Services
Our goal is to accelerate and improve the development of Therapeutic, Medical Device and Products.
Get know more about Sintesi Research and how Sintesi Research support the success of clinical development
Clinical Operations
Sintesi Research acts as a partner for the whole spectrum of clinical investigations, with ad-hoc teams led by experienced Clinical Project Managers
Our services embraces the full path of study, in details:
STUDY DESIGN
- Choice of Investigational design
- Statistic methodology
- Protocol design
- Feasibility investigation
- Risk evaluation
- Clinical development consultancy
- Protocol design
FEASIBILITY
- Sites / countries identification
- Feasibility questionnaire
- finalization / management
- SQV on site
- Feasibility Report finalization
REGULATORY
- Medical document review and preparation
- IRB/IEC/RA submission
- Local insurance policies
- Economic contracts and agreement
- Medical Device: technical dossier review
CLINICAL MONITORING
- PIs and study staff training
- Monitoring activities (SQV, SIV, IMV, COV)
- Operational assistance
- Risk based Monitoring
- On-site Monitoring
- Remote monitoring
ELECTRONIC ARCHIVE
- Sidox, a validated platform for TMF and ISF
- TMF standardized on GCP-compliant template
- TMF files (gTMF, CSF, CoSF, ISF)
- Easy monitoring (i.e. Checklist function)
- Optimized inspection-readiness
- Privacy guaranteed
PROJECT MANAGEMENT
- Project / Monitoring Plan preparation
- Sites management
- Tracking of study activities
- Protocol deviations management
- GCP compliance assessment
- Study staff coordination
- Newsletter finalization and management
- Project website dedicated
DATA MANAGEMENT
- Database set-up and maintenance
- CRF design
- Online randomization
- Alert management upon specific events
- Data Cleaning / Data Coding
- Uploading of diagnostic imaging files
- @PRO (electronic patient diary)
- Drug and supply management
- Customized report generation
STATISTICS
- Protocol design
- Sample size calculation
- Statistical Analysis Plan
- Statistical programming
- Statistical reporting
MEDICAL WRITING
- Clinical documents
- Study protocol
- Investigator Brochure
- Papers / Abstracts
- Clinical Study Reports
- Operating manuals
- Literature reviews
- Investigational medicine Product review
- Advisory Board Coordinating
LABORATORY MANAGEMENT
- In-house studies
- Client’s facility studies
- Wide range of non-GLP and GLP analyses
- Pharmacokinetic/toxicokinetic
- Metabolism, immunology and analytical chemistry
- Imagery, surgery and histopathology
MEETING ORGANIZATION
- Investigator meetings
- Logistic management
- Slides and report preparation and presentation
SUPPLY MANAGEMENT
- Centralized path to supply and ship clinical trial drugs
- Supply chain management from to shipping and replenishment
- Monitoring of kits supplies onsite
PROJECT DEDICATED WEBSITE
- Project Team contacts always available
- Full and updated Site list
- Key project documents at disposal
- IMP / Central Lab. instructions with videos and tutorials
- Project status / Newsletter
- FAQs section
- CRA training / Investigators meeting
- Video materials always at disposal
SAFETY MANAGEMENT
- Safety review/preparation of clinical trial documents
- Preparation of Safety Monitoring/Management Plans
- Individual processing for Serious Adverse Events (SAEs)
- Case narrative
- Expedited reporting (through EudraVigilance)
- Aggregate report preparation and reporting (DSUR)
- Investigation and assessment of Incidents
- Reporting Incidents with Manufacturer’s Incident Report
- Pharmacovigilance governance
- Training
- Post marketing surveillance
Medical Science Liason
The MSL scientific expert acting as the key link between clinicians, research and the industry.
Main activities:
Main activities:
- engage study site personnel like Principal and Sub- Investigators, study coordinators or nurses to maintain focus on eligibility criteria and study procedures,
- facilitate the recruitment, to help in case of problems,
- find solution and at the end to ensure the quality of execution of the clinical trial.
Patients Adherence Support
Patients are required to follow long-term treatments for their
disease itself or to prevent any potential health risks.
Patient acceptance of their medication influences behaviour towards treatment.
Using in-house call-center, with certified nurses, trained in adherence and experienced in patient communication. We employ only medical doctors, nurses, psychologists and educators
Using in-house call-center, with certified nurses, trained in adherence and experienced in patient communication. We employ only medical doctors, nurses, psychologists and educators
- Home Care & Nursing
- Telemedicine
- Local Nurse Educators
- Patient Networking
- Psycological support
- Nutritional support
- Patient enrolment
- Disease information
- Teatment information
- Treatment adherence
- Visits scheduling
- Visits reminders
- Administration reminders
- Administrative assistance
- Electronic vouchers
- Laboratory integration
- Statistics & KPI
- Pharmacovigilance
Product Promotion
Market segmentation analysis
Local trend and competitors’ position
Sales forecast
Pre-marketing support and advisory
Local trend and competitors’ position
Sales forecast
Pre-marketing support and advisory
Product launch support
Meeting with local distributor partners
Direct introduction and product presentation
Scouting the market, according to therapeutic area
Selecting the strategic partner
Mediation and export price negotiation
Meeting with local distributor partners
Direct introduction and product presentation
Scouting the market, according to therapeutic area
Selecting the strategic partner
Mediation and export price negotiation
Registration of products
approved by the FDA in the United States or any other government approval required by a government or Regulatory Authority of a country in the Territory necessary to permit the marketing, import, use and sale of a Licensed Product in such country.
approved by the FDA in the United States or any other government approval required by a government or Regulatory Authority of a country in the Territory necessary to permit the marketing, import, use and sale of a Licensed Product in such country.
Investment opportunities
Global investment options with Home Medics access to financial opportunities including USA, Europe, Switzerland, Japan & China.
We have the tools to tailor each request according to customer needs.
Global investment options with Home Medics access to financial opportunities including USA, Europe, Switzerland, Japan & China.
We have the tools to tailor each request according to customer needs.
Sintesi Research S.r.l.
Via delle Stelline 9 – 20146 Milano
P.IVA & C.F. 05059100965
REA: 1793968
Via delle Stelline 9 – 20146 Milano
P.IVA & C.F. 05059100965
REA: 1793968
