At PSR we have an expert team of hands-on Clinical Research Ascociates (CRA’s) who are specifically selected based on their experience in rare disease studies. They will work with Investigational centers to ensure your study is conducted in accordance with the protocol, standard operating procedures, applicable regulatory requirements and ICH-GCP.
Our CRA’s are science, nursing or medical graduates who understand the complexities of rare disease clinical trials and all have a minimum of 5 years of experience. PSR prides itself in working with local CRA’s and therefore can benefit from in-depth understanding of local regulations and hospital procedures. Together with their language and cultural advantages, the local CRA’s are able to interact with the appropriate staff to ensure effective study progress from regulatory set-up and submissions, study initiation, through monitoring until study close out.
The CRA’s are used to working with current technology like eCRF, eTMF and other common technologies, but are also familiar with more rare disease specific solutions like patient advocacy groups and home nursing solutions to maximize trial efficiency and lower patient burden. PSR’s dedicated CRA’s will help to ensure that your study is conducted smoothly, within the timelines and are very much aware of the importance of open and continuous communication.
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 Project Managers 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.
Our Clinical/Medical Monitoring service includes:
- Experienced CRA’s
- Local regulatory submissions
- Remote monitoring solutions
- Source Data Verification
- Site Management
- Ambulatory care coordination
- Monitoring plan
- CRA management
- Strict monitoring guidelines
- Subject safety
- Risk-based monitoring
- Local CRA’s
- Site staff training
- Patient Reported Outcomes (ePRO)
- Recruitment strategies