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news roundup
Medidata announced that Lundbeck will continue to rely on Medidata’s operational capabilities while utilizing solutions within Medidata’s Clinical Cloud platform to increase the accuracy of its research and data reporting in order to optimize clinical trial results.
Gaps in the good manufacturing practice controls on medicines for clinical trials are targeted in new rules from the European Union. A new regulation setting out GMP for investigational medicinal products entered into force on October 9.
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ERT Video Series
Check out the ERT video series, filmed on the show floor at DIA 2017, for interviews on Innovating Clinical Trial Management, eCOA in Clinical Research: Trends and Advances, and Optimizing Clinical Trial Imaging through Advanced Technology.
 Click here to watch all 10 short videos |
OmniComm Systems signed a contract with Beijing Hospital of the Ministry of Health in China to provide its TrialOne clinic automation solution to the hospital’s Phase I clinical research unit.
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Navigating the Regulatory Complexities of Orphan Drugs: Know the unwritten rules of designations and what's next
Live Webinar: Thursday, November 2 at 11:00am EDT
 Register now |
According to the European Forum for GCP (EFGCP), geriatric and pediatric drug development should be viewed together because of their shared aspects.
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Rare Diseases and the Eye - Envisioning Strategies for Success
Live Webcast: Friday, October 27 at 11:00am EDT
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Rare disease trials differ from those in most other therapeutic areas because the indications are more complex and involve smaller patient populations. In a series of white papers, PRA experts discuss the barriers drug developers face when positioning a new trial in the rare disease space and how to minimize these while engaging with the right patients.
 Learn more |
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Future-proofing your Pharmacovigilance Delivery Model: Achieving scalability and cost effectiveness with AI/smart machines
Live Webinar: Wednesday, October 25 at 11:00am EDT
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Articles
Given the growing range of health-related, voice assistant applications, healthcare and life sciences organizations are increasingly starting to design a range of scenarios for deploying voice assistant platforms, such as Alexa, in the clinical trial setting. This articles looks at four potential-use cases.
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RBM Technology Impact on Clinical Roles: Centralized Monitoring is streamlining activities and changing roles across clinical development
Live Webinar: Wednesday, October 18 at 11:00am EDT
 Register now |
This article explores how to mitigate potential risk for in-home trials in regard to the clinical trial supply. Challenges include: improper medication storage and managing access to caregivers and patients only, and ensuring that medications are secure from unauthorized persons, including children and visitors.
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Clinical Trial Simulation: An Efficient Tool for Improved Study Designs, Dose Selection and Go/No-go Investment Decisions
On Demand
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Blog Posts
This year, the FDA released its Digital Health Innovation Action Plan its directives on ensuring high quality, safe and effective mHealth products, announced its alignment with Software as a Medical Device guidance, and publicized its decisions on the Digital Health Software Pre-certification Program.
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Proactive Planning, a Transformational Revolution to Improving Clinical Trial Quality?
On Demand
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The CFDA have considered measures to reduce the time to market, in order to ease drug shortages and meet the public demand for affordable medicines.
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Accelerate NASH Development: Next-generation Approaches to Overcome Recruitment and Study Execution Challenges
On Demand
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Oncology
Osaka International Cancer Institute and Parexel announced an alliance to advance clinical development in Japan. Their partnership will aim to drive greater efficiencies in support of patient recruitment for clinical trials in oncology and hematology, accelerating the development of innovative and effective new cancer treatments for patients.
The latest generation of oncology treatments is entering the market faster than ever before, owing much to the emergence of precision medicines and tumor immunotherapies. This shifting landscape poses complex challenges for sponsors as they design clinical trials. Proactive drug developers can adapt by building flexibility into their clinical trial protocols.
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This free on-demand webcast discusses the measurement of residual disease, as it relates to prediction of treatment outcome for leukemia, lymphoma, and myeloma. Although the value of minimal residual disease (MRD) measurement in oncology is well defined in clinical development, the best technical approach can be variable based on a number of factors.
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