Pharma is finally catching up to the on-demand world—offering direct-to-patient (DTP) services that promise convenience, faster delivery, and a more personalized experience. Major players like Pfizer, Lilly, and Novo Nordisk are leading the way, cutting out intermediaries like pharmacists, PBMs, and even traditional physicians.

But convenience comes at a cost.

By removing these safeguards, companies take on massive compliance liabilities. Telehealth prescribing raises serious questions around physician independence and anti-kickback regulations. Fulfillment introduces risks tied to product integrity, recalls, and data privacy. Even cash-based payments can trigger transparency violations and pricing scrutiny.

The risks are real: HIPAA breaches, malpractice claims, and federal investigations can derail even the most well-meaning DTP strategies. That’s why pharmaceutical companies must treat compliance as foundational—not an afterthought.

The path forward? Define clear boundaries between pharma, prescribers, and delivery partners. Invest in internal audits. Build scenario-based risk plans. And most importantly, bring legal and compliance professionals to the table from day one.

At Kulkarni Law Firm, we specialize in helping pharma companies innovate without compromising compliance. If your organization is exploring or expanding its DTP strategy, let’s make sure you’re protected—before risks become reality.

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Today, we're diving into a hot topic in clinical trials: should you use AI to negotiate your next clinical trial agreement? Darshan is joined by Elizabeth from the University of Cincinnati and Istvan Fekete from Huron Consulting, who share their experiences and thoughts on using AI for contract and budget negotiations. They discuss the potential and limits of AI, highlighting concerns over copyright, data ownership, and "black box" decision-making. While AI can streamline contract review with tools like word plugins, there's consensus that human oversight will remain crucial. AI can help create initial drafts and flag key points, but will people over-rely on it, missing critical details in the process?

Istvan emphasizes that even with AI assistance, human expertise in contract review remains irreplaceable. Elizabeth raises a thought-provoking question: Will AI reduce the number of people at conferences like Magi in ten years, or will it expand the industry as AI tools increase contract efficiency? We’ll find out!

#AI #clinicaltrials #clinicalresearch #AIinclinicaltrials #pharmainnovation #smartnegotiations #legalinnovation #contractnegotiation #clinicaltrialtech #clinicaltrialagreements #pharmaregulations #clinicaltrialtech #darshantalks #dt #kulkarnilawfirm #klf #recentrecap

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In this discussion, Edye Edens and Darshan Kulkarni tackle one of the most common questions in clinical research: How many SOPs should a site have? While many assume a fixed number like 12, the reality is more nuanced.

From a site perspective, having extensive SOPs can feel overwhelming, but they are essential for compliance and audits. SOPs are the first thing requested during inspections by the FDA or sponsors. However, sites must strike a balance—too few SOPs indicate a lack of structure, while too many can create unnecessary complexity.

For IRBs, SOPs are a given, as they must document their policies for both internal staff and external researchers.

Sponsors and CROs also rely on SOPs to ensure patient safety and regulatory compliance. They don’t necessarily need extreme detail, but they do need a clear framework to verify consistent procedures.

Key takeaways:

• SOPs should set a structured, repeatable process—not be reactive documents.
• Having too few SOPs signals weak compliance; having too many leads to contradictions.
• M&A buyers and private equity firms look for strong SOP structures when acquiring research sites.
• AI and shared templates can help, but SOPs must be customized and regularly updated.

For new sites, a starting range of 5–10 SOPs is reasonable, expanding to 10–20+ SOPs as operations grow. Ultimately, SOPs should be strategic, practical, and tailored to the site's needs—ensuring compliance without unnecessary burden.

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