Services

Interventional Clinical Trials

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 selection of trial sites
• Management of clinical trials and study budget, timelines and key milestones
• Functional leadership of the CRAs

3.    Sponsor / Vendor Oversight

We carry out  Sponsor (Vendor) Oversight for you - from feasibility to the end of the clinical trial:
• Feasibility of the clinical trial and selection of trial sites
• Support in drafting the contract and with budget and contract negotiations
• Preparation of a tailored Sponsor Oversight Process including an Oversight Plan
• Conducting Sponsor Oversight Activities

Quality Management

We support your clinical trial with:

• Audits & Inspection preparations

  • Vendor Audits for the qualification / re-qualification of vendors
  • Audits of Investigator Sites
  • Trial Master File Audits

• Preparation of a tailored Quality Management System including writing of SOPs
• Preparation of a tailored Risk Management Process including a Risk Management Plan

Training

We perform trainings (face to face and remote) on various topics of clinical research:

  • GCP-Training
  • Training on current topics of clinical research
  • Individual / In-house trainings

Please contact us if you would like to plan an individual or an Inhouse-training. Together with you we will prepare a tailored training outline.

Consulting

We advise pharmaceutical and biotechnological companies, hospitals and medical practices in the context of clinical trials. We support you:

1. With planning and conducting of clinical trials
2. With planning and conducting of Sponsor Oversight processes within Investigator Initiated Trials.
 

Please contact us!
This website is using cookies to provide a good browsing experience

These include essential cookies that are necessary for the operation of the site, as well as others that are used only for anonymous statistical purposes, for comfort settings or to display personalized content. You can decide for yourself which categories you want to allow. Please note that based on your settings, not all functions of the website may be available.

This website is using cookies to provide a good browsing experience

These include essential cookies that are necessary for the operation of the site, as well as others that are used only for anonymous statistical purposes, for comfort settings or to display personalized content. You can decide for yourself which categories you want to allow. Please note that based on your settings, not all functions of the website may be available.

Saved!