Preclinical & Product Development
Drug & biomarker development, modeling & simulations. Protocol development.
Clinical Research
Protocol management. Feasibility Studies. Site & investigator identification. Regulatory & ethics. On-site & risk-based study monitoring. Patient recruitment. Project & vendor management. Trial rescue. Pharmacovigilence & risk management.
Regulatory Affairs
Strategic regulatory advisory. Clinical trial applications. Ethics committee submissions. Clinical trial agreements. IMP labels. Import & export licenses. Translations.
Clinical Trial Data Management
CRF/eCRF design & development. Database design, development & variations. Query design, development & validations. Data cleaning. Randomization management. Medical coding. AEs reconciliation. Statistical planning, analysis & reporting.
Medical Writing
We assist clients with medical writing for drug development.
Training & Quality Assurance Compliance
SOP writing, management & training.
Therapeutic Experience
Infectious diseases. Respiratory. Medical devices. Rare diseases. Vaccines.
Helping Partners With Registration Of Clinical Trials
Praedicare Africa has extensive experience with submission of clinical trial packages to regulatory authorities and Ethics Committees for all phases of study. CTA / IND submission and maintenance throughout the program lifecycle. NDA / MAA product registration, submission, and maintenance throughout the product lifecycle. Import / export license application assistance. End-of-trial activities. Quick turnaround for approval due to in-house regulatory team maintaining constant communication with RA and ECs.
Clinical Trial Management Core Services
- Study Feasibility
- Site and Investigator Selection
- Investigator Team Training & Management
- Investigator Site Capacity Building
- Investigator Meeting
- Regulatory Authority Applications & Communication
- Ethics Committee Applications & Communication
- Patient Recruitment
- On-Site & Remote Site Monitoring & Close-Out
- Mycobacterial Laboratory Monitoring
- Project Management
- Data Collection & Cleaning
- Trial Rescue
Clinical Trial Management
Clinical trials are designed based on quantitative forecasting from pre-clinical data. Praedicare has decades of experience running all phases of clinical trials, including clinical trial design. We utilize unique and proprietary quantitative translation tools, biomarker tools, and treatment endpoint tools, that is completely exclusive to Praedicare.
