Services

STUDY DESIGN

• Choice of Investigational design
  
• Statistic methodology
• Protocol design
  
• Feasibility investigation
  
• Risk evaluation
  
• Clinical development consultancy
  

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

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

PRODUCT DISTRIBUTION

• Local trend and competitors’ position
  
• Sales forecast
  
• Pre-marketing support and advisory
  

• 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
  

• 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.
  

• 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.

PATIENT SUPPORT PROGRAM

• To help patients manage their diseases particularly, after a new treatment has been prescribed
  
• These program can include a wide range of services such as:
  
• Patient education
  
• Medication reminders
  
• Access to healthcare professionals and tools to help the patient to understand side effects
  

MEDICAL AFFAIRS

1. Advisory Board


2. Medical Scienze Liason
Who acts as a bridge between the pharmaceutical company and the medical/scientific community, focusing on approved products or those in late-stage development
• Build relationships with Key Opinion Leaders (KOLs)
  
• Provide non-promotional scientific information about drugs and therapies
  
• Attend scientific congresses and clinical presentations
  
• Support clinical trials
  
• Gather field insights to report back to internal teams (R&D, Medical Affairs)
  


3. Clinical Trial Liason / Site Engagement Manager
Focused on operational and scientific support to clinical trial sites during the conduct of clinical studies.
• Serve as the main contact between sponsor and clinical sites.
  
• Motivate and support sites to improve patient recruitment
  
• Present the study protocol, preliminary data, and updates
  
• Identify and resolve recruitment barriers
  
• Facilitate communication between CROs, sponsors, and sites
  
• Regularly visit sites to maintain engagement
  


4. Medical Scienze Liason