DarshanTalks Podcast

著者: Darshan Kulkarni
  • サマリー

  • Welcome to DarshanTalks!

    We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there!

    Powered By The Kulkarni Law Firm - Helping regulators see your business the way you do.

    We focus on life science issues involving medical affairs, marketing and advertising, and clinical research so that you can learn about the industry, enhance your business and grow your career.

    © 2025 DarshanTalks Podcast
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あらすじ・解説

Welcome to DarshanTalks!

We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there!

Powered By The Kulkarni Law Firm - Helping regulators see your business the way you do.

We focus on life science issues involving medical affairs, marketing and advertising, and clinical research so that you can learn about the industry, enhance your business and grow your career.

© 2025 DarshanTalks Podcast
エピソード
  • How to Network Like a Pro at Conferences
    2025/03/12

    In this episode, Darshan sits down with Brook White from CRIO to dive into the value of attending conferences and how to make the most of them. They met at a past conference and quickly realized how much we had to learn from each other, so I asked Brook to come on and share her insights.

    They start by discussing whether conferences are truly valuable—considering the costs, time investment, and potential for networking. While online learning can be beneficial, conferences offer unique opportunities for interaction and relationship-building, which can lead to new clients, partnerships, and ideas. Brooke emphasizes the importance of setting clear goals before attending a conference, whether it's for lead generation, education, or brand awareness.

    They also talk about market segmentation and how CRIO approaches conferences with a targeted strategy, dividing attendees into categories like existing clients, partners, and prospective future clients. This helps the team prioritize and engage with the right people, even before the conference begins. Brooke shares her process of reaching out to these groups and how CRIO maximizes their time at events.

    Finally, they touch on the importance of building relationships at conferences—whether you're engaging with potential partners, clients, or learning from industry leaders. And while swag might seem trivial, Brooke explains that it's more about creating brand recognition and offering an opportunity to engage with attendees.

    If you're heading into conference season, this conversation is packed with valuable tips to help you navigate the event landscape more effectively.

    #SOSconference2025 #SaveOurSites2025 #clinicaltrials #clinicalresearch #clinicaltrialcompliance #clinicaltrialmanagement #FDACompliance #darshantalks #dt #kulkarnilawfirm #klf

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    17 分
  • Getting Ready for SOS 2025: FDA 483s, SOPs, and Site Survival
    2025/03/10

    In this conversation, Edye Edens and Darshan Kulkarni discuss the excitement and plans for the upcoming Save Our Sites (SOS) Second Annual Conference in Oklahoma City. They highlight the importance of connecting with key industry leaders and peers in person, including names like Dan Sfera, Brad Hightower, and others who have been instrumental voices in the clinical research space.

    Darshan shares that Kulkarni Law Firm (KLF) will be participating and is excited to engage with attendees, talk about their offerings, and provide exclusive giveaways related to compliance and FDA inspections. Darshan emphasizes that KLF will focus on how to prevent and respond to FDA 483s, covering topics like audit readiness, proper handling of inspections, and how to de-escalate findings before they escalate into warning letters. He also underscores the importance of understanding the inspection process, including the fact that "it's a negotiation until the report is issued," and the role of policies, procedures, and professional conduct during audits.

    Edye highlights her session on SOPs (Standard Operating Procedures), where she will speak alongside Jen Pages, Scott Wit, and Brad Hightower (moderator). Their panel will cover critical topics like:

    • How to start SOPs if you don’t have any
    • Scaling SOPs as your site grows
    • Using SOPs strategically to protect and defend sites in audits and inspections
    • Addressing sponsor expectations regarding site processes

    They aim to address real-life issues sites face, including how to tailor or adapt SOP templates and how to leverage them to prevent issues with sponsors and regulators. A surprise giveaway will also be available for those who attend the session.

    Both Edye and Darshan emphasize that SOS is about community supporting community, not just traditional presentations. The goal is to share actionable, free value, foster real conversations about clinical site challenges, and help each other grow in the clinical research space. They also playfully joke about friendly competition on session attendance, adding a light-hearted tone to the conversation.

    In summary, attendees can expect:

    • Deep dives on 483 prevention and response
    • Practical SOP guidance for sites
    • Meaningful networking and community building
    • Unique giveaways and actionable takeaways

    Stay tuned for more updates.




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    11 分
  • Maximizing Site Value
    2025/03/07

    When selling a clinical trial site, many owners focus solely on the amount they’ll receive, but the real key is understanding the multiplier that determines your valuation. In M&A transactions, hitting the right EBITDA threshold—such as $3M, $10M, or $25M—can significantly increase your multiplier, turning a 6X valuation into 10X or more. While some claim multipliers as high as 26X, the reality is more complex.

    Beyond valuation, choosing the right private equity partner is just as critical. Do they want a standalone site, or will you be part of a network? Will you need to align with new processes or teams? Is your payout immediate, or will some be deferred? Many sellers are caught off guard when the check they expected never arrives as planned.

    If you're considering an M&A transaction, don't just focus on the final price—understand the full process. We help clinical research sites navigate these deals strategically. Call, click, or email to learn more!



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    2 分

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