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Clients trust us to oversee and guide them at every stage of research and development process, from establishing research infrastructure through the meticulous compliance requirements.

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<p>Clients trust us to oversee and guide them at every stage of research and development process, from establishing research infrastructure through the meticulous compliance requirements.</p>

Our nationwide team is adept at designing proactive strategies to protect our clients’ interests and safeguard their innovations while adhering to the highest standards of compliance with the myriad federal and state laws intended to ensure the integrity of research, the safety and privacy of research subjects and collected data, and proper use of federal funding.

<p>Our nationwide team is adept at designing proactive strategies to protect our clients’ interests and safeguard their innovations while adhering to the highest standards of compliance with the myriad federal and state laws intended to ensure the integrity of research, the safety and privacy of research subjects and collected data, and proper use of federal funding.</p>

We provide clients with an exceptional understanding of the changing dynamics of the regulatory landscape. Our team is experienced in dealing with federal agencies ranging from the Department of Health and Human Services, Food and Drug Administration, Office of Human Research Protections, the National Institutes of Health and more. We counsel clients through new frontiers in healthcare, including precision medicine, genetic research and biorepository and data registry developments.

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In a village of La Mancha, the name of which I have no desire to call to mind, there lived not long since one of those gentlemen that keep a lance in the lance-rack, an old buckler, a lean hack, and a greyhound for coursing.

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<p>We provide clients with an exceptional understanding of the changing dynamics of the regulatory landscape. Our team is experienced in dealing with federal agencies ranging from the Department of Health and Human Services, Food and Drug Administration, Office of Human Research Protections, the National Institutes of Health and more. We counsel clients through new frontiers in healthcare, including precision medicine, genetic research and biorepository and data registry developments.</p>

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<h5 class="wp-block-heading">Our clients include:</h5>


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<ul class="wp-block-list">
<li>Academic medical centers</li>



<li>Commercial sponsors</li>



<li>Contract research organizations (CROs)</li>



<li>Institutional Review Boards (IRBs)</li>



<li>Healthcare systems and community-based providers</li>



<li>Small device and pharmaceutical manufacturers</li>



<li>Private equity groups investing in healthcare entities</li>



<li>Public and private healthcare institutions and research sites</li>



<li>Site management organizations (SMOs)</li>
</ul>


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<li>Contract research organizations (CROs)</li>

<li>Institutional Review Boards (IRBs)</li>

Healthcare systems and community-based providers

<li>Healthcare systems and community-based providers</li>

Small device and pharmaceutical manufacturers

<li>Small device and pharmaceutical manufacturers</li>

Private equity groups investing in healthcare entities

<li>Private equity groups investing in healthcare entities</li>

Public and private healthcare institutions and research sites

<li>Public and private healthcare institutions and research sites</li>

<li>Site management organizations (SMOs)</li>

<ul><li>Academic medical centers</li><li>Commercial sponsors</li><li>Contract research organizations (CROs)</li><li>Institutional Review Boards (IRBs)</li><li>Healthcare systems and community-based providers</li><li>Small device and pharmaceutical manufacturers</li><li>Private equity groups investing in healthcare entities</li><li>Public and private healthcare institutions and research sites</li><li>Site management organizations (SMOs)</li></ul>

Our robust spectrum of services includes:


<h5 class="wp-block-heading">Our robust spectrum of services includes:</h5>



<ul class="wp-block-list">
<li>Advise on insurance billing review processes and appropriate billing for trial participants</li>



<li>Prepare and negotiate agreements for clinical trials, investigator services, and CRO services</li>



<li>Prepare research sites for government inspections and sponsor audits</li>



<li>Advise on federal grant and contract compliance</li>



<li>Advise institutional review boards on human subjects protections</li>



<li>Privacy and data protection, including HIPAA and GDPR</li>
</ul>


Advise on insurance billing review processes and appropriate billing for trial participants

<li>Advise on insurance billing review processes and appropriate billing for trial participants</li>

Prepare and negotiate agreements for clinical trials, investigator services, and CRO services

<li>Prepare and negotiate agreements for clinical trials, investigator services, and CRO services</li>

Prepare research sites for government inspections and sponsor audits

<li>Prepare research sites for government inspections and sponsor audits</li>

Advise on federal grant and contract compliance

<li>Advise on federal grant and contract compliance</li>

Advise institutional review boards on human subjects protections

<li>Advise institutional review boards on human subjects protections</li>

Privacy and data protection, including HIPAA and GDPR

<li>Privacy and data protection, including HIPAA and GDPR</li>

<ul><li>Advise on insurance billing review processes and appropriate billing for trial participants</li><li>Prepare and negotiate agreements for clinical trials, investigator services, and CRO services</li><li>Prepare research sites for government inspections and sponsor audits</li><li>Advise on federal grant and contract compliance</li><li>Advise institutional review boards on human subjects protections</li><li>Privacy and data protection, including HIPAA and GDPR</li></ul>

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<section class="wp-block-contentpilot-expand-more"><div class="wp-block-contentpilot-expand-more__excerpt is-visible" data-selector="expand-more"><p></p></div><div class="wp-block-contentpilot-expand-more__full-content" data-selector="expand-more"><p>We provide clients with an exceptional understanding of the changing dynamics of the regulatory landscape. Our team is experienced in dealing with federal agencies ranging from the Department of Health and Human Services, Food and Drug Administration, Office of Human Research Protections, the National Institutes of Health and more. We counsel clients through new frontiers in healthcare, including precision medicine, genetic research and biorepository and data registry developments.</p><h5 class="wp-block-heading">Our clients include:</h5><ul><li>Academic medical centers</li><li>Commercial sponsors</li><li>Contract research organizations (CROs)</li><li>Institutional Review Boards (IRBs)</li><li>Healthcare systems and community-based providers</li><li>Small device and pharmaceutical manufacturers</li><li>Private equity groups investing in healthcare entities</li><li>Public and private healthcare institutions and research sites</li><li>Site management organizations (SMOs)</li></ul><h5 class="wp-block-heading">Our robust spectrum of services includes:</h5><ul><li>Advise on insurance billing review processes and appropriate billing for trial participants</li><li>Prepare and negotiate agreements for clinical trials, investigator services, and CRO services</li><li>Prepare research sites for government inspections and sponsor audits</li><li>Advise on federal grant and contract compliance</li><li>Advise institutional review boards on human subjects protections</li><li>Privacy and data protection, including HIPAA and GDPR</li></ul><p></p></div><button class="wp-block-contentpilot-expand-more__more-button is-visible" data-selector="expand-more">View More</button><button class="wp-block-contentpilot-expand-more__less-button" data-selector="expand-more">View Less</button></section>

Payal P. Cramer

Lori P. Markley

Atlanta

Counsel

Industries

Healthcare

<ul>
<li>Counsel a large healthcare provider in establishing a centralized clinical research program with an infrastructure geared toward regulatory compliance.</li>
<li>On behalf of researchers, commercial sponsors and contract research organizations, prepare, review and negotiate clinical trial agreements, investigator agreements, research services agreements and other related agreements.</li>
<li>Advise academic medical centers on patient privacy protections in the conduct of research.</li>
<li>Advise community-based health systems in regulatory requirements related to Medicare billing of clinical trial costs and assist in developing processes to capture charges in a compliant manner.</li>
<li>Advise community-based hospitals on investigator compensation models.</li>
<li>Advise institutional review boards on regulatory compliance.</li>
<li>Provide guidance to manufacturers on federal Anti-Kickback Statute compliance and Sunshine Act reporting.</li>
<li>Advise financial services corporations and software developers regarding health information privacy.</li>
</ul>


Clinical Research, Population Health Research and Human Subject Protection

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