Resources
Events

MAGI's Clinical Research Conference - 2019 East Program

May 7, 2019

On Tuesday, May 7, health care and life sciences attorney Marylana Saadeh Helou will be presenting at MAGI's Clinical Research Conference - 2019 East Program with Susan Kravitz, Clinical Contracts Manager at Thomas Jefferson University. The two will present on "CTAs for Investigator-Initiated Trials" that will describe differences in CTAs for IIT and regular industry-sponsored trials and negotiate IIT CTAs.

Firm Highlights

Matter

Informed Consent Form Templates

Developed 23 different types of global research informed consent templates for a major pharmaceutical company along with detailed negotiation guidelines for compliance with applicable laws and best practices.

Matter

Conflicts of Interest

Reviewed medical center's systems, policies and procedures for identifying, assessing, and managing investigator and institutional conflicts of interest.

News

61 Verrill Attorneys Honored as Best Lawyers, 12 as Lawyers of the Year

(September 3, 2019) – More than 60 Verrill attorneys were once again recognized as "Best Lawyers" by Best Lawyers® 2020 . In addition, 12 attorneys from the firm were named "Lawyer of the Year,"...

Publication/Podcast

CMS Cracking Down on Health Care Fraud and Abuse

To increase provider and supplier transparency and accountability, the Centers for Medicare & Medicaid Services (CMS) recently issued a final rule (Final Rule) with comment period that allows CMS greater ability to prevent fraud...

Publication/Podcast

Massachusetts Budget Update: Commonwealth Now Waiting on Governor Baker

On July 22, 2019, the Massachusetts House of Representatives ("House") and Senate Conference Committee ("Conference Committee") released the Commonwealth's $43.1 billion fiscal year 2020 budget bill (" H. 4000 "). It passed the House...

Matter

Research Non-Compliance Investigations

Assisted various hospital systems and research institutes with the investigation of alleged non-compliance with applicable U.S. Department of Health and Human Services (HHS) and U.S. Department of Food and Drug Administration (FDA) regulations in...

Matter

European Union GDPR—Institution

Counseled a preeminent health system and academic medical center on its compliance with the European Union General Data Protection Regulation (GDPR) in relation to its clinical and research activities, including its international research studies...

Publication/Podcast

Keep Medicare Enrollment Information Correct and Current or Suffer Consequences

While most providers understand the need to bill Medicare correctly, many often fail to recognize the potentially disastrous results of not keeping Medicare informed of your correct and up-to-date practice information . A recent...

Publication/Podcast

Massachusetts Final Budget: How the Act Will Affect Pharmaceutical Companies

On July 31, 2019, Governor Charlie Baker signed a $43.3 billion fiscal year 2020 budget (" General Appropriations Act "). Originating from the Conference Committee's budget, the General Appropriations Act accounts for any vetoes...

Publication/Podcast

BORIM Issues Guidance on Recent Changes to Practice of Medicine Regulations

The Massachusetts Board of Registration in Medicine ("BORIM") recently finalized revisions to 243 CMR 2.00 (Licensure and the Practice of Medicine). These changes took effect on August 9, 2019. Because of the uncertainty resulting...