Academic clinical trials are essential for clinical research especially for optimizing patient treatment.
Even though the legal responsibilities, tasks and duties are the same s for conventional clinical trials, IITs are special due to the fact that the financial budgets are in general limited. The peculiarities and difficulties have to be considered, an optimal planning from the very first moment is mandatory in order to perform and finalize them successfully.
Application processes for public funding (public grants) is often a very time consuming; funding decisions are made within a years’ time frame at a minimum. In this early phase, CTC North already offers support for the calculation and planning of clinical studies. A sound calculation of the planned clinical trial including costs for contingency plans is the basis for a reasonable funding application and avoids that the study has been calculated too tightly and cannot be finalized.
Our approach is to discuss and decide together with the sponsor which tasks can be performed by the sponsor in case the financial resources are limited and which tasks we suggest should be overtaken by experts in order to guarantee an ideal use of the financial and personnel resources.
The primary objective during the planning and conduct of clinical trials is the identification of potential risks and minimizing them.
We have many years of broad experience in planning, management and conduct of IITs as well as in public funding applications. Therefore, problem-solving approaches for all conceivable challenges are included in our actions that supports to finalize clinical trials successfully.
Besides conducting Phase I studies in both healthy volunteers and patients since 2006, we have also performed more than 60 phase II–IV trials (including medical device trials) with patients while acting as a study site within multicenter clinical trials. These experiences added valuable know-how to CTC Norths principle investigators, study nurses and project managers. Thus, our personnel does not plan studies theoretically. They do exactly know which difficulties and challenges can occur during the conduct of clinical trials, e.g. complicated and not clearly defined protocols, extensive documentation, complex in- and exclusion criteria, misjudgment regarding recruitment performance, etc. They help and support qualified based on their longtime experience within the conduct of clinical trials.
The Clinical Trial Management division has a long term experience in the organization and coordination of multicenter Investigator-Initiated Trials in several indications. CTC North has conducted more than 60 single- and multicenter trials during the last 8 years, about the half of them were IITs.
These services can comprise the entire process of a clinical study from the very beginning e.g. support during application of public grants, development of the study protocol until final report. However, all services can be provided separately.
We are able to offer all services for preparation, organization, coordination and management of clinical trials, which that means in particular:
• Consulting and support during application of public funding
• Project management
• Site Management
• Regulatory affairs
• Medical writing
• Safety management
• Data management
This range of services applies for national clinical trials as well as for European projects. Currently, CTC North is partner in an EU (Horizon 2020) funded clinical study project and is subcontracted for clinical trial services in two projects funded under the FP 7 Health program.
Also in our focus is the provision of advisory services to investigators and research scientists at the UKE and other university hospitals as well as to pharmaceutical and medical device companies in Germany.
Saskia Borregaard, PhD
Director, Clinical Trial Management
Tel.: +49 40 524719 200
Fax: +49 40 524719 119