Project Management
Clinical Trial Project Management
Our Project Manager will lead a multi-disciplinary clinical study team at DELPHINIUM to establish a smooth and efficient collaboration. As your primary point of contact they will facilitate communication between the project team and Sponsor.
- Provides leadership and direction to the project team, including specifications for time, quality and cost of deliverables
- Coordinates full range of clinical development services.
- Continuous monitoring of study progress, tracking timelines, budget, quality, and communication and optimizes processes where possible.
- Coordinate timely and accurate regulatory submissions.
- Organization and conduct of successful meetings.
- Coordinating statistical analysis and reporting of study data.
- Maintains a flexible, solution-oriented approach issues are innovatively and proactively addressed.
Regulatory submissions
Regulatory submissions and approvals are a critical part of the clinical trial process. Our regulatory affairs team specializes in guiding you through the complex process of obtaining necessary approvals from both the Ethical Committee and Competent Authorities.
We prepare applications and dossiers through the Clinical Trials Information System (CTIS), the mandatory platform for submitting clinical trial information in the European Union. We ensure a quick turnaround time of responding to queries and efficiently manage amendments, maintaining continuous communication with Ethical Committees and Competent Authorities.
Post-approval, we assist in ensuring compliance with all regulatory requirements, including safety reporting and protocol amendments. Our end-to-end support ensures your clinical trial progresses smoothly and adheres to all regulatory standards.
We work together with the BEBO Foundation for the Assessment of Ethics of Biomedical Research. They are an independent Medical Research Ethics Committee (MREC) for biomedical scientific research involving human subjects. The BEBO has weekly meetings.
