WHY CHOOSE US
Clinical and Observational research
Comprehensive Clinical Research Support by GB Pharma
At GB Pharma, we partner with pharmaceutical, biotech, medical device, supplement, and cosmetic companies, as well as IRCCS and Scientific Foundations, to manage every phase of clinical research. Our tailored, highly qualified approach ensures strict adherence to international regulatory standards (ICH-GCP, EMA, FDA), delivering high-quality, compliant, and customized solutions throughout the clinical trial process.
Integrated Scientific and Clinical Consulting Solutions
We offer integrated clinical scientific consulting for studies across all phases of clinical trials: Phase II–IV, Investigator Initiated Studies (IIS), PASS, PAES, observational studies, and Real World Evidence (RWE) studies. Our services ensure efficient study management, regulatory compliance, and optimized outcomes for every project in the pharmaceutical and medical device sectors.
WHY CHOOSE US
Our Clinical Research Services
PROJECT MANAGEMENT
Integrated clinical study coordination, from planning and drafting a Study Management Plan to operational execution, ensuring efficient and compliant study delivery.
DOCUMENT MANAGEMENT & PREPARATION
Preparation of protocols, Investigator Brochures, CRFs, Informed Consent Forms, operational plans, and supporting documentation, fully compliant with ICH-GCP, with secure storage in Electronic Trial Master File (eTMF).
REGULATORY SUPPORT & SUBMISSION
Comprehensive management of regulatory processes, including preparation and handling of regulatory documentation and submissions to Ethics Committees, AIFA, and through the CTIS platform.
SITE MANAGEMENT & FEASIBILITY
Identification of clinical sites, feasibility assessment, study initiation, and continuous support for investigational sites to ensure smooth operations.
CLINICAL MONITORING
On-site and remote monitoring activities to ensure data integrity, compliance, and quality throughout the study.
DATA MANAGEMENT & BIOSTATISTICS
Design of eCRFs, data management and validation, statistical analysis, and scientific reporting to support evidence-based decisions.
PHARMACOVIGILANCE IN CLINICAL STUDIES
Management of adverse events, safety monitoring, and reporting according to regulatory standards, ensuring patient safety and compliance.
MEDICAL WRITING
Preparation of the Final Clinical Study Report, medical writing of manuscripts for scientific publications, and management of submissions to high-impact journals.
Quality Control & Auditing
Implementation of an efficient quality system for the management and maintenance of clinical studies, ensuring high compliance levels and audit readiness.
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Therapeutic Areas
- Oncology/Hematology
- Neurology
- Cardiovascular
- Immunology (i.e. Psoriasis, Rheumatoid Arthritis and so on)
- Gastroenterology
- Metabolic Disease (i.e. Obesity, Diabetes and so on)
- Urology and Nephrology
- Respiratory
- Pain/Arthritis and Orthopedics
- Dermatology
- I.C.U. Diseases
