Clinical Trials
Prioritizing Patient Safety.
We offer Lean and Agile solutions which will meet your timelines for clinical trials whether you apply in the USA (FDA) and in Europe (EMA).
We can support Sponsors with a wide range of services thanks to our network of clinical experts who can address the different laws across the several European jurisdictions.
Better, Faster and Safer Therapies for Patients
Clinical Trials
Faster and Safer Therapies
Our Lean and Agile solutions meet timelines for clinical trials in the USA and Europe. Our network of clinical experts addresses different laws across several European jurisdictions. Trust us to bring faster and safer therapies to market.
Prioritizing Patient Safety
We support companies enhancing safety protocols, monitoring and reporting adverse events, and ensuring that patients are fully informed about the risks and benefits of participating in a clinical trial.
Patient Experience
Our focus is on providing patients with more than just access to therapy – we aim to develop patient services that cover everything from funding to engagement. We invest in patient-centric digital capabilities that allow us to anticipate patient needs and expectations, thanks to predictive measures built on the analysis of patients’ data.
Drug Development
To stay ahead of the curve, we focus on reducing costs to bring an asset to the market and improve the return on pharmaceutical innovation (RPI). We use hybrid clinical trial models to cut costs, accelerate the completion of trials, and support patient engagement.
Regulatory
We accelerate the integration of science and technology in medicines development to meet regulatory requirements. Regulators require more evidence which cannot all come from clinical trials. We use digital collaboration to demonstrate real-life value, starting from R&D and increasing patient involvement, to gather more collaborative evidence generation for better scientific quality of evaluations by regulators. We enable collaboration with healthcare systems as early as possible, by considering rolling reviews which can be considered outside of public health emergency. We ensure patient privacy by adapting GDPR policies.
🧠💪 Our area of expertise covers
- Clinical trial’s authorisation procedure
- Good Clinical Practice
- Safety Reporting
- Clinical Trial Data Transparency
🚀 Our capabilities include
- Quality Assurance & Compliance
- Regulatory
- Pharmacovigilance
- Development
- Medical
- Statistical
- Market Access
- IT & Data Management
