A leading global pharmaceutical sponsor began a program of clinical trials to discover if a new bronchodilator could demonstrate superior and sustained lung function for patients with COPD. Learn how integrated Respiratory, eCOA, Cardiac Safety and Centralized Data Surveillance solutions enabled the sponsor to prove efficacy and safety during the program, helping to secure new drug approval from U.S. and European regulatory bodies.
Premier Research, a leading clinical development service provider, struggled with their time-intensive manual data entry process. In this case study, learn how the company implemented a technology-based solution that was flexible enough to adapt to all their trial needs, including the improvement of employee productivity and trial data accuracy, and the replacement of paper-based reports which led to reduced inefficiency and better communication among stakeholders.
If current manufacturing practices are followed to handle small batches of API on industrial size machines, it results in handling difficulties and lower product yield.
The complexity of clinical trials continues to rise. New biomarkers for safety and efficacy continue to emerge, and new types of information – like genomic profiles – have become critical to submissions for drug approval. Against this dynamic backdrop, the central challenge facing trial sponsors is the need to bring together diverse data sets, draw meaningful insights from them and act quickly to maximize return on investment.
Challenge: A biotech company launched a Named Patient Programme (NPP) that required complex and dedicated operational support. The NPP demanded expedited patient eligibility review and urgent drug shipment to an extremely sick patient population. High patient demand from a global population encouraged them to seek a pharma services provider to manage the programme.
Time is always of the essence in clinical trials. But when competitors have the lead in bringing an alternative therapy to market, “the need for speed” takes on a whole new focus. This was the case with one top tier global pharmaceutical company that was just beginning its development program for several infectious disease indications.
Certainly, every sponsor wants to minimize wastage in clinical trial supplies, but the motivation to do so is extraordinary when the product under study is unusually expensive. A top-tier, international pharmaceutical company engaged Almac to ensure that it did not incur undue drug supply costs for a global study involving a very expensive investigational product. With some ingenuity and customisations to the IXRS® platform for managing patients, supplies, and trial data, Almac helped the client re-envision its study design and supply strategy.
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.
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