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Clinical Trials Management

LT Clinical Research provide services through all phases of Drug Discovery & Development. Our Clinical Research Associates (CRAs) have graduate-level academic qualifications and vast professional experience in life sciences.

 

Our clinical monitoring experts work across functions to ensure quality and compliance.
All activities are performed according to the international accepted principles of ICH-GCP guidelines and the SA GCP guidelines (2006). 

LT Clinical Research maintains a comprehensive list of SOPs, and also operates under our client’s SOPs when required.

 

Clinical Trial Monitoring Capabilities include:

  • Conducting feasibility studies
  • Regulatory document review, submissions and management
  • Identification and selection of investigators (Site identification)
  • Site initiation, training and closeout of a clinical trial
  • Assist site with rapid recruitment and retention of patients
  • Site or clinical monitoring
  • Drug accountability
  • Data query resolution
  • Project Management

 

clinical trial management

 

Clinical Trial Rescue Services
Provide sponsors with clinical trial rescue services for clinical studies in Africa.

  • Risk analysis and innovative solutions
  • Study management capacity provision and oversight
  • Management of third party service providers/vendors
  • Co-Monitoring support and Training
  • Site compliance audit and CAPA plans & implementation support

 

Clinical Auditing services
Conduct clinical quality audits according to ICH-GCP specifications and client requirements.

  • Oversight of clinical investigations
  • Audits of third party service providers
  • Audits of specific systems

More details on our auditing services are covered under our GxP Consulting Services

 

Therapeutic Focus

  • Infectious Disease
  • Cardiometabolic Disease
  • Oncology
  • Ophthalmology
  • Devices

 

Track Record

  • HIV – prophylaxis, treatment and Epidemiology
  • Complicated Skin and Skin Structure infections (cSSSI)
  • Hospital Acquired Pneumonia
  • Genitourinary
  • Rotavirus Infection
  • Medical Devices

 

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All Rights Reserved - LT Clinical Research (Pty) Ltd. - 2012.
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