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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

Project management
• Monitor time, cost &, quality
• Team Coordination, Logistics, customer & vendor communications
•  Applied risk management
• Provide training

Study monitoring
• Assess study feasibility
• Conduct site selection
• Coordinate study start-up
• Administer individual site organization

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.
Insourcing
• Individual experts, entire teams or a customized groups 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 and procedures 
•Research  GCP Global Clinical Professionals can recommend different approaches for the development of a study.

 

 

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