The market for clinical trial management system software is expected to be worth nearly $1.8 billion by 2019 with much of the double-digit growth taking place in developing countries, according to Persistence Market Research.
Source: Clinical Trials Advisor
Category Archives: Clinical Trials Advisor
The FDA issued two draft guidances to encourage using the 510(k)-Clinical Laboratory Improvement Amendments (CLIA) waiver dual application pathway for new in vitro diagnostic devices, and to update its policies for demonstrating accuracy to obtain a CLIA designation.
Source: Clinical Trials Advisor
Amid the push among House and Senate Republicans to pass a sweeping tax reform bill, clinical researchers called on the federal government to modernize the research and development tax credit.
Source: Clinical Trials Advisor
Employee turnover has spiked at contract research organizations internationally, but it remains steady in the U.S., according to HR+Survey Solutions.
Source: Clinical Trials Advisor
A new requirement has been added to the FDA’s Reviewer Certification Program — training in the development, evaluation and use of patient-reported health outcomes, the agency said in its first report on PROs in medical device premarket submissions and post-market studies.
Source: Clinical Trials Advisor
The FDA issued final guidance explaining the new framework the agency will use when assigning IDE devices to one of two categories prior to clinical studies — Category A: Experimental and Category B: Nonexperimental/investigational.
Source: Clinical Trials Advisor
An Alzheimer’s research group offers positive news on clinical trials for Alzheimer’s drugs as well as suggestions for the way forward, in a new report.
Source: Clinical Trials Advisor
The FDA warned investigational medical device sponsor UVLrx Therapeutics for failing to obtain required authorization from its Institutional Review Board.
Source: Clinical Trials Advisor
The FDA issued a new draft guidance for sponsors developing treatments for gastroesophageal reflux disease in infants, children and adolescents — outlining clinical trial design considerations and the agency’s current thinking on extrapolating data in pediatrics.
Source: Clinical Trials Advisor
Developers of antiviral drugs for prophylaxis and treatment of respiratory syncytial virus should expose at least 100 adults in clinical trials ahead of pediatric studies, the FDA said in new guidance for drugmakers.
Source: Clinical Trials Advisor