Our team is highly motivated and undergoes regular trainings which are documented in individal training logs.
The administrative team is trained in GCP, project management, data collection and documentation and preparation of monitoring, audit and inspection visits. There are also regular training on communication skills to increase the communication quality with out clients.
For the CRFF-Solutions team members who are involved in the quality in-process control (QA) seperate trainings are performed including how to deal with findings, implement correction and preventions means. They are also instructed on the importance of boundary conditions for investigational procedures in clinical trials.
Clinical teams at the trial sites are trained in GCP, and how to perform clinical trials. This includes also how to interact with trial participants and their family members/life partners. Patient centric attitude guarantees high recruitment and retention rates.
The CRFF-Solution Team
CRFF-Solutions' Exeptional Recruitment Model
In Case of Multi-Center Phase IIb and III Trails
This procedure guarantees fast recruitment rates and can bring clinical trials with recruitment problems back to the right track.
The CRff-Solutions team is then managing multiple clinical sites which are well trained and experienced in the permormance of clinical trials. Each clinical trial site (CS) is supported by recruitment centers (RC) which refer patients to the clinical trial sites.
CRff-Solutions can provide a modified recruitment model as presented on the figure below.
The most difficult and most unpredictable part in clinical drug development is recuritment of patients in clinical trials. Without a plannable recruitment rate, no successful clinical drug development. is possible.
CRFF-Solutions has therefore establische a recruitment system which allows patient recruitment with a high predictability.
The figure presents the CRFF-Solutions' recruitment and team building system for mono-center phase I and POC trials in target and special populations.
The clinical trial is performed in one our phase I unit or in one of our hospital based clinical sites which are well trained and experience in the performance of clinical trials. This clinical site is supported by preselected and also trained recruitment cemters (RC), referring suitable patients to the clinical trial side. I case of patients as trial participants, experts of the therapeutic atrea join the the CRFF-Solutions team as supportive team.
The CRFF-Solution team was assisting as rescue provider in a multi-center, multinational clinical trial performed in eight countries and three continents around the world.
Our team in Moldova was activated when the study was already in a critica phase of recruitment with a significant delay in the plannde time schedule.
During a fast approval process within 30 days, our team selected a suitable clinical site, performed a intensive trial specific training and started recruitment of patients immediately after full approval was granted.
The figure clearly shows the superiority of the CRFF-Solutions`' recruitment and team building model compared to the common way of clinical site and investigator based patient recruitment.
The figure below shows the mean efficacy parameter as a function of patients screened and included.
See How Effective the CRFF-Solutions' Recruitment Model also for Rescue Site Providing is
High Quality of Clinical Data
Our First Priority
Our internel qualtiy control (QC) system is based on in-process control. Well trained quality control managers are present during the most importent parts of the clinical trial.
All major procedures are documented in standard operation procedures. Each QC activity is documented in a standard report to senior management. There are regulare or ad hoc meeting with the clinical team to discuss findings and agree on corrective and preventive means.
Electronic Data Capture and Documentation
e-health and m-health devices and appropriate apps can also be implemented in ambulant clinical trials to lower burden for patients and guarantee data capture according to protocol requirements.
The e-CRF system allows online monitoring during the the most critical trial phases. This is especially important when trial participants are involved in small groups or as they show up in the trial center. Therefore monitoring time and costs can be significantly reduced
Safety data are available for independent review and advisory boards in short time.
The CRFF-Solution teams have experience with e-CRF and e-ISF data documentation.
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CRFF-Solutions is a cooperation of companies active in clinical research, covering all areas of clinical drug development. Emerging from classical phase I units, the cooperation extended phase I activities from male and female healthy young and elderly volunteers to target (e.g. oncology patients) or special populations. The latter serve as pharmacological models to investigate the impact of imaired organ function on the absorption, distributins, metabolization and excretion of investigational compounds.
CRFF-Solutions gained also experience in a variety of interaction trials also with PK/PD correlation.
Emerging from highly standardized early clinical drug develoment, CRFF-Solutions transferred its concept of controlled boundary conditions to hospital based clinical sites, specialized in different therapeutic areas, for pahse II and phase III clinical trials
Phase I clinical trials in male and female young and elderly healthy subjects as well as in special patient populations (e.g. oncology patients or renal or hepatic impaired patients)
Core Activities are:
Proof of concept trials in the target population (phase IIa)
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Interaction trials including pharmacocintec parameters and surrogate parameters for pharmacodynamic
Rescue site provider in case of recruitment problems in phase II and III multi-center trials
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First experience in phasless drug development by combining phase I and IIa in one protocol within less than six month
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Phase I pahrmacodynamic trials (e.g. TQT trials according to FDA standards in healthy subjects and risk populations (e.g. post-infarction patients)
Clinical trial site selection and management for multi-center pahse IIb and III trials
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CRFF-Solutions History
