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FDA has upgrade the Investigational New Drug (IND) safety reporting from paper eCTD format to E2B format, improving potential safety signals in clinical studies

ISPOR EU 2019 WINNER - Best General Poster Research Presentations: Health Care Use and Costs in Acute Myeloid Leukaemia (AML) Patients Undergoing Stem Cell Transplantation.

Significant progress has been made in our understanding of the molecular lesions responsible for tumor cells to exhibit uncontrolled growth.

The current wave of emerging digital technologies offers an opportunity to significantly disrupt pharma business operating models in a variety of ways.

The use of digital technology in clinical trials is creating more convenient, engaging and innovative treatments for patients

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.

Overcoming these challenges can greatly improve chances for a successful rare or orphan drug trial.

The integration and mastery of digital technologies is becoming essential to improve the efficiency of clinical trial operations.

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.

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,

The key to success in the medical device market is to ensure that value benefits align across stakeholders, especially with the payers.

Hybrid CSS-MCR studies can be advantageous in generating real world evidence to answer epidemiology questions efficiently and effectively.

A new era is emerging in which clinical practice and clinical research inform one another through RWE.

Using Big Data and AI to return pharma productivity to sustainable levels.

Emerging research approaches and real-world evidence are fulfilling the needs of rare disease patients with increased speed.

RWE is being used to provide a more comprehensive data set for regulators’ and payers’ use in approval and reimbursement decisions.

According to an ICON survey, artificial intelligence (AI) was considered the digital technology with the most potential to improve R&D productivity

Taking into consideration the lessons learned from Alzheimer’s disease studies could benefit the design of neuro-protective studies.

The size and significance of the APAC market make clinical trials, on the cutting edge of oncology development, an attractive investment.

Sites participating in ACT trials need to be prepared with regulatory intelligence, scalable logistics, adequate resources and dedicated data management teams.