ARTICLES BY DARSHAN KULKARNI

• Is Ignoring Gender Non-Conformity Research Holding Us Back?

  3/4/2024

  Including individuals across the gender spectrum in clinical trials isn't just the right thing to do, it's also strategic move with benefits for science, society, and business.

• Are Your Trials Compliant With The Updated Physician Payments Sunshine Act?

  12/7/2023

  Sponsors must proactively mitigate Sunshine Act compliance risks by conducting thorough internal audits, reevaluating policies and procedures, and ensuring all financial interactions with healthcare providers align with legal and ethical standards.

• Impact Of Research Misconduct Updates On Clinical Trial Sponsors

  10/31/2023

  The Office of Research Integrity (ORI) has proposed updates to the Public Health Service Policies on research misconduct. Darshan Kulkarni outlines how the new proposals should influence sponsors to reevaluate their existing clinical trial practices and policies.

• What Sponsor Companies Need To Know About The Updated DOJ Corporate Compliance Programs

  6/13/2023

  In March 2023, the criminal division of the U.S. Department of Justice (DOJ) updated its Evaluation of Corporate Compliance Programs document to serve as a guide for prosecutors in assessing the effectiveness of a company's compliance program.

• Reflecting On The Syneos Health Acquisition: The Due Diligence Imperative

  5/22/2023

  Syneos Health made headlines when it announced it may soon be acquired by a private equity consortium for approximately $7.1 billion. This transaction represents an exciting opportunity for both parties, but it also underscores the importance of thorough due diligence to ensure that the acquiring party maximizes value from the target entity.

• The Use Of Space Limited Social Media To Distribute Risk Information

  3/16/2015

  While there is a lack of specific guidance on sharing risk communications via social media, it may be possible to enhance the safety of biopharmaceuticals by using timely and measurable social media communications without violating FDA guidelines or regulations.