Your therapies need to demonstrate measurable effectiveness and safety through clinical evidence and quality outcomes. ITREAS understands the value chain and the need for more creative and sophisticated outsourcing approaches that are required as a result of the increased cost of clinical development and higher demands for quality. Timely planning and commitment, a practical but thorough qualification process, as well as a strong governance model are all key when pursuing outsourcing of tasks and activities.dapibus leo.
Regulatory Authorities require you to ensure independent and bias-free safety and efficacy analyses.
We offer you valuable support to increase the robustness of your data.
Whether it concerns a novel drug dose finding study, or a large phase III trial, ITREAS enables you to realise your research strategies and to conduct state-of-the-art clinical trials through our extensive scientific, medical and operational expertise. We also provide unparalleled access to high quality, high recruiting investigative sites. All our processes are continuously monitored and quality controlled in order to deliver high quality data in line with the highest industry and regulatory standards. We offer you valuable support such as endpoint reporting manaagement and independent blinded adjudication services that increase the robustness of your data. This will reduce your timelines and avoids unplanned analyses as Regulatory Authorities require you to ensure independent and bias-free safety and efficacy analyses.
Our team has ample experience with all major pharmaceutical companies, as well as several biotechnology firms, in the design, execution, analysis, publication and presentation to health authorities of clinical trials.
- Preparation of a ready-to-submit protocol
- Biostatistics
- eCRF development
- Feasibility assessment and selection of an adequate number of high quality clinical centres with a proven track record
- Regulatory and ethics committee submissions
- Site training
- Blinded adjudication and processing of endpoints and core safety data