Clinical monitoring services for pharmaceutical, biotechnology, and medical device companies
Clincal Monitoring
Veristat offers comprehensive clinical monitoring services from site initiation to site closeout. Our clinical services are tailored to our clients’ needs, complimenting product development plans and overarching corporate and quality management policies. All monitoring activities are conducted in accordance with the study protocol, standard operating procedures, ICH, GCP, and applicable FDA regulations.
Flexibility
For small early phase studies through large multi-center studies, we provide strategic monitoring plans to support all clinical programs. Significant emphasis is placed on flexible and creative problem-solving approaches that highlight efficiency and streamlining of activities, thereby providing optimal solutions for our clients. Further, our highly experienced clinical staff operates within an integrated and collaborative environment focused on teamwork.
Expertise
Our clinical monitoring services are provided by qualified, knowledgeable professionals with extensive clinical research and therapeutic area experience. Veristat’s regional Clinical Research Associates (CRAs) have minimum of 5 years of industry experience. Sponsors always have the opportunity to review CVs and perform reference checks prior to approving monitoring personnel for their study. This approach ensures maximum coverage and management for each program, and provides our clients with a skilled and qualified therapeutically focused team.
Clinical Monitoring services include:
- Site selection & feasibility
- Patient recruitment
- Site qualification & initiation
- Interim monitoring & site management
- Safety reporting
- Regulatory document management
- Remote monitoring via EDC
- Management of monitoring documentation
- On-site monitoring visits including:
- - Source data verification (EDC and paper)
- - Query management and resolution
- - Confirmation of HIPAA compliance
- - Tracking of protocol violations, and re-education of study personnel
- - Study drug accountability
- - Oversight of serious adverse event reporting
- - Review of investigator files
- - Development of study procedures manuals and tools
- - Clinical supply management
- - Patient recruitment and retention support
- - Regulatory document management
- - Safety reporting
Clinical Project Management
Veristat's clinical monitoring personnel promote the development of positive, professional working relationships with site personnel. Focused communication between scheduled on-site visits fosters these relationships and ensures optimal use of study personnel’s time at scheduled on-site visits. Internally, clinical monitoring, data management, and biostatistical personnel work in a coordinated fashion to ensure maximum efficiency of on-site monitoring visits as well as data availability for project milestones and analyses. Veristat’s expertise in EDC technology further facilitates monitoring and data management efficiency.
Clinical Project Management services include:
- Site contract administration
- Supervision & training of clinical monitors
- Risk mitigation planning
- Continuous quality control
- Timeline & budget tracking
- Preparation & implementation of SOPs
- Investigator meeting coordination