Monitoring and Site Management
Scientific Expertise and Efficient Problem-Solving with Accelsiors
At Accelsiors, we understand the crucial role of qualified monitors, in-depth local knowledge, and proactive risk management in running successful clinical trials. Here’s how we put these principles into practice. We believe our monitoring team is integral to the successful navigation of clinical trials, and we’re committed to delivering excellence at every step of the journey.
Qualified Monitors for Quality Assurance and Patient Recruitment
Our monitoring teams comprise over half of highly educated people – with degrees in life science. This expertise helps us to assure the quality of our clinical trials and devise effective patient recruitment strategies, even for complex studies where patient acquisition and retention can be challenging.
Harnessing Local Knowledge for Better Results
We believe in the power of local insight. Our teams are well-versed in the unique cultural nuances, regulatory requirements, and standard care practices of the regions we operate in. This equips our Clinical Monitoring staff to effectively drive patient recruitment targets and ensure that enrolled patients meet the required criteria for successful study completion.
Proactive Risk and Issue Management for Smooth Execution
We consider the involvement of our Clinical Research Associates (CRAs) in Risk and Issue Management as an essential component of clinical monitoring execution. Our processes empower our staff to proactively identify, analyze, and mitigate risks using a variety of tools, including Key Performance Indicators, site performance indicators, adjusted monitoring strategies, and remote monitoring.
Building and Maintaining Strong Site Relationships
Achieving a timely and accurate database lock is critical for your clinical trial’s success. At Accelsiors, we prioritize this milestone from the very beginning. Our Study Closure Stream team, guided by project and data management experts, proactively ensures data integrity throughout your trial.
Accelsiors cultivates close relationships with all the sites we work with. Our clients’ success hinges on our ability to foster clinical study progress at every stage, from start-up to completion. With our highly experienced staff and robust relationships with Key Opinion Leaders, we’re equipped to handle any potential challenges and ultimately exceed our clients’ expectations.
Clinical Monitoring Services
- Feasibility strategy set up based on previous experience and country / site specific analysis
- Identification and selection of sites and investigators according to study protocol requirements and target patient 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 optimized data integrity and accelerated patients recruitment
- Site closure activities including document management and supply reconciliation and destruction/shipment
Feasibility & Study start-up services
- Feasibility strategy set-up
- Confidentiality Agreement (CDA) development
- Investigator Briefing Package and Feasibility Questionnaire (FQ) development
- Identification and selection of study sites and investigators according to study protocol requirements and target patient population
- Obtaining executed CDAs and completed FQs
- Conservative re-assessment of sites’ patient pools and enrollment projections
- Assessment of regulatory feasibility
- Feasibility Report writing
- IRB/IEC and Competent Authorities approval
- Site’s contracts development, investigator’s fees set up, and negotiation
- Coordination of Investigators meetings, including all applicable logistics
- Different staffing and training of Site Coordinators
- Translations
- Import/Export License management
- Insurances