A leading global contract research organization was contracted to conduct a two phase global oncology trial on behalf of a mid-sized Pharma company. The study was comprised of both phase I (dose finding and dose confirmation) and phase II (dose expansion) components. The original goal was to activate 20-25 sites for the phase I component and an additional 55 sites to be on boarded for phase II. By the time the protocol was received, sites had been selected and the First Site Initiation Visit (FSIV) was targeted to occur in less than five months. The core regulatory pack was due for finalization within 11 days of receipt of the protocol.
It’s not often that two clinical data managers who are years apart in their experience feel equally at ease during a clinical trial. But this is precisely what took place at Ancillarie, a support services company that has been serving pharmaceutical and biotechnology companies since 2012. In 2013, seeking an electronic data capture (EDC) system to catalyze their clinical research, they began a collaborative relationship with Medrio. Since then, they have conducted three clinical trials using Medrio’s software – all dermatology studies. Over the course of those studies, both veteran and early-career data managers at Ancillarie have found Medrio’s software to be convenient and user-friendly, and have achieved comparable efficiency in their research.
DataFlex Solutions, a contract research organization (CRO), uses a dynamic, flexible, remote based model with efficient use of standards and cutting edge reporting tools to provide cost effective and innovative solutions to clients.
Unlike in the past, today’s small CROs specializing in distinct therapeutic areas are competing with their much larger counterparts. One reason for this change is the availability of CloudEDC™.
It is widely recognized within the pharmaceutical and medical device industries that there is a distinct competitive advantage that comes with being first to market.
CUREM Research Partners is a contract research organization (CRO) providing customized clinical trial research support including study management, clinical monitoring, and data management.
Ophthalmology research is a fast growing field of clinical research, and with roughly 3,000 open or active ophthalmology related trials, the need for CROs specializing in optimizing ophthalmology trials is growing with it.
Observational studies are becoming increasingly important as pharmaceutical and device companies compile evidence of the real world value of their products.
Proving therapeutic equivalence is an important step in the approval process for a biosimilar. The research needed is time, labor and resource intensive, making it critical to maximize the investment. UBC’s Clinical Development team is supporting a sponsor with a Phase IV study of a gastroenterology biosimilar. This late phase study has yielded three important lessons for biosimilar manufacturers.
Study startup is one of the most challenging and costly stages of the clinical research life cycle. Recent statistics indicate that nearly 80% of studies fail to meet enrollment timelines, and up to 50% of research trial sites enroll one or no patients . At the same time, protocols are growing in complexity, competition for patients in oncology studies is on the rise, and increased regulatory requirements demand more of study teams. Recognizing these challenges, in 2012, a US Monitoring Operations organization made an investment in study startup.
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