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
CLINICAL REASEARCH FOR
Medical Devices, Food Supplements & Cosmetics
MEDICAL DEVICES
- Support to the Client to ensure compliance with the new Medical Devices Regulation (MDR – Regulation (EU) 2017/746), which has been applicable since 26 May 2021, guiding them through this complex transition period.
- Experience in the following therapeutic areas:
- Cardiology
- Cardiovascular
- Neurology
- Gastroenterology
- Respiratory
- Planning and conduct of pre-market studies, ensuring regulatory compliance and optimizing approval timelines.
- From the identification of clinical sites to patient enrollment, managing the entire process to obtain the authorizations required for market placement.
- Management of all types of clinical investigations involving medical devices from Class I to Class III, including implantable devices.
- Post-market surveillance solutions, including observational studies, clinical registries, and safety data analyses, to support continuous product improvement.
FOOD SUPPLEMENTS
Over the years, GB Pharma has built strong partnerships with European Key Opinion Leaders in intestinal microbiota research and has enhanced its expertise in managing clinical studies involving food supplements across several areas of interest.
- Gastroenterology
- Metabolic disorders
- Pregnancy
- Urology
- Cardiovascular
- Nutritional support
COSMETICS
Cosmetic studies assess efficacy and safety by evaluating ingredients, formulations, and their effects on the skin. These studies may include dermatological assessments, stability testing, and clinical studies to ensure safe and high-performing results.
GLOBAL COVERAGE
An international network serving clinical research
GB Pharma is an Italian Contract Research Organization (CRO) with a well-established international presence. Thanks to a network of partners and strategic collaborations, GB Pharma manages clinical studies in Europe, Latin America, and non-European countries, ensuring scientific expertise, operational speed, and full regulatory compliance.
The benefits of our international network
- Integrated management of global multicenter studies
- Rapid access to investigational sites and target populations
- Knowledge of local regulations and country-specific requirements
- Ability to adapt projects to different market needs