Clinical Operations Network
Amselstra├če 25
D-68307 Mannheim, Germany
(nearest airport is Frankfurt/Main)
Tel.: +49 (621) 789 7000
Fax: +49 (621) 789 7010

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Clinical Trial Rescue Services

Every study has its difficulties and sometimes, despite the best efforts, a clinical trial is not proceeding as planned. As clinical trials are complex many issues can arise and jeopardize your development program - poor site compliance, inadequate expertise, or lack of resources. No matter the reason, CONET will help you get your study back on track. Our primary concern is maintaining data integrity.

Your study needs Clinical Trial Rescue Service?

In the course of a clinical trial, many issues can come up. In spite of careful preparation for study execution, the unexpected can always happen. If you start managing your study internally, you might discover that you do not have enough resources or required expertise. Timelines are not met because resources are taken away from the study team. When project deadlines are accelerated there might be a need for increased clinical services like monitoring or site management. Perhaps another CRO you have chosen is no longer able to fulfill your expectations or needs.

When your clinical trial has significant operational issues, it is time to bring in a new team of experts who have the experience to analyze the problems and provide quick and proper corrective action. CONET's focus on quality and expertise is the key to resolve your project problems.

CAPA: Corrective and Preventive Action

Whether you are experiencing problems with quality, compliance, resources and/or timelines, CONET offers a rescue service for any aspect of your clinical trial. Each study is unique and therefore every rescue is different. After a detailed root cause analysis of the problems our clinical trial team develops and implements a customized corrective and preventive action plan to resolve the current issues and prevent the recurrence of the same problem.

CONET offers rescue service for your entire trial or any aspect of your trial:
  • Issue analysis and solutions
  • Study management oversight
  • Management of vendors
  • Co-monitoring as an additional training tool
  • Emergency or increased site monitoring
  • Emergency site auditing
  • Data analysis
  • CAPA (Corrective and Preventive Action) plans and implementation

While we can't guarantee that we can save your study, our past success with clinical trial rescue is an excellent testimonial and predictor for the future.

Case Study

In the final phase of a clinical research development program a phase 3 clinical trial was conducted in USA and Europe. Clinical trial activities in Europe were provided by CONET for Eastern Europe, another CRO was responsible for 8 countries in Western Europe. Due to a high rate of personnel turnover (especially concerning CRA personnel) data quality was jeopardized in some countries. Therefore the sponsor decided to transfer the responsibility for project management, regulatory and monitoring activities for 4 Western European sites to CONET.

After take-over, an FDA inspection was announced to be conducted at the site with the highest recruitment rate. A successful FDA inspection was essential for receiving marketing approval for the study drug in the US. CONET's rescue monitoring team performed an emergency review to detect critical issues. A large number of protocol deviations and inadequate source data documentation were found due to insufficient training of study staff, reporting requirements to the Ethics Committees and to the sponsor were not followed completely, to list only some of the findings. The CONET team developed a corrective and preventive action plan (CAPA) and performed re-training of site staff. In addition, extensive re-monitoring of study data including source data verification was conducted. The end result - US marketing approval was granted one month after the FDA inspection took place.

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