The shift of clinical assessment from the controlled environment of a trial site to the uncontrolled environment of a patient's home is a considerable challenge. Read about ICONs creation of a suite of wearables that could be combined and deployed in a non-clinical setting and tailored to specific therapeutic areas.
The rapid shift to VBHC is reshaping markets for medical and diagnostic devices in several important ways. Its incentives significantly affect the purchasing behavior of payers, clinicians and patients – and what device makers must do to win their business. Generally, this includes determining how these various stakeholders define value, and gathering evidence to build a value based purchasing case early in the product development cycle. In this paper, we examine some of the major factors that influence how different stakeholders define value. We then describe a model for mapping stakeholder value that can help drive profitable device development programs in increasingly value driven markets.
Determining appropriate stratifications and relevant clinical endpoints for specific sub-populations can be challenging. Therefore, it is necessary for development strategies to incorporate explorations and determinations of suitable biomarkers early in the development of a new therapy.
In this webinar, you’ll hear about exciting new advisory and managed disclosure services from TrialScope, including: compliance, policy and process assessments, as well as plain-language summaries, protocol registration, results posting, and redaction services.
Mark P. Wade, Executive Director, Life Sciences at TransPerfect shares his thoughts on the ISOQOL 25th Annual Conference in Dublin. Hear what professionals that live and breathe Clinical Outcome Assessment (COA) measures learned from this event.
A CRO with deep therapeutic, regulatory and operational expertise facilitates the risk-assessment process by highlighting items within the protocol design that have the potential to impact overall risk levels. Identifying these risks and potential operational challenges early in the process is essential to the success of RBM later in the study.
Like any relationship, the theme to a long and healthy one always boils down to communication. In part 2 of this series, here are five more investments in communication that help Trial Interactive stay in sync with the growth of our users.
The big challenge for study sponsors is that clinical trial transparency remains a “volatile” area with continuously evolving requirements and expectations. Most life sciences companies don’t have the time, money or resources to develop a compliance solution.
A client was developing a new drug for complex neurodegenerative disease in pre-clinical development. The drug may be only effective for a particular subgroup of patients. They needed to generate a hypothesis on the molecular pathway and the targeted drug activity and identify a biomarker signature defining potential response to the new drug. Read how Cytel’s analysis produced a biomarker signature that was provided to the client for in-vivo validation.
ClinCard's Tax Toolkit supports research sites and sponsors in remaining IRS Tax compliant while maintaining confidentiality and privacy.
mCore is Medrio's all Phase eClinical suite which includes CloudEDC™. It is well suited for Phase II, III, IV, in Pharma, Diagnostics, Medical Device, and Animal Health studies.
Medical device and diagnostic companies are struggling to keep up with changing regulations and the growing demand for clinical data is draining resources. Vault Medical Device Suite streamlines the device and diagnostic lifecycle for greater efficiency and compliance.
goBalto Activate improves operational efficiencies with real-time monitoring of items on the critical path to ensure key milestones are met.
m1 is Medrio's eClinical suite for Phase I including CloudEDC™ and all the features you need to make your Phase I trial run smoothly.