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.
Our services include the following elements:
Continuous Analysis of Patient Files
Our Flying Study Nurses regularly compare all patient records of a test center with the included and excluded criteria of the study. They also take into account the anticipated course of the patient’s illness. In addition, they report reasons for screening failures back to sponsors and CROs so that they can be avoided in the future. Where appropriate, the study assistants shall propose adjustments to the inclusion and exclusion criteria. The comprehensive analysis provides sponsors and CROs with information on the costeffectiveness of the study centers.
Preparation of Documents
If necessary, our Flying Study Nurses bring patient files up to date and simultaneously create GCP-compliant Trial Master Files. By creating a professional GCP/ICH infrastructure on-site, they create the foundation for the smoothest possible monitoring, which reduces the time required and the number of questions to test centers. Compliance with international quality standards also allows the study to proceed according to plan and collect valid data that can be easily evaluated and documented.
Implementation of Clinical Studies by Flying Study Nurses
Our trained study assistants coordinate study projects in test centers and are available to all parties involved as permanent contacts. Since they concentrate exclusively on the realization of clinical studies, they strengthen their visibility on-site. Their tasks include organizational activities as well as accompanying patients. Through their time-consuming care services, Flying Study Nurses receive important additional information about their state of health, which they pass on directly to the doctors. Due to their many years of practical experience, they are also familiar with challenging projects in the fields of bio-technology and medical products.