Late Phase Studies
At Linical we understand the challenges surrounding late phase clinical research and provide expert guidance for successful Non-Interventional Studies (NIS).
Real-World Evidence and Non-Interventional Studies
Real-world evidence (RWE) is playing an increasing role in health care decisions and there is major potential to increase the use of RWE to support lifecycle product development and to assist decision-making for regulators, payers, healthcare professionals (HCP) and patients.
In contrast to clinical trials, Non-Interventional Studies (NIS) reflect how a product is used in daily medical practice. By following patients in the real world, observational studies gather additional data that was not available at the time of the drug being marketed.
Late Phase CRO Services
Linical has decades of experience conducting Phase IV clinical trials including observational studies. Our specific late phase study plans incorporate NIS-based site selection and strategic regulatory approaches. We also provide an operational and monitoring model that is tailor-made for observational studies to ensure project success.
Our highly specialized team has specific expertise and provides guidance and key strategies to design and conduct successful Non-Interventional Studies.
Our late phase clinical development services include:
- Cohort Studies
- Prospective: Registries (Disease or Product)
- Retrospective: Chart Review Studies
- Case-controlled Studies
- Post-authorization Safety Studies (PASS)
- Drug Utilization Studies (DUS)
- Risk Minimisation Measures Surveys
- Health Economics and Time & Motion Studies
- Secondary Database Studies