- Pharmaceuticals: phase II-IV clinical trials
- Pharmaceuticals: non-interventional studies
- Medical device trials
Monitoring
According to the rules of good clinical practice (ICH-GCP), clinical monitoring is mandatory for all trials, whereby the scope of monitoring may vary. The scope depends on the complexity of the trial, on the risk potential and on safety considerations. All monitoring combinations are thus conceivable: on-site monitoring (at the trial site), remote monitoring (monitoring through access to the electronic CRF) or risk-based monitoring (concentration of monitoring resources on critical data, processes and/or trial sites).
Clinical monitoring is absolutely indispensable when it comes to ensuring very high data quality – without monitoring, the validity of the data cannot be ensured. Our team of experienced monitors comprises employed and freelance CRAs. Our highly qualified clinical monitors are located all over Germany, allowing us to flexibly support your trial. At the European level, we collaborate with CROs or freelancers in the respective countries. On request, we can agree on previously fixed rates to make the monitoring aspect a predictable factor in your trial budget.
We boast almost 20 years of experience in all types of monitoring in accordance with ICH-GCP and national legislation.
Allow our experienced CRAs to convince you of the quality of our work and ask us to take care of your monitoring.
- Recruitment of trial sites
- Evaluation of sites during selection or qualification visits
- Initiation
- On-site monitoring including close supervision and support of the trial sites between visits
- Remote monitoring
- Risk-based monitoring
- Site management
- Support of the site staff in all questions
- Support of the trial staff in reporting serious adverse events (SAEs)
- Support of the trial sites in preparing for audits or inspections
- Close-out visits
Need more information? Please don’t hesitate to contact us. Many questions can be answered quickly and easily in a personal conversation.
Monitoring
To ensure solid data quality also in NIS (non-interventional studies), monitoring is increasingly performed by experienced CRAs.
Our highly qualified clinical monitors are located all over Germany, allowing us to flexibly support your trial. On request, we can agree on previously fixed rates to make the monitoring aspect a predictable factor in your trial budget.
We boast almost 20 years of experience in all types of monitoring: on-site monitoring (at the trial site), remote monitoring (monitoring through access to the electronic CRF) or risk-based monitoring (concentration of monitoring resources on critical data, processes and/or trial sites).
Allow our experienced CRAs to convince you of the quality of our work and ask us to take care of your monitoring.
- Recruitment of trial sites
- Evaluation of sites
- Initiation
- On-site monitoring including close supervision and support of the trial sites between visits
- Remote monitoring
- Risk-based monitoring
- Site management
- Support of the site staff in all questions
- Close-out visits
Need more information? Please don’t hesitate to contact us. Many questions can be answered quickly and easily in a personal conversation.
Monitoring
According to ISO 14155, clinical monitoring is compulsory for all trials, as clinical monitoring is absolutely indispensable to guarantee very high data quality – without monitoring, the validity of the data cannot be ensured. Our team of experienced monitors comprises employed and freelance CRAs. Our highly qualified clinical monitors are located all over Germany, allowing us to flexibly support your trial. At the European level, we collaborate with CROs or freelancers in the respective countries. On request, we can agree on previously fixed rates to make the monitoring aspect a predictable factor in your trial budget.
We boast more than 10 years of experience in all types of monitoring in accordance with ISO 14155 and national legislation.
Allow our experienced CRAs to convince you of the quality of our work and ask us to take care of your monitoring.
- Recruitment of trial sites
- Evaluation of sites during the selection or qualification visit
- Initiation
- On-site monitoring including close supervision and support of the trial sites between visits
- Remote monitoring
- Risk-based monitoring
- Site management
- Support of the site staff in all questions
- Support of the trial staff in reporting serious adverse events (SAEs)
- Support of the trial sites in preparing for audits or inspections
- Close-out visits
Need more information? Please don’t hesitate to contact us. Many questions can be answered quickly and easily in a personal conversation.