At PSR, we have the experience to set up and run orphan drug studies successfully. Our project managers are very experienced and familiar with managing complex, multinational studies in the rare disease space, and have the know-how to use novel approaches to gain access to patients and maintain protocol compliance.
When managing our projects, we create true partnerships with our clients, investigators, key opinion leaders and all other stakeholders in the program. Our project managers highly value the term Team Effort both from an internal team perspective as well as for external stakeholders.
In close collaboration with the sponsor and patient groups, we may present a study to a group of patients, also teaching them about clinical trial participation in general.
In order to increase patient recruitment and retention, we always strive to limit the burden on patients and their families as much as possible, for instance by facilitating home healthcare and cross-border enrolment.
Our experienced PMs save no effort to find out-of-the-box solutions to ad-hoc challenges, in order to keep a rare disease patient in a trial. Losing a patient for practical or logistical reasons should be avoided at all times.
Current Project Management/Clinical Operations core activities are:
- Coordinating study start-up
- Overall timeline and budget compliance
- Managing all involved stakeholders
- Coordinating all involved departments (e.g. data management, clinical monitoring)