Clinical Research Services
HIPAA and GDPR compliance
Clinical researchers occupy a special position in using data about health. With the growth of international clinical research, the data gathered and analyzed includes health information of not just US citizens, but those from the European Union and other regions. Since the advent of HIPAA and, more recently the EU’s General Data Protection Regulation, compliance with data privacy regulations is a key component of ethical research.
Clinical trials compliance and FDA Good Clinical Practices guidance
Clinical research touches not just on rules regarding patient data, but the ethics and legalities administering frequently novel interventions to patients. For studies subject to FDA oversight, compliance with FDA GCP is essential to administering a trial that will withstand audit. At the core of compliance is a deep knowledge of the source, interpretation, and application of regulations governing trials.
Healthcare vendor and business associate agreements
Clinical research organizations are on the cutting edge of medical science and a major part of their operations include the management of outside contracts with subject matter experts, software as a service (SaaS) vendors, contract workers, real estate leases, pharmaceutical manufacturers, and compounding pharmacies. A critical goal for every contract is managing risk to the organization through compliance and indemnification provisions. We provide full review, authoring, and negotiation services for contracts and outside agreements.
Internal policies and procedures for clinical research and operations
In research, SOPs are the roadmap to success as an organization and they govern all aspects of operations, research, data privacy and security, and human resources. Ensuring SOPs are crafted and update with the guidance of legal counsel ensures that not only do SOPs address mission-critical subject matter areas, but the interplay between topics like data privacy, IT, and human resources is not overlooked.
Full organization services, including creation of founding articles, bylaws and conflict of interest policies
Many clinical research organizations operate in a special legal arena in conducting scientific research. Many exist as non-profit organizations, which places specific requirements on articles of incorporation, bylaws, and conflict of interest policies within the organization. As for-profit entities, operating and shareholder agreements can take on a high level of complexity. The guidance of legal counsel from start-up through maturity of your organization is important to mitigating risk, maximizing organization, and ensuring smooth operations for years to come.
Applications for non-profit tax-exempt status
Organizing as a non-profit entity places special obligations on a company. From formation of articles of incorporation with state regulators, drafting tax-compliant bylaws and conflict of interest policies, to the filing of your application, experienced guidance from start-up will ensure a smooth filing with regulators and that your organization can get to work. We offer assistance with all aspects of drafting corporate documents, compliance policies, and completion of necessary applications with the IRS.
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Bush Health Law PLLC is law firm that offers legal counsel to clinicians, researchers, and organizations to support the mission of quality, innovative healthcare. With offices in Gainesville, Florida, the firm serves healthcare clients throughout Florida, including Gainesville, Alachua, Jacksonville, Ocala, Lake City, Tallahassee, St. Augustine, Daytona Beach, Melbourne, Orlando, Leesburg, Lady Lake, Tampa, St. Petersburg, and Lakeland. Copyright © 2019 Bush Health Law PLLC. All rights reserved.