Clinical Research Services
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.
- 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).