Online Extras

Executive moves abound in the CRO world this month; plus a list of the 2015 RAPS Fellows.

Without question, advanced cellular and gene therapies require well-defined cold-chain management solutions that reduce risk and include all elements of packaging, data collection and logistics expertise to ensure high-quality, effective treatments reach the point of care, and ultimately, the patient.

Accruing patients depends greatly on engaged, enthusiastic PIs, as they are the gatekeepers in helping patients decide to participate in clinical trials. Building staff awareness and enthusiasm are also essential for retaining participants.

Japan is increasingly a region where opportunities for global registration studies abound, supported by government policies as well as the medical community and its local population. However, incorporating Japan as an integral part of your global trial execution strategy does not come without its unique challenges.

The findings of analyzed data on clinical trial agreements (CTAs) stored in an online negotiation tool through which sponsors and investigators submit offers and counteroffers on clinical grant costs are shared in this article.

In this article, you will find a structured summary and critical review of the new addendum, and as well as ideas on how to prepare for these regulatory changes.

Although the devil will be in the detail of the final compromise text of the General Data Protection Regulation (GDPR), we have highlighted below how a few of the proposed changes could potentially impact the pharmaceutical industry.

Real-world evidence (RWE) research is an increasingly important component of biopharmaceutical product development and commercialization. The growing industry need for broader information on real-world effectiveness and safety-both of which will impact the eventual reimbursement and utilization of new products-is driven by regulators, public and private payers, and prescribers, all of whom seek to better understand the impact of a new product in a real-world setting. The result is that real-world evidence is now included earlier in the research and development phase.

The topic of patient centricity remains very active in the clinical trials industry, as the concept continues to emerge and evolve.  The purpose of this Patient Centered Clinical Trials facilitated by our friends at eyeforpharma virtual roundtable is to (a) better understand the definition of patient centricity, (b) uncover challenges associated with industry wide patient centered technology adoption and (c) how patient centricity/engagement technologies will push the biopharmaceutical industry to c

Mobile strategies bring near-endless possibilities to engage with patients in clinical trials.

TransCelerate's Quality Management System (QMS) Initiative delineates specific mechanics that will be used to build a QMS Conceptual Framework to facilitate and encourage proactive approaches towards executing Good Clinical Practices, and proper change management expected to support a culture of quality.

Considerations for Using a Mobile Medical App as an Investigational Device

IBM and ICON plc recently announced a collaboration to use the Watson system to enhance oncology clinical trial feasibility, recruitment and start up via Trial Matching.

Much of the growth that has taken place in the top tier of CROs in recent years has been in the acquisition of some of the smaller, more innovative companies, rather than an increase in the number of compounds under study.

New faces among the Pharma Industry rise the ranks.

The world of RBM is continually changing as biopharmaceutical enterprises are dabbling into different approaches and methods. There are several outsourced models that exist, when approaching RBM, such as integrating cloud-based solutions to provide centralized monitoring teams with analytics, or fully outsourcing RBM functions and technologies to CROs.  However, some companies, such as Novartis, appear to be in-sourcing their RBM technologies and functions. 

Across the pharmaceutical industry, advances in digital technology play a key role in driving the efficiency of the drug development process, particularly for clinical trials.

 The Top 5 Risk-Based Monitoring Articles 

Clinical trials are time sensitive, costly endeavors with high-risk and high-expectations at every juncture.

New faces among the Pharma Industry rise the ranks.

Demand for outsourced services to provide clinical development capacity and expertise has grown substantially over the last 10 years.

Promising new approaches to optimize data and outcomes.

Over the past three decades, clinical imaging has become an integral part of the drug development process for biopharmaceutical companies.

While the fundamental concerns behind the design of most modern clinical trials are effectively the same, clinical trials that take place during public health emergencies face additional layers of challenges.

 This following list comprises all of our most popular Tweets from 2015. Find out what made the cut and read more about trending topics regarding Clinical Trials.Follow @Clin_Trials for more information!   

The aforementioned article emphasized that a reduction in data quality ultimately leads to enrolling more clinical trial subjects in order to maintain equivalent statistical power.

The need for more efficient clinical trials is driving greater use of cloud-based solutions, especially with the rise in globalization

In this analysis, distinctions between who hires who in non-Chinese and China-based companies emerges.

EDC has become the data management platform of choice around the world, offering advantages such as increasing the quality and timely collection of data. Medrio, an EDC company that offers eClinical software solutions, has quoted that 70% of clinical trials are using EDC as a forms of collecting data in the United States. In China, we have seen adoption rates for EDC increase dramatically in recent years, fuelled by improved technology developments in mobile applications, and the increasing experience with EDC usage in clinical research.