Clinical & Observational
research

Why us

With more than 20 years of experience and more than 217 clinical projects managed so far, we are a mid-size CRO providing our Clients with proven expertise and a highly-skilled staff in clinical operations.

Our support starts from early phases to the late phase and, combined with a Regulatory support, helps Pharma & Biomedical Companies to speed up the time to market. We have proven expertise in managing clinical trials, observational, epidemiologic and RWE studies.

With a complete package of services we aim to be the partner that drives the Client into the clinical development program.


EARLY DEVELOPMENT

EARLY DEVELOPMENT

We support our Clients to move from research to clinical development by fully managing clinical trials at this stage and providing effective advices how to efficiently start and ground the clinical development. We can manage Phase I trials, as well as BE/BA studies. We also offer a flexible approach for Clients looking for a partner able to step in throughout the clinical development.

CLINICAL DEVELOPMENT

CLINICAL DEVELOPMENT

Our support is made up of a mix of services, experience and expertise that maximize the chances of successful trials. Our support in Phase II / Phase III trial starts from feasibility phases to statistics and data analysis. Through our network we can manage clinical trials in multiple locations providing ad-hoc local expertise.

LATE PHASE CLINICAL DEVELOPMENT

LATE PHASE CLINICAL DEVELOPMENT

Once products are authorised, collecting data is part of a winning strategy to maximize and value your product life-cycle. Therefore we support our Clients in conducting observational and epidemiological studies, as well as Phase IV trials. Our expertise is also extended to RWE studies and PASS / PAES.

We support our Clients to move from research to clinical development by fully managing clinical trials at this stage and providing effective advices how to efficiently start and ground the clinical development. We can manage Phase I trials, as well as BE/BA studies. We also offer a flexible approach for Clients looking for a partner able to step in throughout the clinical development.

Our support is made up of a mix of services, experience and expertise that maximize the chances of successful trials. Our support in Phase II / Phase III trial starts from feasibility phases to statistics and data analysis. Through our network we can manage clinical trials in multiple locations providing ad-hoc local expertise.

Once products are authorised, collecting data is part of a winning strategy to maximize and value your product life-cycle. Therefore we support our Clients in conducting observational and epidemiological studies, as well as Phase IV trials. Our expertise is also extended to RWE studies and PASS / PAES.

Project Management

Someone used to say: “If you fail to plan, you are planning to fail” Our PM experts, together with our lean-approach and mid-size structure, make easier the Project Management of your study, ensuring study milestones are met.

Study feasibility

A network of sites and KOLs has been build-up during more than 20 years of experience in the field. We can provide you with a pool of sites and Investigators who may join your project and help you in moving faster your clinical program.

Medical writing

Scientific rigor and accuracy is what we offer. Our medical writing team may support you in the drafting and reviewing of clinical document from protocol to clinical study report writing.

Regulatory and Ethics submission

Our “plus” is a team coordinated by a 20-years experience senior professional. A multi-lingual team and a panel of local national experts help you to respect timelines and ensure study start and updating run smoothly.

QA & Auditing

Our team of GCP/GVP & Auditors has more than 30 years of experience and may advice you on how effectively manage clinical studies and maintain an updated Quality System to reach the highest level of compliance.

Monitoring

Our monitoring concept relies on the idea that providing an effective support to investigational sites will positively affect the conduct of the trial. Our monitoring team is made of professionals with experience in various therapeutic areas and are a source of customer satisfaction feedbacks.

Data Management

From the drafting of Data Management Plan to centralized monitoring, passing to query management and database lock are key services we propose to collect high quality and reliable data.

e-tools

Digitalization of Clinical trials is essential to meet Client regulatory timelines. Find more on our Technology page. eCRF, eTMF and eCTMS is what we use to streamline your clinical trial processes.

Statistics

When managing a study, our statisticians are involved since early phases and their close cooperation with PM, Data Manager and Monitors ensure the most accurate results. Our statistic support includes study design, sample size calculation, database design, statistical analysis plan, randomization coding and statistical report writing

Pharmacovigilance

Through a Department dedicated to pre- and post- marketing Pharmacovigilance and Clinical Trial Safety Officers we ensure pharmacovigilance information are exchanged timely and properly, ensuring the safety of patients on clinical trials. We can support Sponsor on managing SDEA, SAEs, SUSAR and DSUR, as well as regulatory submission / notification.

Vendor selection & management

You can simply rely on our qualified vendors. Alternatively, together with our QA team we can select and manage vendors on your behalf. Our main vendors include centralized labs and Phase I Units.

Someone used to say: “If you fail to plan, you are planning to fail” Our PM experts, together with our lean-approach and mid-size structure, make easier the Project Management of your study, ensuring study milestones are met.

A network of sites and KOLs has been build-up during more than 20 years of experience in the field. We can provide you with a pool of sites and Investigators who may join your project and help you in moving faster your clinical program.

Scientific rigor and accuracy is what we offer. Our medical writing team may support you in the drafting and reviewing of clinical document from protocol to clinical study report writing.

Our “plus” is a team coordinated by a 20-years experience senior professional. A multi-lingual team and a panel of local national experts help you to respect timelines and ensure study start and updating run smoothly.

Our team of GCP/GVP & Auditors has more than 30 years of experience and may advice you on how effectively manage clinical studies and maintain an updated Quality System to reach the highest level of compliance.

Our monitoring concept relies on the idea that providing an effective support to investigational sites will positively affect the conduct of the trial. Our monitoring team is made of professionals with experience in various therapeutic areas and are a source of customer satisfaction feedbacks.

From the drafting of Data Management Plan to centralized monitoring, passing to query management and database lock are key services we propose to collect high quality and reliable data.

Digitalization of Clinical trials is essential to meet Client regulatory timelines. Find more on our Technology page. eCRF, eTMF and eCTMS is what we use to streamline your clinical trial processes.

When managing a study, our statisticians are involved since early phases and their close cooperation with PM, Data Manager and Monitors ensure the most accurate results. Our statistic support includes study design, sample size calculation, database design, statistical analysis plan, randomization coding and statistical report writing

Through a Department dedicated to pre- and post- marketing Pharmacovigilance and Clinical Trial Safety Officers we ensure pharmacovigilance information are exchanged timely and properly, ensuring the safety of patients on clinical trials. We can support Sponsor on managing SDEA, SAEs, SUSAR and DSUR, as well as regulatory submission / notification.

You can simply rely on our qualified vendors. Alternatively, together with our QA team we can select and manage vendors on your behalf. Our main vendors include centralized labs and Phase I Units.

More in detail

Brochure

Clinical-Development-pre-marketing

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Late-phase clinical development

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Clinical services for Medical Device

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International activities

CRO Network

Over the last year we have been selecting CROs all over the world. All CROs as part of our network share the same mission: provide a service with the highest level of expertise at a local level and at a competitive price.

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