A customer enlisted Catalent to support their child-resistant blister packaging requirements for a global Phase III study. A flexible design was created with an integrated blister card that could also support larger study requirements of 1.9 million monthly dosing cards. Through customized commercial blistering equipment a solution was provided that would accommodate the customer’s growing demands for clinical supplies.
How the right technology can dramatically improve compliance, efficiency, and visibility in trials involving imaging.
These clinical packaging strategies can be used to help successfully manage the supply of an expensive drug product throughout the duration of clinical testing. Without doing so, there could be costly interruptions or extended delays that would have a devastating impact on a company’s timeline to commercialization.
Achieve cost-efficiencies and speed data delivery by combining bioanalytical and central laboratory services for clinical trials.
With most sponsors utilizing an outsourcing model of some kind, the biggest opportunity might still lie ahead. As the industry adapts to be more budget minded and efficient, the quest for innovation remains. So, what does meaningful innovation look like for the clinical trial industry?
Typically Clinical Research Organizations (CROs) involvement in the clinical trial process has centered on site management in terms of identifying potential sites and managing patient recruitment. They also offer services related to activities such as protocol development, data management, laboratory services, and toxicology analysis amongst others. Managing clinical supplies has always been seen as a backroom activity, one which sponsors tended to keep a firm hold on, perhaps highlighting their importance to the sponsor in terms of meeting First Patient In (FPI) deadlines.
Historically, scientific innovation alone in the absence of any significant pricing pressures was sufficient to maintain return on investment (ROI) and deliver on unmet medical needs.
CTI Clinical Trial & Consulting Services, a full-service global contract research organization (CRO) specializing in complex therapeutic areas, adopted the Medidata Clinical Cloud® as its preferred platform of clinical trial technology to efficiently run the operations of its rapidly growing global business. The company has been using Medidata’s cloud-based platform for over three years.
The Infectious Disease Division of a world-renowned nonprofit research organization in the Pacific Northwest is the world’s largest clinical trials network for the development and testing of an HIV vaccine. The group conducts all phases of clinical trials, from evaluating experimental vaccines for safety and their ability to stimulate immune responses to testing vaccine efficacy. Due to the nature of their work, researchers at the center frequently need to modify protocols during their clinical trials, either by changing the timing of scheduling windows or by inserting new steps into the protocol, such as adding vaccines or changing dosage, which may require collecting additional consent forms from research subjects.
Every quarter, Synergy Research Group, a full-service CRO headquartered in Moscow, Russia, issues its Orange Paper. The report, which looks at the state of clinical trials in Russia, is comprised of research done by combing through data from the country’s Ministry of Health. The Orange Paper offers a concise snapshot of clinical trials in the region.
The Q2, 2014 Synergy Orange Paper was just released. One of the more significant findings is that the gap between previous years’ trials and the current period is closing. In the first quarter of 2014, there were 18 percent fewer trials than in the same quarter in 2013. In the second quarter, there was a gap of only three percent.
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