Clinical Trial Insurance

Clinical trial insurance is a small but important detail for the success of your research. With over 20 years of experience in the field of subject insurance, Baerkraft will help you meet all requirements. Our unique online application process ensures maximum clarity and efficiency.

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Clinical Trial Insurance Does Matter

Organizing and conducting clinical trials comes with numerous challenges for project managers, sponsors, and other stakeholders. Among these tasks is ensuring that the trial and its participants are adequately insured, a requirement almost always mandated by law or contracts. Timely and accurate insurance coverage prevents delays in risk assessment and documentation, which could otherwise significantly disrupt the trial’s progress.

While insurance may seem like a straightforward task, varying regulatory requirements and country-specific complexities can make the process unexpectedly demanding. This is where Baerkraft excels. With over 20 years of experience in clinical trial insurance and a broad network of insurers and CROs, Baerkraft provides not only the necessary insurance coverage but also hands-on support for optimizing processes and ensuring compliance.

This article will show how Baerkraft helps make the insurance process efficient, reliable, and stress-free, so you can focus on what truly matters: the success of your clinical research.

The Complexity of Subject Insurance

On the surface, insuring a clinical trial may seem like a standard administrative task. However, a closer look reveals numerous challenges that must be addressed to ensure a smooth and timely insurance process.

First, there are the extensive regulatory requirements that vary significantly depending on the country and type of trial. In the European and German contexts, for example, the requirements are defined under the Medicinal Products Act (AMG) and the Medical Device Regulation (MDR). Navigating these rules requires precise knowledge of legal frameworks and insurance policies, not only for trial-specific insurance but also for related policies such as product liability for sponsors, general liability for CROs and study sites, and professional liability for investigators. Regulations in other jurisdictions can differ substantially, adding to the complexity.

Insurance is therefore more than a procedural step; it is a critical part of trial planning. Coverage is valid only for the specified version of the study protocol and patient information. Ethics committees and regulatory authorities require a valid insurance certificate for the version of the protocol to be approved. Any changes to risk-relevant details must be reported to the insurer, understood by them, and confirmed with a certificate before the protocol can be submitted for approval. Failure to manage and update risk information can halt the entire trial and lead to significant costs that, in worst cases, far exceed the insurance premiums.

Work with Baerkraft

At Baerkraft, we specialize in solving these issues. With years of experience and the use of advanced technology and optimized workflows, we significantly reduce the administrative burden of insuring your clinical trial. Over the past two decades, Baerkraft has successfully supported hundreds of clinical trials. Our clients consistently praise our efficient processes, responsive service, and personal touch.

Our globally unique dynamic online application process ensures clarity and accuracy from the outset, making it easier to navigate the complexities of clinical trial insurance.

Beyond advanced processes and modern technology, Baerkraft offers a highly qualified team with extensive experience in clinical trials. Our experts combine practical knowledge of regulatory demands with longstanding relationships with insurers and CROs. This means we know the fastest routes to progress in insurance matters. We speak the same language as sponsors, CROs, and study sites, enabling efficient and targeted communication.

Our Insurance Process

Dynamic Online Risk Assessment

Our globally unique dynamic online application process is the starting point for insuring your clinical trial. Designed for efficiency, it captures complex information accurately and adapts to the specific requirements of your trial, minimizing effort and reducing errors.

Streamlined Tender Process

Baerkraft’s tender process ensures you receive the best possible insurance offers quickly and efficiently:

  1. Once your completed questionnaire is submitted, it is immediately reviewed by an internal expert. If there are any uncertainties, we contact you directly to clarify.
  2. After review, your questionnaire is forwarded to all relevant underwriters specializing in clinical trial insurance.
  3. All received offers are compiled into a clear, tabular summary, highlighting key conditions and differences between offers to facilitate informed decisions.
  4. Upon selecting an offer, we promptly communicate your choice to the chosen insurer, who will issue the required insurance certificate for ethics committees or regulatory authorities.


Note: Providing key documents, such as the current patient information and, for multicenter studies, a list of study sites and investigators, at the start of the process allows us to deliver a comparison of offers within five business days.

Proactive Support During the Contract Period

Clinical trials are dynamic, often requiring adjustments to insurance coverage or the rapid handling of amendments. Baerkraft offers proactive project management throughout the contract period, supporting you with:

  • Policy and Invoice Review: Ensuring all documents are complete and accurate.
  • Deadline Management: Timely reminders for contract extensions or terminations to avoid delays or complications.
  • Claims Assistance: Guiding you through the communication and resolution process in case of insurance claims.
  • Reporting Changes: Helping you comply with mandatory reporting of risk-relevant changes or events to keep your coverage up to date.

„TrialPlus“ Extended Support Service

For enhanced trial support, Baerkraft offers the optional „TrialPlus“ service, including:

Monthly Reporting:

  • Monitoring risk-relevant updates (e.g., protocol changes).
  • Tracking active countries, sites, investigators, and screening activities.#
  • Maintaining a status overview and history of required documents.
  • Managing all contractual obligations and reporting logs.
  • Detailed cost tracking and activity histories.


Secure Document Management System:

  • Dedicated data room for critical documents (e.g., questionnaires, policies).
  • Web-based platform with SSL encryption and GDPR compliance.
  • Daily backups for maximum data security.


Advanced Communication Support:

Our expert team offers unmatched problem-solving support for insurance, obligations, and document management, leveraging years of experience and a global network.

Summary and Next Steps

While insurance may seem secondary to the broader scope of clinical trials, its smooth execution is essential for your study’s success. Baerkraft combines expertise, tools, and networks to streamline the process, letting you focus on your research.

Need an insurance quote for your next trial?

Fill out our online questionnaire today, and we’ll start the tender process immediately. Let’s ensure your trial is fully protected.

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