August 13th 2020
A compilation of recent notable news developments that pertain to the clinical trials industry.
Preparing Specialty Lab Data for FDA Submission in the New Regulatory Environment
March 12th 2018Biomarker and specialty lab data are increasingly being incorporated in FDA submissions given the robust insights they provide on key clinical objectives, including pharmacological effects, and drug safety and effectiveness.
Sponsors Ask: Is Our Trial Plan Realistic? Toward a Data-Driven Feasibility Assessment
December 21st 2017Today, a data-driven approach to feasibility assessment can help ensure that a sponsor’s clinical research plan is designed to enroll the right patients, rely on the right investigators, and take place in the right countries for success.
Beyond RBM: How Intelligent Analytics are Being Used to Drive Value and Support ICH Compliance
November 3rd 2017Steve Young looks at the tremendous benefits that organizations stand to reap by effectively implementing the core principles included in the ICH update and the significant opportunities that the application of intelligent analytics and centralized statistical monitoring may present.
The Risk Based Monitoring Plan
October 30th 2017Sponsors and CROs are looking into implementation of a Risk Based Monitoring approach to their clinical trials to achieve the objectives related to enhanced data quality, better monitoring of patient safety, and creating efficiencies in overall operations.
Aligning Data Entry and Site Payment Incentives For Clinical Trials and Patients
September 28th 2017With recent reports indicating that organizations do not have a way of tracking and managing the timeliness of data entry or of site payments, The Metrics Champion Consortium wanted to see if there were opportunities to align incentives in the industry so that both sites and sponsors can achieve their goals with positive impact on clinical trials and patients.
How Voice Recognition Technologies Can Be Used to Accelerate Patient Trials
September 27th 2017Because of the growing rate of voice assistant applications, such as Alexa, healthcare and life sciences organizations are beginning to design a range of scenarios for deploying these voice assistant platforms in the clinical trial setting.
Meeting the Clinical Supply Challenge with IRT
September 14th 2017Managing clinical trial supply is not easy for the pharmaceutical industry between drug overages and right medical distribution. However, this is an important topic for sponsors to consider because the right strategy can help save money and reduce unnecessary spending.