Clinical Research Services

Formation

Clinical Research Services Provided

Amongst others we provide the following services to our valuable customers:

Start up:

  • Feasibility study (Identification sites & Principal Investigators for Sponsors).
  • Research sites Assessment or Qualification to confirm suitability to perform Clinical Trial (Studies).
  • Assessment of Research Laboratories and Pharmacy to confirm suitability to perform Clinical Trial (Studies).

Regulatory:

  • Outsourcing Protocol application information’s on behalf of the Sponsors.
  • Regulatory and Ethics Submissions.

Training:

  • Training of Clinic Trial sites (ICH-GCP Training, Regulatory affairs, Source Documentations, etc.).
  • Training of Investigators interested in Research.
  • Training of Study Coordinators
  • Training of Clinial Trial assistants
  • Training of CRAs (Trainee/Junior).

Monitoring:

  • Clinical Reports writing (Assessment, Initiation, Monitoring and CAPA).
  • Site Initiation visits, Interim Monitoring visits and Close out visits or Combo visits.
  • Data Collection tools and Data Quality improvement.Recherche
  • Oversight Supervision of contracted CROs/Vendors site Monitors (CRAs).
  • Oversight Quality study Assessment and Risks Management on behalf of the sponsors.
  • Oversight activities and Assistance to the Principal Investigator (PI) and to the Sponsors/CROs or Vendors Clinical Operation Team.
  • Development of Quality Management Plan to support Research sites.
  • Identification of site issues and Development of Corrective Action/ Preventive Action (CAPAs) to assist clinical sites and to ensure a timely resolution of issues.
  • Proactive preparation of sites for Audits and Regulatory inspections.
  • Facilitation and Coordination of study sites (Management). 
  • Project Management.
  • Monitoring and Evaluation (M&E).