An integrative approach of more up-to-date methodologies, clinical trials can effectively accelerate the delivery of higher quality data, early safety detection and at significantly lower cost. In an ever changing and complex regulatory environment, the challenges to bringing a new health product to market can seem overwhelming. Global knowledge with local experts will drive your trials through the best pathways.
Risk Based Management
Improve decision-making and lead to a more effective and efficient management and oversight framework, as well as optimal use of institutional resources. Therefore following ICH, GCPs and all updated regulations by health autorities.
In order to ensure that all employees are responsible and perform their tasks with the highest level of care and commitment, it is essential that they are trained through appropriate programmes. This is why our training sessions for the pharmaceutical industry cover various topics such as: Good Clinical Practice, Qualified Person, Legislative Compliance…
For a new investigational product to become an effective component of our healthcare system, the clinical development process and subsequent propagation into the market must be strategic, focused and unified.
Expertise on Medical Device
Medical device trials require an added level of specialized service and regulatory knowledge to be executed successfully. Although such clinical trials have many similarities to those for pharmaceuticals, the regulatory evaluation of devices is distinct with critical differences:
- Class of the device or risk stratification varies the requirement for a clinical trial, to demonstrate effectiveness consistently meets the labelled application.
- Safety reporting. For devices, manufacturers are required to report all SAEs, even if they are not directly related to the device or the procedure in which the device is used. This requirement applies not just to implantable, but also to in vitro devices and diagnostics which are not used directly by the patient.
- Clinical trial design and population studied, Medical devices may not be appropriate to insert the device into healthy subjects. Instead, a device trial may be initiated in a small pilot population with the disease or condition under study before moving into the larger pivotal populations.
- Clinical Trial classification, varies from medicinal products.
- Exploratory Study at early stages of device development.
- Pivotal Study to demonstrate the device is safe and effective for a specific use within a defined patient population and it’s used to gain regulatory approval to market the device.
- Postmarket Study
Being familiar with the specifications and format of drug and medical device clinical trials is crucial to ensure the trials run as smoothly and efficiently as possible, adding an extra value for successful commercialization.