In order for clinical study projects to proceed according to plan, it is crucial to include the required number of suitable patients in the study within the given time.
If this is not successful, their implementation may start to waver. Possible consequences: Important milestones are either not attained or are attained at a later time, the entry into the next study phase or even the marketability of the product is delayed, additional costs are incurred and the pressure from competitors increases. Negative recruitment figures are usually attributable to various causes. The most common are overworked staff in medical offices and clinics as well as an inadequate on-site GCP/ICH infrastructure.
This is where Invisio Clinical Studies Consulting comes in. We use our experience from more than 100 national and international Phase 1 to Phase 4 clinical studies to identify and recruit potential patients – regardless of whether the study projects are in the planning stage or have already started. If required, our Flying Study Nurses implement clinical studies in the respective test centers and thus relieve the staff on-site.
By optimizing patient recruitment, Invisio supports sponsors and CROs in implementing their study project as planned, on time and within budget.
How Invisio finds the right patients
Invisio supports sponsors / CROs as a strategic partner in the search for suitable study participants for national and international clinical study projects at phases 1 to 4. Here are the services at a glance:
- Regular comparison of all patient records with inclusion and exclusion criteria of the study, taking into account the expected course of the disease
- Feedback of reasons for screening failures to sponsors / CROs
- Proposals for adapting the study’s inclusion and exclusion criteria
- Comprehensive analysis of the profitability of the study centers and alternative proposals
- Interface between project participants, organization of relevant dates, monitoring of schedule and budget
- Coordination of the study project at trial centers (also at several parallel sites)
- Establishing and maintaining a professional GCP/ICH infrastructure on site
- Selection, coordination and care of patients at the trial center / their home
- Updating of patient records
- Creation of GCP-compliant trial master files
Benefit from further positive effects
- Focus on implementation of the clinical study strengthens its visibility on site
- Professional GCP/ICH infrastructure creates a foundation for smooth monitoring as well as reduces the time required and the number of queries to trial centers
- Adherence to international quality standards enables the study to proceed according to plan
- Collection of valid data that can be evaluated and substantiated at any time
- Through intensive care, Invisio Flying Study Nurses receive additional information about patients’ health status, which they pass on to the doctors
- Invisio Flying Study Nurses are familiar with challenging projects in the fields of biotech and medical devices
- Reduces the workload for permanent staff in trial centers