news roundup
Asia-Pacific CRO Novotech has expanded its business offering to include clinical trial site management organization (SMO) services with the launch of Novotech SMO Korea Co. Limited in South Korea. The new business will train and provide clinical research coordinators and associates who will be able to support clinical trial principal investigators with site feasibility, patient recruitment and IRB support.
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About Bridging Clinical Research and Clinical Health Care Collaborative
The Bridging Clinical Research and Clinical Health Care Collaborative is sponsored by SCORR Events, a division of SCORR Marketing, the leading marketing and communications firm in the health science industry. SCORR Events was established to provide education, collaboration and opportunities for industry professionals to advance health sciences.  Learn more
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Mapi Language services and YPrime will establish an operational interface between Mapi's process and YPrime's eCOA platform to facilitate Linguistic Validations. The integration allows for cross validation and eliminates the manual versioning and migration integrity of paper originated COAs.
The partnership intends to enable automated data transfer for observational research from electronic hospital records (EHRs) to electronic data capture (EDC). Clinerion's Patient Recruitment System will extract and interpret information from EHRs, and will integrate with Cisiv's platform, Baseline Plus, to improve data quality and enable more effective data collection in real-world settings.
GB Sciences, Inc. announced it has signed a consulting services agreement with Worldwide Clinical Trials, Inc. to assess the company's intellectual property portfolio and help with pre-IND planning for its cannabis-based formulations.
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Articles
This article explains the use and characteristics of Enterprise Project Management Office's in pharma to coordinate all aspects of projects in the organization.
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Minimal Residual Disease Detection: Key Considerations for Clinical Development in Oncology
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Applied Clinical Trials spoke with Thomas Wicks, TrialScope's chief strategy officer, and Julie Holtzople, clinical trial transparency operations director for AstraZeneca, about the launch of its Trial Results Summaries Portal implementation and the goals of the layperson summary program.
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Blog Posts
To give cell therapies the best chance of success, now is the time to ensure that every protocol or technology involved in delivering a live therapeutic to a patient meets the highest standards of integrity, efficacy, and consistency.
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Capturing Continuous Glucose Monitoring Advantages
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The CTR represents an important step toward facilitating clinical research on medicines in the EU. However, there are some issues regarding ethical review. The wording of Article 4 is not acceptable; ethical review of the study protocol must be mandatory.
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Upcoming RBM Events
CBI will host the Global Risk-Based Monitoring conference in Barcelona in mid-September. And, in the United States, CBI's Risk-Based Trial Management and Monitoring event will be held in Philadelphia the first week of November.
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Shortening Biosimilar Development: A Case Study Integrating Early Clinical (Phase I) with late phase (Phase III) Biosimilars Development
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With ICH E6 (R2), it is incumbent on the sponsor to oversee and manage compliance for all clinical trial activities, regardless of in-house or through a CRO.
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Dr. Jonathan Rowe, Executive Director and Head of Clinical Development Quality Performance and Risk Management, at Pfizer discusses how they are leveraging predictive models to manage study risk and quality.
The regulatory push to the paperless clinical trial has occurred despite a pharmaceutical industry that has been risk-averse in adopting modern-day technology tools that could support clinical trials.
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