Comprehensive Legal Support for Clinical Trials and Medical Law – Your Legal Security in Healthcare Innovations
The Importance of Clinical Trials and Medical Law
Clinical trials are the cornerstone of modern medicine, enabling the development of new therapies, drugs, and technologies that save and improve lives. However, conducting clinical trials involves numerous regulatory, ethical, and legal challenges. Partnering with our law firm ensures that your clinical trials are conducted safely and in compliance with all applicable regulations, no matter their scale or location.
Our law firm specializes in supporting entities conducting clinical trials, healthcare facilities, and pharmaceutical companies. With our expertise, your organization can focus on scientific innovation, leaving legal and regulatory matters in the hands of experienced professionals.
Why Choose Our Law Firm?
- Expertise in Clinical Trials and Medical Law
We have extensive experience working with pharmaceutical companies, research centers, and medical facilities. We understand the specifics of clinical trials and stay up-to-date with current regulations in Poland, the European Union, and beyond. - Knowledge of National and International Regulations
We provide assistance to ensure compliance with key regulations such as:
- The EU Clinical Trials Regulation (CTR) No 536/2014,
- International Good Clinical Practice (GCP) guidelines,
- GDPR in the context of participant data protection.
- Tailored Solutions for Each Client
Every clinical trial project is unique, so our legal solutions are tailored to the specific needs of your organization. Whether conducting local or global trials, you can rely on our support. - Comprehensive Support at Every Stage of Clinical Trials
From preparing documentation and negotiating contracts to obtaining ethical approvals and representing clients in disputes, we provide end-to-end assistance.
Our Services for Clinical Trials and Medical Law
1. Preparation and Review of Clinical Trial Documentation
Proper documentation is the foundation of any clinical trial. We offer:
- Drafting and reviewing clinical trial protocols.
- Preparing informed consent forms for participants, ensuring legal and ethical compliance.
- Drafting agreements between sponsors, CROs (Contract Research Organizations), and research sites.
2. Obtaining Ethical and Regulatory Approvals
We assist in navigating the process of obtaining the necessary approvals to initiate clinical trials:
- Preparing applications for ethics committees and regulatory bodies, such as the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products (URPL) in Poland.
- Ensuring documentation meets all legal and ethical requirements.
3. Data Protection in Clinical Trials (GDPR Compliance)
Protecting participant data is a critical component of every clinical trial. Our services include:
- Conducting GDPR compliance audits.
- Drafting data protection policies and data processing agreements.
- Advising on data breaches and handling regulatory notifications.
4. Risk Management and Regulatory Compliance
We help minimize the legal risks associated with clinical trials:
- Conducting compliance audits with GCP and other applicable standards.
- Developing internal risk management procedures.
- Preparing for inspections by regulatory authorities, such as EMA or FDA.
5. Representation in Disputes and Legal Proceedings
In case of legal issues, we provide:
- Representation in disputes with trial participants, regulatory bodies, or business partners.
- Defense in cases related to product liability.
- Resolving conflicts between sponsors and research sites.
6. Marketing and Product Launch Advisory
We assist pharmaceutical and biotech companies with:
- Developing strategies compliant with advertising and promotional regulations for medical products.
- Ensuring marketing activities align with legal requirements.
- Launching new drugs and technologies in compliance with the law.
7. Support for Innovations and Digitalization in Clinical Trials
We help organizations leverage cutting-edge technology in medicine:
- Advising on the implementation of telemedicine and digital solutions in clinical trials.
- Ensuring compliance of innovative projects with regulatory frameworks.
- Supporting research projects involving artificial intelligence and big data.
Our Approach to Clients
Understanding the Specifics of the Medical and Research Industry
We know the challenges facing the clinical trials industry, so our services are tailored to the unique needs of each client.
Proactive and Risk-Preventive Action
We don’t just react to problems; we help anticipate and avoid them through expert advice and the implementation of compliance procedures.
Transparency and Communication
We keep our clients informed of progress and explain complex legal issues in clear terms, so you always know where your project stands.
Success Stories from Our Clients
1. Successful Launch of a Multi-Center Clinical Trial
We assisted a major pharmaceutical company in organizing a multi-center clinical trial in Poland. We prepared comprehensive documentation, obtained ethical approvals, and ensured compliance with GCP regulations.
2. Data Protection in Clinical Research
We represented a sponsor in a case involving a data breach affecting clinical trial participants. Our actions helped avoid significant financial penalties and mitigated reputational damage.
3. Bringing a New Medical Product to the EU Market
We supported a biotech startup in registering and certifying an innovative medical device under the MDR, enabling its sale across European markets.
Benefits of Working with Us
- Legal Security
With us, your clinical trials are compliant with regulations, minimizing risks of fines and lawsuits. - Efficiency and Time Savings
Our assistance allows you to focus on the scientific and business aspects of your projects, leaving legal complexities to the experts. - Support for Development and Innovation
We help bring innovative products to market, supporting your organization’s growth. - Effective Risk Management
Our advisory services help avoid legal issues before they arise.
Contact Us Today!
Clinical trials and medical law are complex fields requiring specialized knowledge and experience. Our law firm is your trusted partner in building safe, compliant, and innovative research projects. Contact us to learn how we can help your organization succeed in the clinical trials industry.
Your safety and growth in medical innovation are our mission!
