Reducing time to market is one of the key objectives in drug development and Accelsiors excels in reducing the time between the availability of the final protocol and the first patient enrolled. Due to our geographic presence and comprehensive and harmonised processes, we are able to gain access to extended patient populations, allowing for expedited recruitment.

WE ARE CONSCIOUS OF THE IMPORTANCE OF:

• Study Monitor’s qualification and expertise. Our monitoring team consists of >50% of Medical Doctors, who fosters the right patients’ recruitment strategy with sites even for complex clinical studies where patients can be difficult to recruit and to retain
• Local country cultures knowledge, the regulatory specificities, as well as the local practices including patients’ standard of care and treatment pathways. This enables Accelsiors Clinical Monitoring staff to drive robustly patients’ recruitment target, as well as ensuring that the enrolled patients meet the required criteria and go through the entire study completion successfully
• Risk Management, as consolidated in GCP/ICH addendum effective in November 2016. It is an essential success factor in all aspects of clinical monitoring execution and our processes engage our staff in pro-actively identifying, analysing and mitigating risks (Key Performance Indicators, sites performance indicators, adjusted monitoring strategy, remote monitoring)

• Accelsiors maintains a close relationship with all the sites we work with. Our client’s success relies on our ability to boost clinical study progress not only during the start-up phase but at every stage until study completion. This can be achieved, thanks to our highly experienced staff and our existing relationships with Key Opinion Leaders. At Accelsiors we believe that our monitoring team is a key success factor in order to tackle all potential challenges and ultimately meet and exceed our client’s expectations.

CLINICAL MONITORING SERVICES

• Feasibility strategy set up based on previous experience and country / site specific analysis
• Identification and selection of sites and investigator’s according to study protocol requirements and target patient’s population
• Coordination of investigator meetings, including all applicable logistics
• Direct Staffing and training of Study Site Coordinators where required

• Overall study start-up delivery: (Sites agreements, IEC / IRB and Competent Authorities submissions, Import /Export license, Translation, Insurances)
• Initiation and ongoing monitoring of investigational sites according to applicable local and international regulations
• Ensuring appropriate support to sites staff for optimised data integrity and accelerated patients recruitment
• Site closure activities including document management and supply reconciliation and destruction/shipment

Learn more about our comprehensive clinical development services

Accelsiors offers a complete range of expertise in support of your specific needs: Scientific, analytical and regulatory complemented by global resources, state-of-the-art technologies and project management methodology for the most effective execution of your development program across all phases of clinical drug development.

Full service CRO solutions

Medical & Scientific affairs

Data Science

Regulatory Affairs

Early Phase Development Solutions

Late Phase Development Solutions

Clinical development services