Vanguard Research Group Services
For Sponsors
VRG can support your study trial as a full or partial service CRO (contract research organization) and has experience collaborating with most major CROs when engaged to provide partial services.
What sets VRG apart, is our specialized network of community health and academic health centers that deal with thousands of patients, located throughout the US (click here for locations).
Together, we will help drive your next clinical trial to success.
Protocol Development & Clinical Consultation
- Provide protocol development and consultation services to sponsors by our highly experienced team (view leadership team)
- Opportunity to consult with key players at clinical sites not primarily focused on research, and benefit from insider knowledge of the processes used at those sites.
- High acceptance of protocol and study procedures by sites resulting in enhanced compliance and study success
Site Feasibility & Selection
- Work with research-experienced, clinically-oriented, real-world clinics situated throughout the majority of US states. Choose sites strategically to represent the population of the continental US, to fill specific location gaps for your trial or to reduce travel time for CRAs
- Expedite the feasibility process by working with carefully pre-selected sites with a highly successful track record and well known to VRG
- All sites are health centers with their own patient population, supporting successful recruitment and retention through existing patient-investigator relationships
- Our investigators have years of experience with their populations and the rating scales commonly used as study endpoints in supporting the validity of results
- Benefit from experienced VRG staff highly familiar with each site to conduct or accompany your staff at pre-selection and initiation visits to facilitate a quick and smooth selection process
Site Management Services
- Support in the preparation and submission of required regulatory documents for quick turnaround
- Monitor and support training and startup process to ensure high standards and timely completion
- Assist sites in establishing any sub-contracts with vendors as necessary
- Collaborate with sites to ensure recruitment and retention success and share best practices across the network of sites
- Provide day to day management of sites to support compliance with study procedures and protocols
- If necessary, conduct booster site visits to enhance recruitment
- Support sites in close out visits
IRB
- Provide support to sites for central and local IRB submissions to guarantee timelines and deadlines are met
- In depth knowledge of sites’ IRB requirements expedites IRB timelines through minimized iterations
Site Contracting & Payment
- VRG supports sites in contracting and payment tracking, acting as a liaison to the sponsor/CRO (contract research organization), shortening timelines
- Achieve high efficiency by having VRG contract with and pay sites directly
Central Data Collection for Primary Endpoints
- Provide consistent assessment of data points across sites and study time points through the use of highly trained, central raters
- Use of HIPAA compliant data platforms
Data Management & Monitoring
- Work with individual sites to ensure that data points are entered into Case Report Forms according to contract specified timelines
- Full CRA services including a hybrid of in person and remote monitoring visits
- Experienced in risk based monitoring
Technology
- Experience in developing and conducting clinical research trials exploring digital therapeutics
- Collecting implementation data and user testing for digital therapeutics in behavioral health clinics
- Ensure proper digital therapeutic application and drive the implementation process in the behavioral health clinic treatment setting
Imaging
- Clinical sites with imaging capacities available
- Experience with conducting imaging sub studies