Classical monitoring on site

The Accovion monitor’s first priority is acting as the main line of communication between the sponsor and the investigator. Considering this, it is obvious that the monitor significantly affects the investigator and site performance. The monitor’s knowledge and capabilities strongly influence the timeliness and reliability of data.

Central monitoring

Central monitoring is in accordance with ICH E6 (GCP, sec. 5.18.3) and, as part of a sound monitoring plan, an accepted method by authorities and quality assurance professionals. Central monitoring often means “monitoring from the office”. This can be achieved by regular telephone meetings with various investigational site team members.

By applying state-of-the-art technology to a clinical trial, central monitoring can be an efficient complementary method to classical monitoring.

Data driven monitoring

Monitoring time is valuable and should be spent carefully. Data driven monitoring can support a highly complex trial and is an intelligent solution for limited resources in a huge megatrial. Using this concept, the questions WHEN and WHERE need to be answered prior to each monitoring visit.

The Accovion Data Management team intensively and continuously supports Accovion clinical monitors and provides them with data driven solutions and information on site performance, data quality and patient safety. Accovion clinical monitors can choose from a variety of information to decide the WHERE and to fix the WHEN. Because Accovion’s Data Management team has a reputation for excellence, you can trust the team’s innovative ideas to support the data driven monitoring concept. 

Applied risk management in monitoring

Your highly complex study competes with many other trials for recruitment of patients with severe diseases, and securing capable and motivated investigators is another important key to the success of your trial. To reduce risk and increase effectiveness, Accovion can support the creation of a risk management plan specific to your trial that will drive the way your trial is monitored. The Accovion applied risk management concept works successfully as a team approach between all involved parties.

Motivation concepts for sites

A variety of challenges can occur during the conduct of a clinical trial, such as:

• Slow patient recruitment
• Late data reporting
• Informed consent problems
• Reported data quality below expectations
• High number of protocol deviations
• Records not kept adequate and accurate

Accovion can perform site “booster” visits at one or more sites to identify causes and find timely solutions. We will conduct a detailed and professional root cause analysis and together with the site team, agree on individual solutions. We will work hard to ensure clinical trial sites pay adequate and proper attention to your trial.

Accovion will follow up on solution agreements and maintain a high level of motivation at each site. Sometimes small adjustments and innovative ideas are the best solutions. Let Accovion help you to find them.