From planning through to set-up and execution, the experienced Afortiori Development team can help you to effectively manage your clinical trial, and in the most cost-effective way.
Clinical Trial Planning
Our team conducts careful planning and negotiation of timelines to ensure that study timelines are realistic, achievable and include robust site selection.
Typical steps in clinical trial planning include:
- Study team and sponsor orientation and team building to support effective collaborative working
- Rigorous therapeutic area and protocol training for the team
- Selecting only those sites with the capability and capacity to recruit and a commitment to success, taking into consideration:
- Competitor trials
- Patient access
- R&D support
- Clinical study coordinator availability
- Sites are carefully reviewed and assessed with the sponsor to ensure that site capability and capacity are clear and agreed
Clinical Trial Set-up
At Afortiori Development, we undertake a risk-based approach to optimise recruitment, data collection and site performance.
Clinical trial set-up generally involves:
- Creation of requisite study documentation to support the effective and efficient operation of the trial including:
- Protocol, IC, PIL, Risk Management Plan, Study Supplies Plan, Safety Management Plan, Specimen Management Plan, Vendor Coordination Plan
- All ethics and regulatory work is carefully coordinated and managed by a dedicated specialist team to ensure all documents are submitted on time and questions are addressed fully
- Ensuring that database design and implementation is a seamless process. Data management support is extremely effective with training, query management, reports and data exports planned and managed to ensure trial data capture and cleaning is robust.
Our team understands the importance of ensuring that all documents in a trial are carefully managed and quality assured. We provide exceptional support to ensure this process is of the highest quality.
Clinical Trial Execution
Afortiori Development are experts in obtaining quality data in compliance with regulations ensuring patient safety during clinical trial execution. We also ensure that the trial is managed to time and target.
Our clinical trial execution approach involves:
- Study monitoring and management of sites to optimise patient recruitment and high quality study data
- Informed patient safety management for critical decision making and intervention through pharmacovigilance activity
- Management of data query resolution at site and remotely where possible to ensure efficiencies and proactive data cleaning throughout the study
- Proactive, effective overall study project management to oversee adherence to timelines and budgets
- End of study reports to include analysis of all data
- Transfer of data and TMF activities to ensure an effective and efficient study close-out
Clinical Trial Planning
Our team conducts careful planning and negotiation of timelines to ensure that study timelines are realistic, achievable and include robust site selection.
Typical steps in clinical trial planning include:
- Study team and sponsor orientation and team building to support effective collaborative working
- Rigorous therapeutic area and protocol training for the team.
- Selecting only those sites with the capability and capacity to recruit and a commitment to success, taking into consideration:
- Competitor trials
- Patient access
- R&D support
- Clinical study coordinator availability
- Sites are carefully reviewed and assessed with the sponsor to ensure that site capability and capacity are clear and agreed
Clinical Trial Set-up
At Afortiori Development, we undertake a risk-based approach to optimise recruitment, data collection and site performance.
Clinical trial set-up generally involves:
- Creation of requisite study documentation to support the effective and efficient operation of the trial including:
- Protocol, IC, PIL, Risk Management plan, Study Supplies Plan, Safety Management plan, Specimen Management Plan, Vendor Coordination Plan
- All ethics and regulatory work carefully coordinated and managed by a dedicated specialist team to ensure all documents are submitted on time and questions are addressed fully
- The use of our preferred provider, Share CRF, means that database design and implementation is a seamless process. Data management support is extremely effective with training, query management, reports and data exports planned and managed to ensure trial data capture and cleaning is robust
Our team understands the importance of ensuring that all documents in a trial are carefully managed and quality assured. We provide exceptional support to ensure this process is of the highest quality.
Clinical Trial Execution
Afortiori Development are experts in obtaining quality data in compliance with regulations ensuring patient safety during clinical trial execution. We also ensure that the trial is managed to time and target.
Our clinical trial execution approach involves:
- Study monitoring and management of sites to optimise patient recruitment and high quality study data
- Informed patient safety management for critical decision making and intervention through pharmacovigilance activity
- Management of data query resolution at site and remotely where possible to ensure efficiencies and proactive data cleaning throughout the study
- Proactive, effective overall study project management to oversee adherence to timelines and budgets
- End of study reports to include analysis of all data
- Transfer of data and TMF activities to ensure an effective and efficient study close-out