Our CRO is composed by multidisciplinary professionals with different backgrounds and experiences. With a focus on advanced therapies we give support at all stages of your clinical study: from regulatory, application and documents approval to project management including clinical monitoring, medical and safety control and data management and statistic.
CONTRACT RESEARCH ORGANIZATION
A skilled CRO team to give support at all stages of your clinical study
STUDY START UP
A multidisciplinary team for sites selection, regulatory submissions and contracts
We support you in the crucial moment of any clinical study: from protocol evaluation to site activation.
JSB CRO Start Up Team simultaneously runs all the aspects for a rapid and smooth study start up. We support the Sponsor in selecting study sites, finalising contracts and regulatory documents for submission ensuring all regulatory documentation is completed:
- Cover Letter
- EudraCT number confirmation
- EudraCT application form (Annex 1)
- Protocol & Protocol Synopsis
- Investigator Brochure
- Investigational Medicinal Product Dossier (IMPD) (Full, Simplified, SmPC)
- Example of Labeling
Our team will fully handle contacts with National Authority, Ethic Committee and Study Sites to strengthen from the beginning the study efficacy.
PROJECT MANAGEMENT AND CLINICAL MONITORING
Planning, organization and control
A complete support in the management of any clinical study and in any phase, thanks to strong planning, organizing and controlling skills.
A dedicated team conducts each clinical study according to ICH-GCP, local regulations and SOPs. We are experienced in tracking and planning, overseeing the development of each study and keeping the trial on schedule. Our support includes an efficient data flow among clinical sites, sponsor, project and data management team according to the clinical monitoring plan, always in compliance with sponsor timelines.
Our skilled clinical research associates (CRAs) conduct high-standard monitoring activities with attention to quality standards and Investigators needs. Our clinical monitors manage data collection, source documents verification, CRF fulfillment and queries resolution safely and effectively.
MEDICAL & SAFETY
Take the risk under control
To identify, asses and minimize the risk in any clinical study, we have a Medical Monitoring department with a wide clinical experience that guarantees the enrolled subjects safety.
Our Medical Monitoring department will guarantee the enrolled subjects safety and the clinical trial data integrity, supervising start-up activities, protocols development and security plans. Thanks to the medical background and the knowledge of the specific study we offer trainings to the staff of the clinical trial site, we control that all the activities are carried out in compliance with GCP and critically review the monitoring plan.
The MM department has also a fundamental role in the Pharmacovigilance for the SAE and SUSAR reporting and assessment, in the event adverse verification and correct documentation for each visit. Very important is the Safety Management to identify, assess and minimize risks related to the clinical study.
DATA MANAGEMENT AND STATISTICS
The perfect database system to support your study
JSB data manager gives a complete support to all the fundamental aspects of data management: from documents preparation to the following eCRF monitoring, query submission and statistical analysis.
We assist in the collection and management of all data related to a clinical study. Our Data Manager has the fundamental role of coordinator between different roles involved in the research: the medical team, sponsors, ethical committees, local data managers, ensuring that quality, integrity and security standards must be fulfilled.
Our Data Manager is involved in all the necessary documents preparation, in the administrative procedures and the following study management, that includes eCRF monitoring and query submission. In order to guarantee an efficient and effective data management our CRO has developed Contrappunto software, with innovative technologies and a user-oriented approach, for an easy and intuitive use.