With more than 20 years of experience, our organization offers to our Clients proven expertise and and a highly-skilled staff in clinical operations
Our support starts from “early phase” to the “late phase” and, combined with a Regulatory support, helps pharmaceutical, medical device, supplement and nutraceutical companies to speed up the time to market. We have proven expertise in managing clinical trials, observational, Real Word Evidence, PASS, PAES studies.
With a complete package of services we aim to be the partner that drives the Client into the clinical development program and in the post-approval and post-marketing phases.
EARLY CLINICAL DEVELOPMENT
We facilitate the transition from research to clinical development through comprehensive management of early-stage clinical trials, offering advice aimed at the best program design.
Phase I/II studies
Phase IIa/IIb studies
Bioequivalence and Bioavailability (BE/BA) Studies
Managing a clinical drug development program requires experience and expertise. Our support is aimed at achieving project success by applying a risk-based approach that allows us to anticipate possible risks and identify the most effective solutions.
We also offer a flexible approach for those Clients looking for a partner who can effectively take over within an established development process.
Bioequivalence and Bioavailability (BE/BA)
Bioequivalence studies are of great importance and conducting them needs due planning and experience.
Through our qualified vendors we reduce the cost of Bioequivalence studies and assist pharmaceutical companies to bring their products to market quickly and on budget, in full compliance with international regulatory requirements.
REGISTRATIVE STUDIES PHASE III
Managing the complexity of Phase III clinical trials can be challenging: our support ensures a proven high success rate, thanks to our mix of services, experience and expertise.
Our range of services is comprehensive and constantly updated, ideally starting with study feasibility analysis and concluding with statistical analysis and final report.
Through our Network we can manage clinical trials in multiple countries, providing specialized expertise in local activities.
Our commitment and shared risk approach
We are committed to planning ahead with the Sponsor to identify risks and develop mitigation strategies.
How?
Project Plan
A detailed document to ensure a strategic planning of your trial. Through this plan we define project timelines, communication plans, project metrics and deliverables.
Monitoring Plan
A tailored monitoring plan is implemented for each study. We combine compliance-oriented and risk-based solutions to set-up a plan that best fits with the study objectives.
Efficient issue escalation
As a CRO we can ensure our Sponsors that any issue is promptly and efficiently managed. No intermediate figure, but Sponsor dedicated Project Managers allow us to streamline issue escalation.
OBSERVATIONAL AND POST-MARKETING STUDIES
From the moment the product is licensed, data collection is definitely an important part of the strategy to maximize and enhance the life cycle of the product. GB Pharma has been successfully engaged in observational studies for more than two decades.
observational studies
real world evidence (rwe)
OBSERVATIONAL STUDIES
Observational studies contribute to the validation of efficacy, tolerability and safety in normal clinical practice.
Observational studies-retrospective and prospective-must provide a design, results, endpoints, data quality, transparency, and methodological rigor that are appropriate and usable for both regulatory decision making and “evidence” confirmation.
Our experience in conducting different study designs including.
- Cohort studies
- Case Control Studies
- Cross-Sectional Studies
- Case Series
- Hybrid Design
ensures the success of your study and the optimization of marketing strategies.
GB Pharma has expertise in managing local and European studies.
REAL WORLD EVIDENCE (RWE)
GB Pharma offers expertise in managing RWE studies to support product efficacy, value, and safety.
The collection and analysis of scientific evidence on the efficacy of a product is classically done through the randomized controlled trial (RWE).
However, in order to better understand how the product “behaves in the real world,” an increasingly important role is played by Real Word Data (RWD), understood as The data on the health status of patients and health care delivery contextualized in normal clinical practice.
Real Word Evidence studies are critical from several perspectives. RWE analyses contribute to:
- Generation of evidence to support treatment effectiveness
- More appropriate use of health technologies
- Improved treatment and quality of life for patients
Our support begins with proposing the most appropriate design and/or ‘identifying the most qualified sources of “Real Data,” and continues through the conduct until the final results are reported.
Not only that, we also do:
Registry studies allow the recording and evaluation over time of the effects and outcomes in terms of efficacy and safety of diagnostic or therapeutic procedures in clinical practice, in a given population, and in the context of a health care system. Our support ensures that the necessary organizational and functional criteria are met and that the registry study is scientifically valid as a result.
Health-Related Quality of Life (HRQoL) measurements, usually through questionnaires, contribute to awareness of the effectiveness of treatments and improvement of patients’ living conditions.
PASS & PAES STUDIES
As GB Pharma, we combine our regulatory and clinical know-how to support our clients in study design and data collection required by Regulatory Authorities during marketing authorization application or postauthorization evaluation procedures.
Post-authorization safety study (PASS)
POST-AUTHORIZATION EFFICACY STUDY (PAES)
PASS / PAES
POST-AUTHORIZATION SAFETY STUDY (PASS)
GB Pharma has an almost unique combination of clinical, regulatory, methodological and statistical expertise that results in optimal solutions in post-authorization study management. We have experience in managing prospective PASS and also in managing the additional requirements for PASS imposed by EMA.
POST-AUTHORIZATION EFFICACY STUDY (PAES)
GB Pharma guides you at the procedural, regulatory level and in the implementation of post-authorization efficacy reviews (PAES), whether mandated by Regulatory Authorities or done on a voluntary basis.
We follow ENCePP guidance on methodological standards in pharmacoepidemiology and the ENCePP Code of Practice.
GB Pharma has long-term expertise in regulatory submission and conducting studies and programs such as:
Expanded Access
Compassionate Use Program
CLINICAL RESEARCH SERVICES
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 writin
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.
INTERNATIONAL ACTIVITIES
Global Coverage
We have selected and qualified CRO partners around the world over the years. All CROs that are part of our network share our same mission: to provide service with the highest level of expertise locally and with appropriate through cost effective solutions.