Online Extras

Clinical research in China has shown potential as many biopharma companies look to enter the market, though the infrastructure is lacking. Peter Schiemann, PhD conveys his perspectives on the challenges that sponsors are facing in China.

The need for biopharma to demonstrate the value of medical products is changing trial design in order to generate real world data. Dr. Catherine Bonuccelli of GSK discusses the Salford Lung Study, its patient-centric design and how it differs from randomized clinical trials.

The use and awareness of risk-based monitoring is now impacting clinical trials of all sizes, indications and types as a core component more than ever before. Sponsors and sites are expected to expand its use to include all phases of clinical research and all therapeutics areas.

Clinical trials endure high drop out rates due in part to long schedules, high travel costs and long reimbursement times. Outsourcing specialized clinical trial traveling services can help alleviate this concern by allowing sponsors to efficiently manage travel and other expenses.

Pharma has been transitioning from its paper based methods of the past toward automated cloud based systems in order to offset the cost of drug development. The emphasis is now shifting toward improved study startup processes for shorter clinical trial timelines.

Large clinical research enterprises have the resources to establish high standard clinical trial Quality Management Systems, while smaller enterprises may not have the means to do so. This article covers how clinical research enterprises can leverage technologies to develop an efficient clinical trial QMS.

A key success factor for lean models is the possession of technology that can measure performance and manage risk in a well-organized and user-friendly manner. This article describes the results of an investigation to identify and describe the basic requirements for such technology solutions.

Updated employee announcements, business news and recognition in the industry today.

Investment in mHealth and the adoption of wearables are significant initiatives that are changing the clinical trial process toward a more patient centered approach. These wearable technology initiatives have the potential to be the most innovative advances in drug development.

One year ago, the China Food and Drug Administration (CDFA) was pushed to accelerate its activities to promote new or updated regulations and guidelines. Since then the results have been smoother processes for innovative drug development in China.

TransCelerates work on their clinical trial Quality Management Systems (QMS) initiative began about one year ago. This article summarizes findings from a recent DIA publication about the initiative and evaluates potential issues during QMS framework implementation.

Following the UK’s decision to leave the European Union, the result has been uncertainty and speculation as pharma attempts to understand its implications. How this change will effect the pharma and life sciences industry as well as the European community remains to be seen.

Studies in Hepatic and Renal Impaired special populations have almost always required drugs with systematic absorption resulting in unclear conclusions. A solution for this would be a study design based on pharmokinetic properties that incorporates principles of Hepatic and Renal Impaired pathologies.

The Cancer Moonshot 2020 Initiative has been a long time coming for the team working to develop the program’s infrastructure and logistics. Following years of planning the result has been an increased response in the belief that a vaccine-based immunotherapy to battle cancer will be available by 2020.

TransCelerate’s Site Qualification and Training Initiative has launched a special project aimed at improving Electronic Data Capture system efficiencies between sponsors and sites. Adam Colley of Merck explains the improvements that this initiative will provide for training providers and sites.

Updated employee announcements, business news and recognition in the industry today.

With the ever-present gap in ability to recruit patients into clinical trials, emerging solutions take different tactics to find the right patients and enroll them quickly.

With the healthcare industry’s transition from paper to digital, verification is changing beyond that of a signature in ink. Electronic signatures are a new medium in clinical trials that the industry is now turning to in this transition to digital.

While the clinical trials industry is currently examining mHealth technology pilots, the healthcare industry has developed them to the point of full deployment. Mon Weschler of Montefiore elaborates on his experiences successfully piloting and deploying these technologies.

The selection of study endpoints is one of many risks that a clinical research study can face. An independent review can help avert this by identifying potential issues within clinical trial data early in the study and allowing the study team to monitor, intervene and reduce study risks.

TransCelerate has launched 11 informational programs through its Site Qualification and Training (SQT) initiative to improve understanding of clinical operations for new site personnel. Katarina Hugeneck of Eli Lilly and Theresa Stewart of Allergan discuss the SQT initiate with Moe Alsumidaie.

The Avoca Group’s Quality Consortium’s fifth annual Summit took place in May and June of this year bringing together over 250 attendees from 50 companies. This years event brought out unifying themes around innovation and patient centricity.

In the shifting landscape of product development, the pharma and biotech arenas increasingly emphasize the need to use less internal R&D resources, increase efficiency, and reduce costs. One product development strategy is the utilization of lean outsourcing models for clinical studies.

The drug development process has been seen as inefficient and disappointing by those in the R&D space. Model and Simulation provides a potential relief to these issues by delivering significant business, scientific and clinical value to drug developers.

To provide more targeted training and validate understanding to employees, it is important to establish baseline knowledge. This case study explores how Chiltern developed its Medical Device Body of Knowledge training program.

Updated employee announcements, business news and recognition in the industry today.

OmniComm’s Keith Howells speaks to ACT about whether electronic data capture (EDC) can be considered innovative in today's pharma.

Virtual clinical trials use tech devices and social engagement platforms to conduct trials from a patient’s home. These electronic processes offer new opportunities for a patient-centric approach to clinical research.

With North America and Europe accounting for the majority of active clinical trial sites in 2016, the need for globalization is increasing. Brazil, Russia, India and China are emerging markets with potential, but not without challenges.

Respiratory disease trials are difficult to initiate, both in terms of patient recruitment and accurately collecting data. Alternative methods are required to improve outcomes and develop new treatments for respiratory diseases.