Real World & Outcomes Research Unit
Expertise and flexibility in gathering and generating the real world evidence that you need
In the photo: Liliana Cunha, Perpétua Rocha – Global Director, Sofia Roa, and Paula Maldini
Market access strategy in pre- and post-commercialization framework is a key issue in the current biopharmaceutical competitive market environment.
There is an increasing need and awareness for the collection and analyses of real world epidemiologic and clinical evidence, in different formats and from different sources, to allow the Device and Biopharmaceutical Industry to answer questions and needs from different stakeholders.
Our Real-World & Outcomes research unit can target particular therapeutic areas or populations where relevant treatment outcomes are required to ascertain the effectiveness, safety, surveillance, risk management, acceptability, utilization patterns and cost-effectiveness of a product. Whether you need an integrated or a stand-alone solution, our team of pharmacoepidemiologists, pharmacovigilance, regulatory and research operations can help you to create the right approach to ensure that you access the benefits, risks and results of treatments in a real-world setting.
Patient centric research, using electronic PROs (patient report outcomes) collects particular concerns, circumstances and preferences from the patients which will support the evidence that is essential for the biopharmaceutical and medical devices industry. Through this approach we can support the product development lifecycle by combining different type of services:
With 20 years of experience of scientific, clinical and operational expertise in late stage research, our specialized team has created value for therapies and maximized communication opportunities with key customers throughout the conduction of several studies that supported or assessed:
- Product safety, effectiveness and quality in a real-world setting;
- Regulatory authority requirements and commitments for post-approval safety surveillance and effectiveness;
- Health care resource utilization data to support reimbursement;
- Physician Practice Patterns and adherence to established treatment guidelines;
- Clinical Outcome Assessment (COA) and patient reported outcomes (PRO) including quality of life, patient adherence, preference and treatment satisfaction to better communicate the product value;
- Diseases prevalence and incidence;
- Knowledge of burden or impact of illness;
- Unmet Medical needs / off-label use;
- Promote and monitor health management programs.