Clinical research specialists from the heart of Europe

The regulation governing clinical trials conducted within the European Union is outlined in Regulation (EU) 536/2014 of the European Parliament and of the Council of 16 April 2014. According to this regulation, if a Sponsor of a clinical trial is not established within the EU, it must ensure that a natural person or legal entity is appointed as their Legal Representative within the EU.

Under Article 74 of the Regulation, the Legal Representative is responsible for ensuring that the Sponsor complies with its obligations under the Regulation (including administrative duties and responsibilities related to the conduct of clinical trials). Additionally, the Legal Representative serves as the point of contact for all communication between the Sponsor and the relevant institutions or authorities in the affected Member States.

Through years of experience, we’ve learned that proper feasibility is crucial to study success. At HD trial, we focus on identifying and clarifying the critical elements of the study protocol, engaging key opinion leaders across therapeutic areas to discuss these points for each country. This strategy allows us to select the right trial sites for successful collaboration throughout the clinical study.

From the very beginning, we at HD trial have built a strong network of high-quality trial sites and doctors who are experts in their fields and eager to discuss new studies with us.

The way clinical trials are conducted in the European Union (EU) has undergone significant changes since the introduction of the Clinical Trials Regulation (Regulation (EU) 536/2014) on 31 January 2022. This Regulation standardises the submission, assessment, and supervision of clinical trials across the EU, facilitated by the Clinical Trials Information System (CTIS).

CTIS serves as the single-entry point for submitting clinical trial information within the EU and the European Economic Area (EEA). It includes a Sponsor workspace for clinical trial sponsors and their partners, and an Authority workspace for EU Member States, EEA countries, and the European Commission.

At HD trial, we handle the preparation and collection of all necessary documents for submissions through CTIS. We also oversee the creation of applications for initial clinical trial approvals, maintain regular communication with authorities, and manage supplementary submissions in line with European and local legislation, providing support throughout the entire duration of the trial.

We provide expert guidance and flexibility when negotiating contracts with trial sites and investigators, leveraging our proven contract templates that can be adapted to suit each client’s unique requirements. These templates enable us to swiftly and efficiently set terms, saving both time and costs for our clients.

With our extensive experience in contract negotiation, you gain a reliable partner who streamlines the entire clinical trial process, oversees the efficient, transparent execution of every phase, and manages full compliance with current regulatory requirements.

We provide a comprehensive range of monitoring activities, including Site Selection, Site Initiation, Routine Monitoring, and Site Close-Out Visits. These visits can be conducted either on-site or remotely, in line with our flexible Standard Operating Procedures, which are designed to meet both international and local requirements.

We recognise the crucial role trial sites play in the success of clinical studies. That’s why we build trust-based relationships with each site, maintaining the right level of oversight and providing continuous support to study personnel throughout every phase of the clinical study.

We understand the daily pressure study personnel are under to balance clinical research with their routine clinical responsibilities. That’s why we aim to simplify their tasks whenever possible and offer support in every way we can.

Our Project Managers are fully accountable for every aspect of the project. They lead the project team and act as the primary point of contact for the Sponsor throughout.

Our project management is a seamless, efficient process, with thoughtful planning forming the foundation for every project’s success.

Managing risks is a key part of what we do. We identify potential challenges early on and create tailored resolution plans to help minimise costs, improve transparency, and strengthen the collaborative relationships with our clients. This approach enables us to consistently achieve successful outcomes for every project.

Clinical research demands precision in every word. Yet, we often come across translations that fall short—whether due to inexperience or a lack of understanding of the complexities of clinical trials. These errors can lead to costly delays and unnecessary complications.

At HD trial, we collaborate with expert translators who specialise in clinical research and use the latest Artificial Intelligence and Computer-Assisted Translation tools, alongside strict confidentiality protocols, to deliver translations that are both fast and of the highest quality.

Like us, they are true professionals, passionate about their work and always striving for improvement.

We are committed to upholding the highest ethical standards, strictly adhering to the principles of the Helsinki Declaration and Good Clinical Practice (GCP).

To support this commitment, we offer both online and in-person seminars tailored to elevate professional expertise in clinical research. Our training is customised for sponsors, CROs, and investigators, and is available for both newcomers to ICH-GCP and experienced professionals seeking to deepen their knowledge.

Moreover, the SMO provides Home Care services, offering patient’s home visits during clinical trials to enhance comfort and safety.

We also facilitate access to calibrated equipment for trial sites, with the SMO loaning equipment as required.

Finally, during feasibility, the SMO helps us gather up-to-date information, accelerating the process and improving efficiency for all involved.

At HD trial, we partner with a provider of an innovative online platform to streamline clinical trial subject reimbursement. This platform offers a customisable configuration for each study protocol and reimbursement requirement, enabling automated payments with just a simple click from site staff to confirm milestones in the system.

The platform simplifies the reimbursement process for sponsors, CROs, and investigators, making it straightforward and easy, while also significantly reducing the administrative burden on trial sites.

Data confidentiality and security are maintained at all times.