Conducting a clinical trial in an efficient and cost-effective manner requires a strong partnership between the MedTech sponsor and the Clinical Research Organization (CRO). To ensure that both parties are on the same page, it is important to understand each other's needs and expectations. This includes understanding the informed consent process, selecting the right institutions, adhering to ethical standards, and utilizing the right tools. Eliminating doses that are not effective, differentiated, or safe can increase the value and efficiency of the study by reducing costs.
To ensure that all parties involved are on the same page, it is important to understand each other's needs and expectations. Institutions are unlikely to support a clinical research company that will harm their results, and industry sponsors are unlikely to choose centers that cannot document a proven history of accumulating funds. When Roche conducts clinical trials in developing countries, they must adhere to the same high standards of ethical conduct and scientific integrity as they do in other countries. This includes following the principles of the Declaration of Helsinki and abiding by the laws and regulations of the country in which the research is conducted. This provides greater protection to individuals participating in clinical trials. Low-cumulation clinical trials present a double obstacle when it comes to transferring advances from research to the clinic.
The fundamental ethical question of clinical research is whether the outcome of the research can reasonably be expected to benefit society without harming the people enrolled in the trial. Many essential documents are specific to medical device trials, such as the clinical research plan, instructions for use, declarations of conformity and the clinical research report. Real-time access to scheduling information allows clinical and research teams to more easily track enrollment and other study progress, document study milestones for sponsors, and stay on top of bills and their reimbursement. Contract Research Organizations (CROs) with experience in pharmaceutical clinical trials can provide strategic information that contributes to the overall clinical evaluation and accelerates device development. SparcRequest can link related services from its catalog to optimize research workflows, for example, linking compliance review of research billing to ClinicalTrials. For more information on clinical trials protocol registration policy and publication of clinical trial results, please refer to relevant documents.
To ensure compliance with good clinical practice (GCP), Roche will provide training to employees working in clinical research and related areas.