Clinical Trials

Leading clinical trials lawyers

along with clinical research

experts from pharma and life

sciences industry sectors,

advising on the legal and

regulatory aspects of your

clinical trials.

The elite clinical trials lawyers have first-hand experience of conducting and evaluating applications for clinical trials required to test new treatments in a broad range of clinical research in the pharmaceutical and biopharmaceutical industry. The clinical trials team at our law firm comprises lawyers with doctorates and post doctorates as well as scientists with doctorates and post doctorates. A lawyer from the clinical trials team will advise and assist you if you are planning to bring new drugs, biotechnology products or medical devices to market and are conducting or intend to conduct medical research studies, in particular, in the development of new medicinal products, vaccines and diagnostic products for diseases.

In addition, our clinical trials lawyers have phenomenal expertise in advising on clinical research involving the use of existing medicinal products, testing the efficacy and reduction of certain side effects of existing medicines and disease prevention.

Our leading clinical trial solicitors are experts in advising and assisting academic and industry-led clinical trials for vaccines, biotechnology products, diagnostic products for diseases, radiotherapy, physical and psychological therapies as well as medical devices. A quality trial lawyer will draft clinical trial agreements for your company where necessary between sponsors and host institutions, physicians, contract research organisations and/or government bodies.

Our trial lawyers have expertise in dealing with complex clinical research issues and we will assemble a global team for global clinical studies, if required. We take a cross-disciplinary approach to meet your legal and regulatory needs.

Our Services

Our legal and regulatory services include:

Trial Applications Advising on Application Dossiers CrossborderTrials Regulatory Approval
Advising on the legal and technical aspects of Clinical Research (Phase 1 to Phase 4) for Controlled Trials, Blind Trials, Randomisation Early Stage (Phase 1) Development. Clinical Trials Design informed Consent Trial Protocols Strategic Review and advice on Protocols Clinical Development Plans Systematic Reviews
Clinical Trial Agreements Structuring and negotiating Clinical Trial Agreements with Sponsors Sponsored Research Agreements Negotiating Agreements with Clinical Research Organisations (CROs) Non Disclosure Agreements Joint Venture Agreements Material Transfer Agreements
Clinical Investigation Agreements between Clinical Research Organisation, sponsors of Commercial Research and institutions
Commercial Contracts Manufacturing Agreements Supply Agreements Consultancy Agreements including Agreements with Qualified Persons Commercial Litigation General Data Protection Regulation Protection of Patients’ Data Intellectual Property Rights
Investigational Medicinal Products Investigational Advanced Therapy Medicinal Products
Company-sponsored Commercial Research for Medical Devices

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Testimonials

DNA Diagnostics Centre

‘We really appreciated RT Coopers professional expertise regarding a project they assisted with. Detailed and structured feedback was crucial and very important to our innovative concept. I will definitely revert back to Rosanna and the team on other projects in the near future.’ Daniell Leigh, Director

Testimonials

Ice Healthcare Ltd

“RT Coopers Solicitors operate in the real world and deliver what they say they’ll deliver. A highly responsive, straight talking, client focused team who will pull out all the stops to deliver on-time results of the highest standard. Definitely a team you want along side you when the going gets tough. I think that says it all…...” Janet Dean, Operations Director

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