Services

Interventional clinical trials and non-interventional studies

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

Quality Management

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)

GCP Training

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. 

Consulting

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