We offer support in all stages of the product life cycle.
Whatever the size and purpose of the project, each one will receive the same level of attention to detail and assurance of receiving high quality service within the budget and timelines agreed.
Full service skills and proven trusted processes make the company an ideal partner for sponsored studies, for independent clinical trials and drug/medical device developers looking to outsource.
We conduct clinical activities through Project Team organization: for each new project a dedicated Project Team is created and a Project Manager is appointed to manage the full team.
The clinical project management consists of the Project Manager, CRAs, Data Manager, Statistician, Clinical Trial Assistant and is supported by Quality Assurance and the Scientific Director for all relevant issues.
We have an experienced team of monitors, all with profound clinical trial monitoring experience.Our clinical research associates (CRAs) focus on developing strong site relationships an ensure their observance to data quality and subject safety.
We believe that risk based monitoring improves sponsor supervisions clinical investigations. As clinical research data becomes increasingly digitized and as data standardization is achieved, a transition to centralized, analytics-enabled monitoring has become a reality.
Last, but not least, one of the most important tasks in the start-up of a clinical trial is the submission to the Ethics Committees and Competent Authorities. We have extensive experience in the administrative and technical aspects of presenting studies and obtaining Authorities and Ethics Committee approval.
Our excellent relationship with ECs allows us to help clients start their clinical trials rapidly.
A team of Regulatory Affairs Specialists supports Sponsors through the pre and post marketing drug and medical device regulations and in all stages of development.
Our experience in all aspects of the clinical trials submission process (IRBs/ECs and EMA Authorities) will ensure smooth compliance at every phase of the trial.
Qualified regulatory staff, medical writers, data managers and statisticians work together with your team to ensure the clinical, scientific and regulatory integrity of every project from submission through to marketing, application submission and regulatory review.
Our Safety Unit guarantees the proper management and sharing of all safety information through the clinical trials entrusted to us, in accordance with ICH GCP, current law and SOPs currently in force for each project.
We properly document and report each non-serious and serious adverse event to the applicable Regulatory Authorities.
We deliver seamless data processing and storage at every stage of the project using latest high-speed and high-capacity technology.
We customize software according to our clients need and we offer study data storage.
Our web-based platform ensures fast and accurate processing of study data as well as data protection.
The query management system enables audit trailing and CRF tracking.
Quality is an essential element of how we work. We do it ethically, with a strong regulatory foundation, and always with an eye to patient protection above all else.
Our Quality Assurance Department assures compliance with quality standards required by local, national and international laws, as well as with the ICH GCP and regulatory guidelines. Routine activities cover regular investigational site and internal system auditing, together with organization and supervision of training implemented internally.
We have developed a comprehensive library of Standard Operating Procedures (SOPs) and Guidelines, which guarantees that client requirements are met and our employees conform to regulations.
Additionally ensuring that all company activities are controlled and documented and that we are able to operate also with our client’s SOPs when requested.
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