Your CRO partner for successful management of clinical studies in Europe, US and Canada for medical devices, IVDs and combination products

 

Gap analysis for clinical studies

Is your company experiencing problems with your clinical study, such as enrolment issues or significant delays in study start? Are you unable to identify the causes of the problem or solutions seem impossible to find? By conducting a clinical gap analysis, our senior clinical experts can help you understand why the problem is occurring, and help you implement solutions.

 

Project Management 

Effective management of clinical studies is critical to help ensure study completion on-time and within budget. Challenges include compliance with country-by-country requirements, selection of suitable study sites able to meet recruitment targets and quality requirements, managing study conduct to help avoid protocol deviations, and ensuring adverse events are properly assessed and reported.

Our Project Management Team, with extensive international experience and a broad knowledge of many therapeutic areas, provides efficient study overview and coordination.

 

EC/IRB and Competent Authority Submissions

Gemar provides a dedicated team for the preparation of Ethics Committee (EC) and Institutional Review Board (IRB) submissions, while our Clinical Regulatory and Vigilance Unit is responsible for study submission to European Competent Authorities and FDA, for which around 60% of studies are approved after the first submission.

 

Site selection and monitoring 

Gemar supports clients in their selection of investigational sites in Europe and US, to allow efficient recruitment and high data quality.

Thanks to a network of clinical research associates (CRAs), Gemar combines local presence with centralized CRA management and quality control. Our CRAs have at least 4 years' experience in monitoring international studies in accordance with GCPs and most have both medtech and pharma backgrounds.

 

Data Management and Biostatistics

Gemar can provide expert data management services for device and IVD studies, offering both electronic data capture (EDC) and paper based solutions. Our biostatistical experts, who have extensive experience in interacting with FDA, can support clients in study design and protocol statistics as well as with data analysis.

 


 

Contact us by e-mail to define a meeting for a confidential discussion about your project.