Research Innovation And Entrepreneurship

We help organizations build sustainable, compliant research programs.

Representative services include:

• Research governance and organizational evaluation, design and updates
• Research compliance program development
• Research policy development
• Clinical research infrastructure
• Research risk assessments
• Research quality systems
• Academic-industry partnerships
• Strategic collaborations
• Research funding compliance
• Research expansion initiatives

Building compliant research programs that scale.

Complex research relationships require sophisticated contracting.

We negotiate and structure:

• Sponsored research agreements
• Material transfer agreements
• Data use agreements
• Biobank agreements
• Consortium agreements
• Collaboration agreements
• Licensing support
• Research services agreements
• Confidentiality agreements
• Multi-site trial agreements
• International research collaborations

Structuring research partnerships that move science forward.

We help clients translate discoveries into patient care, products and partnerships.

Our team assists with:

• Technology commercialization
• Startup formation
• Licensing transactions
• Venture collaborations
• Innovation incubator development
• Research investment transactions
• Joint ventures
• Strategic alliances
• Precision medicine initiatives

Turning discoveries into clinical, commercial and strategic value.

Leading research institutions increasingly empower faculty, physicians and research scientists to move discoveries into new therapies, diagnostics, medical devices, digital health solutions and startup companies.

Building an innovation ecosystem requires more than technology transfer. Institutions must create policies, governance structures and incentive programs that encourage entrepreneurship while protecting research integrity, managing conflicts of interest and complying with federal funding requirements.

Hall Render helps organizations design practical, legally sound innovation frameworks that align institutional mission with commercialization objectives and compliance obligations.

Representative Services

We advise institutions on:

• Faculty entrepreneurship strategies
• Innovation institute development
• Research incubators and accelerators
• Startup company policies
• Faculty consulting arrangements
• Founder and advisor relationships
• Equity ownership and compensation structures
• Conflict of interest and conflict of commitment programs
• Faculty participation in sponsored companies
• Outside activities policies
• Institutional venture funds
• Innovation incentive programs
• Revenue-sharing and royalty distribution policies
• Small Business Innovation Research (“SBIR”) and Small Business Technology Transfer (“STTR”) participation
• Industry engagement strategies

Creating pathways for innovators to launch, partner and lead responsibly.

Successful innovation programs require thoughtful governance. Institutions must encourage entrepreneurial activity while safeguarding academic independence, protecting human subjects, preserving public trust and complying with regulatory obligations.

Our attorneys work with executive, department and research innovation leaders, technology transfer offices, compliance professionals and institutional counsel to develop and support practical frameworks that:

• Encourage faculty innovation and commercialization
• Attract industry collaboration and investment
• Support startup formation and technology development
• Manage conflicts without discouraging innovation
• Protect federally funded research assets
• Strengthen institutional oversight and governance
• Preserve scientific integrity and public confidence

Advancing entrepreneurship without compromising research integrity.

Data, artificial intelligence and digital tools now sit at the center of modern research and require governance that keeps pace with innovation.

We advise on:

• AI governance
• Research data governance
• HIPAA
• Common Rule
• Data sharing
• Secondary use of research data
• Digital health research
• Software development collaborations
• Machine learning tools
• Algorithm validation
• Digital biomarkers
• Real-world evidence
• Cybersecurity
• Information governance

Governing data, AI and digital tools for responsible research innovation.

We support sponsors, institutions, investigators and research teams through clinical trial startup, operations, compliance and closeout.

Representative services include:

• Clinical trial agreements
• Investigator-sponsored research
• Master clinical trial agreements
• Contract research organization (“CRO”) agreements
• Site management organization agreements
• Budget negotiation
• Coverage analysis
• Medicare billing compliance
• FDA regulatory counseling
• Human subject protections
• IRB governance
• Informed consent
• Research audits

Supporting compliant, efficient clinical trials from startup to closeout.

When research issues become enforcement matters, experience matters and coordinated legal response is critical.

We counsel organizations regarding:

• Office for Human Research Protections (“OHRP”) investigations
• Office of Research Integrity (“ORI”) matters
• Research misconduct
• False Claims Act investigations
• Grant compliance
• NIH compliance
• Export controls
• Economic sanctions
• National security issues
• Internal investigations
• Corrective action plans
• FDA inspection readiness

Responding strategically when research risk becomes enforcement risk.

Scientific discoveries represent some of an organization’s most valuable assets. A thoughtful intellectual property strategy is essential to protecting innovation, attracting investment, supporting industry collaborations and bringing new technologies to providers and patients.

Hall Render works with research institutions, academic medical centers, health systems, technology transfer offices, startups and life sciences companies to develop comprehensive intellectual property strategies that align scientific innovation with institutional and commercial objectives.

Our multidisciplinary team includes patent counsel qualified in both the United States and Europe, providing coordinated advice on domestic and cross-border patent strategy, prosecution and portfolio management. We integrate this patent experience with capabilities across research transactions, technology commercialization, FDA regulation, corporate transactions, health care regulation, tax, privacy and litigation to help clients protect and maximize the value of their intellectual property portfolios.

Our team helps clients address intellectual property considerations at every stage of innovation, including:

• Intellectual property strategy and portfolio development
• U.S. and European patent counseling, filing and prosecution
• Coordinating global patent strategies across jurisdictions
• Structuring collaborations to clearly define ownership of future inventions
• Protecting patent rights before public disclosure or publication
• Invention disclosure review and evaluation, patentability assessments and freedom-to-operate analyses
• Coordinating patent filing and prosecution strategies with grant funding and sponsor obligations
• Managing Bayh-Dole compliance and federally funded inventions
• Aligning patent prosecution with commercialization and licensing objectives
• Supporting faculty entrepreneurs and startup companies
• Conducting intellectual property diligence for investments, mergers, acquisitions and strategic partnerships
• Defending and enforcing valuable intellectual property assets

Protecting innovation. Maximizing value.

Scientific discovery depends on global collaboration, cross-border investment and international talent. At the same time, research institutions face increasing legal and regulatory obligations designed to protect sensitive research, intellectual property, federally funded projects and emerging technologies from inappropriate foreign influence and national security risks.

Hall Render helps research institutions, academic medical centers, health systems and life sciences companies navigate the evolving landscape of research security, export controls, foreign investment and international collaborations while preserving opportunities for innovation.

We work with institutional leadership to develop governance frameworks that support open scientific inquiry while satisfying sponsor expectations, federal requirements and institutional risk management objectives.

Representative matters include:

• Research security governance
• International collaboration and consortia
• Sponsor-specific compliance programs
• Foreign engagement disclosures
• Technology transfer risk assessments
• Data governance and cybersecurity coordination
• AI and emerging technology risk management
• Incident response planning
• Government reviews and investigations
• Board and executive leadership education
• Export controls

Protecting sensitive research while enabling global collaboration.

Academic medical centers (“AMCs”) sit at the intersection of patient care, education, research and commercialization. Their innovation strategies depend on aligned governance across the hospital or health system, medical school, university, faculty practice plan, research enterprise, technology transfer office and affiliated clinical departments.

We help AMCs and university-affiliated health systems structure the legal and operational relationships that support research growth, faculty entrepreneurship, clinical innovation, translational science and industry collaboration while protecting academic mission, research integrity, tax-exempt status, public trust and institutional control.

AMC and faculty-specific services include:

• University, medical school, hospital and faculty practice plan affiliation structures
• Faculty practice plan governance, service lines, funds flow, effort allocation and compensation alignment
• Academic department, clinical enterprise and research enterprise operating models
• Faculty appointment, outside activity, consulting, moonlighting and institutional commitment policies
• Faculty founder, inventor, board service and equity participation management
• Institutional conflict of interest reviews involving leadership roles, equity interests, sponsored programs and commercialization activity
• Internal faculty-institution disputes involving royalties, intellectual property ownership, invention assignment and commercialization revenue sharing
• Third-party disputes involving sponsor rights, startup participation, commercialization rights and related innovation conflicts
• Tax-exempt, private benefit, unrelated business income tax (“UBIT”), Stark Law, Anti-Kickback Statute and funds-flow issues unique to AMC affiliation models

Aligning academic mission, clinical operations, faculty innovation and research commercialization.

Children’s hospitals occupy a distinct position in the research innovation ecosystem. They combine mission-driven pediatric care, specialized research programs, rare disease expertise, philanthropic and federal funding, academic affiliations and growing commercialization activity. Innovation in this setting often involves minors and other populations requiring additional protections, parental permission and assent, long-term data stewardship, genetic and genomic information, pediatric AI tools, ultra-rare disease research and heightened public trust.

We help children’s hospitals and pediatric research institutions advance discovery while managing the legal, regulatory, ethical, operational and reputational risks that arise when pediatric research moves toward clinical deployment, technology development, data use, commercialization and strategic partnerships.

Pediatric-specific services include:

• Pediatric research governance for studies involving minors, parents, guardians, assent and re-consent at age of majority
• Rare disease, ultra-rare disease, pediatric oncology, gene therapy and individualized therapy research arrangements
• Longitudinal pediatric data, registries, biobanks, biospecimens, genomic information and future-use consent frameworks
• Pediatric AI, digital health, remote monitoring and clinical decision support validation for children and adolescents
• Children’s hospital innovation collaborations involving philanthropy, foundations, family advisory groups, academic partners and research sponsors
• Return of results, incidental findings, genetic privacy and family communication issues in pediatric research
• Pediatric subject injury, reimbursement, coverage analysis and trial budget issues involving minors and family support costs

Helping children’s hospitals innovate responsibly while protecting pediatric patients, families and institutional trust.