Law Firm of Legal Counsels
Joanna Pesta - Aleksandra Łozińska
Professional legal services for clinical trials
We provide support to sponsors, investigators, and research centers in the effective conduct of clinical trials, ensuring regulatory compliance and the protection of their interests – in Poland, across Europe, and worldwide.
Contract Negotiation and Management
We provide comprehensive support in drafting, reviewing, and negotiating clinical trial agreements, ensuring regulatory compliance and protecting our clients’ interests.
Regulatory Advisory
We assist in interpreting and applying national and international regulations related to clinical trials, including GDPR, EMA guidelines, and GCP standards.
Legal Support at Every Stage of the Trial
We offer ongoing legal assistance from the planning phase through collaboration with sites and vendors, to the completion and close-out of the study.
About us
We are a law firm specializing in legal services for clinical trials. Since 2009, we have been providing our clients with support grounded in experience, in-depth knowledge, and expert understanding of applicable regulations.
With offices in Poland and Belgium, we assist clients both locally and internationally. Our clients include research centers, investigators, sponsors, and service providers (vendors) who value our professional approach and effectiveness in solving even the most complex legal challenges.
Our mission is to deliver reliable and prompt legal solutions that enable the smooth conduct of clinical trials in compliance with regulations and in alignment with the interests of all involved parties.
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Contract Negotiation
We provide expert support in negotiating clinical trial agreements in Poland and across international markets. Our services include:
Clinical trial agreements (both commercial and non-commercial),
Agreements with investigators and research staff,
Contracts with vendors (e.g., CROs, laboratory service providers, IT companies),
Non-disclosure agreements (NDAs).
We ensure that each contract complies with legal regulations, reflects the specific needs of the research project, and protects our clients’ interests.
Regulatory Advisory
We assist clients in interpreting national and international regulations related to clinical trials, including European frameworks (such as GDPR and EMA guidelines) and global GCP (Good Clinical Practice) standards.
Legal Support at Every Stage of a Clinical Trial
From project planning, through negotiations with contractors and vendors, to study completion and financial close-out — we operate globally, delivering legal solutions tailored to both local and international requirements.
Clinical Trial Budget Negotiation
Our firm specializes in negotiating clinical trial budgets, ensuring maximum compensation for research sites and investigators.
We understand the specifics of clinical trial protocols and are skilled at analyzing them to determine appropriate compensation structures, securing the best financial terms for our clients.
Why Choose Us?
Over a Decade of Experience
Since 2009, we’ve been helping clients achieve their research goals. Years of hands-on practice have given us unique insights and a deep understanding of the clinical trials industry.
International Perspective
With offices in Poland and Belgium, we successfully support clients across European and global markets. We combine in-depth knowledge of local regulations with the international reach of our services.
Specialization in Clinical Trial Law
We focus exclusively on this niche area of law, enabling us to deliver top-tier legal services. We understand both the regulatory landscape and the specific needs of the medical and pharmaceutical industries.
Tailored and Flexible Approach
Every clinical research project is unique – that’s why we adapt our legal strategies to the specifics of your case, ensuring maximum legal protection and efficient support.