMF services field other than: Veeva, Medidata, Phlex, Montrium
SureClinical, Justintime, Ennov, ArisGlobal, DrugDev, Oracle, CureMetrix, CloudByz, Bizzmane
Name 3 documents that AI Automate classifies correctly 100% of the time.
1572, ICF, Medical License, MV Report, CV,
What does it mean to double-blind?
Neither the patient nor the investigator knows who is getting a placebo and who is getting the drug/treatment
List at least 3 essential documents that are required to be collected from a Principal Investigator
1572, ICF, Financial Disclosure (FDF), Medical License, CV
SUSAR
Suspected Unexpected Serious Adverse Reaction
Which company did Phlex buy to bring AI, automation and connect regulatory and clinical tech?
Cunesoft