Conducting a clinical trial requires a sponsor, which can be a person, institution, company, or organization such as a contract research organization (CRO). The sponsor is responsible for initiating, managing, or funding the clinical trial, but does not actually carry out the research. The principal investigator is responsible for the investigation and must be qualified to do so. A CRO is a company that provides clinical trial services for the pharmaceutical, biotechnology and medical device industries.
They offer services such as regulatory matters, clinical trial planning, center selection and initiation, recruitment support, clinical monitoring, data management, trial logistics, biostatistics, medical writing, and project management. When the parties agree that the UAB will be a center, the sponsor will provide a clinical trial agreement (CTA). In some cases, the agreement provided by the sponsor will be a simple work order since the main terms of the agreement have already been negotiated between the parties under a project master agreement (PMA).The FDA evaluates whether the study staff is qualified to perform delegated tasks, whether they received adequate training and explanation of the protocol, whether the participation of the principal investigator is adequate and continuing, and if participating third parties and contracted research organizations have adequate oversight. Active clinical monitoring can help predict potential clinical trial challenges or identify problems early so that they can be addressed before they cause significant delays that increase costs or derail the trial altogether. Working with a CRO can offer innovative tools that can increase efficiency and reduce time and costs. The budget for a clinical trial will be per patient or per visit with additional items such as start-up costs and fees for clinical trials funded by the UAB industry to be billed separately.
Planning the clinical trial and launching the study include creating the clinical plan and protocol and obtaining necessary approvals from regulatory authorities and ethics committees. Following standards of good clinical practice for clinical research will allow collection of quality data and facilitate analysis and publication process. After completion of a clinical trial, CROs offer sponsors and investigators comprehensive but efficient monitoring plans to manage clinical trials and build trust in integrity of clinical trials.