Clinical Trial Project Management

Delivering projects responsibly, efficiently, on time and on budget

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:

Take control of your clinical research budget

Having a dedicated Clinical Project Manager assigned as a single point of contact ensures that the goals and objectives of your clinical trial are appropriately communicated and successfully achieved. The ethica CRO Clinical Project Manager will guarantee that all ethical, financial, and scientific requirements set out in the study protocol are attained, using study-specific tools to track and manage study metrics such as, enrolment status, essential documents, clinical trial monitoring, participant and CRF tracking, drug accountability, data queries, and adverse events.

Our Clinical Study Management Services

Our biotech 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.

Study Start-Up

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 Maintenance

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
Clinical site monitoring
Management and monitoring of clinical supplies
Clinical data management services and eCRF maintenance (i.e., centralized statistical monitoring, data query generation and resolution, medical coding, quality control, etc.)

Study Closure

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 mission is to protect the rights, dignity, welfare and privacy of the women, men and children who participate in research projects under our supervision. Our accredited standard operating procedures (SOPs) are centered around the protection of the rights and welfare of all research participants.

Our project management procedures for clinical trials

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 therapeutic areas of expertise, we can help you make strategic decisions and overcome any obstacles you may face during the execution of your clinical trial.