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, NIS gather additional data that was not available at the time of the drug being released in the market. As a consequence of all this, these studies provide a strong external validity and allow companies not only to meet regulatory requirements, but also to generate economic evidence and enhance key customer relationships to grow leadership in the therapeutic area.
NIS Delivery at Linical
At Linical we understand the challenges surrounding Non-Interventional Studies and support sponsors in providing optimal study designs with budgets developed for NIS particularities, following NIS-specific SOPs and processes, and a RWE-specific training program for team members.
Our specific study plans are designed with NIS-based site selection and regulatory approach along with an optimal operational and monitoring model for observational studies ensuring project success.
Linical has wide experience, global reach, and skilled resources to provide full support in Non-interventional studies having successfully conducted more than 300 studies with a strong focus on Europe and Asia.
We have a highly specialized team with a very low turnover rate. Linical is adaptable and flexible, offering tailored solutions to our clients.
Our work spans through main therapeutic areas, including Oncology, Infectious Disease & Immunology, Neurology and Endocrinology and key indications, offering a full range of Non-Interventional Studies:
- 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
- Late phase randomized clinical trials
Optimize your NIS
Our Team combines specific expertise with a flexible approach, providing guidance and key strategies to design and conduct successful Non-Interventional studies
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With the right size, right reach and right team, Linical can help you navigate the most complex
aspects related to non-interventional studies
Understanding the role of Non-Interventional Studies in the generation of RWE: Efficient and quality delivery of NIS
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Strength and Limitations of Non-Interventional Studies (NIS)
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