Dr. Lindsay McNair, MD, MPH, MSB | Chief Medical Officer, WCG

Dr. Lindsay McNair has extensive experience in the pharmaceutical industry. Prior to joining WCG, she was a consultant to pharmaceutical and biotechnology companies, providing medical guidance on clinical development strategies and study designs for new drug studies, and medical oversight of all phases of clinical trials. Dr. McNair teaches graduate-level courses on the scientific design of clinical research studies. She has been actively involved in IRB work for 18 years, and has a Master’s of Science in Bioethics with a concentration in research ethics.

COVID-19 Insights from Former FDA Commissioner, Scott Gottlieb, MD

The coronavirus has spread beyond the point of containment, and there’s a looming shortage of personal protective equipment. Hear insights from former FDA Commissioner, Scott Gottlieb, MD.
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COVID-19 Preparedness for Health Care Institutions with Dr. Paul Biddinger of Massachusetts General Hospital
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How do I establish an IRB for reviewing clinical trials?
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Should we create a protocol deviation for an unscheduled visit?
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Question: Can participants be reconsented over the phone when an ICF is updated?
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Question: What are ethical considerations for a trial with a pre-study washout period?

We are working with a sponsor on the design and conduct of a double-blind placebo-controlled study of an investigational new drug for Alzheimer’s disease. The study design includes a one-month...
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Question: Is IRB review required for survey results that may be published?

I am working with a for-profit company to develop survey questions for patients who have a specific illness. Without IRB approval I may not be able to publish any results; but, getting IRB approval or
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An Introduction to Ask the IRB Experts Forum

Clinical research is complicated. At WCG, we get questions about clinical research all the time— from researchers, from clinical team members at biopharma companies, from members of institutional...
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Question: Do sponsors have to change their informed consent documents?

I work for a small biotech company. We’ve been hearing some of our investigators talk about a new regulatory requirement for informed consent documents that includes a summary section in the front...
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Single-Patient Expanded Access: WIRB experience in 2018

In 2018 WIRB approved 100% of the single-patient EA requests that were submitted for review.
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Recommendations for Study Sponsors on Informed Consent Documents
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Is the Government Shutdown Already Impacting Drug Development?

For biopharma sponsors, investigators, patients and families, these limitations are already translating into real impacts on development programs.
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Removing Barriers: Reimbursement and Compensation for Participation in Oncology Clinical Trials

The impact of participant payments on clinical trial recruitment.
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The Eligibility Conundrum in Clinical Trial Protocols: FDA Issues Workshop Report
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Importance of Training Today’s Oncology Research Reviewers on Tomorrow’s Science
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Citizen Ethicists: Does moving protocol review into the hands of potential participants provide adequate protections?
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Not Like Everyone Else: Unique Challenges for Small & Emerging Biopharma Companies

Small and emerging biopharmas are conducting almost 50% of clinical trials in the U.S., often with lean teams, resources and infrastructure. Learn how to reduce the pressure on teams and timelines.
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Clinical Trial Recruitment Practices: The Evolution of Ethical Considerations
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Practical Ethicist: Assessing Research Benefits
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Clinical Researcher: Getting the Right Signatures on Informed Consent Documents
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Dr. Lindsay McNair, MD, MPH, MSB | Chief Medical Officer, WCG

COVID-19 Insights from Former FDA Commissioner, Scott Gottlieb, MD

The coronavirus has spread beyond the point of containment, and there’s a looming shortage of personal protective equipment. Hear insights from former FDA Commissioner, Scott Gottlieb, MD.

COVID-19 Preparedness for Health Care Institutions with Dr. Paul Biddinger of Massachusetts General Hospital

How do I establish an IRB for reviewing clinical trials?

Should we create a protocol deviation for an unscheduled visit?

Question: Can participants be reconsented over the phone when an ICF is updated?

Question: What are ethical considerations for a trial with a pre-study washout period?

We are working with a sponsor on the design and conduct of a double-blind placebo-controlled study of an investigational new drug for Alzheimer’s disease. The study design includes a one-month...

Question: Is IRB review required for survey results that may be published?

I am working with a for-profit company to develop survey questions for patients who have a specific illness. Without IRB approval I may not be able to publish any results; but, getting IRB approval or

An Introduction to Ask the IRB Experts Forum

Clinical research is complicated. At WCG, we get questions about clinical research all the time— from researchers, from clinical team members at biopharma companies, from members of institutional...

Question: Do sponsors have to change their informed consent documents?

I work for a small biotech company. We’ve been hearing some of our investigators talk about a new regulatory requirement for informed consent documents that includes a summary section in the front...

Single-Patient Expanded Access: WIRB experience in 2018

In 2018 WIRB approved 100% of the single-patient EA requests that were submitted for review.

Recommendations for Study Sponsors on Informed Consent Documents

Is the Government Shutdown Already Impacting Drug Development?

For biopharma sponsors, investigators, patients and families, these limitations are already translating into real impacts on development programs.

Removing Barriers: Reimbursement and Compensation for Participation in Oncology Clinical Trials

The impact of participant payments on clinical trial recruitment.

The Eligibility Conundrum in Clinical Trial Protocols: FDA Issues Workshop Report

Importance of Training Today’s Oncology Research Reviewers on Tomorrow’s Science

Citizen Ethicists: Does moving protocol review into the hands of potential participants provide adequate protections?

Not Like Everyone Else: Unique Challenges for Small & Emerging Biopharma Companies

Small and emerging biopharmas are conducting almost 50% of clinical trials in the U.S., often with lean teams, resources and infrastructure. Learn how to reduce the pressure on teams and timelines.

Clinical Trial Recruitment Practices: The Evolution of Ethical Considerations

Practical Ethicist: Assessing Research Benefits

Clinical Researcher: Getting the Right Signatures on Informed Consent Documents