Launching a clinical trial site is an exciting opportunity, but it comes with important legal, regulatory, and operational challenges.

Darshan Kulkarni Says:
Starting a clinical trial site is an exciting step, but it requires careful planning to address key legal and regulatory considerations. Privacy compliance is a major factor—going beyond HIPAA to account for email and text marketing laws, state-specific business registrations, and corporate structures like MSOs to manage ownership rules. It’s also crucial to consider the corporate practice of medicine doctrine, which may require physician-owned entities in certain states. Lastly, marketing strategies must comply with privacy laws, especially when using global resources, to avoid GDPR and HIPAA violations. Proper planning upfront can help prevent costly legal and operational missteps.

Edye Edens Says:
Before diving into clinical research, focus on market fit and funding. Many businesses fail not because of a poor product but due to inadequate financial planning and infrastructure to support growth. Similarly, clinical trials often fail due to challenges in patient recruitment. Entrepreneurs should assess whether they have the resources, funding, and bandwidth to build and sustain the business. Compliance should be considered as part of this analysis, especially as more complex operations demand more robust compliance programs. Once the initial groundwork is laid, businesses can move forward with logistics and infrastructure planning for long-term success.

Nidhi Kulkarni Says:
Expanding clinical trial sites overseas introduces additional steps and challenges. Start with a feasibility study to assess patient demographics and available resources, then register the site with local regulatory authorities and obtain approvals. Build infrastructure by establishing legal business entities, opening local bank accounts, and partnering with labs, pharmacies, and vendors. Finally, focus on data privacy compliance—whether under India’s Digital Personal Data Protection Act, Europe’s GDPR, or the U.S.’s HIPAA. Develop clear standard operating procedures to manage audits, inspections, and recordkeeping effectively. Taking these steps can help ensure smooth operations and regulatory compliance from the outset.

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Darshan reacts to a fake interaction between a drug sales representative and a doctor. He shares insights on pharmaceutical marketing tactics, highlighting that while doctors often find sales reps personable, they may not trust them as much as medical science liaisons (MSLs) due to limitations on what reps can legally discuss about drugs. Darshan explains industry regulations, such as the Pharma Code and the Sunshine Act, which restrict certain gifts to avoid conflicts of interest. He also critiques exaggerated claims by reps, such as new drugs having unprecedented benefits without comparative studies, stressing that the FDA requires rigorous evidence.

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Pharmaceutical companies, like Pfizer, are venturing into digital healthcare platforms, raising questions about competition with traditional pharmacies. Pfizer recently announced its initiative, "Pfizer for All," a digital platform that offers services such as vaccine scheduling and potential savings on medications, possibly bypassing pharmacy benefit managers (PBMs). This platform supports patients with private and government insurance, but there are concerns about how it addresses those without insurance.

The platform also enables same-day telehealth appointments with independent providers, which may raise regulatory concerns, particularly around kickbacks, given the scrutiny telehealth has faced from authorities like the DOJ and FDA. Pharmacists are encouraged to consider how this could impact their practice and whether patients might prefer these new options. The dialogue continues about the potential shift in pharmacy dynamics as digital platforms gain traction.

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