Investigator-initiated clinical trials
We support academic institutions, hospitals, and investigators in successfully planning and executing investigator-led studies.
Expert support for investigator-initiated trials
Investigator-initiated trials are clinical studies where the investigator or research institution acts as the sponsor. These types of trials can be conducted by a university or may be initiated by doctors employed by local governments or working in private practice. Investigator-driven clinical trials play a critical role in advancing clinical knowledge and exploring new uses, populations, or approaches—but they also come with significant regulatory and operational responsibilities.
At Aurevia, we support academic institutions, hospitals, and investigators in successfully planning and executing investigator-sponsored studies. Our teams have deep knowledge and hands-on experience in supporting both pharma and MD/IVD studies, across multiple indications and development phases, in multinational and multi-site settings.
Whether you need full-service support or targeted expertise, our teams ensure your clinical study meets regulatory requirements while maintaining scientific integrity and operational efficiency.
Our support for investigator-initiated trials covers:
- Guidance on sponsor-investigator responsibilities and regulatory requirements
- Sponsor oversight
- Clinical project management, study planning, feasibility assessments, and protocol development support
- Preparation and submission of regulatory and ethics applications
- Development of essential study documentation (e.g., protocol, informed consent, other patient-facing documents, and study files)
- Setup and management of Trial Master File (TMF)
- Support with site selection, site initiation, and training
- Monitoring and quality oversight
- Safety reporting and pharmacovigilance/vigilance support
- Data management, medical writing, and biostatistics support
- Vendor coordination and oversight (e.g., labs, CRO partners, technology platform providers)
- Support for audits, inspections, and compliance readiness
- Study close-out and reporting
Flexible support tailored to your needs
If this is your first time running an investigator-initiated trial, the list of responsibilities can be daunting, including: planning the study; writing the protocol, patient information, and informed consent; regulatory submissions and managing study documentation; site initiation and management; data management and analysis; study close-out and reporting; and ensuring the study is conducted according to GCP and other applicable laws and regulations.
With Aurevia as your partner, you gain the structure, expertise, and support needed to run your study with confidence.
Our team collaborates closely with investigators and institutions to ensure that all activities are aligned with applicable regulations, while maintaining a practical and efficient approach.
We understand that investigator-initiated trials vary widely in scope and resources, which is why we offer flexible solutions, from advisory support at key stages to full-service clinical trial management.
As an investigator or sponsor-investigator, having access to experienced clinical and regulatory experts can make all the difference in navigating the complexities of trial conduct—while allowing you to stay focused on the scientific objectives.
Our culture is our key to success
At Aurevia, our team has a strong connection to each other, as well as to our customers. Our focus on relationships truly makes a difference and is the key to the project's success.
Practical, investigator-focused approach
We tailor our support to the realities of academic and investigator-led research, balancing compliance with efficiency.
Reliable and quality-driven delivery
We prioritize transparency, clear communication, and high-quality outcomes throughout the study.
Scalable and flexible solutions
Whether you need support for standalone activities, an entire study or a broader research program, we adapt to your needs.
Geographical coverage
With teams in Sweden, Germany, Poland, and Finland, and a strong European network, we support investigator-initiated trials across multiple countries and sites.
Integrated clinical and regulatory expertise
Our multidisciplinary team brings together expertise in clinical operations, regulatory affairs, and quality assurance.
Get in touch with us
Explore our CRO services
Clinical operations
Our experienced teams can help you plan, design and conduct your clinical studies from start to finish.
Clinical project management
Clinical Project Managers (CPMs) oversee your clinical study to solve challenges and streamline your project.
Medical writing
Let our medical writers prepare and update your regulatory and technical documentation quickly and efficiently.
Data management
We support you with robust data management services that ensure the quality of your clinical study data.
Biostatistics
We offer custom solutions for high-quality data analysis to help you design and analyze your clinical study.
Outsourcing solutions
We provide experienced clinical research consultants who integrate seamlessly into your team when you need extra resources.
Pharmacovigilance
Pharmacovigilance services including services for medical monitoring, coding of adverse events and safety reporting.
Vigilance
Vigilance services including services for medical monitoring, coding of adverse events and safety reporting.
Investigator-initiated trials
Expert support for academic institutions, hospitals, and investigators in successfully planning and executing investigator-initiated clinical trials.
Our customer-centric approach means that our client’s needs guide our focus to create impactful results.
We prioritize transparency, dependability, and delivering high-quality results.
We deliver agile, tailored solutions through deep expertise and a commitment to excellence.