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.
Fundamental Changes Required to Realize Benefits of CRAACO
April 8th 2019The recent industry-wide focus on widened access to health care, patient-centric approaches, and high-quality care have increased the interest in the concept of clinical research as a care option, Customer Project Manager of Trialbee, Hannah Van de Meek writes.
Managing Clinical Trial Complexity as Gene Therapy Progresses
March 28th 2019The history of gene medicine is filled with hope, tragedy, and successes. VP of Rare Diseases & Pediatrics for Premier Research, Angi Robinson, writes how patient well-being must always prevail, and challenges mustn’t stop us from helping solve unmet medical needs.
A New Approach to Temperature Monitoring in a Changing Clinical Supply Chain Environment
Examining the implications of shipping temperature-sensitive clinical supplies in an evolving clinical supply chain, including shipments direct to patient homes (DTP) and the need for temperature monitoring thereof.
The Turning Point for Clinical Research: Global Data Standardization
Clinical research is only as effective as its ability to have an impact on health.
Determining if Data from Electronic Health Record Systems Can Be Trusted in a Clinical Trial Setting
Electronic Health Record (EHR) systems are being used increasingly by clinical investigative sites.
Optimizing Study Design in Real-World Evidence Generation: Rely on Input from a Specialist
December 13th 2018Real-world evidence (RWE) is needed in addition to clinical trial data to understand drug effectiveness in a real-life setting and to profile patient populations in terms of their clinical characteristics and drug utilization.
Want to Ensure Trial Success? Effective Management of Internal Team Calls may be a Key
December 6th 2018It is important to devote quality time to challenge yourself and your teams on whether there is a need to strategize and rethink the way you are conducting teleconferences for your clinical trials.
Multiple Expansion Cohort Clinical Trials: A Shorter Path to Success for Oncology Drugs
November 27th 2018The rapid rise of targeted drugs and biologics in oncology has spurred sponsors and the FDA to innovate, leading to the creation of a variation to the typical trial design that can include multiple expansion cohorts.
Trends in Global Public and Patient Perceptions of Clinical Research
November 1st 2018To inform our understanding of public and patient trust and confidence, this article provides a high-level summary of the results of two studies monitoring trends in international public and patient attitudes and perceptions.