Changes in Clinical Safety Reporting to the FDA
FDA has upgrade the Investigational New Drug (IND) safety reporting from paper eCTD format to E2B format, improving potential safety signals in clinical studies
Healthcare Resource Use and Costs in AML Patients Undergoing Stem Cell Transplantation
ISPOR EU 2019 WINNER - Best General Poster Research Presentations: Health Care Use and Costs in Acute Myeloid Leukaemia (AML) Patients Undergoing Stem Cell Transplantation.
Innovation in Oncology Drug Development
Significant progress has been made in our understanding of the molecular lesions responsible for tumor cells to exhibit uncontrolled growth.
Top Five Digital Technologies Set to Transform Pharma R&D
The current wave of emerging digital technologies offers an opportunity to significantly disrupt pharma business operating models in a variety of ways.
The Impact of Digital Technology on Patient Engagement in Clinical Trials
The use of digital technology in clinical trials is creating more convenient, engaging and innovative treatments for patients
Payers Report that ICER Analyses Increasingly Guide US Price Negotiations
According to a survey conducted by ICON in July 2019, prescription drug cost effectiveness analyses by the Institute for Clinical and Economic Review (ICER) are playing an increasingly important role in price negotiations.
Four Challenges to Successful Rare Disease Drug Development
Overcoming these challenges can greatly improve chances for a successful rare or orphan drug trial.
Harnessing Big Data: The raw material of digital transformation
The integration and mastery of digital technologies is becoming essential to improve the efficiency of clinical trial operations.
Challenges and Advances in NASH Clinical Trials
NASH is massively under-diagnosed, partly because it is a silent disease and partly because definitive diagnosis is by histopathology of a liver biopsy with associated risks.
MDR / IVDR Regulatory Roundup
Less than one year remains before the European Union’s new Medical Device Regulation (MDR) goes into effect on May 26, 2020, and only about a fourth of medical device companies plan to be fully complaint,
Value-Based Healthcare: Matching who benefits with who pays
The key to success in the medical device market is to ensure that value benefits align across stakeholders, especially with the payers.
Real-World Evidence Generated through Hybrid Studies
Hybrid CSS-MCR studies can be advantageous in generating real world evidence to answer epidemiology questions efficiently and effectively.
RWE and the Clinical Research Landscape
A new era is emerging in which clinical practice and clinical research inform one another through RWE.
Pharma ROI Restoration
Using Big Data and AI to return pharma productivity to sustainable levels.
The Rare Disease Revolution
Emerging research approaches and real-world evidence are fulfilling the needs of rare disease patients with increased speed.
Real World Evidence: The Evolving Views of Regulators and Payers
RWE is being used to provide a more comprehensive data set for regulators’ and payers’ use in approval and reimbursement decisions.
Can AI improve R&D productivity enough to restore ROI to sustainable levels?
According to an ICON survey, artificial intelligence (AI) was considered the digital technology with the most potential to improve R&D productivity
Key Considerations for Disease-Modifying Parkinson’s Disease Trials
Taking into consideration the lessons learned from Alzheimer’s disease studies could benefit the design of neuro-protective studies.
Oncology Clinical Trials in Asia Pacific
The size and significance of the APAC market make clinical trials, on the cutting edge of oncology development, an attractive investment.
Adoptive Cellular Transfer (ACT): Novel Cancer Trials Demand That Participating Sites Act Differently
Sites participating in ACT trials need to be prepared with regulatory intelligence, scalable logistics, adequate resources and dedicated data management teams.