Observational studies are becoming increasingly important as pharmaceutical and device companies compile evidence of the real world value of their products.
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.
Fisher Clinical Services was contacted in early 2013 by a virtual biotech that had a set of unique challenges. With just one compound in the pipeline, the company was in trouble because its previous vendor made drug supply errors that compromised patient safety in Phase II. Not only was the clinical team navigating the ethics investigation triggered by this violation of trust, the legal team was fending off lawsuits from investors.
Today, comparator procurement is one of the most expensive components of clinical trials. This cost can take on further meaning as the risk of a temperature excursion or a loss of drug due to time out of environment can result in additional charges and even delays in the trial.
Clinical trial data are the lifeblood of every submission, and it’s no wonder that clinical trial teams might be wary of trial participants who are not sourced by the research sites themselves. So the question is: Is there a difference in quality between externally recruited and in-practice patients? We have analyzed the data and the results are in.
This seven-year outcomes study was critical to the success of a compound that is expected to build on the sponsor’s leadership position in diabetes care. Because of the study’s importance, as well as the costs associated with this multiyear program, keeping enrollment and study timelines on track was of paramount importance to the sponsor.
This phase III global program, involving four protocols and approximately 300 sites, was critical for a sponsor striving to make its compound the leader in a potential $1B gout market by 2018.
A leading pharmaceutical company needed assistance in obtaining comparator study medication for a global Phase III program. The global trial was focused on an infectious disease and involve 130 sites.
A major global pharmaceutical Sponsor was seeking a new approach to enhance the efficiency of their supply chain process including their label and translation management approaches.
Our client, one of the top major pharmaceutical companies with research priorities aligned to significant global health needs – diabetes, heart disease, cancer and mental health - had a high number of studies already in progress in the Asia Pacific region.
|
|
|
|
|
|
|
|
|