Monitoring

Pre-study visits – the key to a successful trial

Qualification of investigator and site, as well as a realistic estimate of recruitment – a highly critical step in the planning phase of a trial! Our team is trained to realistically assess the feasibility of recruitment and clinical performance of a site – for the sake of our sponsors.

Initiation visits

Training and motivation –- essential prerequisites for streamlining clinical performance: Our monitoring team invests a lot of effort to prepare excellent training documents and trial overviews in order to create the basis for a successful trial. Intensive interaction with the sponsor and supervision of the senior monitor results in excellent success.

Effective clinical monitoring as daily routine …

Our skilled and well-trained CRAs ensure highest quality source data verification and effective interaction with study sites. Our CRAs conduct on-site monitoring visits throughout the study to:

• Verify subject eligibility and informed consent
• Oversee data collection
• Ensure investigator compliance with the protocol and regulations and identify any deviations to the clinical study plan
• Review source documentation and case report forms
• Ensure reporting of adverse events
• Ensure regulatory compliance
• Resolve data queries
• Conduct interim analyses as requested by clients

… but also in difficult situations

Unexpected difficulties during clinical performance, accumulation of “missing data” at a site, any situation of misconduct or even fraud – sometimes obvious, sometimes difficult to appraise – in such situations experience matters. But not only experience – a well-developed escalation system within the monitoring group helps the “lone fighter” at the site to come to the right decision quickly.

The close-out visit – a prerequisite for successful inspections

Besides the collection of study drug and outstanding patient data and study forms, adequate preparation of plans for record retention and fulfilment of ongoing investigator responsibilities are highly important for reducing the risk of critical inspection findings. Our CRAs provide strong support for the centres.

Monitoring early clinical trials

Phase-I(II) is different! Our monitoring team offers a high level of early-phase experience to streamline the processes of source data verification and to care for the specific regulatory requirements in early clinical trials. They gain their experience in our own highly professional clinical pharmacology unit under supervision of our QA department.