This article covers some of the factors that need to be considering when using over-encapsulation as a blinding option in clinical studies. There are many blinding options available today, but over-encapsulation still seems to be the most popular.
DBCaps capsules are often specified for over-encapsulation of active comparators in double-blind clinical trials. The complete line of these specially-designed capsules offer increased patient compliance. They also feature a patented locking mechanism to provide unsurpassed protection from bias caused by breaking the blind. This paper provides a technical review of formulation considerations regarding the use of gelatin DBcaps capsules for clinical trials.
Over-Encapsulation is the most widely used method of blinding supplies in clinical studies, which are larger, more complex, and more global than ever before. This article reviews techniques for successful over-encapsulation and suggests solutions to common problems.
PPD, one of the top CROS worldwide, is reducing trial timelines, cost, and risk through simplified data exchange and monitoring with Oracle Siebel CTMS Cloud. PPD successfully migrated data from 124 studies to the Oracle Health Sciences Cloud in just six weeks, achieving rapid time to value.
With this highly available and secure monitoring cloud, PPD and trial sponsors gain actionable insight into studies to accelerate clinical development while reducing trial costs and risk. As PPD put it:
“Oracle Siebel Clinical Trial Management System Cloud Service dramatically simplifies how we manage study data and communicate with clients, especially in studies involving multiple CROs….saving us time, reducing the cost of studies and creating better results for our clients.”
Download the case study to learn more.
IRT integrations have gone from a nice-to-have to a must have. From simple IRT data transfers to EDC, to complex deep integrations with sponsor supply chain management systems, Cenduit Integral has technology and experts to simplify the entire user experience. CENDUIT We see things others don’t. TM
In this new white paper “The mHealth Connection to Advance Clinical Research: Emerging Role of Mobile Health and Digital Technologies to Foster Patient-centric Trials”, learn how a current PPD-conducted study assess the feasibility of wearable data collection devices in clinical trials to achieve focused endpoints and improve the patient experience.
Learn the reasons for Phase III study failures and explore solutions for reducing the risk of failure with PAREXEL colleagues Dr. Sy Pretorius, Chief Scientific Officer and Dr. Alberto Grignolo, Corporate Vice President/Consulting.
This white paper will provide summary results from a comprehensive survey on eSource conducted by Applied Clinical Trials (in collaboration with OmniComm Systems). The presenters will highlight opportunities for adoption in the light of current regulatory guidance, the exciting confluence of eSource and Risk Based Monitoring initiatives, and specific technical approaches for gathering and managing eSource data. The presentation will include examples of direct data capture for laboratory data, direct instrument capture and ePRO.
INNOVATIVE SOLUTIONS FOR REDUCING COSTLY CLINICAL SUPPLY WASTE: See how a top tier trial sponsor partnered with Almac for a creative and effective solution in the management of costly investigational product..