This guideline, which ensures regulatory compliance with the requirements of ICH GCP E6, came into effect on 9 September 2023. It introduced a new consolidated framework of standards for computerised systems and electronic data in clinical trials. It is a unique guideline in its thoroughness and extent on the matter. OSP…
This expansion of Thermo Fisher’s clinical trial network in Europe will help foster global clinical trial innovation and provide biorepository storage solutions. Thermo Fisher Scientific Inc., a global leader in serving science, has launched this cutting-edge facility to support pharma and biopharma customers with tailored, end-to-end solutions throughout the clinical…
This new medication, approved by the US FDA in October 2023, combines 1,000 mg of acetaminophen and 300 mg of ibuprofen to address mild to severe pain in adults. The introduction of Combogesic IV offers healthcare providers in the US an innovative and non-opioid option for pain management. The American…
Spectrum supports study teams by providing real-time predictions and control over trial timelines and costs, ensuring successful trials in today’s complex landscape. Clinical trials today are more intricate than ever. Late-phase studies now collect over 3.5 million data points, triple the amount from a decade ago, and must juggle an…
This key study explores the influence of CYP2C9 genetic polymorphisms on the pharmacokinetics (PK) of delta-9-tetrahydrocannabinol (THC) and its active metabolites in Alzheimer’s disease (AD) patients. Titled ‘A study on CYP2C9 polymorphism, in Puerto Rican Alzheimer’s patients and its role in the Pharmacokinetics of ∆-9-tetrahydrocannabinol,’ it is accessible at the…
This key study explores the influence of CYP2C9 genetic polymorphisms on the pharmacokinetics (PK) of delta-9-tetrahydrocannabinol (THC) and its active metabolites in Alzheimer’s disease (AD) patients. Titled ‘A study on CYP2C9 polymorphism, in Puerto Rican Alzheimer’s patients and its role in the Pharmacokinetics of ∆-9-tetrahydrocannabinol,’ it is accessible at the…
However, the eCOA/ePRO market has seen minimal innovation since the transition from paper-based forms to digital formats two decades ago, leaving a gap in meeting the escalating demand for improved patient reported outcomes driven by heightened regulatory requirements. Speaking on the pressing need for industry-wide transformation, Steve Rosenberg, CEO of…
However, the eCOA/ePRO market has seen minimal innovation since the transition from paper-based forms to digital formats two decades ago, leaving a gap in meeting the escalating demand for improved patient reported outcomes driven by heightened regulatory requirements. Speaking on the pressing need for industry-wide transformation, Steve Rosenberg, CEO of…
Promising to redefine the landscape with its latest solutions, the company hopes to take center stage, offering advancements in data management and patient engagement. Join us for an exclusive preview of how Qinesca is poised to win over the industry and why this unveiling is the must-see event of the…
John Romano, president, and co-founder, shares exclusive insights into how these innovations are set to tackle industry challenges and enhance patient outcomes. Can you share any new products or services your company is unveiling at this year’s DIA? The Gifthealth team continues to innovate and develop tools to improve the…