CRO

Monitoring & Site Management

Solutions

Fyzil Global prioritizes quality and data integrity in clinical trial monitoring, ensuring compliance with ICH GCP and all relevant regulations through rigorous training of our Clinical Research Associates (CRAs).
Our clinical monitors oversee the progress of your study to ensure that progress is conducted, recorded, and reported in accordance with your protocol, keeping in mind a variety of considerations such as objective, purpose, design, complexity, blinding, size, and endpoints of the study.

At Fyzil Global, our CRAs are committed to overseeing every aspect of your study, from initial site qualification to closure.
We offers comprehensive clinical trial monitoring and site management services, guiding studies from feasibility to site closeout ensuring the integrity and success of your research endeavor.

Solutions

Monitoring & Site Management

We provide solutions tailored to your unique needs.

Site Identification & Selection: Identifying and selecting sites suitable for your study's requirements.
Site Feasibility Assessments: Assessing site capabilities and suitability for study participation.
Site Qualification & Initiation: Ensuring sites meet all necessary qualifications and initiating study activities.
A Combination of Approaches: Customized monitoring plans tailored to your study requirements, combining various monitoring strategies as needed.

Ongoing Site Monitoring & Management: Providing continuous oversight and management of study sites.
Remote Monitoring via EDC: Conducting remote monitoring activities using electronic data capture systems.
Targeted or Risk-Based Monitoring: Implementing monitoring strategies tailored to study needs.
Clinical Trial Vendor Management: Managing relationships with clinical trial vendors to ensure seamless operations.

Regulatory Document Management: Collecting, reviewing, and managing regulatory documents.
Electronic Trial Master File Management (eTMF): Maintaining electronic trial master files for efficient document management.
Verification of Electronic Case Report Form (eCRF): Rigorous checks to maintain data accuracy throughout the study duration.
Source Document Review: Thorough review to ensure protocol compliance and adherence to Good Clinical Practices (GCPs).

Budget and Contract Negotiations: Negotiating budgets and contracts with sites to optimize resource allocation.
IRB/EC Submissions: Managing and facilitating submissions to institutional review boards or ethics committees.
Study Closeout: Efficient resolution of queries and seamless closure, including the return or destruction of intellectual property.
Timely Correspondence: Detailed reports and prompt updates on trial progress, fostering clear communication throughout.

Ensure the success of your clinical research with our comprehensive Monitoring & Site Management solutions.
Trust Fyzil Global for excellence at every stage of your trial.

SUBMIT RFI

Our Approach

Focused Oversight: Our CRAs oversee study progress to ensure adherence to protocol, considering various factors such as study objectives, complexity, blinding, and endpoints.
CORE Monitoring Approach: We employ a compliance-oriented monitoring process tailored to each project and study site, ensuring meticulous oversight throughout.
Flexible Monitoring Plans: We develop adaptable monitoring plans, incorporating frequency and duration of Routine Monitoring Visits (RMVs) and data entry expectations, adjusted as per study needs.
Comprehensive Evaluation: We systematically assess protocol compliance, perform Source Data Verification (SDV), and prioritize subject safety and welfare, adhering to applicable GCPs and regulations.
Partnership-Centric Approach: Our CRAs establish true partnerships between sponsors, research sites, and project teams, integrating sponsor requirements into Site Management and Clinical Monitoring Plans.
Thorough Documentation: We ensure complete documentation of on-site and remote monitoring activities, issue escalations, deviation management, training, and follow-up in monitoring reports.
Risk Management Strategy: Site initiation emphasizes protocol training, focusing on procedures unique to the study, while all queries, issues, deviations, and files are closed prior to site closure.
Continuous Training: Our CRAs undergo consistent, high-level training in GCP, electronic data capture (EDC), and Dave Global’s SOP curriculum, ensuring proficiency across various EDC platforms.
Enhanced Tracking: Utilizing our CTMS, our monitoring management team meets weekly to review projects, ensuring efficient tracking and accountability.