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Adam Amdur of the Sleep Apnea Association speaks with Moe Alsumidaie about his company’s SleepHealth mobile app study and the impact of mHealth in clinical trials.

To ensure success of clinical trials, biopharmaceutical companies must explore leveraging a variety of channels to prepare investigators. Such a process has the potential to save money and provide effective training for future trials.

Catch up on the latest business and people news in the industry today.

This article examines the requirements for developing an effective Clinical Trial Protocol, observing that it takes time, commitment, and a full team effort to produce protocols of an acceptable standard.

Generic drug repurposing can often create medical solutions regardless of the supporting entity. “Unsolved” diseases can benefit from this strategy despite commercialization challenges.

While launching a new clinical study is an exciting stage of product development for trial personnel, road blocks can emerge. A new approach is needed to cope with the volume of activates required for the study product registration.

If an FDA investigation results in a Form 483 then it is important to prove that earlier issues have been resolved upon re-inspection. The following steps using your Corrective and Preventive Action (CAPA) program are crucial to appropriately handling and responding to an FDA Form 483 in helping avoid a Warning Letter.

Identifying Key Risk Indicators (KRIs) is an important step in successfully applying risk-based monitoring initiatives to a clinical trial. These factors, within risk management, assist by defining risk areas in order to measure and monitor them centrally throughout the trial.

A key function in clinical trials, patient enrollment, has fallen behind during a time where technology has played a vital role in the industry. Adaptive patient recruitment allows for clinical data to be collected and reviewed in real-time as to improve enrollment outcomes as they are taking place.

Despite challenges in the pharma sector, we are experiencing a technological shift in the way clinical research data is obtained from patients. New devices have allowed for the collection, reporting and response to data from a patient’s body using sensor technology.

Updated employee announcements, business awards and recognition, and company news.

The CRO Forum has been asked by TransCelerate to collaborate on reviewing its initiatives. Alan Metz, Forum Chair, and Amy Kissam, Forum Vice-Chair, sit down with Moe Alsumidaie to elaborate on the CRO’s involvement.

The biopharmaceutical industry is starting to adopt TransCelerate’s Risk Assessment Categorization Tool (RACT) in order to identify risks and plan a comprehensive clinical trial risk mitigation strategy. We recently wrote about the RACT moving to the cloud, and the advantages of using such systems. Some of these advantages include the ability for study teams to evaluate R&D portfolio risks by collecting and analyzing RACT data in aggregate.

Major Depressive Disorder patients display a reduced ability to feel pleasant experiences known as Anhedonia. Such a feature provides difficulties when treating depression and engaging patients during clinical trials.

The success of a clinical trial depends on the sponsor’s ability to effectively execute its programs. Both quality of research and aptitude to complete the study on time determine the likelihood of advancement of a product to the next stage of development.

Orphan medicines have become a formidable R&D segment with robust growth that is expected to continue. Expansion is needed to cope with the issues of development and patient recruitment. An understanding of regulations, therefore, is critical.

Solutions to overcoming the most frequent missteps when collecting valuable spirometry data in respiratory studies.

The impact of the Fourth Industrial Revolution is evident in our everyday lives and healthcare and pharmaceutical industries are no exception and perhaps provide one of the biggest opportunities for a positive impact.

The dilemma facing clinical operations executives when selecting a CTMS solution to manage clinical trials is to go with an existing approach/solution or explore alternative options.

A summary of professional moves in the clinical trials industry, as well as business news and recognition announcements.

Six TransCelerate Member Companies formed BioCelerate, a subsidiary to focus on identifying innovative solutions for operational challenges in the preclinical space.

Changes to cardiac safety assessments could equal more drugs in the pipeline and cost savings to sponsors.

People

With all the buzz around wearables, actigraphs-which monitor sleep and daytime activity levels-have been around for decades.

This case study describes how innovative structural design at a study site is leveraging innovative telehealth technologies and nursing home infrastructures to recruit and retain Alzheimer’s patients.

The latest people and business news includes ACRO appointments and awards for CROs and service providers.

Considerations should be made in regard to social media and clinical trials. Public use and disclosure of an invention before filing for a patent can invalidate the claims and locating evidence to demonstrate public use of an invention can be challenging, particularly if the use is not commercial or publicized.

This case study examines using centralized manual data review with statistical approaches to compare value and fit.

For organizations looking to increase transparency in the study startup process, the sheer volume of data and the silos in which they exist can be a daunting hurdle. New generation systems enable teams to capture, analyze, share, and visualize study startup data in one system.

The information in this article serves as a good start by providing factors to keep in mind if your organization is considering adopting ePRO. Appropriateness of ePRO often varies by study and is evaluated individually. As the research landscape continues to shift, being prepared will help ensure a successful IRB review of your study and facilitate a smoother research process overall.