Any capable CRO can provide manpower and execute orders on behalf of a sponsor, no questions asked, with little stake or interest in the endeavor’s ultimate success. What you need is a strategic ally, a company that joins you, lockstep, in pursuing shared goals and greater outcomes. Not a vendor, but a partner.
When one pharmaceutical sponsor was faced with unreliable demand forecasts, Almac Clinical Services helped implement a LEAN supply chain approach to ensure clinical sites received the right drug quantities needed to support all patients in a global Phase III trial.
NGS sequencing presents new possibilities for influenza vaccine development. This white paper covers the challenges of developing influenza vaccines and new approaches that may eventually lead to a more universal solution.
Hemolysis is a primary driver of the need for re-draw, resulting in wasted time and resources. This paper explains how can hemolysis be prevented during specimen collection as well as hemolysis and specimen handling.
Traditionally hard-to-treat neurological diseases – including Alzheimer’s and Parkinson’s – which were once considered to be common, are being reclassified as a collection of rare diseases based on genetic markers. This article shares new strategies for enrolling patients and outlines the challenge of measuring the efficacy of the experimental treatment and determining whether it’s producing the desired effect.
For clinical trials of rare diseases, challenges such as recruiting patients, staying within timelines and handling the inevitable trial amendments can be amplified since the eligible patient population is so limited. This article highlights recent changes that are benefitting rare disease trials including multi-center trials, regulatory bodies establishing programs aimed at incentivizing rare disease drug development and smaller requirements for the number of patients in which a therapy must be tested before it can be considered for approval.
Nothing derails a clinical study timeline more than poor planning and not anticipating and preparing for the potential roadblocks. While you may not be able to anticipate everything, many of the risks and challenges outlined in this article can in fact be averted if you understand the landscape and prepare accordingly.
Successful clinical trials require accurate demand forecasting, efficient distribution channels and a secure supply chain strategy. Find out how Almac Clinical Services helped one sponsor implement an optimized clinical supply strategy that resulted in an uninterrupted clinical trial and reduced costs.
Every day, the eSource revolution is reducing organizations’ reliance on monitoring visits and source data verification - and thus serving as a crucial safety net in the event of unforeseen changes to monitoring staff. Particularly the ability to minimize the disruption caused when a CRA leaves an organization mid-study.
IN 2018 there were many changes, trends, regulations and priorities that shaped the direction of the clinical research and drug development fields. In this paper, WCG experts share what they anticipate in 2019, and what everyone should be prepared for as we approach another year of change.
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