Ergomed, a full-service Clinical Research Organization (CRO) specializes in oncology and rare/orphan diseases. The company places a specific emphasis on patient centricity, quality, consistency in study execution, expertise of staff, reliability and integrity of data, data protection and safety.
This article explores the unique support provided by Ergomed’s Site Management (SM) to investigational sites conducting clinical trials in rare disease indications.
Site Manager’s Role
The Site Manager at Ergomed is an integral part of the operational study team, responsible for providing continuous site and participant-centric support to investigational sites. This support aims to enhance site compliance with study protocols and ICH-GCP, leading to higher data credibility, increased participant recruitment, and higher participant retention.
Examples of Site Management Support across Multiple Rare Disease Case studies
Conducting clinical trials in rare disease indications presents unique challenges, including:
- limited participant populations,
- extended enrollment phase which can impact site motivation and awareness of protocol requirements,
- higher risk for participant drop out (e.g., living far from the site, lack of transportation),
- complex visit procedures often outside of standard care.
Ergomed’s Site Management addresses these challenges through:
Creation of Site-Specific Study Execution Mapping (SSSEM)
Prior to Site Initiation Visit our Site Managers investigate how the requirements of the protocol will be executed according to the policies and procedures of a site, taking into account each site’s specific policy, resources, personnel, and in some cases, physical layout. Mapping the study at each site is critical to study success, because each site will have a unique way of working, and the goal is to ensure that we operationalize the trial most efficiently, regardless of each site’s nuances.
Through our SSSEM process we ensures a seamless study execution, smooth patient journeys, and confident site teams, setting the foundation for trial success.
Critical aspects of trial execution captured in the SSSEM include:
- Participant identification pathways and recruitment resources
- Execution considerations for assessments in the protocol
- Specific considerations associated with the preparation and administration of the investigational medicinal product (IMP)
- Discharge and follow-up process
Continuous Site Oversight and Support in scheduling visits and study procedures
Investigational sites receive customized training to handle the specific protocols and procedures associated with rare disease trials, ensuring compliance and data integrity.
Given the limited participant populations and extended enrollment phase associated with rare disease trials we expect long breaks between new patient identified or patient visits which requires continuous site training to minimize the risk of protocol non-compliances and decreased patient evaluability.
Ergomed Site Manager provides real-time support to the sites, consultancy and re-trainings in relation to visit scheduling and performance of visit procedures e.g.: biological sample management, IMP management, image uploads, etc., ensuring smooth trial execution, compliance and data integrity.
Study Coordinator support with managing logistics with site referrals, cross-border recruitment and a family centric approach
Limited participant populations in rare indication trials require to develop targeted recruitment strategies to identify and enroll eligible participants efficiently. Our Site Managers coordinates with the Patient Concierge Service provider to arrange travel for the participant and family, accommodation, translator and reimbursement of costs. When allowed to have some of the procedures performed at participant’s home, Site Manager support the site in arranging Home Care Services.
Supporting Complex Clinical Trials
The Site Management support provided in non-rare trials shares some similarities with rare disease trials, however, there are notable differences:
Broader Participant Populations
Regular clinical trials often involve broader participant populations, making recruitment less challenging compared to rare disease trials.
Site Manager’s focus is to:
- Maintain close relationship and communication with the site to discuss recruitment status and challenges,
- Collect feedback/ pre-screening logs for Medical Monitor review to identify potential misunderstanding of the eligibility criteria and further re-training, if required,
- Tracking of recruitment activities against enrollment projections.
Standardized Protocols
The protocols and procedures in non-rare regular clinical trials are generally more standardized, requiring less specialized training and support but requiring logistic and administrative support from Site Manager including but is not limited to:
- Supporting sites in preparation for First Participant First Visit,
- Support in ordering and tracking of IMP and other Clinical Trial supplies,
- Proper completion of relevant study documentation,
- Facilitating biological sample processing & shipments to Central Laboratory,
- Patient travel/expenses reimbursement.
Routine Study Compliance Oversight
The SM team provides routine monitoring and support to Site Coordinators to ensure compliance with study protocols and regulatory requirements, similar to rare disease trials but with less intensive oversight on:
- Participants visit scheduling,
- Compliance of visit procedure (ePRO compliance, safety laboratories, imaging),
- Participant status in the study.
Conclusion
Ergomed’s Site Management team plays a crucial role in supporting investigational sites. While the fundamental principles of site support remain consistent, the unique challenges of rare disease trials necessitate specialized expertise, targeted recruitment strategies, customized training, and close collaboration. By addressing these challenges, Ergomed ensures the successful execution of clinical trials, maintaining the highest ethical and quality standards and regulatory compliance.