Compared to conventional approaches, a model-based approach to enrollment forecasting provides a more realistic assessment of the possible risks and outcomes for any given scenario, by accounting for the nonlinearity and randomness of real-life enrollment processes. In addition, a model-based approach offers many more advantages other than more realistic expectations.
This article will provide helpful pointers from Paul Terrill, Director of Strategic Consulting at Cytel to ensure smooth communication between statistical and clinical stakeholders.
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.
How a diagnostics startup drastically reduced timelines and costs, and easily shared data across dispersed sites.
As sponsors increasingly outsource their clinical trial operations to CROs in search of greater cost efficiency there is a higher premium on eClinical technology and other resources that empower CROs to better navigate that competition.
Having the right specialists on their team enables Premier Research to recruit subjects relatively quickly, despite extremely complex selection criteria for this multiple myeloma clinical trial. In addition, maintaining a close and cooperative customer relationship assisted in moving the study forward.
Adopting a patient-centric focus in your trial is known to lead to more engaged patients and higher quality, more accurate clinical data.
Use of electronic consent can help improve the current paper document approach, but there is more to it than just replacing paper with a multi-media eConsent. What does it take to make eConsent patient centric?
In this presentation, Medpace Medical Device experts discuss key considerations for generating real-world evidence and how to apply critical insights in order to drive late-stage clinical research.
In this webinar, we explore four areas that can dramatically affect the cost and timelines of your clinical program and offer insight into elimination and control of these hidden landmines.
Trial sponsors must carefully plan their data consolidation and analysis strategies not only in preparation for CDISC-compliant submissions, but to respond to market influences and evolving clinical partnership models.
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.
Cytel’s ACES system supports adaptive design implementation in a secure, audit-trailed environment. ACES facilitates sponsor-committee communications and interim data handling as prescribed by regulatory guidance and according to the study protocol and committee charter.
Sharp’s Clinical IRT staff has extensive experience in reporting, data exports, and integrations. Adding new custom reports to your system is fast and easy using the ALEA interface. An IRT System is only as valuable as the data it produces. Get the most value for your IRT dollars using Sharp Clinical IRT. Our clinical data expertise includes the following:
CRO manages multiple, complex statistical analysis deliverables for a program of studies, CDISC compliant outputs, and data pooling for NDA submission to the FDA with minimal sponsor oversight.