During this session, the panelists discussed the role that SMOs and dedicated clinical trial sites (Site Platforms) play within the life sciences industry, what makes them attractive to investors, and the key criteria...more
On June 26, 2024, the US Food and Drug Administration (FDA) released its much-anticipated draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies....more
7/16/2024
/ Clinical Trials ,
Comment Period ,
Diversity ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Life Sciences ,
Patient Privacy Rights ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation
On April 15, 2024, the US Food & Drug Administration (FDA) announced the establishment of the Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI). C3TI will serve as the central support...more
YOUR SOURCE FOR SUCCESS IN PHARMA AND DEVICE SERVICES INVESTING -
Join C-suite executives, senior private equity professionals, investment bankers and other industry leaders for a deep dive into the investment...more
4/19/2024
/ Acquisitions ,
Biopharmaceutical ,
Biotechnology ,
C-Suite Executives ,
CEOs ,
Clinical Trials ,
Events ,
Health Care Providers ,
Health Technology ,
Innovation ,
Investment Banks ,
Investment Funds ,
Investment Opportunities ,
Investors ,
Med Tech ,
Medical Devices ,
Mergers ,
Pharmaceutical Industry ,
Private Equity ,
Private Equity Firms ,
Private Equity Funds ,
Regulatory Requirements ,
Research and Development ,
Supply Chain ,
Venture Capital
Hear from a global team on the crucial legal and regulatory topics investors need to know when buying or investing in Clinical Trial Site Management Organizations.
Investing in pharma services is complicated, but our team...more
Over the past few years, the life sciences and healthcare industries have experienced a notable increase in focus and interest in decentralized clinical trials (DCTs), in which some or all of the trial-related activities...more
The US Food and Drug Administration has issued draft guidance outlining the agency’s recommendations for using real-world data from (and curating such data in) registries to support regulatory decision-making. Pharmaceutical...more
Healthcare research has faced severe disruption during the COVID-19 public health emergency and underscored the need for novel technological solutions that harness and utilize data beyond traditional clinical research models....more
7/23/2020
/ Business Opportunities ,
Collaboration ,
Coronavirus/COVID-19 ,
Data Collection ,
Data Privacy ,
Digital Data ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medical Devices ,
Medical Research ,
Medical Technology Companies ,
Pharmaceutical Industry ,
Public Health ,
Real World Evidence ,
Research and Development ,
Webinars
In a highly anticipated and scrutinized decision, the Centers for Medicare & Medicaid Services (CMS) released a new public data set on April 30, 2015, that includes detailed data regarding the prescribing patterns of...more
On October 31, 2014, the Centers for Medicare & Medicaid Services (CMS) issued its final Medicare physician fee schedule rule for CY 2015 (the Final Rule), which also includes certain changes to the Sunshine Regulations. ...more
The U.S. Food and Drug Administration (FDA or the Agency) issued the June 6, 2014, draft guidance (Draft Guidance) in response to stakeholder inquiries into the Agency’s views on disseminating new scientific or medical...more
In a highly significant decision that may have far-reaching implications for the U.S. Food and Drug Administration’s (FDA) regulatory approach to off-label drug promotion, the U.S. Court of Appeals for the Second Circuit...more