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The redundancy of process and documentation for activating trial sites has been an issue in the past as it can lead to delays in trial initiation. Rapid study startup can illuminate these inefficiencies by removing or reducing non-value tasks.

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

Predictive modeling has allowed biopharma companies the opportunity to solve inaccurate, inefficient and misinformed site selection practices by leveraging big data.

Clinical technologies have the ability to streamline the daily processes of site staff and insure a more efficient clinical trial.

The adoption of M&S to the pharma industry has been slow, but more noticeable in recent years as these practices have improved the efficiency of drug development processes.

When designing and using an electronic informed consent form, there are many factors that should be considered when applying to clinical research.

With the new regulatory guidelines concerning GCP, questions have arisen as to how best RBM plans can comply. These questions and answers will assist sponsors in assuring compliance.

While wearable devices are mainly an advantageous way to collect data from monitoring a trial participant’s progress, there are scientific and operational considerations to be aware of.

The Expert Determination standard of protecting patient privacy can answer the growing demand for better data for research and analytics in healthcare.

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

New technologies have accelerated the speed and effectiveness of clinical research and trials. This convergence is making it possible for new innovations and possibilities to bring groundbreaking treatment options to patients.

Traceability plays a crucial role in ensuring the integrity of source data and in reinforcing clinical research results. CDISC has developed Trace-XML as an extension of its Define-XML model for delivering clinical data lifestyle traceability from data collection through to final analysis.

While patient centricity has been a newfound goal of the pharma industry, many would argue that adopting this philosophy has been more talk than action thus far. eClinicalHealth conducted a case study to learn what patient engagement means to industry professionals.

A patient-centered study design can improve the trial experience by engaging directly with patients. QuintilesIMS recently completed a case study that supported this concept and showed value toward patient recruitment.

As business grows with the addition of more CROs, questions have arisen from sponsors about how to conduct effective CRO oversight. A survey of clinical leaders provides insights to help address key challenges and regulations more quickly and effectively.

Endpoint adjudication is gaining importance in pharma today, however, no guidance on endpoint adjudication currently exists. The LinkedIn Endpoint Adjudication Community has generated an Events Charter Template to shed light on the subject for those in need of guidance.

The advancement of technology has allowed for new solutions to become available in all areas of clinical trials. Patient Recruitment Systems are no exception as they can be used to improve the trial process by optimizing protocols, selecting high potential sites and enabling more studies.

Over the last decade, many initiatives sponsored by various entities, including academic and clinical research centers have focused on efforts to streamline clinical trial eligibility and data collection. Oncology trial design is no exception as endpoints and eligibility criteria have also changed with the value of the data generated in early phase studies.

The range of imaging modalities available for the enhancement of clinical trial endpoint data is as broad as the range of treatment methods available. Whether in the laboratory, clinical or real-world environment, medical photography can be tailored to document working practices and record both subjective and objective efficacy data.

A new SaaS platform for clinical trials, soon available to all pharma companies, aims to automate clinical supply, improve patient compliance and enable better medication adherence.

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

Vendor oversight in clinical trials is a subject not often discussed despite a disconnect in how it is carried out between multiple departments. Celeste Gonzalez of Boston Scientific shares her perspectives on the subject.

Gamification is the application of game design principles and techniques to non-game contexts intending to create value for players and stakeholders alike. If applied, this principle can potentially drive greater innovation and efficiencies in clinical research.

Centralized monitoring is a suitable way in which sites can identify and control investigational risks while improving performance. This new approach can not only help sponsors to monitor site performance, but also facilitate proper oversight resulting in good ROI.

With pursuits in rare and orphan disease beginning to move more into the drug development mainstream, the opportunities and challenges in patient engagement and trial execution for these conditions are ever-evolving, as one strategy expert in the field discusses.

FDA officials agree that large comparative clinical trials defeat the purpose of the abbreviated development program for biosimilars. Clinical testing is expected to gain market approval for most biosimilars, while emphasizing significant differences in developing biosimilars and innovator therapies.

The FDA’s launch of patient centric initiatives has led the industry to gear towards incorporating the patient’s voice in medical product development. Tom Krohn of Antidote discusses his company’s patient centered approach towards clinical trial matching by focusing on the patient.

Hospitals and health systems are making significant changes to their research operations in conjunction with the increasing complexities of clinical research. Adopting a centralized clinical trials office (CTO) can greatly assist in managing these changes.

As biopharma companies continue to explore and experience ways in which risk-based monitoring is implemented, the process of such can be misconstrued. Peter Schiemann elaborates on some of the current issues of RBM interpretation and implementation.

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