Patients of gastroesophageal reflux disease (GERD) that have been frequently diagnosed, or misdiagnosed, have been dissatisfied with the available treatment. To resolve this issue, industry players must define meaningful endpoints for future trials, incorporate patient reported outcomes, and apply biomarkers.
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.
Medidata and SHYFT Analytics have partnered with a goal of increasing access to healthcare data analytics in clinical trials.
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.
Cancer therapy has seen progress - not groundbreaking, but improving thanks to the scientific and technological tools at our disposal. This fall offers industry events and trial evaluations that aim to continue this progressive trend toward a breakthrough.
Cenduit announced the launch of new drug management modules for its interactive response technology (IRT) system.
The director general leaves his position at the European Federation of Pharmaceutical Industries and Associations (EFPIA) after five years to pursue “a fresh challenge.”
Just because information can be gathered and shared more quickly among stakeholders does not mean that it can identify risk. This article describes the need for pharma to adopt fully-vetted, standardized operational-level time, cost and quality performance metrics as tools for tracking and predicting performance.
Japanese CRO CMIC HOLDINGS has chosen goBalto’s Activate solution to further its clinical study startup process throughout Asia.
Gastroparesis patients face a series of symptoms for which there is currently a significant void in treatment. With complications and questions aplenty, answers are in high demand as physicians search for suitable medicines to combat this disease.
Conducting observational studies is becoming a vital part of the clinical trial process, but research teams often struggle to operationalize these more creative and non-traditional study methodologies.
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.
Boehringer Ingelheim and the Duke Clinical Research Institute (DCRI) announce the expansion of the Idiopathic Pulmonary Fibrosis – PROspective Outcomes (IPF-PRO) Registry.
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.
SCRS announces Site Scholarships sponsored by Total Clinical Trial Management (TCTM).
Delve Health announces the release of Study Pal, a platform that aims to replace paper processes by configuring study information through its mobile application.
This Best Practice in Patient Recruitment report displays what percentages of patients are recruited from and where.
Biomedical Systems announces a partnership with Chicago based digital health company Foundry Health.
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.
Eosinophilic esophagitis (EoE) is a rare esophageal condition that currently has no FDA-approved medications resulting in major gaps in treatment. Therefore, the need for better options and opportunities for drug development is apparent.
The way the Open Payments system is couching investigator transactions is questionable and confusing.
Bioclinica has signed an agreement to be acquired by international private equity firm Cinven.