Pharma/Biotech Consulting

In the fast-paced world of drug and product development, innovation never stops. That's why having a strategic partner who can navigate and support a clinical development project's success is crucial. McKain Consulting understands your needs and brings the necessary experience to help you achieve your goals.

Whether you're a small start-up or a large pharmaceutical company, we're here to help you succeed.

McKain Consulting provides more than 15 years of industry experience across a range of therapeutic areas.

We offer a variety of services tailored to your unique needs:

Clinical -Regulatory Strategy

Offers strategic advice to develop well-rounded clinical development programs.

Study Design & Protocol Development

Contributes to the design of clinical trials to ensure they meet regulatory standards and requirements.

Medical Monitoring

Provides medical and scientific oversight of clinical trials to ensure trial participant safety and data integrity.

Trial Data Analysis & Report Writing

Analyzes safety and efficacy data and contributes to authorship of clinical study reports and filing documents.

Trial Recruitment

Supports clinical trial recruitment and retention efforts including the conduct of motivational visits.

Due Diligence

Evaluate assets prior to acquistion or investment. Input encompasses evaluation of safety and efficacy data, market value, and competitive landscape

Audits and Inspections

Assists sites and sponsors with preparation for audits and inspections. Supports responses to findings including developing corrective action plans.

FDA Meetings

Provides expert advice, guidance on regulatory requirements, and preparation of meeting requests, briefing packages and meeting attendance and support.

About McKain Consulting, LLC

With my extensive industry experience and many hard-won victories, it's fair to say I've earned my beautiful gray hair!

Hi! I'm Laura McKain, MD.

I lead McKain Consulting.

As a physician scientist and board-certified, licensed physician with over 12 years of clinical experience and 15 years of pharmaceutical industry experience, I bring a wealth of expertise to pharmaceutical and biotech consulting. With extensive trial experience across multiple therapeutic areas and indications, I have helped to plan and execute programs that succeed. My industry experience not only encompasses successfully navigating various challenges but also leveraging those experiences to effectively solve problems as they arise .

I have a track record of contributing to succesful clinical development programs and securing new drug approvals in the US and Europe. My work has spanned various therapeutic and functional areas in pharma and contract research organizations. I am skilled in planning programs that adequately assess benefit and risk and conducting trials in a manner that ensures the safety of clinical trial participants while maintaining the scientific integrity of the data.

My work and consulting has been in a variety of industry settings, from large global organizations to start-ups. I have worked with clients that include established global pharma companies and virtual companies, even "two guys and a molecule!" Common consulting tasks include study design, protocol writing, medical monitoring, data review and analysis, report writing, preparing NDA documents, due diligence, and more. I have niche expertise in women’s health studies including pregnancy drug exposure registries, contraceptive trials, and lactation studies. I also have experience with complex inpatient trials in acute conditions.

My approach to pharmaceutical and biotech consulting is founded on a blend of professional rigor, extensive experience, and a friendly, approachable demeanor. Let's work together to bring your vision to life.

Contact McKain Consulting LLC

Email us at Laura@McKainConsulting.com
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