CRO Services
A strategic partner for clinical research
Advice Pharma supports sponsors, pharmaceutical and biotechnology companies, and medical device manufacturers in the development and management of complex clinical studies, providing integrated expertise, established processes and advanced technological solutions.
We operate across the entire clinical study lifecycle, from initial planning through to final reporting, ensuring high standards of quality, regulatory compliance and operational excellence.
Our goal: more efficient studies, more reliable data and better-informed decisions.
The Advice Pharma Advantage
Full-Service Approach
A single partner providing integrated management across the entire clinical research journey.
Multidisciplinary Expertise
Specialist teams in Clinical Operations, Regulatory Affairs, Data Science, Pharmacovigilance and Digital Health.
Operational Excellence
Structured processes, transparent governance and continuous performance monitoring.
Technology and Innovation
Proprietary digital platforms designed to improve operational efficiency and data quality.
Quality and Compliance
Compliance with GCP, ICH and MDR requirements, as well as key international regulations.
Types of Studies We Support
- Interventional clinical studies, Phases I–IV
- Clinical investigations of medical devices
- Prospective and retrospective non-interventional studies
- Registry-based studies and Real-World Evidence studies
- Nutraceutical studies
- Compassionate use programmes
- Digital solutions and decentralised clinical studies
Our Services
From study planning through to close-out, we support every stage of the clinical research journey with expertise, innovation and reliability.
We support the strategic design of clinical studies through feasibility analyses, risk assessments and operational planning, with the aim of maximising the likelihood of project success.
Key capabilities
- Feasibility assessment and site selection
- Study design and methodology
- Recruitment strategy
- Risk assessment
- Operational planning
We manage the entire study start-up process, ensuring the timely activation of clinical sites and full compliance with national and international regulatory requirements.
Key capabilities
- Regulatory submissions
- Ethics and administrative approvals
- Study start-up management
- Site activation
- Vendor coordination
We coordinate every stage of the study through an approach focused on effective governance, performance oversight and proactive risk management.
Key capabilities
- Programme governance
- Timeline and budget control
- Risk management
- Stakeholder management
- KPIs and strategic reporting
We provide clinical monitoring services based on traditional monitoring models and Risk-Based Monitoring, ensuring data quality, patient protection and GCP compliance.
Key capabilities
- On-site monitoring
- Remote monitoring
- Risk-Based Monitoring (RBM)
- Site management
- Quality oversight
We ensure the structured management of clinical data through validated processes, dedicated technologies and rigorous quality controls.
Key capabilities
- eCRF design and validation
- Data review and cleaning
- Query management
- Medical coding
- Data quality metrics
We provide methodological and analytical support to transform complex data into robust and scientifically reliable evidence.
Key capabilities
- Study design support
- Sample size calculation
- Statistical Analysis Plans
- Statistical analysis
- SAS and R programming
- CDISC standards
We manage safety activities throughout every stage of the product lifecycle, ensuring timely delivery, full traceability and regulatory compliance.
Key capabilities
- Safety management
- AE and SAE processing
- Safety reporting
- Medical device vigilance
- Regulatory compliance
We develop high-quality clinical, regulatory and scientific documentation that meets rigorous methodological requirements and complies fully with international standards.
Key capabilities
- Study protocols and synopses
- Clinical Study Reports
- Regulatory documentation
- Scientific publications
- Medical communications
We support the validation of systems and digital platforms used in GxP-regulated environments, ensuring reliability, security and data integrity.
Key capabilities
- CSV strategy
- Validation planning
- Risk assessment
- IQ, OQ and PQ
- Data integrity
- Compliance assessment
We streamline the contractual and financial management of clinical sites through transparent, traceable and efficient processes.
Key capabilities
- Contract negotiation
- Budget management
- Site payments
- Compliance management
We provide clinical sites with continuous operational support designed to improve efficiency, compliance and patient recruitment performance.
Key capabilities
- Site engagement
- Operational support
- Study coordination
- Performance monitoring
- Compliance enhancement
We design and conduct observational and post-authorisation studies, transforming Real-World Data into reliable evidence to support clinical, regulatory and market access decision-making.
Aree terapeutiche
Oncology
Cardiovascular Diseases
Dermatology
Haematology
Urology
Pain Management
Neurology
Rare Diseases
Metabolic Diseases