Clinical Trial 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.
- Site feasibility & selection
- Site initiation, training and closeout
- Assist site with rapid patient recruitment & retention strategies
- Site Monitoring
- Product accountability
- Data query resolution
Provide sponsors with trial rescue services for clinical studies in Africa
- Risk analysis and innovative solutions
- Study management capacity and support
- Co-Monitoring support and re-training capacity and support
- Site compliance audit and CAPA plans development & implementation support
Conduct clinical quality audits according to ICH-GCP standards and client requirements
- Oversight of clinical Investigators
- Audit of Third party vendors
- Audit of specific clinical trial systems
More details on audit services and technical training & support are covered under the GxP Consulting Services page.
- Sourcing of clinical trial material and supplies
- Sourcing of Phase I safety testing infrastructure
- Protocol development
- On-Site training and support
- GCP application
- Study documentation and archiving
- SOP writing and management
- Vendor management
- Oversight of Third-party contracting services
- Third-party provider management and assessment
- Infectious Diseases
- Cardio metabolic Disease
- Oncology
- Ophthalmology
- Vaccines
- Respiratory
- Hematology
- Dermatology
- Rheumatology
- Endocrine and Metabolism
- Gastroenterology/Hepatology
- Immunology & Inflammation
- Pain Management
- Women's and Reproductive Health
- Neglected Tropical Diseases
- Devices and Diagnostic tools
- HIV - prophylaxis and Epidemiology
- Multi-Drug Resistant TB
- HIV and Pneumococcal Disease (Epidemiology & Surveillance)
- Pediatric malaria and Co-infections with helminthes (Epidemiology)
- Complicated Skin Structure Infections (cSSSI)
- Hospital Acquired Pneumonia
- Genitourinary Medicine
- Rotavirus Infection
- Nutrition (Bioavailability)
- Medical Devices