Our clients include not only the sponsors, but our investigators and patients. Our philosophy is to treat each participant in the clinical trial process with the same respect and consideration. Because we have built solid relationships with investigators and patients, we achieve our goal of accelerating the drug process timeline while ensuring the quality of our services.
Sponsor Services
Investigator Services
Patient Services
Sponsor Services
Centralization of Clinical Trial Start-up
Our centralized approach to start-up and regulatory documentation collection and submission helps to accelerate the study initiation timeline.
  • Identify multiple affiliated physicians for study consideration
  • Qualify interested sites prior to proposal
  • Negotiate contracts and budgets on behalf of sites
  • Prepare regulatory packets on behalf of sites
  • Arrange and attend site qualification / initiation visits
  • Design patient recruitment campaigns
Clinical Operations
Our Regional Directors have extensive training in conducting clinical trials. They serve as a vital contact point to facilitate sponsor and site interaction. Our Regional Directors are dedicated to patient recruitment and retention for individual studies and Quality Assurance. They manage the clinical trial from site approval to closeout.
Regional Directors:
  • Ensure appropriate set-up for conducting trials
  • Prepare source documents, regulatory submissions and subject folders for each study
  • Utilize Study Manager™ software for management of study
  • Monitor and suggest patient recruitment campaigns
  • Provide general troubleshooting
  • Oversee CRCs assigned to the particular site
  • Manage the development of sites in their region
Information Technology
As part of a controlled flow of information, Research Solutions uses Study Manager™ software to more effectively conduct clinical trials.
The system consists of:
  • Patient visit tracking system
  • Patient recruiting database
  • Overall study management
Research Solutions provides staff with the latest computer capabilities including email and internet access. Coordinators have experience with EDC and remote data entry.
Investigator Services
Research Solutions links sponsors with highly focused investigators. Beyond required adherence to protocol, we work with sites according to specific study expectations, including therapeutic experience, location, office environment and patient mix.

Qualified Experienced Investigators

Research Solutions represents numerous investigators throughout the US. Our centralized investigator database allows us to quickly match qualified investigators with appropriate studies.
Research Solutions provides sponsors with
  • Experienced investigators for phase II-IV studies
  • Training of new investigators and staff in GCP guidelines and FDA regulations
  • Established relationships with thought leaders and high target physician clinics for larger phase III and phase IV studies
Turnkey project management system:
  • Marketing the site to pharmaceutical companies and CRO to secure a steady flow of studies
  • Completing regulatory documentation
    IRB submission and maintenance of approvals
  • Providing Quality Assurance Monitoring
  • Representing site in the event of sponsor or FDA audit
  • Providing Study Manager Software for management of study
  • Negotiating contracts and budgets
  • Maintaining file storage
  • Preparing source documents for each study
  • Attending site qualification visits with the sponsor and site
  • Assigning one central point of contact through the project manager
  • Preparing patient recruitment plan at study initiation
 

Patient Recruitment and Relations and Call Center

Research Solutions develops a centralized patient recruitment program for identification and rapid enrollment of patients. For each study, we develop a campaign that quickly ensures active patient participation. A combination of recruitment and retention tools are always considered.
Research Solutions is HIPAA compliant and protects patient rights to privacy.
Patient Recruitment Services

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