Manager, Clinical Studies
A clinical investigation is a systematic and planned regime of continuous generation, collection, analysis, and evaluation of clinical data on a medical device.
Clinical investigations are demanding processes, but they are also the most reliable way to produce high-quality information about the operation of a medical device.
Labquality provides services and expertise in the planning, preparation, and conduct of clinical investigations in accordance with the internationally acknowledged ISO 14155:2020 standard, as well as considering MDR and national requirements.
It is advisable to start planning the investigation in the early stages of product development so that it will align with clinical evaluation. Seamless collaboration with our clinical investigation CRO team and medical device consultants will guarantee the best possible results for our clients.
Research design should begin early in product development to align with clinical evaluation.
✔ Identify and determine the need, conditions, and requirements for a clinical investigation
✔ Participate in the preparation, writing, and evaluation of the investigation plan
✔ Prepare the necessary processes and documents needed for the investigation
✔ Prepare the permits and manage the permitting processes efficiently
✔ Act as project managers of the clinical investigation, and they will put together the necessary team and tools to conduct the investigation
✔ Prepare budgets and negotiate contracts with the healthcare units that will conduct the studies
✔ Prepare a monitoring plan and monitor the investigation
Data management ensures that high-quality data is being collected in the investigation. Data management services cover clinical investigation plan review and data management sections, data quality controls, CRF system specification and support for built-up, data management activities during trial and creation of the final study database including database locking.
Labquality now offers an even wider range of clinical investigation CRO services through its new subsidiary ARTIMED Medical Consulting GmbH in Germany.