What We Do

Range of Services:

Research GCP Global Clinical Professionals can offer full trial management or individual services that complement your in-house competencies. Research GCP and its TEAM of Medical Experts, Principal Investigators, Clinical Coordinators, Project Managers, Regulatory staff and CRAs work closely with your project leader to ensure that comprehensive planning, communication plans and project activities are documented in detail. We offer one of the most complete groups that will perform as your safety net around the world.

Summary of Services:
  • Study Conduct in Phases I-IV
Scientific and Clinical Affairs:
  • Protocol Design
  • Clinical Feasibility
  • Patient Populations and Subjects Inclusion Criteria
  • Focus on FDA Guidelines as per Population Studied
Site Qualifications:
  • Feasibility
  • Site Audits
  • PI Interviews and background check
  • Site Staff Interviews
  • General Site Assessments
  • Geographic Assessments
  • Inspection of dedicated drug room/pharmacy, lab area (processing, freezer storage of samples) and secure document room
  • Review of calibration/service records for protocol required equipment
  • Review 911 protocol
  • Review staff training/personnel records
  • Review SOPs
Project Management:
  • Monitor time, cost &, quality
  • Team Coordination, Logistics, customer & vendor communications
  • Applied risk management
  • Provide training
  • Contact person for all TEAM members
  • Coordinate all teleconferences
  • Work with Lead CRA on CRA activities and on any issues that arise
Study Monitoring:
  • Assess study feasibility
  • Conduct site selection
  • Coordinate study start-up
  • Administer individual site organization
  • Coordinate and conduct all study site interim visits and the close-out visit
  • Ongoing review of Site Master File
  • Review of Source Documents against eCRF/CRF entries. Approve/ship out eCRF/CRF
  • Ongoing drug/device accountability
  • Ongoing training as needed at the site (new staff members, etc.)
  • Ongoing review of recruitment efforts
  • Ongoing conversation with the PI and staff on the conduct of the study and any adverse findings
  • Prepare and finalize all study site visit reports
Regulatory Affairs:
  • Formulate regulatory plans to IRBs/IECs
  • Organize regulatory compliances to local Regulatory Authorities
  • Protect and Store study files – reports and source documents as per regulating body
  • Assist Clinical Sites/Sponsor with submissions to IRB/IECs as needed/directed
  • Observe timelines for IRB/IEC updates
  • Maintain Master Study File and Clinical Site Files for each site
  • Routinely audit the files for completeness
  • Close-out the study files as per sponsor’s instructions
  • Retain study files as required by FDA CFR







  • Individual experts, entire teams or a customized group selected by your needs
  • Consult, Short term- or long-term
  • All experience levels and certifications
  • Global presence
Investigator Trainings:
  • Teach adherence to ICH/GCP standards
  • Educate all investigative site staff on global and local regulations
  • Define protocol specific requirements
Clinical Study Supplies Logistics

Successful clinical trials depend heavily upon providing study supplies to the correct study site physician at the correct time. Research GCP Global Clinical Professionals can provide the project management resources and technical expertise that our clients need to be successful. When you contract Research GCP Global Clinical Professionals for logistical reasons you benefit from acquiring the following assets and strengths:

  • Experienced Clinical Trial Management Teams that will remain on your project throughout the duration of your study. 
  • A dedicated project head who spearheads all your communications amongst all parties involved directly or indirectly. 
  • We also offer insight into the ever-changing regulatory environment; and the ability to support your needs from strategy, planning through execution.  
General Consulting in Research & Development Processes & Procedures:
  • Research  GCP Global Clinical Professionals can recommend different approaches for the development of a study.