01
Study Design and Development
- Support in study protocol design
- Definition of endpoints and inclusion/exclusion criteria
- Study feasibility analysis
02
Clinical Trial Management
- Selection and initiation of investigator sites
- Negotiation with hospitals and research centers
- Coordination of activities among sponsors, investigators, and regulatory authorities
03
Clinical Monitoring and Surveillance
- On-site and remote monitoring visits
- Verification of protocol compliance (GCP – Good Clinical Practice)
- Quality control and completeness of collected data
04
Data Management and Biostatistics
- Design of electronic Case Report Forms (eCRF)
- Preparation and development of electronic randomization platforms (IVRS/IWRS)
- Design of clinical databases (EDC – Electronic Data Capture)
- Data cleaning and query management
- Statistical analysis and results reporting
05
Regulatory Affairs and Compliance
- Preparation and submission of documents to regulatory authorities (EMA, FDA, AIFA, etc.)
- Management of ethical approvals (Ethics Committees, IRB)
- Compliance with international regulations (ICH-GCP, GDPR, etc.)
06
Pharmacovigilance and Patient Safety
- Collection and management of adverse event reports (AE/SAE)
- Safety reporting to competent authorities
- Risk management and benefit/risk assessment
07
Patient Recruitment and Management
- Support in subject enrollment
- Informed consent management
- Patient logistics and follow-up
08
Investigational Product Logistics and Management
- Drug distribution and traceability
- Inventory management and cold chain maintenance
- Drug accountability reconciliation
09
Medical Writing and Documentation
- Preparation of protocols, reports, and scientific publications
- Clinical Study Report (CSR) preparation
- Regulatory dossier documentation
10
ICT Services
- Server setup and management (configuration, maintenance, and security)
- Backup management (disaster recovery plans and secure data storage)
- Database management (optimization, security, and clinical data integrity)
- Web application development (eCRF platforms, investigator portals, and trial management systems)
FURTHERMORE, ALEPH PROVIDES
ICT
SERVICES
- LAN/VLAN assistance
- Hosting
- Tailor-made software
- Web design (internet website)
- Server setup and maintenance
- 3D printing
EDITING SERVICES
- Printed version Scientific journals management
- Scientific journals website’s development and management
- Scientific journals indexing on Pubmed Central
- Scientific/medical texts translation (from Italian to English and vice versa)
AND … UPON REQUEST
TRAINING COURSES OF
- CRA training and certification
- Biostatistics
- Informatics/computer science
partners
OUR CUSTOMERS & PARTNERS
WHERE TO FIND US AND HOW
Contact us
9, Via Cucchiari
20155 Milan Italy
Phone: +39 02 40707107
Fax: +39 02 700541273
VAT number: 07688250963