Clinical Trials
Clinical trials are research studies conducted with human volunteers to test new drugs, medical devices, surgery procedures:
- These trials are essential for determining whether new treatments are safe and effective before they can be approved for widespread use.
- They are a fundamental component of medical research, enabling the discovery and validation of new treatments that can improve health outcomes.
- Through rigorous testing and ethical conduct, these trials ensure that new medical interventions are safe and effective for public use. As medical science continues to evolve, clinical trials will remain indispensable in the quest for better healthcare solutions.
Clinical trials are vital for advancing medical knowledge and improving patient care.
- They help researchers discover new treatments for diseases, understand how existing treatments can be improved, and identify potential risks associated with medical interventions.
- By participating in clinical trials, volunteers and patients contribute to the development of new therapies that can benefit future patients.
To protect volunteers, clinical trials are regulated in most countries and liability insurance must be written to cover volunteers in the event of adverse reactions and their consequences.
The insurance market in the field of life sciences and clinical trials is expanding rapidly, promising numerous opportunities for companies and insurers. Technological advancements and the globalization of clinical trials require innovative insurance solutions tailored to the specific needs of each country.
SATEC expended solution for Clinical Trials Insurance
SATEC acquisition
SATEC recently acquired Audit & Risk Solutions (A&RS, December 2024) led by Frédéric Nouaille – a specialized broker in Life Sciences and Med Tech – unlocking new insurance opportunities and expanding our international client’s base.
With this acquisition, we aim to become a one-stop shop broker for clinical trials insurance available for UnisonSteadfast members.
i4CT Platform
A&RS’s dedicated team and platform i4CT – Insurance for Clinical Trials – insures several hundred trials each year in Europe and worldwide.
- i4CT provide customized Clinical Trials insurance solutions that comply with the regulatory requirements of every country.
- It partners with best carriers in medical and life sciences having global footprint.
- Its goal is to simplify the underwriting and management process.
Centralized insurance approach
The goal is to centralize insurance services for clinical trials, providing increased expertise and responsiveness. This approach simplifies procedures for clients and ensures optimal compliance with local regulations.
Global insurers often have to set up local policies to fulfill strict regulations on non-admitted insurance. Our solution enables us to navigate within these varied regulatory environments.
Specialized brokers established in Europe and in the US already partner with A&Rs / i4CT, including UnisonSteadfast members.
Focus on Medical Trial & Insurance
Ethics and compliance
Ethical standards are paramount in clinical trials to protect the rights and well-being of participants. Trials must be approved by regulatory authorities and ethics committees before they begin. Participants provide informed consent, ensuring they understand the trial's purpose, procedures, risks, and benefits. Transparency and adherence to ethical guidelines are crucial for maintaining public trust in clinical research.
Ethics committees play a crucial role in verifying that insurance complies with the requirements of each country. The responsiveness of insurers is essential to provide the necessary certificates on time, as companies need these documents before conducting their clinical trials. The titles of the trials can change until the last moment, requiring great flexibility and rapid adaptation from insurers. A non-compliant or delayed certificate can block the launch of a clinical trial, highlighting the importance of responsiveness.
Risk and insurance
Insurance for clinical trials is essential to protect participants and companies testing new therapies. Life sciences companies, such as pharmaceutical manufacturers, biotechnology organizations, and medical device manufacturers, need insurance solutions tailored to the countries where the studies are conducted. Concerning the claims, the claims/trials ratio is very favorable (less than 5%) and it demonstrates the effectiveness of the risk management measures in place. In case of a claim, the details are handled confidentially between the insurers and the lawyers of the victims.
Choosing the right coverage
Choosing the right insurance for clinical trials is crucial to ensure the protection of participants and compliance with local regulations. Local obligations regarding clinical trial insurance must be known and respected. These requirements can come from country regulations, ethics committees, or investigative centers. The levels of coverage imposed by local obligations must be respected, and careful consideration must be given to ensure that the risk is adequately covered. Essential components of risk in a clinical trial include the type of study, the product being tested, the number of participants, the country where the study takes place, and the duration of the study.
The life sciences and clinical trials insurance sector offers numerous opportunities for companies and insurers. Innovation and international collaboration are essential to address future challenges and ensure the safety and compliance of clinical trials worldwide.
An insurance global framework available for UnisonSteadfast members
Global opportunity
The acquisition of A&Rs / i4CT by SATEC represents a major opportunity to meet the growing needs for clinical trials insurance globally. It allows the group to strengthen its expertise and expand its international capabilities.
Collaboration and leadership
By centralizing insurance services and collaborating with international partners, SATEC becomes a leader in the field of clinical trials insurance and brings its global solutions to UnisonSteadfast members.
If you want to develop your Life Science portfolio and need the best partners to manage clinical trials insurance, please don’t hesitate to contact us!
Meet the expert: Frédéric, Life Sciences & Med Tech Director @SATEC
Profile
Frédéric graduated as an engineer from Grenoble in 2001, specializing in risk management. Frédéric has held several positions in the world of risk management and insurance: analysis of complex risks (Air Liquide and AXA), civil liability underwriting (AXA), head of a brokerage firm dedicated to the life sciences (Biomedic-Insure) and finally, creation of Audit & RiskSolutions. Frédéric is regularly asked to speak at conferences, particularly about insurance for healthcare companies, both in France and abroad.