July 24th 2020
While there's been hopeful news on treatments and vaccines, sponsors should plan to discuss necessary strategies and contingencies at the outset of new studies or re-opening of halted studies during the COVID-19 pandemic.
Rapid Study Startup: Streamlining Trial Site Activation
February 17th 2017The 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.
Achieving End-to-End Traceability Using Trace-XML
January 12th 2017Traceability 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.
The Future of Patient Engagement: Applying What We Know Now
January 6th 2017While 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.
Endpoint Adjudication of Events Charter Template: What Should Be Included?
December 13th 2016Endpoint 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.
Solutions Driving Efficiency in Clinical Trials
December 12th 2016The 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.
Transformative Directions in Oncology Clinical Trials
December 9th 2016Over 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.
Medical Photography: Limitless Applications
December 7th 2016The 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.
Could Gamification Improve Clinical Trials?
November 18th 2016Gamification 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 for Improving Investigational Sites and Oversight Performance
November 3rd 2016Centralized 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.
Rare Disease Research: It Pays to Engage
November 2nd 2016With 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.
Biosimilar Trials Differ Notably from Innovator Studies
November 1st 2016FDA 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.
Antidote Incorporates Patient Centricity in Subject Enrollment
October 26th 2016The 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.
Centralizing Your Clinical Trials Office
October 20th 2016Hospitals 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.
FDA RBM Guidance is Still Misinterpreted
October 11th 2016As 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.