Clinical Trial, Site Selection & Management

Integrated Clinical Trial Monitoring Services

How to Build A Successful Clinical Trial

 

In clinical research, trial success is dependent on the foundation of your study management and sites executing the study. Versiti Clinical Trial Services works to seamlessly integrate with your team to institute this foundation and set you up for success. 

Trial management services that we provide include:

  • Project Management
  • Biostatistics
  • Data Management and EDC systems
  • Electronic Trial Master File (eTMF)
  • Site Feasibility
  • Site Management, Contracts and Payments 
  • US and Global Clinical Trial Monitoring
  • Patient Engagement and Recruitment
  • Vendor Management
  • Central Lab Services
  • US and Global Supply Chain Services
  • Pharmacovigilance
  • IRB submissions
  • GCP Audits and FDA Readiness
  • Quality System Development and remediation
  • Clinical Trial Rescue

The Versiti Method for Clinical Trial Success

  • Collaboration – Our experts work closely with your team to understand your clinical study objectives and challenges.
  • Plan – We build a collaborative plan for addressing trial management and monitoring needs.
  • Execute – Our team oversees strategic site identification, qualification, and monitoring.

The 3 Building Blocks of Clinical Trials

Collaborate: Engage with our experts to understand your clinical trial objectives and challenges.
Plan: Develop tailored study designs and conduct feasibility assessments to ensure trial readiness.
Execute: Implement strategic site identification, qualification, and monitoring to drive trial success.

Versiti lays the groundwork for clinical trial success by expertly managing three critical pillars of execution.

Clinical Trial Feasibility Assessments

Versiti Clinical Trials customizes study designs that align with your therapeutic goals and target populations, then conducts comprehensive feasibility assessments to evaluate the trial’s viability, weighing such considerations as:

  • Clinical trial protocol design
  • Patient recruitment potential
  • Resource availability
 
 

Clinical Trial Site Identification and Selection

Site selection identifies trial locations that can effectively recruit participants and achieve the study protocol. Key site considerations include:

  • Access to the target patient population
  • Site infrastructure and equipment
  • Staff experience and qualifications
  • Regulatory and ethical compliance

We use our extensive network and industry expertise to identify and qualify clinical trial sites that meet your specific study requirements based on the above criteria in tandem with historical performance.


Clinical Trial Monitoring and Site Management

High-quality clinical trial site management ensures that selected sites operate efficiently and in full compliance throughout the trial. Services include:

  • Training site staff on protocols and procedures
  • Monitoring staff recruitment and retention
  • Ensuring data accuracy and timely reporting
  • Maintaining regulatory documentation
  • Facilitating communication between sponsors, CROs, and sites

Our monitoring services maintain the integrity of your clinical trial by ensuring compliance with regulatory standards and study protocols, while safeguarding data quality and patient safety throughout the trial.


 

Additional Clinical Trial Services for your Project

 
Regulatory Guidance & Global Filings
Versiti offers expert regulatory strategy and global filing support to accelerate approvals, reduce costs, and ensure compliance worldwide.
 
Accredited IRB Services
Learn more about Versiti Clinical Trials’ ethical AAHRPP-accredited IRB services with industry-leading review and response times.
 
Quality Strategy Services
Ensure regulatory readiness and GxP compliance with Versiti’s expert-led validation, auditing, training, and remediation services for clinical research.