Clinical Study Management
Clinical research is an ever-evolving field of regulations, guidance and expertise, often making efficient clinical study management quite challenging. The complexity of taking an investigational product (whether a drug, a biologic, a medical device, or a natural health product) from inception to regulatory approval has increased exponentially over the years. The multifaceted nature of clinical trials requires project managers with specialized skills in regulatory compliance, safety monitoring, data management, financial management, effective participant recruitment marketing, and research participant protection. Successful clinical trials depend on three key components:
Rigorous quality systems for process development, training, auditing and monitoring
Effective budgeting and financial management processes
Effective delegation of responsibilities through standardized processes and centralized collaborative workflows
Take control of your clinical research budget
Our Clinical Study Management Services
ethica CRO provides full-spectrum clinical study management services with a focus on the health and protection of research participants. We structure our study management services to ensure that all involved parties can efficiently navigate critical components of your clinical trial. These services are offered as a turn-key package for the overall management of your study, or on a selective basis when only specific CRO services are required.
- Development of study documentation and tools
- Collection and creation of all applicable regulatory and ethics documentation
- Site feasibility assessments
- Investigator recruitment
- Contract and budget negotiations
- Vendor qualification, selection and contracting
- Investigator meeting planning and logistics
- eCRF development
- Study advertisement and participants recruitment material development
- Labelling and shipment of investigational products and clinical trial materials
- Study communications and support (i.e. sites, sponsor, vendors, etc.)
- IRB coordination
- Site payment administration
- eTMF and CTMS management
- SAE management and processing
- Vendor management
- On-site monitoring
- Management and monitoring of clinical supplies
- Data management services and eCRF maintenance (i.e., centralized statistical monitoring, data query generation and resolution, medical coding, quality control, etc.)
- Site close-out activities
- Data query and adverse event resolution
- eTMF and CTMS closure
- Regulatory document collection
- IRB and regulatory reporting
- Return, final accountability, and destruction of investigational products
Our study management approach
Our clinical study management procedures
Thanks to our proven and established standards, we ensure that all parties involved in your clinical trial have a clear understanding of their tasks and responsibilities and possess the proper qualifications and training to fulfill their duties in an efficient and ethical manner. ethica CRO’s highly qualified project teams ensure the efficient planning and coordination of each clinical study by following a thorough and comprehensive study management plan.
We provide a comprehensive line-itemized quotation detailing all professional services and pass-through costs required for the entire lifecycle of your clinical trial. This quotation is carefully followed throughout the study lifecycle to ensure that scheduling and budget is respected with regard to our mandated services, with an eye on maximizing cost-effectiveness.
At the time of project initiation, a kick-off meeting provides training to all team members regarding the foundations of the Project Management Plan (PMP). At this time, all involved parties have the opportunity gain full understanding of the project’s objectives, confirm their respective tasks and responsibilities, and prioritize the trial’s milestones.
The PMP is integrated into ethica CRO’s collaborative workflow management platform, where all research activities are overseen, allowing Clinical Project Managers to conveniently monitor the status, timeline, and budget of your overall study and at any given site. The PMP also serves for day-to-day monitoring, including vendor and investigator payment status, investigational product shipments, monitoring visits, protocol deviations, unanticipated problems, and adverse events. As the study progresses, the PMP may also be subject to updating due to potential issues encountered during the study conduct. Thanks to our accredited SOPs and collective expertise, we can help you make strategic decisions and overcome any obstacles you may face during the execution of your clinical trial.