1. Clinical Monitoring
We carry out monitoring of clinical trials for you - from pre-screening to the closure of the trial sites:
• Clinical Monitoring at trial sites / remote monitoring
• Training and support of site staff
• Support in the maintenance of the study documentation
2. Clinical Study Management (Study Management)
We carry out clinical trials for you - from feasibility to the end of the clinical trial:
• Feasibility of the clinical trial and the trial sites
• Management of clinical trials and study budget, timelines and key milestones
• Functional leadership of the CRAs
3. Medical Writing
We support you with Medical Writing:
• Preparation of Clinical Study Protocols / Observational Plans
• Preparation of Patient Information Forms and Informed Consent Documents
• Preparation of Clinical Study Reports
• Preparation of scripts, poster or lay person communications
4. Site Management Oversight
We carry out site management oversight for you - from feasibility to the end of the clinical trial:
• Feasibility of the clinical trial and the trial sites
• Support in drafting the contract and contract negotiations
• Oversight of site management responsibilities
We can also support your clinical trial by:
• Reviewing and pre-auditing the Trial Master File (TMF)
• Visiting study sites and executing pre-audits
• Creating a visit report and Corrective and Preventive Action Plan (CAPA)
We perform GCP training for site staff: as repetitive training or for medical personnel starting to perform clinical trials. At the end of the training, a certificate is issued to all participants.
We advise pharmaceutical and biotechnological companies, hospitals and medical practices in the context of clinical trials. We support these:
1. When starting to perform clinical trials
2. During the set-up of a clinical trial
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